MEDICINES AND RELATED SUBSTANCES: SUBSIDIARY LEGISLATION
INDEX TO SUBSIDIARY LEGISLATION
Medicines and Related Substances (Prohibition of Use of Certain Medicines in Animals) Order
Medicines and Related Substances Regulations
MEDICINES AND RELATED SUBSTANCES REGULATIONS
(section 69)
(27th December, 2019)
ARRANGEMENT OF REGULATIONS
REGULATION
PART I
Preliminary
1. Citation
2. Interpretation
PART II
Medicines
3. Registration of medicine
4. Validity period of registration of medicine
5. Renewal of registration
6. Exemption from registration of medicines for individual patient
7. Import of unregistered medicines for personal use
8. Exemption from registration of medicines for wholesale
9. Exemption of donated unregistered medicines
10. Variations
11. Notifications
12. Recall of medicines by other institutions outside Botswana
13. Recall of medicines by Authority
14. Withdrawal of marketing authorisation
15. Suspension or revocation of marketing authorisation
PART III
Licensing
16. Licensing of pharmaceutical operations
17. Licensing of manufacturing facility
18. Licensing of pharmacy
19. Licensing of pharmaceutical wholesaler
20. Licensing of pharmacies within a group practice
21. Licensing of dispensaries in surgeries and institutional dispensaries
22. Variation of licence
23. Suspension or withdrawal of licence
24. Renewal of licence
PART IV
Record Keeping and Import of Medicines
25. Record keeping
26. Import of medicines
27. Parallel import of medicines
28. Import of samples for registration
29. Post-market surveillance
30. Adverse medicine reactions
31. Counterfeit medicines
32. Medicines in transit
33. Designation of ports
34. Disposal of unwanted medicines
35. Classification and description of medicines
36. Prescription of medicines
37. Contents of prescriptions
38. Emergency administration
39. General dispensing
40. Dispensing of Schedules 1A, 1B and 1C medicines
41. Emergency dispensing of Schedules 1A, 1B and 1C medicines
42. Dispensing of Schedule 2 medicines
43. Dispensing of Schedules 1D and 3 medicines
44. Emergency supply of medicines by pharmacist
45. Storage of medicines by prescribers
46. Dispensing of medicines by healthcare providers other than pharmacists
47. Sale and use of precursor chemicals
48. Storage of medicines
49. Product information
50. Import and export of narcotics, psychotropics and precursor chemicals
51. Records for narcotics, psychotropics and precursor chemicals
52. Correction of records
53. Advertising and promotion
54. Inspection of premises
PART V
Control of Clinical Trials
55. Application for use of medicines for clinical trials
56. Monitoring of clinical trial
57. Inspection and audit of clinical trials
58. Suspension or termination of approval to conduct clinical trials
59. Disposal of unused medicines in clinical trials
PART VI
Cosmetics
60. Registration of cosmetics
61. Exemption for registration of cosmetics
62. Publication of list of prohibited ingredients
63. Labelling of cosmetics
64. Licensing of manufacturing cosmetics
65. Import of cosmetics
PART VII
Complementary Medicines
66. Registration of complementary medicines
67. Validity period of registration of complementary medicines
PART VIII
General
68. Harmonisation and collaborative activities of Authority
69. Appeals Committee
70. Banned medicines
71. Offences and penalties
72. Revocation of Cap. 63:04 (Sub. Leg.)
S.I. 163, 2019.
PART I
Preliminary (regs 1-2)
These Regulations may be cited as the Medicines and Related Substances Regulations.
In these Regulations, unless the context otherwise requires—
“Active Pharmaceutical Ingredients (APIs)” means any substance or combination of substances used in a finished pharmacological activity or to otherwise have direct effect in the diagnosis, cure, mitigation, treatment or prevention of disease, or to have direct effect in restoring, correcting or modifying physiological functions in human beings;
“authorised person” means any person given the responsibility for ensuring the medicines’ requirements are in compliance with the laws and regulations in force in Botswana;
“bonded warehouse” means a warehouse where goods are stored and held before being cleared to enter the country and these may also be used to store goods in transit;
“complementary medicines” means a labelled substance or mixture of substances manufactured, sold or represented for use as adjuvants to conventional therapy in—
(a) the mitigation or prevention of an abnormal physical state; or
(b) restoring, correcting or modifying physical, mental or organic functions in humans, and originate from plant, mineral, animal including micro-organisms, homeopathic preparations, nutritional substances in accepted pharmaceutical dosage forms, a combination of the above or any other such preparations as may be approved by the Authority;
“guidelines” means documents outlining regulatory requirements applied by the Authority in line with these Regulations as listed in Schedule 6;
“notification” means changes that could have minimal or no adverse effects on the overall safety, efficacy and quality of the Finished Pharmaceutical Product (FPP);
“parallel importation” means cross-border importation of a medicine or a product registered by the Authority, without the consent of the patentee, where the medicine has been put on the market by the patentee or by another acting with the patentee’s consent, or having an economic tie to the patentee;
“qualified person” means a person registered with the relevant professional body to undertake work or practise within a specific technical field or area meeting the minimum requirements in the guidelines; and
“variations” means—
(a) major variations which are changes that could have major effects on the overall safety, efficacy and quality of the FPP; or
(b) minor variations which are changes that may have minor effects on the overall safety, efficacy and quality of the FPP.
PART II
Medicines (regs 3-15)
(1) An application for registration of medicine shall be in Form 1 set out in Schedule 4 and shall be accompanied by—
(a) an application fee set out in Schedule 5;
(b) the Common Technical Document in Form 2 set out in Schedule 4; and
(c) a sample as described in the guidelines.
(2) The Authority shall specify conditions for registration for a particular medicine or group of medicines and may—
(a) amend any conditions for registration;
(b) specify product labelling requirements; or
(c) determine what is to be described in the label or packages of medicines.
(3) Where an application to register medicines is successful, the Authority shall issue the registration certificate to the applicant in Form 3 set out in Schedule 4.
(4) Where an application to register medicines is unsuccessful, the Authority shall inform the applicant in writing, stating the reasons for the decision not to register the medicine.
(5) A summary of technical assessment reports for approved and rejected registration may be published and made available to the public.
(6) A marketing authorisation holder shall be responsible for the importation, advertising and promotion of his or her medicine.
4. Validity period of registration of medicine
A registration certificate issued in terms of regulation 3 shall be valid for five years subject to annual submission of information accompanied by a fee set out in Schedule 5.
(1) A person may apply to the Authority for the renewal of registration of medicines.
(2) An application under subregulation (1) shall be—
(a) in Form 1 set out in Schedule 4;
(b) accompanied by a renewal fee set out in Schedule 5; and
(c) submitted to the Authority not later than six months before the expiry date of registration.
6. Exemption from registration of medicines for individual patient
(1) A medical practitioner may apply in Form 4, upon payment of an application fee set out in Schedule 5 to the Authority to exempt the registration of medicines from outside Botswana, for his or her patient’s personal use.
(2) Subject to subregulation (1), the application shall comply with the guidelines and shall be signed by an importing pharmacist residing in Botswana.
(3) The Authority may, after having considered the application and the supporting documents, grant the exemption.
(4) The validity period of the exemption from registration shall be six months.
7. Import of unregistered medicines for personal use
(1) A person who imports medicine from outside Botswana for personal use shall not import more than one month’s supply of medicine.
(2) Subject to subregulation (1), where a person brings more than one month’s supply, but less than three months’ supply, he or she shall produce, upon request by a competent authority, a certified copy of the prescription from a medical practitioner.
(3) Subject to regulation 6, a person shall apply to the Authority in writing for an exemption from registration for any subsequent supplies of the imported medicine.
8. Exemption from registration of medicines for wholesale
(1) An applicant may apply to the Authority to exempt the registration of medicines for wholesale from outside Botswana under special circumstances as determined by the Authority.
(2) The application shall—
(a) comply with the guidelines; and
(b) be accompanied by the application fee in Form 5 set out in Schedule 5.
(3) The applicant may be required to pay for the inspection of the manufacturing site prior to authorisation.
9. Exemption of donated unregistered medicines
A person may apply to the Authority for exemption from registration of donated medicines in Form 6 as set out in Schedule 4 and he or she shall meet the requirements of the guidelines on donation.
(1) A marketing authorisation holder shall not make a variation in the particulars of a registered medicine without the prior approval of the Authority, except where the change is a notification.
(2) A variation application shall be submitted to the Authority and shall be—
(a) in terms of Form 7 set out in Schedule 4;
(b) accompanied by a variation fee set out in Schedule 5; and
(c) accompanied by the supporting documents as specified in the conditions laid down for each type of variation.
(3) The marketing authorisation holder shall ensure that all the necessary validation has been conducted to demonstrate that the change does not reduce the quality, safety or efficacy of the medicine.
(4) The Authority may cancel the registration of a medicine where variations are made without prior approval of the Authority.
(1) A marketing authorisation holder shall apply to the Authority for a notification of a variation in the particulars of a registered medicine in Form 7 set out in Schedule 4.
(2) Subject to subregulation (1), the applicant shall pay to the Authority a notification fee set out in Schedule 5.
(3) An application for immediate notification shall be submitted soon after implementing the variation.
(4) An application for annual notification shall be submitted within 12 months after implementing the variation.
(5) The Authority shall ensure that quality, safety and efficacy of a medicine is still maintained.
12. Recall of medicines by other institutions outside Botswana
Where an institution outside Botswana recalls some medicines, a marketing authorisation holder shall provide the Authority with the following—
(a) information on the batches of medicine involved;
(b) recall plan and procedure, including the disposal of the recalled medicines;
(c) distribution list; and
(d) a report of the investigation, before and after the recall.
13. Recall of medicines by Authority
(1) Where the Authority recalls medicines, the Authority shall inform the—
(a) public of the procedure to be followed through all possible communication media; and
(b) marketing authorisation holder in writing, of its decision, stating the reasons.
(2) The marketing authorisation holder shall be responsible for the disposal of the medicines.
14. Withdrawal of marketing authorisation
(1) A marketing authorisation holder who wishes to withdraw his or her medicines from the market shall provide the Authority with—
(a) information on the decision to withdraw;
(b) the effective date of withdrawal;
(c) reasons for withdrawal; and
(d) the plan of communication to prescribers and dispensers.
(2) The Authority shall update the register to indicate the withdrawal.
15. Suspension or revocation of marketing authorisation
(1) Where the Authority suspends or revokes marketing authorisation for reasons including—
(a) failure to report adverse reactions to the Authority;
(b) failure to meet safety, quality, efficacy requirements; or
(c) implementing variations without approval of the Authority,
the Authority shall communicate to the marketing authorisation holder in writing, the decision to suspend or revoke the market authorisation.
(2) In the case of a suspension or revocation, the Authority shall, within seven days of taking the decision, communicate to the marketing authorisation holder, conditions of the suspension, the duration and the action the marketing authorisation holder has to take.
(3) In the case of a revocation, the marketing authorisation holder shall be required to recall his or her medicines from the market in line with the guidelines.
(4) The Authority shall notify the public of the decision to suspend or revoke the market authorisation.
PART III
Licensing (regs 16-24)
16. Licensing of pharmaceutical operations
(1) An application for licensing of pharmaceutical operations shall be submitted to the Authority, in Form 8 set out in Schedule 4 accompanied by an application fee set out in Schedule 5.
(2) The Authority may, having considered the application, grant the applicant a licence in Form 9 set out in Schedule 4 and the Authority may attach conditions thereto as it may consider necessary.
(3) The Authority shall inform an unsuccessful applicant in writing, of the decision not to licence the premises and the reasons, in line with the guidelines.
(4) Where premises are licensed, the premises shall be under the supervision of a qualified person in line with the guidelines.
(5) Subject to subregulation (4), any change in the person who supervises the premises shall be communicated to the Authority within 30 days.
(6) The Authority shall keep a database of all licenced manufacturing facilities, pharmacies and pharmaceutical wholesalers.
17. Licensing of manufacturing facility
(1) An applicant may apply to the Authority for a licence to manufacture medicine in Form 8 set out in Schedule 4 accompanied by an application fee set out in Schedule 5.
(2) The Authority shall grant a licence in Form 9 set out in Schedule 4 subject to the submission of all the required documents according to the guidelines.
(1) An application for a licence to operate a pharmacy shall be made to the Authority in Form 8 set out in Schedule 4 and accompanied by a fee set out in Schedule 5.
(2) The Authority shall grant a licence in Form 9 set out in Schedule 4 subject to the submission of all the required documents according to the guidelines.
19. Licensing of pharmaceutical wholesaler
(1) An application for a licence to operate a pharmaceutical wholesaler shall be made to the Authority in Form 8 set out in Schedule 4 and accompanied by a fee set out in Schedule 5.
(2) The Authority shall issue a licence in Form 9 set out in Schedule 4, subject to submission of all the required documents according to the guidelines.
20. Licensing of pharmacies within a group practice
(1) An applicant may apply to the Authority for a licence to operate a pharmacy within a group practice in Form 8 set out in Schedule 4 and accompanied by a fee set out in Schedule 5.
(2) Subject to subregulation (1), the licence may be under that of a hospital or a pharmacy where the pharmacy services are outsourced.
(3) The Authority shall issue a licence in Form 9 set out in Schedule 4, subject to submission of a licence or provisional licence of a hospital or a group practice.
21. Licensing of dispensaries in surgeries and institutional dispensaries
(1) An applicant shall apply to the Authority for a licence to operate dispensaries in surgeries and institutional dispensaries in Form 8 set out in Schedule 4 and accompanied by a fee set out in Schedule 5.
(2) Where the institutions are required to be licensed by other authorities, the Authority shall issue a licence in Form 9 set out in Schedule 4 subject to submission of a licence or provisional licence of a surgery or an institution.
(3) In its assessment of the application, the Authority shall take into account the scope of practice of the institution in granting the licence.
(4) The Authority shall issue a licence, subject to submission of a licence or provisional licence of a surgery or institution.
(1) A licence holder shall apply to the Authority for variation of his or her licence.
(2) The application for variation shall be in Form 8 set out in Schedule 4 accompanied by a fee set out in Schedule 5.
(3) The Authority may approve the amendments and where the Authority does not approve, it shall inform the unsuccessful applicant in writing, stating the reasons for the decision.
23. Suspension or withdrawal of licence
(1) Where the licence holder does not meet the required standards and guidelines, the Authority may suspend or withdraw the licence.
(2) The Authority shall notify the licence holder of the decision and may indicate the actions to be taken by the licence holder and give the licence holder seven days to respond.
(3) The facility shall be closed for the duration of the suspension.
(4) Where a licence is withdrawn the facility shall cease to operate.
(1) An application for renewal of a licence made under these Regulations shall be made at least three months before expiry of the licence.
(2) The application shall be in Form 8 set out in Schedule 4 and shall be in accordance with the guidelines.
(3) The application shall be accompanied by a fee set out in Schedule 5.
PART IV
Record Keeping and Import of Medicines (regs 25-54)
(1) A person dealing with the manufacture, import, export, storage, distribution, promotion, advertising and dispensing of medicines shall, according to his or her scope of operation, keep a record as outlined in the guidelines.
(2) The Authority may at any time in writing, order a person dealing with the manufacture, import, export, storage, distribution, promotion, advertising and dispensing of medicines to produce the record for inspection.
(3) An inspector may at all reasonable times inspect the records.
(1) A person shall apply to the Authority for a permit to import medicines, medical products or cosmetics other than narcotics, psychotropics and precursor chemicals in Form 10 set out in Schedule 4 and accompanied by a fee set out in Schedule 5.
(2) An application for an import permit shall be accompanied by authorisation from a market authorisation holder to import medicines to Botswana in line with the guidelines.
(3) Subject to subsection (1), the Authority shall issue an import permit in Form 11 set out in Schedule 4 and in line with the guidelines.
(4) Upon assessment the Authority may authorise an entity not licensed as a wholesaler to import medicines, medical products or cosmetics upon payment of a fee set out in Schedule 5.
(5) Subject to subregulation (1), a person may apply for a permit to import medicines, medical products or cosmetics that have been exempted from registration in line with the guidelines.
(6) All purchasing orders shall be vetted and authorised by the Authority.
(7) A person authorised to import medicine shall pay a fee as set out in Schedule 5 for each consignment in line with the guidelines.
(8) A wholesaler shall notify the Authority and submit an acknowledgment in line with the guidelines, upon receipt of medicines.
27. Parallel import of medicines
An applicant shall apply to the Authority in Form 11 set out in Schedule 4 for parallel import of medicines—
(a) in the manner outlined in the guidelines;
(b) accompanied by a fee set out in Schedule 5; and
(c) the importer shall provide the authorisation from the Ministry responsible for trade.
28. Import of samples for registration
A person shall apply to the Authority for approval to import samples in Form 10 set out in Schedule 4.
(1) A prescriber, pharmacist and a health care professional shall report any safety, quality and efficacy issues to the Authority and to the marketing authorisation holder in line with the guidelines.
(2) The Authority shall from time to time conduct risk based inspections of pharmaceutical operations and take samples of medicines, medical products or cosmetics on the market for testing and investigation to establish the quality, safety and efficacy in Form 12 set out in Schedule 4.
(3) The Authority shall, where a sample fails to meet the relevant specifications—
(a) issue the marketing authorisation holder or importer with a written warning and up to a maximum of 30 days to identify the source or cause of the quality defect and any action to be taken to improve quality; or
(b) where the failure warrants a recall of the medicines, medical products or cosmetics as set out in the guidelines, the Authority shall order the marketing authorisation holder or importer to recall the medicine, medical product or cosmetic.
(4) The marketing authorisation holder shall remove from the market and dispose at his or her cost, medicines, medical products or cosmetics that do not meet the required standards which disposals shall be in accordance with regulation 34.
(5) The marketing authorisation holder shall keep records of the recall and disposal of the medicines, medical products or cosmetic and he or she shall submit a copy of the records to the Authority.
(6) A person licensed to operate a pharmaceutical operation shall report any suspected problems, regarding the quality, safety or efficacy of the medicines to the Authority.
(7) A marketing authorisation holder or importer shall carry out investigation to identify the root cause of the problem and develop a risk management plan to prevent recurrence including a comprehensive review of the manufacturing process.
(8) The Authority shall assess the report of the investigation and risk management plan where a marketing authorisation was earlier suspended, before it can lift the suspension.
(9) The Authority may investigate and decide on an appropriate action to be taken by either the Authority or the marketing authorisation holder, where any problem is suspected.
(10) The Authority, the marketing authorisation holder or importer and the manufacturer shall keep the public informed about the findings and any relevant information about the medicines, medical products and cosmetics within a specified time according to the guidelines.
(11) The marketing authorisation holder or importer shall in accordance with the guidelines, provide a post market surveillance plan for his or her medicine and report to the Authority, any findings from an accredited quality control laboratory.
(12) All testing shall be done in accredited quality control laboratories.
30. Adverse medicine reactions
(1) The Board shall appoint a committee to deal with adverse medicines, medical products or cosmetics reactions and to review reports of suspected medicine reactions.
(2) A marketing authorisation holder of medicines, medical products or cosmetics shall report to the Authority any adverse reactions in line with the guidelines.
(3) The marketing authorisation holder shall ensure all labels and package inserts are amended to include any new adverse reactions, warning, including precautions within such period as may be determined by the Authority.
(4) A prescriber, pharmacist or a health care professional shall report to the Authority any adverse reactions in accordance with the guidelines.
(1) An importer, exporter, marketing authorisation holder, manufacturer, distributor, dispenser, and promoter of medicines, medical products or cosmetics shall have in place, risk management plans to prevent circulation of counterfeit medicines.
(2) The plans under subregulation (1) shall include the following measures—
(a) to prevent counterfeit medicines, medical products or cosmetics from entering Botswana;
(b) to prevent the sale and use of counterfeit medicines, medical products or cosmetics;
(c) to address counterfeit medicines, medical products or cosmetics once detected on the market; and
(d) to regularly review risk management plans.
(3) The Authority shall publish the information on circulating counterfeit medicines, medical products or cosmetics as and when the need arises.
(1) Any person transiting medicines, medical products or cosmetics through Botswana shall apply to the Authority for a transit permit in line with the guidelines by completing Form 13 set out in Schedule 4 and accompanied by a fee set out in Schedule 5.
(2) The Authority shall issue a transit permit in Form 14 set out in Schedule 4.
(3) The importer of medicines shall ensure that medicines, medical products or cosmetics in a bonded warehouse comply with requirements for transit as set out in the guidelines.
(4) The importer of medicines shall keep records for the medicines, medical products or cosmetics at the bonded warehouse which records shall be open for inspection by the Authority and other relevant authorities.
(1) The Authority shall recommend designation of ports of import and export to the Minister.
(2) The Authority shall review the list of designated ports from time to time.
34. Disposal of unwanted medicines
(1) A person who disposes of medicines shall follow the guidelines and keep disposal certificates issued by the relevant authorities, for the Authority’s inspection.
(2) The destruction of any Schedule 1A, Schedule 1B, Schedule 1C medicines or precursors, in part or whole, shall be reported to the Authority in accordance with the guidelines and, except where the destruction is accidental, the destruction shall be supervised by a pharmacist and witnessed by a police officer.
(3) A person shall dispose of unused medicines in a clinical trial in line with the guidelines.
(4) The Authority may in special circumstances authorise the export of medicines, medical products or cosmetics that do not meet specifications for disposal in line with the guidelines.
35. Classification and description of medicines
(1) The Authority shall carry out a risk based review of the classification of medicines in consultation with the relevant stakeholders.
(2) For purposes of the Act and these Regulations, medicines shall be classified in accordance with the lists set out in Schedule 1 and the lists shall be published in the Gazette.
(1) Prescriptions of medicines shall be written in generic or approved international non-proprietary names (INN) except when a particular brand of medicine is preferred and clinically acceptable reasons for such preference are communicated to the dispenser.
(2) The Minister shall draw guidelines on dispensing and prescription of medicines in terms of section 38(3) and section 39(2) of the Act.
(3) In granting limited powers of prescription of Schedules 1, 2, 3 and 4 medicines under section 39(2) of the Act, the Minister may grant to—
(a) registered nurses in hospitals or Government clinics specialising in medical fields such as ophthalmology, psychiatry, midwifery, or as a registered family nurse practitioner, power to prescribe only those medicines specific to their speciality or training and, where applicable, which are specified for them in the Botswana National Medicines Formulary;
(b) registered nurses in Government clinics and health posts, power to prescribe only those medicines which are specified for them in the Botswana National Medicines Formulary;
(c) dental therapists, power to prescribe only those medicines specified for them in the Botswana National Medicines Formulary;
(d) registered pharmacists, power to prescribe Schedules 1 and 2 medicines only in the circumstances referred to in regulations 38, 40 and 41;
(e) optometrists and chiropractors limited prescribing powers according to their scope of practice;
(f) pharmacists to prescribe Schedule 3 medicines; and
(g) nurses to give repeat prescriptions for Schedules 1, 2 and 3 medicines for palliative care at hospitals, hospices and at home-based care.
(1) A valid prescription shall contain the following information—
(a) particulars of the patient including name, age and gender;
(b) name of the medicine, dosage form, dosage strength, directions for use, duration of treatment or quantity;
(c) name, signature and address of prescriber;
(d) date of prescription; and
(e) the facility stamp.
(2) For Schedules 1A, 1B and 1C medicines the quantity shall be written in words and figures.
(3) A prescriber shall keep a copy of each prescription issued by him or her for a period of one year.
(1) An emergency medical services provider may under emergency situations administer Schedules 1, 2 and 3 medicines without a written prescription.
(2) Subject to subregulation (1), in administering such medicines, the emergency medical services provider shall follow his or her scope of practice as determined by the Botswana Health Professions’ Council.
(3) For medicines which are not within his or her scope, the emergency medical service provider may administer with medical direction and he or she shall keep registers and records of the medicine administered.
(1) A person shall not dispense medicine of a quantity greater than the amount and the stated duration of treatment in the prescription.
(2) A person dispensing medicine shall endorse on the prescription the date when the medicine is dispensed, the quantity dispensed, and he or she shall append his or her signature thereto.
(3) A repeat prescription may be dispensed for a maximum of six times from the date of issue.
40. Dispensing of Schedules 1A, 1B and 1C medicines
(1) Schedules 1A, 1B and 1C medicines may only be dispensed by a pharmacist upon a written prescription by a medical practitioner or dentist, presented for dispensing within 30 days of the date of its issue, and for the supply of a quantity not greater than the quantity indicated on the prescription, which shall not exceed 30 days’ supply.
(2) The prescription shall be retained in the pharmacy for a period of five years after the date it was dispensed.
(3) The dispenser of Schedules 1A, 1B and 1C medicine shall enter a record of such dispensing and the register shall be kept for a period of five years after the last entry.
(4) Separate registers shall be kept for Schedules 1A, 1B and 1C medicines.
(5) Except when being administered to a patient, every Schedules 1A, 1B and 1C medicines shall be kept under safe custody in a lockable cabinet or in a safe securely fixed in terms of regulation 48(2).
41. Emergency dispensing of Schedules 1A, 1B and 1C medicines
(1) Emergency dispensing of Schedules 1A, 1B and 1C medicines may be done where—
(a) there is a repeat prescription for a patient known by both the prescriber and pharmacist;
(b) the pharmacist has contacted the prescriber and the prescriber is confirmed as being a medical practitioner or dentist; and
(c) the pharmacist is satisfied that it is impossible or impracticable to obtain a written prescription.
(2) The prescription may be made by telephone, email or facsimile, in quantities not exceeding those stated in regulation 40(1), on condition that a written prescription shall be provided within 48 hours.
42. Dispensing of Schedule 2 medicines
Schedule 2 medicines may be dispensed in-—
(a) referral hospitals, district hospitals, primary hospitals, mission hospitals, mine hospitals or private hospitals by a pharmacist or an intern pharmacist, a pharmacy technician under the supervision of a pharmacist, or by any authorised dispenser upon a written prescription issued by a medical practitioner or a dentist;
(b) a retail pharmacy, by a pharmacist, a pharmacy technician under the supervision of a pharmacist or by any authorised dispenser upon a written prescription issued by a medical practitioner or a dentist;
(c) a Government clinic, by a pharmacy technician under the supervision of a pharmacist upon a written prescription issued by an authorised prescriber; or
(d) a private health facility by an authorised dispenser.
43. Dispensing of Schedules 1D and 3 medicines
Schedules 1D and 3 medicines shall only be dispensed by a pharmacist or any authorised dispenser upon a prescription.
44. Emergency supply of medicines by pharmacist
(1) Notwithstanding regulation 42, in an emergency Schedule 2 medicines may be supplied or dispensed without a prescription by a pharmacist, where—
(a) there is an immediate need for the medicine requested to be supplied and it is impractical in the circumstances to obtain a prescription; or
(b) the treatment with the medicine has on a previous occasion been prescribed for the person requesting it.
(2) The quantity of the medicine to be supplied in accordance with subregulation (1) shall not exceed five days’ treatment:
Provided that—
(a) where the medicine in question is an ointment, a cream or an aerosol for the relief of asthma, which has been made up for sale in a container elsewhere than at a place of supply, the dispenser may supply the smallest pack available;
(b) where the medicine in question is an oral contraceptive, the dispenser may supply a sufficient quantity for a full cycle; or
(c) where the medicine required is in such a package that it is impractical to split the package, the whole package may be supplied.
45. Storage of medicines by prescribers
(1) A prescriber may, in line with the guidelines store some medicines to administer to his or her patients.
(2) Subject to subregulation (1), the type and quantities of the medicines administered shall be determined by the scope of the prescriber’s practice and the prescriber shall fulfil other requirements set out in the guidelines.
46. Dispensing of medicines by healthcare providers other than pharmacists
(1) A healthcare provider shall apply to the Director of Health Services for an approval to dispense medicines.
(2) An approval shall be given to a medical practitioner, dentist, pharmacy technician and any other health personnel on condition that he or she has competency in dispensing medicines.
(3) A dispensary, clinic, health post and mobile clinic shall meet the standards set out in the guidelines.
47. Sale and use of precursor chemicals
(1) Precursor chemicals at Schedule 2 of these Regulations shall be sold by authorised dealers.
(2) The use of the precursor chemicals that require import permits shall be authorised by the Authority.
(3) Registers of the sale and use of chemicals shall be maintained by the authorised dealers and the register shall capture information as determined by the Authority.
(1) Medicines shall be stored in secure, well ventilated rooms, with adequate lighting and controlled temperatures.
(2) Schedule 1 medicines shall be kept in bolted locked steel cabinets or rooms with controlled access.
(3) The storage facilities shall be protected from pests, harsh weather and shall meet building codes.
(4) The guidelines relating to the storage of medicines shall be updated as the Authority determines.
(1) Any product information shall be provided in line with the guidelines.
(2) The container of every medicine imported, manufactured, processed or packed in Botswana shall bear a label written in English, with the following information clearly indicated thereon—
(a) either the approved name of the medicine as used in official pharmacopoeias or formularies, or the international non-proprietary name;
(b) the brand name, if any;
(c) the contents of the container;
(d) the quantity of active ingredients per dosage unit;
(e) the name of the manufacturer or applicant;
(f) the batch identification;
(g) the expiry date;
(h) any special storage conditions that may be necessary or desirable;
(i) any warnings or precautions that may be necessary or desirable;
(j) any directions for use if sold without prescription; and
(k) any appropriate statutory or restrictive direction or label in terms of subregulation (6);
(l) any conditions of registration stipulated by the Authority during registration; and
(m) manufacture date.
(3) In any special circumstances the Authority may exempt any particular consignment of medicines from the requirements of subregulation (1).
(4) The container of every medicine dispensed to a patient shall have a label bearing the following information—
(a) full name of the patient;
(b) date of dispensing;
(c) pack size;
(d) name and signature of the dispenser; and
(e) all information required for the purposes of subregulation (1).
(5) The container of any medicine exempted from registration shall as far as possible bear the information required under subregulation (1).
(6) The containers of pre-packed medicines shall bear the label with the following—
(a) name, strength and quantity of the medicine;
(b) batch number;
(c) date of manufacture;
(d) expiry date; and
(e) manufacturer.
(7) If the medicine contains any ingredient that is known to cause any allergic reaction, there shall be a warning to that effect.
(8) For medicines which require caution, such medicine shall bear a label giving information and instructions in accordance with the following—
Word Content
(1) “Contains aspirin” (unless name of product includes word “aspirin”); plus “If symptoms persist, consult your doctor”; plus the recommended dosage; plus “Do not use on children under 12 years except on medical advice.”
The label shall include name of the applicant, Botswana registration number and the Schedule.
(2) “Contains an aspirin derivate”; plus “If symptoms persist, consult your doctor”; plus the recommended dosage.
(3) “Contains paracetamol” (unless the name of the product includes the word “paracetamol”); plus “If the symptoms persist, consult your doctor”; plus “Do not exceed the stated dose”; plus the recommended dosage.
(4) “Warning. Asthmatics shall consult their doctor before using this product.”
(5) “Warning. May cause drowsiness. If affected do not drive or operate machinery. Avoid alcoholic drink.”
(6) “Not to be used for babies” or “Not to be administered, except on medical advice, to a child under two years.”
(7) “Oral Rehydration Therapy is recommended in all forms of diarrhoea.”
(8) “For external use only.” This cautionary wording shall be used if a product is an embrocation, liniment, lotion, liquid antiseptic or other liquid preparation or gel for external application.
(9) “Warning. Do not exceed the stated dose.” This cautionary wording shall be used on pharmacy medicines (P) exempted from POD requirements by reason of the proportion or level in such product of any substance, and which are not for external use.
50. Import and export of narcotics, psychotropics and precursor chemicals
(1) An application for import of narcotics, psychotropics and precursor chemicals shall be made to the Authority by a pharmacist in Form 15 set out in Schedule 4 accompanied by a fee set out in Schedule 5.
(2) Upon assessment the Authority shall issue an import permit in Form 16 set out in Schedule 4, to the applicant, which permit shall be valid for six months.
(3) After receipt of the medicines the pharmacist shall notify the Authority and submit an acknowledgment in Form 17 set out in Schedule 4 and a copy of export permit from the relevant country, within seven days.
(4) An application for export of narcotics, psychotropics and precursor chemicals shall be made by a pharmacist in Form 15 set out in Schedule 4 accompanied by a fee set out in Schedule 5.
(5) The Authority shall issue an export permit in Form 18 set out in Schedule 4, valid for six months prior to exportation of the medicines.
(6) After dispatch of the medicines, the pharmacist shall notify the Authority and submit an acknowledgment in Form 17 set out in Schedule 4 within seven days.
51. Records for narcotics, psychotropics and precursor chemicals
(1) Separate registers shall be kept for Schedules 1A, 1B, 1C medicines and precursor chemicals.
(2) Registers to be kept by the manufacturer, seller, importer, exporter or distributor of such medicines shall contain the following information, as appropriate, the—
(a) quantities received, issued, spoiled, disposed of and the balance of the medicine concerned;
(b) name and business address of the supplier;
(c) date on which the medicine was received;
(d) import permit number in the case of imports;
(e) export permit number in the case of exports;
(f) name and business address of the purchaser;
(g) date of sale of the medicine; and
(h) invoice or reference number of such sale.
(3) Registers kept by the dispenser of medicines under subregulation (1) shall contain the following information where appropriate, the—
(a) quantities received, issued, spoiled, disposed of and the balance of the medicines concerned;
(b) name and business address of the supplier;
(c) date on which the medicine was received;
(d) name and address of the patient to whom the medicine was dispensed;
(e) prescription number or reference number upon which the medicine was dispensed;
(f) date of such dispensing; and
(g) name and address of the prescriber.
(4) All invoices for the purchase or supply of Schedules 1A, 1B, 1C medicines or precursor chemicals shall be kept for a minimum of five years.
(5) All registers or records required to be kept under this regulation shall be retained for a period of five years after the date of the last relevant entry, and shall be kept available for inspection by authorised officers.
(6) All registers and records required to be kept under these Regulations shall be balanced within seven days.
(7) A register shall be a bound book with serially numbered pages.
(8) A register shall not transferable without the Authority’s approval.
(1) A person who keeps a register under the Act shall make corrections to the register by drawing a line through the entry being corrected and shall insert his or her initials on the corrected entry.
(2) A correction to a register shall not be marked or done with correction fluid and there shall be no overwriting.
(1) A market authorisation holder shall submit advertising and promotional materials to the Authority for approval before use.
(2) The Authority shall assess advertising and promotional materials according to set guidelines and issue a written approval to the market authorisation holder.
(3) Schedules 1, 2 and 3 medicines shall not be advertised directly to the public.
(4) Subject to subregulation (3), only registered medicines may be advertised or promoted.
(5) Medicines may be advertised to the professionals or in professional journals and publications.
(6) Schedule 4 medicines may be advertised to the public.
(7) Any advertising shall not mislead, compare medicines from other manufacturers and shall not include illustrations or pictures which may offend.
(8) The adverts shall not contain promises that have not been scientifically proven and shall not make reference to symptoms in a manner likely to mislead the public.
(1) The Authority shall ensure all premises are inspected to assess compliance to set guidelines.
(2) An inspector shall present proof of authorisation and identification to the pharmaceutical operator before the inspection under subregulation (1) is carried out.
(3) The inspections shall be done at all reasonable times and where samples are collected during inspections, the inspectors shall provide the pharmaceutical operator with a list of samples taken in Form 24 set out in Schedule 4.
(4) The form under subregulation (3) shall be signed by both the inspector and the person in authority of the inspected premises.
(5) Where an inspector seizes medicines in terms of section 47(3) of the Act, he or she shall complete Form 24 set out in Schedule 4.
PART V
Control of Clinical Trials (regs 55-59)
55. Application for use of medicines for clinical trials
(1) The applicant shall apply to the Authority in Form 19 set out in Schedule 4 accompanied by a fee set out in Schedule 5.
(2) The Authority shall issue an applicant a written approval for use of medicines regulated under the Act.
(3) The Authority shall keep registers of—
(a) medicines and sites approved for clinical trials; and
(b) all authorised and rejected clinical trials.
(4) The clinical trials shall be conducted according to the set standards and guidelines.
(5) All applications for clinical trials shall be registered with a World Health Organisation recognised clinical trials registry.
(6) A detailed report on the results of the clinical trial shall be submitted to the Authority at the completion of the trial.
56. Monitoring of clinical trial
The reporting of adverse events in clinical trials shall be in line with set guidelines and shall meet international standards.
57. Inspection and audit of clinical trials
The Authority shall inspect clinical trial sites for readiness and compliance with good clinical practices.
58. Suspension or termination of approval to conduct clinical trials
(1) The Authority may suspend or terminate an approval to conduct clinical trials where the Authority determines that the use of the medicines under trial is not safe or the anticipated benefits cannot be realised.
(2) The trials may also be suspended or terminated if the conduct is not according to the approval issued under these Regulations.
59. Disposal of unused medicines in clinical trials
A person who disposes of unused medicines in a clinical trial shall notify the Authority in terms of regulation 34.
PART VI
Cosmetics (regs 60-65)
(1) A person shall apply to the Authority for registration of cosmetics in Form 20 Part A set out in Schedule 4 and accompanied by a—
(a) payment of a fee in Schedule 5; and
(b) sample as described in the guidelines.
(2) The registration procedure for cosmetics shall be as outlined in the guidelines.
(3) The Authority shall, upon assessment issue an approval in Form 23 set out in Schedule 4 and in line with the guidelines.
(4) The Authority shall collaborate with other institutions and authorities in any harmonisation and collaborative activities in order to benchmark and facilitate developments of requirements and guidelines for efficient operations and prudent use of cosmetics.
(5) An approval issued in terms of subregulation (3) shall be valid for five years subject to annual submission of information accompanied by the annual fee in Schedule 5.
(6) Any cosmetic product awarded marketing authorisation shall maintain information regarding safety, manufacturing and any other necessary information as detailed in the guidelines and shall be accessible to the Authority.
(7) Regulations 5, 6, 7, 10, 11, 12, 13, 14 and 15 shall apply with the necessary modifications.
61. Exemption for registration of cosmetics
(1) An applicant may apply in Form 20 Part B set out in Schedule 4 upon payment of a fee set out in Schedule 5 to the Authority to exempt the registration of cosmetics from outside Botswana under special circumstances.
(2) The Authority may, after having considered the application and the supporting documents, grant the exemption in line with the guidelines.
62. Publication of list of prohibited ingredients
The Authority shall determine and publish a list of prohibited ingredients according to the guidelines.
The container for cosmetics shall be labelled in English with the following information—
(a) the name of the product;
(b) list of ingredients;
(c) manufacturer’s details;
(d) shelf life, expiry date or period of use after opening;
(e) batch identification;
(f) storage conditions;
(g) directions for use; and
(h) any warnings or precautions.
64. Licensing of manufacturing cosmetics
A person shall apply to the Authority for a manufacturing licence of cosmetics in Form 8 set out in Schedule 4 accompanied by a fee set out in Schedule 5.
(1) A person shall apply to the Authority to import cosmetics in Form 10 set out in Schedule 4 accompanied by a fee set out in Schedule 5.
(2) Upon assessment the Authority shall issue an import permit in Form 11 set out in Schedule 4 and in line with the guidelines.
(3) Only registered or exempted cosmetics may be imported.
(4) The marketing authorisation holder shall submit advertising and promotional materials to the Authority for authorisation before use.
(5) The Authority shall assess advertising and promotional materials according to set guidelines and issue a written authorisation to the marketing authorisation holder.
(6) A person authorised to import cosmetics shall pay a fee set out in Schedule 5 for each consignment in line with the guidelines.
PART VII
Complementary Medicines (regs 66-67)
66. Registration of complementary medicines
(1) An application for registration of complementary medicines shall be submitted in Form 21 set out in Schedule 4 and accompanied by—
(a) an application fee set out in Schedule 5; and
(b) a sample as described in the guidelines.
(2) The Authority shall specify conditions for registration for a particular complementary medicine and may—
(c) amend any conditions for registration;
(b) specify product labelling requirement; or
(c) determine what is to be described in the labels or packages of complementary medicines.
(3) Scientific evidence of safety and efficacy data shall be required for the registration of any therapeutic claim.
(4) Where an application to register a complementary medicine is successful, the Authority shall issue a written approval for registration to the applicant in Form 22 set out in Schedule 4.
(5) Where an application to register complementary medicines is unsuccessful, the Authority shall inform the applicant in writing stating the reason for the decision not to register the medicine.
(6) No application for a complementary medicine shall be made to the Authority for an injectable and eye preparations.
(7) The container for complementary medicines shall be labelled in English with the following information—
(a) the botanical or INN name of the product;
(b) the brand name of the product;
(c) list of ingredients;
(d) the quantity of active ingredients per dosage unit;
(e) name and address of manufacturers;
(f) shelf life, expiry date;
(g) batch identification;
(h) storage conditions;
(i) directions for use;
(j) any warnings or precautions;
(k) any contraindications;
(l) manufacturing date; and
(m) the statement that “there are no approved therapeutic claims”, where applicable.
(8) The Authority shall review allowable indication and functional claims from time to time and shall publish the claims in the Gazette.
(9) A person may apply to the Authority for the renewal of registration of complementary medicines in Form 4 set out in Schedule 4.
(10) Regulations 5, 6, 7, 10, 11, 12, 13, 14 and 15 shall apply with the necessary modifications.
67. Validity period of registration of complementary medicines
An approval issued in terms of regulation 66 shall be valid for five years subject to annual submission of information accompanied by the annual fee in Schedule 5.
PART VIII
General (regs 68-72)
68. Harmonisation and collaborative activities of Authority
The Authority shall collaborate with other institutions and authorities in any harmonisation and collaborative activities in order to benchmark and facilitate developments of requirements and guidelines for efficient operations and prudent use of resources.
Any person aggrieved by the decision of the Authority may appeal to the Appeals Committee.
The Minister shall, in consultation with the Authority publish a list of banned medicines in Schedule 3.
A person who—
(a) contravenes the provisions of these Regulations, for which no penalty is provided;
(b) fails to comply with any direction given or request made by the Authority or any competent authority under these Regulations; or
(c) fails to comply with any condition of a licence,
commits an offence and is liable to the penalties provided for under section 66 of the Act.
72. Revocation of Cap. 63:04 (Sub. Leg.)
The Drugs and Related Substances Regulations are hereby revoked.
(regs. 35, 36, 37, 38, 40, 41 and 43)
|
SCHEDULE 1 MEDICINES |
||
|
NO. |
NAME OF THE MEDICINE |
CATEGORY |
|
1 |
1-Methyl-4-phenylpiperidine-4-carboxylic acid; its salts; its esters and ethers; their salts |
1A |
|
2 |
2-Methyl-3-morpholino-1,1-diphenyl-propanecarboxylic acid; its salts; its esters and ethers; their salts |
1A |
|
3 |
4-Cyano-1-methyl-4-phenylpiperidine; its salts |
1A |
|
4 |
4-Cyano-2-dimethylamino-4,4-diphenylbutane; its salts |
1A |
|
5 |
4-Phenylpiperidine-4-carboxylic acid ethyl ester; its salts |
1A |
|
6 |
Acetorphine hydrochloride |
1A |
|
7 |
Acetorphine; its salts; its esters and ethers; their salts |
1A |
|
8 |
Acetyl-methadol see Methadyl acetate |
1A |
|
9 |
Alfentanil |
1A |
|
10 |
Allylprodine; its salt |
1A |
|
11 |
Alphacetylmethadol; its salts; its esters and ethers; their salt |
1A |
|
12 |
Alphameprodine; its salts |
1A |
|
13 |
Alphamethadol; its salts, its esters and ethers; their salts |
1A |
|
14 |
Alpha-methylphenethylamine see Amphetamine N-(2-(N-methylphenethylamino)propyl)propionanilide see Diampromide Methylphenidate; its salts |
1A |
|
15 |
Amidone see Methadone |
1A |
|
16 |
Amphetamine phosphate |
1A |
|
17 |
Amphetamine sulphat |
1A |
|
18 |
Amphetamine; its salts |
1A |
|
19 |
Anileridine; its salts |
1A |
|
20 |
Benzethidine; its salts |
1A |
|
21 |
Benzylmorphine hydrochloride |
1A |
|
22 |
Benzylmorphine; its salts; its esters and ethers; their salts |
1A |
|
23 |
Betacetylmethadol; its salts |
1A |
|
24 |
Betameprodine; its salts |
1A |
|
25 |
Betamethadol; its salts; its esters and ethers; their salts |
1A |
|
26 |
Betaminoisopropylbenzene see amphetamine |
1A |
|
27 |
Betaprodine; its salts |
1A |
|
28 |
Bezitramide; its salts |
1A |
|
29 |
Carfentanil; its stereoisomers its salts; its esters and ethers; their salts |
1A |
|
30 |
Clonitazene; its salts |
1A |
|
31 |
Codeine hydrochloride see Codeine |
1A |
|
32 |
Codeine phosphate see Codeine |
1A |
|
33 |
Codeine sulphate see Codeine |
1A |
|
34 |
Codoxime see Dihydrocodeinone O-carboxymethyloxime |
1A |
|
35 |
Delta-9-tetrahydrocannabinol see Dronabinol |
1A |
|
36 |
Desomorphine; its salts; its esters and ethers; their salts |
1A |
|
37 |
Desoxyephedrine see Methylamphetamine |
1A |
|
38 |
Desoxynorephedrine see Amphetamine |
1A |
|
39 |
Dexamphetamine phosphate |
1A |
|
40 |
Dexamphetamine sulphate |
1A |
|
41 |
Dexamphetamine; its salts |
1A |
|
42 |
Dextrodiphenopyradine see Dextromoramide |
1A |
|
43 |
Dextromoramide tartrate |
1A |
|
44 |
Dextromoramide; its salts |
1A |
|
45 |
Dextropropoxyphene; its salt; its esters and ethers; their salts but in a preparation for oral use containing not more than 135mg of dextropropoxyphene (calculated as base, per dosage unit, or with a total concentration of not more than 2.5% calculated as base, in undivided preparations: Schedule 2) |
1A |
|
46 |
Diampromide; its salts |
1A |
|
47 |
Diethylthiambutene hydrochloride |
1A |
|
48 |
Diethylthiambutene; its salts |
1A |
|
49 |
Dihydrocodeine phosphate see dihydrocodeine |
1A |
|
50 |
Dihydrocodeine tartrate see dihydrocodeine |
1A |
|
51 |
Dihydrocodeinone enolacetate see Thebacon |
1A |
|
52 |
Dihydrocodeinone O-carboxymethyl-oxime; salts; esters and ethers; their salts |
1A |
|
53 |
Dihydrocodeinone see hydrocodone |
1A |
|
54 |
Dihydrodeoxymorphine see Desomorphine |
1A |
|
55 |
Dihydrohydroxycodeinone see Oxycodone |
1A |
|
56 |
Dihydrohydroxymorphinone see Oxymorphine |
1A |
|
57 |
Dihydromorphine; its salts; its esters and ethers; their salts |
1A |
|
58 |
Dihydromorphinone see Hydromorphone |
1A |
|
59 |
Dimenoxadole; its salts |
1A |
|
60 |
Dimepheptanol; its salts; its esters and ethers; their salts |
1A |
|
61 |
Dimethylthiambutene; its salts |
1A |
|
62 |
Dioxaphetyl butyrate; its salts |
1A |
|
63 |
Diphenoxylate hydrochloride see diphenoxylate |
1A |
|
64 |
Dipipanone hydrochloride |
1A |
|
65 |
Dipipanone; its salts |
1A |
|
66 |
Dronabinol |
1A |
|
67 |
Drotebanol; its salts; its esters and ethers; their salts |
1A |
|
68 |
Ethylmethylthiambutene; its salts |
1A |
|
69 |
Ethylmorphine hydrochloride see Ethyl morphine |
1A |
|
70 |
Etonitazine; its salts |
1A |
|
71 |
Etorphine hydrochloride |
1A |
|
72 |
Etorphine; its salts; its esters and ethers; their salts |
1A |
|
73 |
Etoxeridine; its salts; its esters and ethers; their salts |
1A |
|
74 |
Fenethylline; its salts; its stereoisomers; their salts |
1A |
|
75 |
Furethidine; its salts |
1A |
|
76 |
Glutethimide; its salts; its stereoisomers; their salts |
1A |
|
77 |
Hebaine; its salts |
1A |
|
78 |
Hexobarbitone sodium |
1A |
|
79 |
Hydrocodone bitartrate |
1A |
|
80 |
Hydrocodone; its salts |
1A |
|
81 |
Hydromorphinol; its salts; its esters and ethers; their salts |
1A |
|
82 |
Hydromorphone; its salts; its esters and ethers; their salts |
1A |
|
83 |
Hydroxypethidine; its salts; its esters and ethers; their salts |
1A |
|
84 |
Isomethadone |
1A |
|
85 |
Ketobemidone; its salts; its esters and ethers; their salts |
1A |
|
86 |
Levamfetamine |
1A |
|
87 |
Levomethamphetamine |
1A |
|
88 |
Levomethorphane; its salts |
1A |
|
89 |
Levomoramide; its salts |
1A |
|
90 |
Levophenacylmorphan; its salts; its esters and ethers; their salts |
1A |
|
91 |
Levorphanol tartrate |
1A |
|
92 |
Lofentanil; its stereoisomers; its salts; its esters and ethers; their salts |
1A |
|
93 |
Mecloqualone |
1A |
|
94 |
Mephentermine sulphate |
1A |
|
95 |
Metazocine; its salts; its esters and ethers; their salt |
1A |
|
96 |
Methadone hydrochloride |
1A |
|
97 |
Methadone; its salts |
1A |
|
98 |
Methadyl acetate; its salts |
1A |
|
99 |
Methamphetamine see Methylamphetamine |
1A |
|
100 |
Methylamphetamine hydrochloride |
1A |
|
101 |
Methylamphetamine; its salts |
1A |
|
102 |
Methyldesorphine; its salts; its esters and ethers; their salts |
1A |
|
103 |
Methyldihydromorphine; its salts; its esters and ethers; their salts |
1A |
|
104 |
Methyldihydromorphinone see Metopon |
1A |
|
105 |
Methylphenidate hydrochloride |
1A |
|
106 |
Methylphenidate; its salts |
1A |
|
107 |
Metopon; its salts; its esters and ethers; their salts |
1A |
|
108 |
Morpheridine; its salts |
1A |
|
109 |
Morphine acetate see Morphine |
1A |
|
110 |
Morphine hydrochloride see Morphine |
1A |
|
111 |
Morphine methobromide; its esters and ethers |
1A |
|
112 |
Morphine sulphate see Morphine |
1A |
|
113 |
Morphine tartrate see Morphine |
1A |
|
114 |
Morphine; its salts; its esters and ethers; their salts; its pentavalent nitrogen derivatives; their esters and ethers |
1A |
|
115 |
Morphine-N-oxide; its esters and ethers |
1A |
|
116 |
Morpholinoethylnorpethidine see Morpheridine |
1A |
|
117 |
Myrophine; its salts |
1A |
|
118 |
Nicomorphine; its salts |
1A |
|
119 |
Noracymethadol; its salts |
1A |
|
120 |
Norlevorphanol; its salts; its esters and ethers; their salts |
1A |
|
121 |
Normethadone; its salts |
1A |
|
122 |
Normorphine; its salts; its esters and ethers; their salts |
1A |
|
123 |
Norpipanone; its salts |
1A |
|
124 |
Opium, medicinal |
1A |
|
125 |
Oxycodone; its salts; its esters and ethers; their salts |
1A |
|
126 |
Oxymorphone; its salts; its esters and ethers; their salts |
1A |
|
127 |
Papaveretum see Opium, medicinal |
1A |
|
128 |
Pethidine hydrochloride |
1A |
|
129 |
Pethidine; its salts |
1A |
|
130 |
Phenadone see Methadone |
1A |
|
131 |
Phenadoxone; its salts |
1A |
|
132 |
Phenampromide; its salts |
1A |
|
133 |
Phenazocine hydrobromide |
1A |
|
134 |
Phenazocine; its salts; its esters and ethers; their salts |
1A |
|
135 |
Phendimetrazine tartrate |
1A |
|
136 |
Phendimetrazine; its salts |
1A |
|
137 |
Phenmetrazine hydrochloride |
1A |
|
138 |
Phenmetrazine theoclate |
1A |
|
139 |
Phenmetrazine; its salts |
1A |
|
140 |
Phenomorphan; its salts; its esters and ethers; their salts |
1A |
|
141 |
Phenoperidine; its salts; its esters and ethers; their salts |
1A |
|
142 |
Pholcodine citrate see Pholcodine |
1A |
|
143 |
Pholcodine tartrate see Pholcodine |
1A |
|
144 |
Piritramide; its salts |
1A |
|
145 |
Potassium clorazepate |
1A |
|
146 |
Prazepam |
1A |
|
147 |
Proheptazine; its salts |
1A |
|
148 |
Properidine; its salts |
1A |
|
149 |
Quinalbarbitone |
1A |
|
150 |
Quinalbarbitone sodium |
1A |
|
151 |
Racemethorphan; its salts |
1A |
|
152 |
Racemoramide; its salts |
1A |
|
153 |
Racemorphan; its salts; its esters and ethers; their salts |
1A |
|
154 |
Secobarbitone see Quinalbarbitone |
1A |
|
155 |
Temazepam |
1A |
|
156 |
Thebacon; its salts |
1A |
|
157 |
Tilidate; its salts; its esters and ethers; their salts |
1A |
|
158 |
Trimeperidine; its salts |
1A |
|
159 |
Amferpramone |
1B |
|
160 |
Amylobarbitone |
1B |
|
161 |
Amylobarbitone sodium |
1B |
|
162 |
Benzphetamine; its salts |
1B |
|
163 |
Bezphetamine hydrochloride |
1B |
|
164 |
Buprenorphine |
1B |
|
165 |
Buprenorphine hydrochloride |
1B |
|
166 |
Butalbital |
1B |
|
167 |
Cathine; its salts; its stereoisomers not being phenylpropanolamine; their salts |
1B |
|
168 |
Chlorphentamine hydrochloride |
1B |
|
169 |
Chlorphentamine; its salts |
1B |
|
170 |
Cyclobarbitone |
1B |
|
171 |
Diethylpropion hydrochloride |
1B |
|
172 |
Lefetamine(SPA) |
1B |
|
173 |
Mazindol |
1B |
|
174 |
Mefenorex; its salts; its stereoisomers; their salts |
1B |
|
175 |
Meperedine see Pethidine |
1B |
|
176 |
Mephentermine; its salts |
1B |
|
177 |
Pemoline |
1B |
|
178 |
Pentazocine hydrochloride |
1B |
|
179 |
Pentazocine lactate |
1B |
|
180 |
Pentobarbitone |
1B |
|
181 |
Pentobarbitone sodium |
1B |
|
182 |
Phentermine |
1B |
|
183 |
Phenylmethylbarbituric acid |
1B |
|
184 |
Pinazepam |
1B |
|
185 |
Pipradrol hydrochloride |
1B |
|
186 |
Pipradrol; its salts |
1B |
|
187 |
Allobarbital |
1C |
|
188 |
Barbitone |
1C |
|
189 |
Barbitone sodium |
1C |
|
190 |
Bromazepam |
1C |
|
191 |
Butobarbitone |
1C |
|
192 |
Butobarbitone sodium |
1C |
|
193 |
Camazepam |
1C |
|
194 |
Chlordiazepoxide |
1C |
|
195 |
Chlordiazepoxide hydrochloride |
1C |
|
196 |
Clobazam |
1C |
|
197 |
Clonazepam |
1C |
|
198 |
Clorazepate |
1C |
|
199 |
Clotiazepam |
1C |
|
200 |
Cloxazolam |
1C |
|
201 |
Delorazepam |
1C |
|
202 |
Diazepam |
1C |
|
203 |
Estozolam |
1C |
|
204 |
Ethchlorvyno |
1C |
|
205 |
Ethinimate |
1C |
|
206 |
Ethyl loflazepate |
1C |
|
207 |
Fencamfamin; its salts; its stereoisomers; their salts |
1C |
|
208 |
Fentanyl; its salts |
1C |
|
209 |
Fludiazepam |
1C |
|
210 |
Flunitrazepam |
1C |
|
211 |
Flurazepam hydrochloride; its salts |
1C |
|
212 |
Flurazepam monohydrochloride |
1C |
|
213 |
Halazepam |
1C |
|
214 |
Haloxazolam |
1C |
|
215 |
Heptabarbitone |
1C |
|
216 |
Hexobarbitone |
1C |
|
217 |
Ketazolam |
1C |
|
218 |
Loprazolam mesylate |
1C |
|
219 |
Lorazepam |
1C |
|
220 |
Lormetazepa |
1C |
|
221 |
Medazepam |
1C |
|
222 |
Meprobamate |
1C |
|
223 |
Methylphenobarbitone |
1C |
|
224 |
Methyprylone |
1C |
|
225 |
Midazolam |
1C |
|
226 |
N-Ethylamphetamine; its salts; its stereoisomers; their salts |
1C |
|
227 |
Nimetazepam |
1C |
|
228 |
Nitrazepam |
1C |
|
229 |
Nordazepam |
1C |
|
230 |
Oxazepam |
1C |
|
231 |
Oxazolam |
1C |
|
232 |
Phenobarbitone |
1C |
|
233 |
Phenobarbitone sodium |
1C |
|
234 |
Piminodine; its salts |
1C |
|
235 |
Propylhexedrine; its salts; its stereoisomers; their salts |
1C |
|
236 |
Pyrovalerone; its salts; its stereoisomers; their salts |
1C |
|
237 |
Secbutobarbitone |
1C |
|
238 |
Secbutobarbitone sodium |
1C |
|
239 |
Sufentanil; its salts; its esters and ethers; their salts |
1C |
|
240 |
Triazolam |
1C |
|
241 |
Vinylbital |
1C |
|
242 |
Codeine; its salts 1(A) |
1C |
|
243 |
Acetyldihydrocodeine; its salts 1(A) |
1D |
|
244 |
Codeine; its salts 1(A) |
1D |
|
245 |
Difenoxin (1-(3-cyano-33-diphenyl-propyl)-4-phenylpiperidine4-carboxylic acid) 1A (but if in preparation containing, per dosage unit, not more than 0.5mg of difenoxin and a quantity of atropine sulphate equivalent to at least 5% of the dose of difenoxin: Schedule 2) |
1D |
|
246 |
Dihydrocodeine; its salts 1A |
1D |
|
247 |
Diphenoxylate; its salts |
1D |
|
248 |
Ethylmorphine; its salts |
1D |
|
249 |
Nicocodine; its salts |
1D 1D 1D 1D |
|
250 |
Norcodeine; its salts |
1D |
|
251 |
Pholcodine; its salts 1A |
1D |
|
252 |
Propiram; its salts 1A |
1D |
|
(2) SCHEDULE 2 MEDICINES |
|
|
NO. |
NAME OF THE MEDICINE |
|
1 |
Alfacalcidol (1 alpha hydroxycalceferol) |
|
2 |
Roxarsone (4-hydroxy-3 nitrophenyl arsonic acid) |
|
3 |
Abacavir |
|
4 |
Acebutolol |
|
5 |
Acepromazine |
|
6 |
Acepromazine maleate |
|
7 |
Acetanilide |
|
8 |
Acetarsol |
|
9 |
Acetazolamide |
|
10 |
Acetazolamide sodium |
|
11 |
Acetohexamide |
|
12 |
Acetylcarbromal |
|
13 |
Acetylcholine chloride |
|
14 |
Acetylcysteine |
|
15 |
Acetyldigitoxin |
|
16 |
Acetylstrophanthidin |
|
17 |
Acetylsulphafurazole |
|
18 |
Acetylsulphamethoxypyridazine |
|
19 |
Aconite |
|
20 |
Acrosoxacin |
|
21 |
Actinomycin C |
|
22 |
Actinomycin D |
|
23 |
Acyclovir (except topical preparation Schedule 3) |
|
24 |
Adicillin |
|
25 |
Adiphenine hydrochloride |
|
26 |
Adrenaline |
|
27 |
Adrenaline acid tartrate |
|
28 |
Adrenaline hydrochloride |
|
29 |
Albumin human (immuno) |
|
30 |
Alclofenac |
|
31 |
Alclometasone diproprionate |
|
32 |
Alcuronium chloride |
|
33 |
Aldosterone |
|
34 |
Alendronate |
|
35 |
Alfacalcidol |
|
36 |
Alfuzosin |
|
37 |
Algestone acetonide |
|
38 |
Algestone acetophenide |
|
39 |
Alkomide |
|
40 |
Allyloestrenol |
|
41 |
Alphadolone acetate |
|
42 |
Alphaxalone |
|
43 |
Alprazolam |
|
44 |
Alprenolol |
|
45 |
Alprenolol hydrochloride |
|
46 |
Alprostadil |
|
47 |
Alseroxylon |
|
48 |
Altizide |
|
49 |
Amantadine |
|
50 |
Ambenonium chloride |
|
51 |
Ambuside |
|
52 |
Ambutonium bromide |
|
53 |
Amcinonide |
|
54 |
Ametazole hydrochloride |
|
55 |
Amidopyridone |
|
56 |
Amikacin sulphate |
|
57 |
Amiloride |
|
58 |
Aminocaproic acid |
|
59 |
Aminodarone hydrochloride |
|
60 |
Aminoglutethemide |
|
61 |
Aminophylline |
|
62 |
Aminopterin sodium |
|
63 |
Aminosalicylic acid |
|
64 |
Amiodarone |
|
65 |
Amiphenazole hydrochloride |
|
66 |
Amitriptyline |
|
67 |
Amitriptyline embonate |
|
68 |
Amitriptyline hydrochloride |
|
69 |
Amlodipine |
|
70 |
Ammonium bromide |
|
71 |
Amodiaquine hydrochloride |
|
72 |
Amoxapine |
|
73 |
Amoxycillin |
|
74 |
Amoxycillin trihydrate |
|
75 |
Amphomycin |
|
76 |
Amphotericin |
|
77 |
Ampicillin |
|
78 |
Ampicillin sodium |
|
79 |
Ampicillin trihydrate |
|
80 |
Amsacrine |
|
81 |
Amylocaine hydrochloride |
|
82 |
Anagrelide |
|
83 |
Anastrozole |
|
84 |
Ancrod |
|
85 |
Androsterone |
|
86 |
Angiotensin amide |
|
87 |
Anterior pituitary extract |
|
88 |
Antimony barium tartrate |
|
89 |
Antimony dimercaptosuccinate |
|
90 |
Antimony lithium thiomalate |
|
91 |
Antimony pentasulphide |
|
92 |
Antimony potassium tartrate |
|
93 |
Antimony sodium tartrate |
|
94 |
Antimony sodium thioglycollate |
|
95 |
Antimony sulphate |
|
96 |
Antimony trichloride |
|
97 |
Antimony trioxide |
|
98 |
Antimony trisulphide |
|
99 |
Apiol |
|
100 |
Apomorphine |
|
101 |
Apomorphine hydrochloride |
|
102 |
Apramycin |
|
103 |
Apramycin sulphate |
|
104 |
Aprotinin |
|
105 |
Arecoline |
|
106 |
Arecoline hydrobromide |
|
107 |
Arecoline-acetarsol |
|
108 |
Arsanilic acid |
|
109 |
Arsphenamine |
|
110 |
Atazanavir |
|
111 |
Atenolol |
|
112 |
Atorvastatin |
|
113 |
Atracurium besylate |
|
114 |
Azacyclonol |
|
115 |
Azacyclonol hydrochloride |
|
116 |
Azaperone |
|
117 |
Azapropazone |
|
118 |
Azathioprine |
|
119 |
Azidocillin potassium |
|
120 |
Azithromycin |
|
121 |
Azothioprine |
|
122 |
Azothioprine sodium |
|
123 |
Bacampicillin hydrochloride |
|
124 |
Bacitracin |
|
125 |
Bacitracin methylene disalicylate |
|
126 |
Bacitracin zinc |
|
127 |
Baclofen |
|
128 |
Barium carbomate |
|
129 |
Barium chloride |
|
130 |
Barium sulphide |
|
131 |
Beclamide |
|
132 |
Beclomethasone |
|
133 |
Beclomethasone dipropionate |
|
134 |
Bemegride |
|
135 |
Benactyzine hydrochloride |
|
136 |
Benapryzine hydrochloride |
|
137 |
Bendrofluazide |
|
138 |
Benethamine penicillin |
|
139 |
Benoxaprofen |
|
140 |
Benperidol |
|
141 |
Benserazide |
|
142 |
Benzathine penicillin |
|
143 |
Benzbromarone |
|
144 |
Benzhexol hydrochloride |
|
145 |
Benzilonium bromide |
|
146 |
Benzoclamine hydrochloride |
|
147 |
Benzquinamide |
|
148 |
Benzquinamide hydrochloride |
|
149 |
Benzthiazide |
|
150 |
Benztropine mesylate |
|
151 |
Benzyl penicillin |
|
152 |
Benzyl penicillin calcium |
|
153 |
Betahistine hydrochloride |
|
154 |
Betamethasone |
|
155 |
Betamethasone adamantoate |
|
156 |
Betamethasone benzoate |
|
157 |
Betamethasone dipropiomate |
|
158 |
Betamethasone sodium phosphate |
|
159 |
Betamethasone valerate |
|
160 |
Betaxolol hydrochloride |
|
161 |
Bethanecol chloride |
|
162 |
Bethanidine sulphate |
|
163 |
Bezafibrate |
|
164 |
Bicalutamide |
|
165 |
Biperidine hydrochloride |
|
166 |
Biperidine lactate |
|
167 |
Bismuth glucollylarsanilate |
|
168 |
Bisoprolol |
|
169 |
Bleomycin sulphate |
|
170 |
Boldenone undecylenate |
|
171 |
Bretylium tosylate |
|
172 |
Brimonidine |
|
173 |
Bromocriptine mesylate |
|
174 |
Bromperidol |
|
175 |
Bromvaletone |
|
176 |
Budesonide |
|
177 |
Bumetadine |
|
178 |
Bumetanide |
|
179 |
Buphenine hydrochloride |
|
180 |
Bupivacaine |
|
181 |
Bupivacaine hydrochloride |
|
182 |
Buspirone hydrochloride |
|
183 |
Busulphan |
|
184 |
Butacaine sulphate |
|
185 |
Butanilicaine phosphate |
|
186 |
Butriptyline hydrochloride |
|
187 |
Butylchloral hydrate |
|
188 |
Cabergoline |
|
189 |
Calcitonin |
|
190 |
Calcitriol |
|
191 |
Calcium aminosalicylate |
|
192 |
Calcium amphomycin |
|
193 |
Calcium benzamidosalicylate |
|
194 |
Calcium bromide |
|
195 |
Calcium bromidolactobionate |
|
196 |
Calcium carbimide |
|
197 |
Calcium folinate |
|
198 |
Calcium metrizoate |
|
199 |
Calcium sulphaloxate |
|
200 |
Candesartan |
|
201 |
Candicidin |
|
202 |
Canrenoic acid |
|
203 |
Cantharidin |
|
204 |
Capreomycin sulphate |
|
205 |
Captopril |
|
206 |
Caramiphen edisylate |
|
207 |
Caramiphen hydrochloride |
|
208 |
Carbachol |
|
209 |
Carbamazepine |
|
210 |
Carbenicillin sodium |
|
211 |
Carbenoxolone sodium |
|
212 |
Carbidopa |
|
213 |
Carbidopa monohydrate |
|
214 |
Carbimazole |
|
215 |
Carbon tetrachloride |
|
216 |
Carboplatin |
|
217 |
Carboprostrometamol |
|
218 |
Carbromal |
|
219 |
Carbuterol hydrochloride |
|
220 |
Carindacillin sodium |
|
221 |
Carisoprodol |
|
222 |
Carmustine |
|
223 |
Carvedilol |
|
224 |
Cefaclor |
|
225 |
Cefazedone sodium |
|
226 |
Cefazolin |
|
227 |
Cefepime |
|
228 |
Cefixime |
|
229 |
Cefotaxime |
|
230 |
Cefoxitin sodium |
|
231 |
Cefpodoxime |
|
232 |
Cefprozil |
|
233 |
Ceftazidime |
|
234 |
Ceftizoxine sodium |
|
235 |
Ceftriaxone |
|
236 |
Cefuroxime sodium |
|
237 |
Cephalexin |
|
238 |
Cephalexin sodium |
|
239 |
Cephaloridine |
|
240 |
Cephalosporin C |
|
241 |
Cephalosporin E |
|
242 |
Cephalosporin N |
|
243 |
Cephalothin sodium |
|
244 |
Cephamandole nafate |
|
245 |
Cephazolin sodium |
|
246 |
Cephradine |
|
247 |
Cerium oxalate |
|
248 |
Chenodeoxycholic acid |
|
249 |
Chloral antipyrine |
|
250 |
Chloral betaine |
|
251 |
Chloral formamide |
|
252 |
Chloral glycerolate |
|
253 |
Chloral hydrate |
|
254 |
Chloralose |
|
255 |
Chloralurethene |
|
256 |
Chlorambucil |
|
257 |
Chloramphenicol |
|
258 |
Chlorisondamine chloride |
|
259 |
Chlormadinone acetate |
|
260 |
Chlormerodrin |
|
261 |
Chlormethiazole |
|
262 |
Chlormezanone |
|
263 |
Chloroquine and its salts (except for prophylaxis of malarial prophylaxis Schedule 3) |
|
264 |
Chlorothiazide |
|
265 |
Chlorotrianisene |
|
266 |
Chloroxazone |
|
267 |
Chlorphenoxamine hydrochloride |
|
268 |
Chlorpromazine |
|
269 |
Chlorpromazine embonate |
|
270 |
Chlorpromazine hydrochloride |
|
271 |
Chlorpropamide |
|
272 |
Chlorprothixene |
|
273 |
Chlorprothixene hydrochloride |
|
274 |
Chlortetracycline |
|
275 |
Chlortetracycline hydrochloride |
|
276 |
Chlorthalidone |
|
277 |
Cholestyramine |
|
278 |
Chorionic gonadotrophin |
|
279 |
Chormethiazole edisylate |
|
280 |
Ciclacillin |
|
281 |
Ciclobendazole |
|
282 |
Cimetidine & its salts (except for short term relief of heartburn, dyspepsia and hyperacidity 200mg-400mg per single dose- maximum 4800mg Schedule 3) |
|
283 |
Cinchocaine |
|
284 |
Cinchocaine hydrochloride |
|
285 |
Cinchophen |
|
286 |
Cinoxacin |
|
287 |
Ciprofloxacin |
|
288 |
Ciprofloxacin hydrochloride |
|
289 |
Cisplatin |
|
290 |
Citalopram |
|
291 |
Cladribine |
|
292 |
Clarithromycin |
|
293 |
Clavulanic acid |
|
294 |
Clenbuterol hydrochloride |
|
295 |
Clindamycin and its salts (except for topical preparation Schedule 3) |
|
296 |
Clindamycin hydrochloride hydrate |
|
297 |
Clindamycin palmitate hydrochloride |
|
298 |
Clindamycin phosphate |
|
299 |
Clindinium bromide |
|
300 |
Clobetasol |
|
301 |
Clobetasol 17-propionate |
|
302 |
Clobetasone butyrate |
|
303 |
Clofazimine |
|
304 |
Clofibrate |
|
305 |
Clomiphene citrate |
|
306 |
Clomipramine |
|
307 |
Clomipramine hydrochloride |
|
308 |
Clomocycline |
|
309 |
Clomocycline sodium |
|
310 |
Clonidine |
|
311 |
Clonidine hydrochloride |
|
312 |
Clopenthixol decanoate |
|
313 |
Clopenthixol hydrochloride |
|
314 |
Clopidogrel |
|
315 |
Cloprostenol sodium |
|
316 |
Clorexolone |
|
317 |
Clorprenaline hydrochloride |
|
318 |
Clostebol acetate |
|
319 |
Cloxacillin benzathine |
|
320 |
Cloxacillin sodium |
|
321 |
Clozapine |
|
322 |
Cocculus indicus |
|
323 |
Co-dergocrine myselate |
|
324 |
Colchicine (except for acute gout attack maximum 6mg, 0.5-1 mg per single dose Schedule 3) |
|
325 |
Colestipol hydrochloride |
|
326 |
Colistin sulphate |
|
327 |
Colistin sulphomethate |
|
328 |
Colistin sulphomethate sodium |
|
329 |
Conium leaf |
|
330 |
Corticotrophin |
|
331 |
Cortisone |
|
332 |
Cortisone acetate |
|
333 |
Cotarnine chloride |
|
334 |
Co-tetroxazine |
|
335 |
Co-trimoxazole |
|
336 |
Cropropamide |
|
337 |
Crotethamide |
|
338 |
Croton oil |
|
339 |
Croton seed |
|
340 |
Curare |
|
341 |
Cycloghosphamide |
|
342 |
Cyclopenthiazide |
|
343 |
Cyclopentolate hydrochloride |
|
344 |
Cyclophosmamide |
|
345 |
Cyclosporin |
|
346 |
Cyclothiazide |
|
347 |
Cyproterone acetate |
|
348 |
Cytarabine |
|
349 |
Cytarabine hydrochloride |
|
350 |
Dacarbazine |
|
351 |
Dactinomycin |
|
352 |
Danazol |
|
353 |
Dantrolene sodium |
|
354 |
Dapsone |
|
355 |
Dapsone ethane ortho sulphonate |
|
356 |
Darunavir |
|
357 |
Daunorubicin hydrochloride |
|
358 |
Deanol salts and esters |
|
359 |
Debrisoquine sulphate |
|
360 |
Dehydroemetine hydrochloride |
|
361 |
Delmadinone acetate |
|
362 |
Demecarium bromide |
|
363 |
Demeclocycline |
|
364 |
Demeclocycline calcium |
|
365 |
Demeclocycline hydrochloride |
|
366 |
Deoxycortone acetate |
|
367 |
Deoxycortone pivalate |
|
368 |
Deptropine citrate |
|
369 |
Dequalinium chloride |
|
370 |
Deserpidine |
|
371 |
Desferroxamine mesylate |
|
372 |
Desfluorotriamcinolone |
|
373 |
Desipramine hydrochloride |
|
374 |
Deslanoside |
|
375 |
Desmopressin |
|
376 |
Desonide |
|
377 |
Desoxymethasone |
|
378 |
Dexamethasone |
|
379 |
Dexamethasone 21-isonicotinate |
|
380 |
Dexamethasone phenylpropionate |
|
381 |
Dexamethasone pivalate |
|
382 |
Dexamethasone sodium m-sulphobenzoate |
|
383 |
Dexamethasone sodium phosphate |
|
384 |
Dexamethasone trioxaundecanoate |
|
385 |
Dextromethorphan hydrobromide |
|
386 |
Dextrothyroxine sodium |
|
387 |
Diazoxide |
|
388 |
Dibenzepin hydrochloride |
|
389 |
Dichloralphenazone |
|
390 |
Dichlorophernasine hydrochloride |
|
391 |
Dichlorphenamide |
|
392 |
Diclofenac and its salts (topical preparation & oral 500mg maximum, 50-100mg per single dose Schedule 3) |
|
393 |
Dicyclomine hydrochloride (except in antacid preparation Schedule 3) |
|
394 |
Dienoestrol |
|
395 |
Diethanolamine fusidate |
|
396 |
Diethylamine acetarsol |
|
397 |
Diflucortolone valerate |
|
398 |
Diflunisal |
|
399 |
Digitalis leaf |
|
400 |
Digitoxin |
|
401 |
Digoxin |
|
402 |
Dihydrallazine sulphate |
|
403 |
Dihydroergotamine mesylate |
|
404 |
Dihydrostreptomycin sulphate |
|
405 |
Diltiazem hydrochloride |
|
406 |
Dimercaprol |
|
407 |
Dimethisoquin hydrochloride |
|
408 |
Dimethisterone |
|
409 |
Dimethothiazine mesylate |
|
410 |
Dimethyl sulphoxide |
|
411 |
Dimethyltubocurarine bromide |
|
412 |
Dimethyltubocurarine chloride |
|
413 |
Dimethyltubocurarine iodide |
|
414 |
Dinitrodiphenylsulphonylethylenediamine |
|
415 |
Dinoprost |
|
416 |
Dinoprostone |
|
417 |
Diphetarsone |
|
418 |
Dipivefrin hydrochloride |
|
419 |
Diprenorphine hydrochloride |
|
420 |
Dipyridamole |
|
421 |
Dipyrone |
|
422 |
Disodium etidronate |
|
423 |
Disopyramide |
|
424 |
Disopyramide phosphate |
|
425 |
Distigmine bromide |
|
426 |
Disulfiram |
|
427 |
Disulphamide |
|
428 |
Dithranol |
|
429 |
d-Norgestrel |
|
430 |
Dobutamine hydrochloride |
|
431 |
Docetaxel |
|
432 |
Dolutegravir |
|
433 |
Dompridone |
|
434 |
Donepezil |
|
435 |
Dopamine hydrochloride |
|
436 |
Dothiepin |
|
437 |
Dothiepin hydrochloride |
|
438 |
Doxapram hydrochloride |
|
439 |
Doxazosin |
|
440 |
Doxepin hydrochloride |
|
441 |
Doxorubicin |
|
442 |
Doxycycline |
|
443 |
Doxycycline calcium chelate |
|
444 |
Doxycycline hydrochloride |
|
445 |
Droperidol |
|
446 |
Drospirenone |
|
447 |
Drostanolone |
|
448 |
Drostanolone propionate |
|
449 |
Duloxetine |
|
450 |
Dyaxide |
|
451 |
Dydrogesterone |
|
452 |
Ecthiopate iodide |
|
453 |
Edrophonium |
|
454 |
Efavirenz |
|
455 |
Emepromium bromide |
|
456 |
Emetine |
|
457 |
Emetine bismuth iodide |
|
458 |
Emetine hydrochloride |
|
459 |
Emtricitabine |
|
460 |
Enalapril maleate |
|
461 |
Epicillin |
|
462 |
Epirubicin |
|
463 |
Epithiazide |
|
464 |
Epoprostenol sodium |
|
465 |
Ergometrine tartrate |
|
466 |
Ergotoxine esylate |
|
467 |
Erythromycin & its salts (except topical preparation Schedule 3) |
|
468 |
Erythropoietin |
|
469 |
Escitalopram |
|
470 |
Esomeprazole & its salts (except for the 14-day treatment for frequent heartburn, at a daily dose of 20 mg and in package sizes of no more than 280 mg of esomeprazole Schedule 3) |
|
471 |
Estramustine phosphate |
|
472 |
Etafedrine hydrochloride |
|
473 |
Ethacrynic acid |
|
474 |
Ethamsylate |
|
475 |
Ethchlorvynol |
|
476 |
Ethebenecid |
|
477 |
Ethiazide |
|
478 |
Ethinyloestradiol |
|
479 |
Ethionamide |
|
480 |
Ethisterone |
|
481 |
Ethoheptazine citrate |
|
482 |
Ethopropazine hydrochloride |
|
483 |
Ethosuximide |
|
484 |
Ethotoin |
|
485 |
Ethulose |
|
486 |
Ethyl acetanilide |
|
487 |
Ethyl biscoumacetate |
|
488 |
Ethyloestrenol |
|
489 |
Ethynodiol diacetate |
|
490 |
Etidronate disodium |
|
491 |
Etomidate |
|
492 |
Etoposide |
|
493 |
Factor IX concentrate |
|
494 |
Factor XII concentrate |
|
495 |
Factor XIII concentrate |
|
496 |
Fazadinium bromide |
|
497 |
Felodipine |
|
498 |
Fenbufen |
|
499 |
Fenfluramine hydrochloride |
|
500 |
Fenoprofen |
|
501 |
Fenoprofen calcium |
|
502 |
Fenoterol hydrobromide |
|
503 |
Fenpipramide hydrochloride |
|
504 |
Fenpiprane hydrochloride |
|
505 |
Filgrastin |
|
506 |
Finasteride |
|
507 |
Flavoxate hydrochloride |
|
508 |
Flecainide |
|
509 |
Fluanisone |
|
510 |
Fluclorolone acetonide |
|
511 |
Flucloxacillin sodium |
|
512 |
Fluconazole |
|
513 |
Flucytosine |
|
514 |
Fludarabine |
|
515 |
Fludrocortisone acetate |
|
516 |
Flufenamic acid |
|
517 |
Flugestone |
|
518 |
Flugestone acetate |
|
519 |
Flumedroxone acetate |
|
520 |
Flumethasone |
|
521 |
Flumethasone pivalate |
|
522 |
Flunisolide |
|
523 |
Fluocinolone acetonide |
|
524 |
Fluocinonide |
|
525 |
Fluocortolone |
|
526 |
Fluocortolone hexanoate |
|
527 |
Fluocortolone pivalate |
|
528 |
Fluopromazine hydrochloride |
|
529 |
Fluorometholone |
|
530 |
Fluorouracil |
|
531 |
Fluorouracil trometamol |
|
532 |
Fluoxetine |
|
533 |
Fluoxymesterone |
|
534 |
Flupenthixol decanoate |
|
535 |
Flupenthixol dihydrochloride |
|
536 |
Fluperolone acetate |
|
537 |
Fluphenazine deconoate |
|
538 |
Fluphenazine enanthate |
|
539 |
Fluphenazine hydrochloride |
|
540 |
Fluprednidene acetate |
|
541 |
Fluprednisolone |
|
542 |
Fluprostenol sodium salt |
|
543 |
Flurandrenolone |
|
544 |
Flurbiprofen |
|
545 |
Fluspirilene |
|
546 |
Flutamide |
|
547 |
Fluticasone |
|
548 |
Fluvastatin |
|
549 |
Fluvoxamine |
|
550 |
Follicle stimulating hormone |
|
551 |
Formosulphathiazole |
|
552 |
Formoterol |
|
553 |
Fosfestrol tetrasodium |
|
554 |
Framycetin sulphate (except topical & ophthalmic preparation Schedule 3) |
|
555 |
Frusemide |
|
556 |
Fumagillin |
|
557 |
Fumagillin bicyclohexylamine |
|
558 |
Furazolidone |
|
559 |
Furosemide |
|
560 |
Fusidic acid |
|
561 |
Gabapentin |
|
562 |
Gallamine triethiodide |
|
563 |
Gelsemine |
|
564 |
Gelsemium |
|
565 |
Gemcitabine |
|
566 |
Gemfibrozil |
|
567 |
Gentamicin and its salts (except topical and ophthalmic use Schedule 3) |
|
568 |
Gestodene |
|
569 |
Gestronol |
|
570 |
Gestronol hexanoate |
|
571 |
Glibenclamide |
|
572 |
Glibornuride |
|
573 |
Gliclazide |
|
574 |
Glimepiride |
|
575 |
Glipizide |
|
576 |
Glyceryl trinitrate |
|
577 |
Glycopyrronium bromide |
|
578 |
Glymide |
|
579 |
Gonadorelin |
|
580 |
Gramicidin |
|
581 |
Granisetron |
|
582 |
Growth hormone |
|
583 |
Guanethidine monosulphate |
|
584 |
Guanoclor sulphate |
|
585 |
Guanoxan sulphate |
|
586 |
Hachimycin |
|
587 |
Halcinonide |
|
588 |
Haloperidol |
|
589 |
Heparin and its salts (except for topical use Schedule 3) |
|
590 |
Heptaminol hydrochloride |
|
591 |
Hexachlorophene |
|
592 |
Hexamine phenylcinchoninate |
|
593 |
Hexoestrol |
|
594 |
Hexoestrol dipropionate |
|
595 |
Homatropine |
|
596 |
Homatropine hydrobromide |
|
597 |
Homatropine methylbromide |
|
598 |
Hydralazine hydrochloride |
|
599 |
Hydrargaphen |
|
600 |
Hydrobromic acid |
|
601 |
Hydrochlorothiazide |
|
602 |
Hydrocortamate hydrochloride |
|
603 |
Hydrocortisone and its salts & derivatives (except in preparations for external use and ms 1% Schedule 3) |
|
604 |
Hydroflumethiazide |
|
605 |
Hydroquinone |
|
606 |
Hydroxychloroquine sulphate |
|
607 |
Hydroxymethylgramicidin |
|
608 |
Hydroxyprogesterone |
|
609 |
Hydroxyprogesterone enanthate |
|
610 |
Hydroxyprogesterone hexanoate |
|
611 |
Hydroxyurea |
|
612 |
Hydroxyzine embonate |
|
613 |
Hydroxyzine hydrochloride |
|
614 |
Hyoscine |
|
615 |
Hyoscine and its salts (except oral use Schedule 3) |
|
616 |
Hyoscyamine and its salts (except oral use Schedule 3) |
|
617 |
Ibuprofen (except in preparation for topical and oral use maximum 9600mg, 400mg per single dose Schedule 3) |
|
618 |
Idoxuridine |
|
619 |
Ignatius bean |
|
620 |
Imipenem |
|
621 |
Imipramine |
|
622 |
Imipramine hydrochloride |
|
623 |
Imipramine ion exchange resin bound salt or complex |
|
624 |
Immunoglobulins |
|
625 |
Indapamide hemihydrates |
|
626 |
Indomethacin (except in preparation for topical, rectal and oral use maximum 750mg, 25mg per single dose Schedule 3) |
|
627 |
Indoramin hydrochloride |
|
628 |
Insulins |
|
629 |
Iodamide |
|
630 |
Iodamide meglumine |
|
631 |
Iodamide sodium |
|
632 |
Ipratropium |
|
633 |
Iprindole hydrochloride |
|
634 |
Iproniazid phosphate |
|
635 |
Iptratropium bromide |
|
636 |
Irbesartan |
|
637 |
Irinotecan |
|
638 |
Isoaminile |
|
639 |
Isoaminile citrate |
|
640 |
Isocarboxazid |
|
641 |
Isoconazole nitrate (except topical & vaginal preparation Schedule 3) |
|
642 |
Isoetharine |
|
643 |
Isoetharine hydrochloride |
|
644 |
Isoetharine mesylate |
|
645 |
Isoniazid |
|
646 |
Isoprenaline hydrochloride |
|
647 |
Isoprenaline sulphate |
|
648 |
Isopropamide iodide |
|
649 |
Isosorbide dinitrate |
|
650 |
Isosorbide mononitrate |
|
651 |
Isotretinoin |
|
652 |
Ispaghula |
|
653 |
Itraconazole |
|
654 |
Jaborondi |
|
655 |
Kanamycin sulphate |
|
656 |
Ketamine hydrochloride |
|
657 |
Ketoconazole (except topical & vaginal preparation Schedule 3) |
|
658 |
Ketoprofen |
|
659 |
Ketotifen (except cough preparation Schedule 3) |
|
660 |
Labetolol hydrochloride |
|
661 |
Lactogernic hormone |
|
662 |
Lamivudine |
|
663 |
Lamotrigine |
|
664 |
Lanatoside C |
|
665 |
Lanatoside complex A, B and C |
|
666 |
Lansoprazole (except for the 14-day treatment for frequent heartburn, at a daily dose of 30 mg and in package sizes of no more than 4200 mg of lansoprazole Schedule 3) |
|
667 |
Latamoxef disodium |
|
668 |
Latanoprost |
|
669 |
Lead arsenate |
|
670 |
Letrozole |
|
671 |
Levallorphan tartrate |
|
672 |
Levetiracetam |
|
673 |
Levocetrizine |
|
674 |
Levodopa |
|
675 |
Levofloxacin |
|
676 |
Levonorgestrel |
|
677 |
Levothyroxine |
|
678 |
L-Histidine hydrochloride |
|
679 |
Lidoflazine |
|
680 |
Lignocaine and its salts (except topical use 2% Schedule 3 and less than 2% Schedule 4) |
|
681 |
Lincomycin |
|
682 |
Lincomycin hydrochloride |
|
683 |
Liothyronine sodium |
|
684 |
Lisinopril |
|
685 |
Lithium carbonate |
|
686 |
Lithium sulphate |
|
687 |
Lobeline; its salts |
|
688 |
Lofepramine |
|
689 |
Lofepramine hydrochloride |
|
690 |
Lomustine |
|
691 |
Lopinavir |
|
692 |
Losartan |
|
693 |
Loxapine succinate |
|
694 |
L-Pyroglutamyl-L-histidyl-L-proline amide |
|
695 |
L-Tryptophan |
|
696 |
Luteinising hormone |
|
697 |
Lymecycline |
|
698 |
Lynoestrenol |
|
699 |
Mafenide acetate |
|
700 |
Mafenide hydrochloride |
|
701 |
Mafenite propionate |
|
702 |
Magnesium bromide |
|
703 |
Magnesium fluoride |
|
704 |
Magnesium metrizoate |
|
705 |
Mandragora autumnalis |
|
706 |
Mannomustine hydrochloride |
|
707 |
Maprotiline hydrochloride |
|
708 |
Mebeverine hydrochloride (except in preparation for oral use Schedule 3) |
|
709 |
Mebhydrolin napadisylate |
|
710 |
Mecamylamine hydrochloride |
|
711 |
Meclofenoxate hydrochloride |
|
712 |
Medrogestrone |
|
713 |
Medroxyprogesterone acetate |
|
714 |
Mefenamic acid (except for oral use in dysraenorrhoea Schedule 3) |
|
715 |
Mefruside |
|
716 |
Megestrol |
|
717 |
Megestrol acetate |
|
718 |
Meglumine iodoxamate |
|
719 |
Meglumine ioglycamate |
|
720 |
Meglumine iotraxate |
|
721 |
Meglumine ioxaglate |
|
722 |
Melarsonyl potassium |
|
723 |
Melengestrol |
|
724 |
Melengestrol acetate |
|
725 |
Meloxicam |
|
726 |
Melphalan |
|
727 |
Melphalan hydrochloride |
|
728 |
Mepenzolate bromide |
|
729 |
Mephenesin (except in preparation for oral use Schedule 3) |
|
730 |
Mepivacaine hydrochloride |
|
731 |
Meptazinol hydrochloride |
|
732 |
Mequitazine |
|
733 |
Mercaptopurine |
|
734 |
Mercuderamide |
|
735 |
Meropenem |
|
736 |
Mersalyl |
|
737 |
Mersalyl acid |
|
738 |
Mesna |
|
739 |
Mesterolone |
|
740 |
Metabutethamine hydrochloride |
|
741 |
Metaraminol tartrate |
|
742 |
Metformin hydrochloride |
|
743 |
Methacycline |
|
744 |
Methacycline calcium |
|
745 |
Methacycline hydrochloride |
|
746 |
Methallenoestril |
|
747 |
Methandienone |
|
748 |
Methandriol |
|
749 |
Methdilazine hydrochloride |
|
750 |
Methenolone acetate |
|
751 |
Methenolone enanthate |
|
752 |
Methicillin sodium |
|
753 |
Methimazole |
|
754 |
Methindizate hydrochloride |
|
755 |
Methixene |
|
756 |
Methixene hydrochloride |
|
757 |
Methohexitone sodium |
|
758 |
Methoserpidine |
|
759 |
Methotrexate |
|
760 |
Methotrexate sodium |
|
761 |
Methotrimeprazine |
|
762 |
Methotrimeprazine hydrochloride |
|
763 |
Methoxamine hydrochloride |
|
764 |
Methylclothiazide |
|
765 |
Methyldopa |
|
766 |
Methyldopate hydrochloride |
|
767 |
Methylephedrine hydrochloride |
|
768 |
Methylergotamine maleate |
|
769 |
Methylpentynol |
|
770 |
Methylpetynol carbamate |
|
771 |
Methylprednisolone |
|
772 |
Methylprednisolone acetate |
|
773 |
Methylprednisolone sodium succinate |
|
774 |
Methyltestosterone |
|
775 |
Methylyhiouracil |
|
776 |
Methysergide maleate |
|
777 |
Metoclopramide hydrochloride |
|
778 |
Metolazone |
|
779 |
Metomidate hydrochloride |
|
780 |
Metoprolol tartrate |
|
781 |
Metronidazole |
|
782 |
Metronidazole benzoate |
|
783 |
Mexiletine hydrochloride |
|
784 |
Mezlocillin sodium |
|
785 |
Mianserin hydrochloride |
|
786 |
Minocycline |
|
787 |
Minocycline hydrochloride |
|
788 |
Minoxidil (except in topical preparation Schedule 3) |
|
789 |
Mirtazapine |
|
790 |
Mithramycin |
|
791 |
Mitomycin C |
|
792 |
Mitopodozide |
|
793 |
Mitozantrone hydrochloride |
|
794 |
Molindone hydrochloride |
|
795 |
Mometasone |
|
796 |
Montelukast |
|
797 |
Moxifloxacin |
|
798 |
Moxonidine |
|
799 |
Mustine hydrochloride |
|
800 |
Mycophenolate |
|
801 |
Nadolol |
|
802 |
Naftidofuryl oxalate |
|
803 |
Nalbuphine hydrochloride |
|
804 |
Nalidixic acid |
|
805 |
Nalorphine hydrobromide |
|
806 |
Naloxone hydrochloride |
|
807 |
Nandrolone decanoate |
|
808 |
Nandrolone laurate |
|
809 |
Nandrolone phenylpropionate |
|
810 |
Naproxen |
|
811 |
Naproxen sodium |
|
812 |
Natamycin |
|
813 |
N-Benzoyl sulphanilamide |
|
814 |
Nebivolol |
|
815 |
Nedocromil sodium |
|
816 |
Nefopam hydrochloride |
|
817 |
Neoarsephenamine |
|
818 |
Neomycin and its salts (except topical preparation, ophathalmic preparation Schedule 3) |
|
819 |
Neostigmine bromide |
|
820 |
Neostigmine methylsulphate |
|
821 |
Netilmicin sulphate |
|
822 |
Nevirapine |
|
823 |
Nialamide |
|
824 |
Nicotinaldemyde thio-semicarbazone |
|
825 |
Nicoumalone |
|
826 |
Nifedipine |
|
827 |
Nikethamide |
|
828 |
Niridazole |
|
829 |
Nitrofurantoin |
|
830 |
Nitroxoline |
|
831 |
Nizatidine (except for short term relief of heartburn, dyspepsia and hyperacidity 150mg-300mg per single dose maximum dose 4200mg Schedule 3) |
|
832 |
N-Methyl acetanilide |
|
833 |
Nomifensine hydrogen maleate |
|
834 |
Noradrenaline |
|
835 |
Noradrenaline acid tartrate |
|
836 |
Norethandrolone |
|
837 |
Norethisterone |
|
838 |
Norethynodrel |
|
839 |
Norfloxacin |
|
840 |
Norgestrel |
|
841 |
Northisterone acetate |
|
842 |
Northisterone heptanoate |
|
843 |
Nortriptyline hydrochloride |
|
844 |
Novobiocin calcium |
|
845 |
Novobiocin sodium |
|
846 |
Oestradiol |
|
847 |
Oestradiol benzanoate |
|
848 |
Oestradiol cypaionate |
|
849 |
Oestradiol dipropionate |
|
850 |
Oestradiol diundecanoate |
|
851 |
Oestradiol enanthate |
|
852 |
Oestradiol phenylpropionate |
|
853 |
Oestradiol undecanoate |
|
854 |
Oestradiol valerate |
|
855 |
Oestriol |
|
856 |
Oestriol di-hemisuccinate |
|
857 |
Oestrogenic substances, conjugated |
|
858 |
Oestrone |
|
859 |
Ofloxacin |
|
860 |
Olanzapine |
|
861 |
Oleandomycin phosphate |
|
862 |
Omeprazole (except for 14-day treatment for frequent heartburn at a daily dose of 20 mg in package sizes of no more than 280 mg of omeprazole Schedule 3) |
|
863 |
Ondansetron |
|
864 |
Opipramol hydrochloride |
|
865 |
Orciprenaline sulphate and its salts (except for use in cough preparation Schedule 3) |
|
866 |
Orthocaine |
|
867 |
Ouabain |
|
868 |
Ovarin gland, dried |
|
869 |
Oxaliplatin |
|
870 |
Oxamniquine |
|
871 |
Oxandrolone |
|
872 |
Oxantel pamoate |
|
873 |
Oxatomide |
|
874 |
Oxbuprocaine hydrochloride |
|
875 |
Oxcarbazepine |
|
876 |
Oxedrine tartrate |
|
877 |
Oxolinic acid |
|
878 |
Oxophernasine hydrochloride |
|
879 |
Oxophernasine tartrate |
|
880 |
Oxpentifyline |
|
881 |
Oxprenolol hydrochloride |
|
882 |
Oxybutynin |
|
883 |
Oxymeterone |
|
884 |
Oxymetholone |
|
885 |
Oxypertine |
|
886 |
Oxypertine hydrochloride |
|
887 |
Oxyphenbutazone |
|
888 |
Oxyphencyclamine hydrochloride |
|
889 |
Oxyphenonium bromide |
|
890 |
Oxytetracycline and its salts (except for topical and ophthalmic preparation Schedule 3) |
|
891 |
Oxytocins, natural and synthetic |
|
892 |
Paclitaxel |
|
893 |
Pancuronium bromide |
|
894 |
Pantoprazole (except for the 14-day treatment for frequent heartburn, at a daily dose of 20 mg and in package sizes of no more than 280 mg of pantoprazole Schedule 3) |
|
895 |
Papaverine |
|
896 |
Papaverine hydrochloride |
|
897 |
Papaveroline |
|
898 |
Papaveroline 2-sulphonic acid |
|
899 |
Paraldehyde |
|
900 |
Paramethadione |
|
901 |
Paramethasone acetate |
|
902 |
Parathyroid gland |
|
903 |
Pargyline hydrochloride |
|
904 |
Paromycin sulphate |
|
905 |
Paroxetine |
|
906 |
Pecilocin |
|
907 |
Pempidine tartrate |
|
908 |
Penbutolol sulphate |
|
909 |
Penethamate |
|
910 |
Penicillamine |
|
911 |
Penicillamine hydrochloride |
|
912 |
Penicillin V |
|
913 |
Pentamidine |
|
914 |
Pentolinium tartrate |
|
915 |
Pentoxifylline |
|
916 |
Perhexiline hydrogen maleate |
|
917 |
Pericyazine |
|
918 |
Perindopril |
|
919 |
Perphenazine |
|
920 |
Phebutrazate hydrochloride |
|
921 |
Phenacaine |
|
922 |
Phenacemide |
|
923 |
Phenbenicillin potassium |
|
924 |
Phenelzine sulphate |
|
925 |
Phenethicillin potassium |
|
926 |
Pheneturide |
|
927 |
Phenformine hydrochloride |
|
928 |
Phenglutarimide hydrochloride |
|
929 |
Phenindone |
|
930 |
Phenoxybenzamine hydrochloride |
|
931 |
Phenoxymethylpenicillin |
|
932 |
Phenoxymethylpenicillin calcium |
|
933 |
Phenoxymethylpenicillin potassium |
|
934 |
Phensuximide |
|
935 |
Phentolamine hydrochloride |
|
936 |
Phentolamine mesylate |
|
937 |
Phenyl aminosalicylate |
|
938 |
Phenylbutazone |
|
939 |
Phenylbutazone sodium |
|
940 |
Phenylephrine hydrochloride (except for nasal, flu & ophthalmic preparation Schedule 3) |
|
941 |
Phenytoin |
|
942 |
Phenytoin sodium |
|
943 |
Pheprocoumon |
|
944 |
Phernasone sulphoxylate |
|
945 |
Phthalylsulphacetamide |
|
946 |
Phthalylsulphathiazole |
|
947 |
Physostigmine |
|
948 |
Physostigmine aminoxide salicylate |
|
949 |
Physostigmine salicylate |
|
950 |
Physostigmine sulphate |
|
951 |
Pilocarpine |
|
952 |
Pilocarpine hydrochloride |
|
953 |
Pilocarpine nitrate |
|
954 |
Pimozide |
|
955 |
Pindolol |
|
956 |
Pioglitazone |
|
957 |
Pipenzolate bromide |
|
958 |
Piperacillin sodium |
|
959 |
Piperidolate hydrochloride |
|
960 |
Pipothiazine palmitate |
|
961 |
Piracetam |
|
962 |
Pirbuterol acetate |
|
963 |
Pirbuterol hydrochloride |
|
964 |
Pirentanide |
|
965 |
Pirenzepine hydrochloride |
|
966 |
Piroxicam (except topical preparation and oral for use in acute gout attack maximum 100mg, per single dose 20mg Schedule 3) |
|
967 |
Pituitary powdered (posterior globe) |
|
968 |
Pituitatry gland (whole dried) |
|
969 |
Pivampicillin hydrochloride |
|
970 |
Pivmecillinam |
|
971 |
Pivmecillinam hydrochloride |
|
972 |
Pizotifen and its salts (except cough preparation Schedule 3) |
|
973 |
Plicamycin |
|
974 |
Poldine methylsulphate |
|
975 |
Polidexide |
|
976 |
Polidexide hydrochloride |
|
977 |
Polidexide sulphate |
|
978 |
Polymyxin B sulphate (except topical & ophthalmic preparation Schedule 3) |
|
979 |
Polyoestradiol phosphate |
|
980 |
Polythiazide |
|
981 |
Potassium aminosalicylate |
|
982 |
Potassium arsenite |
|
983 |
Potassium bromide |
|
984 |
Potassium cancrenoate |
|
985 |
Potassium clavulanate |
|
986 |
Potassium perchlorate |
|
987 |
Pralidoxime chloride |
|
988 |
Pralidoxime iodide |
|
989 |
Pralidoxime mesylate |
|
990 |
Pramipexole |
|
991 |
Pravastatin |
|
992 |
Prazosin hydrochloride |
|
993 |
Prednisolone |
|
994 |
Prednisolone 21-steaglate |
|
995 |
Prednisolone acetate |
|
996 |
Prednisolone butylacetate |
|
997 |
Prednisolone hexanoate |
|
998 |
Prednisolone m-sulphobenzoate |
|
999 |
Prednisolone pivalate |
|
1000 |
Prednisolone sodium m-sulphobenzoate |
|
1001 |
Prednisolone sodium phosphate |
|
1002 |
Prednisone |
|
1003 |
Prednisone acetate |
|
1004 |
Prenalterol hydrochloride |
|
1005 |
Prenylamine lactate |
|
1006 |
Prilocaine hydrochloride |
|
1007 |
Primaquine phosphate |
|
1008 |
Primodine |
|
1009 |
Probenecid |
|
1010 |
Probucol |
|
1011 |
Procainamide hydrochloride |
|
1012 |
Procaine hydrochloride |
|
1013 |
Procaine penicillin |
|
1014 |
Procarbazine hydrochloride |
|
1015 |
Prochlorperazine edisylate |
|
1016 |
Prochlorperazine maleate |
|
1017 |
Prochlorperazine mesylate |
|
1018 |
Procyclidine hydrochloride |
|
1019 |
Progesterone |
|
1020 |
Proguanil hydrochloride |
|
1021 |
Prolintane hydrochloride |
|
1022 |
Promazine embonate |
|
1023 |
Promazine hydrochloride |
|
1024 |
Promethazine and its salts (except topical and oral use Schedule 3) |
|
1025 |
Propanidid |
|
1026 |
Propantheline bromide |
|
1027 |
Propicillin potassium |
|
1028 |
Propiomazine hydrogen maleate |
|
1029 |
Propofol |
|
1030 |
Propranolol hydrochloride |
|
1031 |
Propylphenazone |
|
1032 |
Propylthiouracil |
|
1033 |
Proquamezine fumarate |
|
1034 |
Proquazone |
|
1035 |
Prostaglandin F2 alpha tromethamine |
|
1036 |
Protamine sulphate |
|
1037 |
Prothionamide |
|
1038 |
Prothipendyl hydrochloride |
|
1039 |
Protriptyline hydrochloride |
|
1040 |
Proxymetacaine hydrochloride |
|
1041 |
Pseudoephrine hydrochloride |
|
1042 |
Pseudoephrine sulphate |
|
1043 |
Pyrazinamide |
|
1044 |
Pyridostigmine bromide |
|
1045 |
Pyrimethamine |
|
1046 |
Quetiapine |
|
1047 |
Quinapril |
|
1048 |
Quinestradiol |
|
1049 |
Quinestrol |
|
1050 |
Quinethazone |
|
1051 |
Quingestanol |
|
1052 |
Quinidine |
|
1053 |
Quinidine bisulphate |
|
1054 |
Quinidine phenylethylbarbiturate |
|
1055 |
Quinidine polygalacturonate |
|
1056 |
Quinuronium sulphate |
|
1057 |
Rabeprazole |
|
1058 |
Racephedrlne hydrochloride |
|
1059 |
Raltegravir |
|
1060 |
Ramipril |
|
1061 |
Ranitidine and its salts (except in concentrations of 150 mg or less per oral dosage unit and indicated for the treatment of heartburn, in package sizes containing more than 4500 mg of ranitidine Schedule 3) |
|
1062 |
Rauwolfia (serpetina and vomitoria) |
|
1063 |
Reproterol hydrochloride |
|
1064 |
Rescinnamide |
|
1065 |
Reserpine |
|
1066 |
Rfamide |
|
1067 |
Rifampicin |
|
1068 |
Rifamycin |
|
1069 |
Rimiterol hydrobromide |
|
1070 |
Risedronic acid |
|
1071 |
Risperidone |
|
1072 |
Ritodrine hydrochloride |
|
1073 |
Ritonavir |
|
1074 |
Rolitetracycline nitrate |
|
1075 |
Ropinirole |
|
1076 |
Rosuvastatin |
|
1077 |
Rosuvastatin |
|
1078 |
Roxithromycin |
|
1079 |
Salazosulphadimidine |
|
1080 |
Salbutamol |
|
1081 |
Salbutamol and its salts (except inhaler, autohaler and oral use Schedule 3) |
|
1082 |
Salbutamol sulphate |
|
1083 |
Salmetrol |
|
1084 |
Saquinavir |
|
1085 |
Saxagliptin |
|
1086 |
Selegiline hydrochloride |
|
1087 |
Sera and antisera |
|
1088 |
Sertraline |
|
1089 |
Serum gonadotrophin |
|
1090 |
Sibutramine |
|
1091 |
Simvastatin |
|
1092 |
Sissomycin sulphate |
|
1093 |
Sodium aminosalicylate |
|
1094 |
Sodium antimonylgluconate |
|
1095 |
Sodium apolate |
|
1096 |
Sodium arsanilate |
|
1097 |
Sodium arsenite |
|
1098 |
Sodium bromated |
|
1099 |
Sodium bromide |
|
1100 |
Sodium cacodylate |
|
1101 |
Sodium cromoglycate (except for use in ophthalmic & inhalation preparation Schedule 3) |
|
1102 |
Sodium ethacrynate |
|
1103 |
Sodium fluoride |
|
1104 |
Sodium fucidate (except topical preparation Schedule 3) |
|
1105 |
Sodium methylarsinate |
|
1106 |
Sodium metrizoate |
|
1107 |
Sodium monofluorophosphate |
|
1108 |
Sodium stibogluconate |
|
1109 |
Sodium valproate |
|
1110 |
Sotalol hydrochloride |
|
1111 |
Spectinomycin |
|
1112 |
Spiramycin |
|
1113 |
Spiramycin adipate |
|
1114 |
Spirinolactone |
|
1115 |
Stannous fluoride |
|
1116 |
Stanolone |
|
1117 |
Stanozolol |
|
1118 |
Stilboestrol |
|
1119 |
Stilboestrol dipropionate |
|
1120 |
Streptodornase |
|
1121 |
Streptokinase |
|
1122 |
Streptomycin |
|
1123 |
Streptomycin sulphate |
|
1124 |
Strychnine |
|
1125 |
Strychnine arsenate |
|
1126 |
Strychnine hydrochloride |
|
1127 |
Succinylsulphathiozole |
|
1128 |
Sucralfate |
|
1129 |
Sulbactam sodium |
|
1130 |
Sulconazole nitrate |
|
1131 |
Sulfabromethazine |
|
1132 |
Sulfacytine |
|
1133 |
Sulfadicramide |
|
1134 |
Sulfadoxine |
|
1135 |
Sulfametopyrazine |
|
1136 |
Sulfamonomethoxine |
|
1137 |
Sulfapyrazole |
|
1138 |
Sulphacetamide |
|
1139 |
Sulphacetamide and its salts (except topical and ophthalmic use Schedule 3) |
|
1140 |
Sulphacetamide sodium |
|
1141 |
Sulphachlorpyridazine |
|
1142 |
Sulphadiazine |
|
1143 |
Sulphadiazine sodium |
|
1144 |
Sulphadimethoxine |
|
1145 |
Sulphadimidine |
|
1146 |
Sulphadimidine sodium |
|
1147 |
Sulphafurazole |
|
1148 |
Sulphafurazole diethanolamine |
|
1149 |
Sulphaguanidine |
|
1150 |
Sulphaloxic acid |
|
1151 |
Sulphamerazine |
|
1152 |
Sulphamerazine sodium |
|
1153 |
Sulphamethizole |
|
1154 |
Sulphamethoxazole |
|
1155 |
Sulphamethoxydiazine |
|
1156 |
Sulphamethoxypyridazine |
|
1157 |
Sulphamethoxypyridazine sodium |
|
1158 |
Sulphamethylphenazole |
|
1159 |
Sulphamoxole |
|
1160 |
Sulphanilamide |
|
1161 |
Sulphaphenazole |
|
1162 |
Sulphapyridine |
|
1163 |
Sulphapyridine sodium |
|
1164 |
Sulphaquinoxaline |
|
1165 |
Sulphaquinoxaline sodium |
|
1166 |
Sulpharsphenamine |
|
1167 |
Sulphasalazine |
|
1168 |
Sulphasomidine |
|
1169 |
Sulphasomidine sodium |
|
1170 |
Sulphathiourea |
|
1171 |
Sulphathiozole |
|
1172 |
Sulphathiozole sodium |
|
1173 |
Sulphatolamide |
|
1174 |
Sulphaurea |
|
1175 |
Sulphinpyrazone |
|
1176 |
Sulphomyxin |
|
1177 |
Sulpiride |
|
1178 |
Sulthiame |
|
1179 |
Sumatriptan |
|
1180 |
Suxamethonium bromide |
|
1181 |
Suxamethonium chloride |
|
1182 |
Suxethonium bromide |
|
1183 |
Tacrine hydrochloride |
|
1184 |
Talampicillin |
|
1185 |
Talampicillin hydrochloride |
|
1186 |
Talampicillin napsylate |
|
1187 |
Tamoxifen |
|
1188 |
Tamoxifen citrate |
|
1189 |
Tamsulosin |
|
1190 |
Teclothiazide potassium |
|
1191 |
Teicoplanin |
|
1192 |
Telmisartan |
|
1193 |
Temozolomide |
|
1194 |
Tenofovir |
|
1195 |
Terbutaline |
|
1196 |
Terbutaline sulphate |
|
1197 |
Testosterone |
|
1198 |
Testosterone 17B chloral hemiacetal |
|
1199 |
Testosterone acetate |
|
1200 |
Testosterone cyclohexylpropionate |
|
1201 |
Testosterone cypionate |
|
1202 |
Testosterone decanoate |
|
1203 |
Testosterone enanthate |
|
1204 |
Testosterone isocaproate |
|
1205 |
Testosterone phenylpropionate |
|
1206 |
Testosterone propionate |
|
1207 |
Testosterone undecanoate |
|
1208 |
Tetrabenazine |
|
1209 |
Tetracaine |
|
1210 |
Tetracosatrin |
|
1211 |
Tetracosatrin acetate |
|
1212 |
Tetracycline and its salts (except for topical and ophthalmic use Schedule 3) |
|
1213 |
Thallium acetate |
|
1214 |
Theophylline |
|
1215 |
Thiethylperazine |
|
1216 |
Thiethylperazine di-(hydrogen malate) |
|
1217 |
Thiocarlide |
|
1218 |
Thioguinine |
|
1219 |
Thiopentone sodium |
|
1220 |
Thiopropazate hydrochloride |
|
1221 |
Thioproperazine mesylate |
|
1222 |
Thioridazine |
|
1223 |
Thioridazine hydrochloride |
|
1224 |
Thiotepa |
|
1225 |
Thiothexene |
|
1226 |
Thiouracil |
|
1227 |
Thymoxamine hydrochloride |
|
1228 |
Thyroid |
|
1229 |
Thyrotrophin |
|
1230 |
Thyrotrophin releasing hormone |
|
1231 |
Thyroxine sodium |
|
1232 |
Tianulin hydrogen fumarate |
|
1233 |
Tiaprofenic acid |
|
1234 |
Ticarcillin sodium |
|
1235 |
Tigloidine hydrobromide |
|
1236 |
Timolol maleate |
|
1237 |
Tioconazole (except topical & vaginal use Schedule 3) |
|
1238 |
Tiotropium bromide |
|
1239 |
Tobramycin |
|
1240 |
Tobramycin sulphate |
|
1241 |
Tocainide hydrochloride |
|
1242 |
Tofenacin hydrochloride |
|
1243 |
Tolazamide |
|
1244 |
Tolazoline hydrochloride |
|
1245 |
Tolbutamide |
|
1246 |
Tolbutamide sodium |
|
1247 |
Tolmetin sodium dehydrate |
|
1248 |
Tolperisone |
|
1249 |
Topiramate |
|
1250 |
Torasemide |
|
1251 |
Totaquine |
|
1252 |
Tranexamic acid |
|
1253 |
Tranylcypromine sulphate |
|
1254 |
Trazadone |
|
1255 |
Treosulfan |
|
1256 |
Treotinon |
|
1257 |
Tretamine |
|
1258 |
Tretinoin |
|
1259 |
Triacetyloleandomycin |
|
1260 |
Triamcinolone |
|
1261 |
Triamcinolone acetonide |
|
1262 |
Triamcinolone diacetate |
|
1263 |
Triamcinolone hexacetonide |
|
1264 |
Triamterene |
|
1265 |
Tribromoethyl alcohol |
|
1266 |
Triclofos sodium |
|
1267 |
Tricyclamol chloride |
|
1268 |
Trienbolone acetate |
|
1269 |
Trientine dihydrochloride |
|
1270 |
Trifluoperazine |
|
1271 |
Trifluoperazine hydrochloride |
|
1272 |
Trifluoperidol |
|
1273 |
Trifluoperidol hydrochloride |
|
1274 |
Trilostane |
|
1275 |
Trimepramine mesylate |
|
1276 |
Trimeprazine |
|
1277 |
Trimeprazine tartrate |
|
1278 |
Trimetaphan camsylate |
|
1279 |
Trimetazidine |
|
1280 |
Trimetazidine hydrochloride |
|
1281 |
Trimethoprim |
|
1282 |
Trimipramine maleate |
|
1283 |
Trimustine hydrochloride |
|
1284 |
Tripolidine |
|
1285 |
Tropicamide |
|
1286 |
Tubocurarine chloride |
|
1287 |
Tybamate |
|
1288 |
Tylosin |
|
1289 |
Tylosin phosphate |
|
1290 |
Tylosin tartrate |
|
1291 |
Tyrothricin |
|
1292 |
Uramustine |
|
1293 |
Urea stibamine |
|
1294 |
Uridine-5-triphosphoric acid |
|
1295 |
Urifollitrophin |
|
1296 |
Urokinase |
|
1297 |
Ursodeoxycholic acid |
|
1298 |
Vaccines |
|
1299 |
Valaciclovir |
|
1300 |
Valproic acid |
|
1301 |
Valsartan |
|
1302 |
Vancomycin hydrochloride |
|
1303 |
Vasopressin tannate |
|
1304 |
Vecuronium bromide |
|
1305 |
Venlafaxine |
|
1306 |
Verapamil hydrochloride |
|
1307 |
Vidagliptin |
|
1308 |
Viloxazine hydrochloride |
|
1309 |
Vinblastine sulphate |
|
1310 |
Vincristine sulphate |
|
1311 |
Vindesin sulphate |
|
1312 |
Vinorelbine |
|
1313 |
Viomycin pantothenate |
|
1314 |
Viomycin sulphate |
|
1315 |
Vitamin A |
|
1316 |
Vitamin A acetate |
|
1317 |
Vitamin A palmitate |
|
1318 |
Vitamin D |
|
1319 |
Vitamins |
|
1320 |
Warfarin |
|
1321 |
Warfarin sodium |
|
1322 |
Xylazine hydrochloride |
|
1323 |
Yohimbine hydrochloride |
|
1324 |
Zidovudine |
|
1325 |
Zimeldine hydrochloride |
|
1326 |
Zoledronic acid |
|
1327 |
Zomepirec sodium |
|
1328 |
Zopiclone |
|
1329 |
Zuclopenthixol hydrochloride |
|
(3) SCHEDULE 3 MEDICINES |
|
|
NO. |
NAME OF THE MEDICINE |
|
1 |
Acetylsalicylic acid label (1) |
|
2 |
Acetylsalicylic acid label (1) |
|
3 |
Aconite in preparations and mixtures of ms 0.02% |
|
4 |
Acyclovir |
|
5 |
Adrenaline, if- |
|
6 |
Adrenaline, if- (a) in inhalers |
|
7 |
Adrenaline, if- (b) in preparations for external use |
|
8 |
Aescin and its salts |
|
9 |
Aesculin |
|
10 |
Albendazole |
|
11 |
Allopurinol |
|
12 |
Amethocaine |
|
13 |
Amethocaine and its salts in preparations for non-parenteral use (except those intended for local ophthalmic use: Schedule 2). |
|
14 |
Amethocaine gentisate |
|
15 |
Amethocaine hydrochloride |
|
16 |
Astemizole |
|
17 |
Atropine & its salts in preparations for external use and anti-diarrhoeal preparations, (except those intended for local ophthalmic & parenteral use: Schedule 2) |
|
18 |
Atropine sulphate |
|
19 |
Azatadine maleate label (5) |
|
20 |
Belladonna alkaloid |
|
21 |
Benzocaine |
|
22 |
Benzocaine in preparations for external use and ms 4% (except preparations for local ophthalmic use: Schedule 2)) |
|
23 |
Benzoyl peroxide |
|
24 |
Benzoyl peroxide in preparations for external use with ms 10% |
|
25 |
Bromhexine hydrochloride |
|
26 |
Brompheniramine maleate |
|
27 |
Bupivacaine hydrochloride in preparations for non-parenteral use, (except those intended for local ophthalmic use: Schedule 2) |
|
28 |
Bupivacaine in preparations for non-parenteral use, (except those intended for local ophthalmic use: Schedule 2) |
|
29 |
Butacaine sulphate in preparations for non-parenteral use, (except those intended for local ophthalmic use: Schedule 2) |
|
30 |
Butalbital |
|
31 |
Butanilicaine phosphate in preparations for non-parenteral use, (except preparations intended for local ophthalmic use: Schedule 2) |
|
32 |
Butylscopolamine |
|
33 |
Cantharidin in preparations for external use and ms 0.01% |
|
34 |
Caramiphen edisylate in: |
|
35 |
Caramiphen edisylate in:(a) tablet preparations and ms 7.5mg (calculated as base) |
|
36 |
Caramiphen edisylate in:(b) liquid preparations and ms 0.1% (calculated as base) |
|
37 |
Carbenoxolone sodium in preparations for external use ms 2% |
|
38 |
Carbocisteine |
|
39 |
Cetirizine |
|
40 |
Cetirizine and its salts |
|
41 |
Chloramphenicol |
|
42 |
Chloramphenicol cinnamate |
|
43 |
Chloramphenicol palmitate |
|
44 |
Chloramphenicol sodium succinate |
|
45 |
Chlorhexidine |
|
46 |
Chloroquine phosphate |
|
47 |
Chloroquine sulphate |
|
48 |
Chlorpherinamine maleate, label (5) (But in preparations for parenteral use: Schedule 2) |
|
49 |
Cimetidine |
|
50 |
Cimetidine hydrochloride |
|
51 |
Cinchocaine hydrochloride in preparations for non-parenteral use ms 3%, (except preparations for local ophthalmic use: Schedule 2) |
|
52 |
Cinchocaine in preparations for non-parenteral use and ms 3%, (except preparations for local ophthalmic use: Schedule 2) |
|
53 |
Cinnarizine |
|
54 |
Clemastine, label (5) |
|
55 |
Clioquinol |
|
56 |
Clioquinol in preparations for external use |
|
57 |
Clotrimazole |
|
58 |
Colchicine |
|
59 |
Cromoglycate Sodium |
|
60 |
Cromolyn Sodium |
|
61 |
Cyanocobalamin (except parenteral use Schedule 2) |
|
62 |
Cyclizine hydrochloride in preparations for non-parenteral use |
|
63 |
Cyproheptadine |
|
64 |
Dequalinium chloride in: |
|
65 |
Dequalinium chloride in:(a) throat lozenges or throat pastilles and ms 0.25mg |
|
66 |
Dequalinium chloride in:(b) external paint preparations and ms 1% |
|
67 |
Desloratadine |
|
68 |
Dextromethorphan hydrobromide |
|
69 |
Dextromethorphan hydrobromide in preparations for internal use with md 15mg (calculated as base) |
|
70 |
Diclofenac and its salts |
|
71 |
Dicyclomine hydrochloride |
|
72 |
Diethylamine Salicylate |
|
73 |
Di-Iodohydroxyquinoline |
|
74 |
Dimenhydrinate in preparations for non-parenteral use label (5) |
|
75 |
Dimethindine maleate, label (5) |
|
76 |
Dimethisoquin hydrochloride in preparations for non-parenteral use, (except preparations for local ophthalmic use: Schedule 2) |
|
77 |
Diphenhydramine hydrochloride in preparations for non-parenteral use, label (5) |
|
78 |
Diphenylpyraline hydrochloride, label (5) |
|
79 |
Econazole |
|
80 |
Econazole and its salts |
|
81 |
Econazole nitrate |
|
82 |
Emetine hydrochloride in preparations for internal or external use and ms 1 % (calculated as base) |
|
83 |
Emetine in preparations for internal or external use and ms 1 % |
|
84 |
Ephedrine & its salts in: (a) preparations for internal use (except nasal sprays and nasal drops) with md 30mg (calculated as base) and mdd 60mg (calculated as base) label (4) |
|
85 |
Ephedrine & its salts: (b) nasal sprays or nasal drops and ms 2% (calculated as base), label (4) |
|
86 |
Ergotamine tartrate |
|
87 |
Etofylline |
|
88 |
Ferrous & its salts (except Iron in preparations for internal use and mdd 100mg (calculated as iron) Schedule 4 and Iron preparation for parenteral use Schedule 2) |
|
89 |
Ferrous arsenate |
|
90 |
Fexofenadine Hydrochloride |
|
91 |
Folic acid |
|
92 |
Folic acid (Schedule 2) in preparations for internal use and mdd 500 micrograms |
|
93 |
Glucagon |
|
94 |
Gramicidin in preparations for external use and ms 0.02% |
|
95 |
Griseofulvin |
|
96 |
Heparin |
|
97 |
Heparin calcium |
|
98 |
Hexachlorophene in preparations for external use and: |
|
99 |
Hexachlorophene in preparations for external use and:(a) in soaps with ms more than 0.1% but not more than 2% label (6) |
|
100 |
Hexachlorophene in preparations for external use and:(b) in medicines other than soaps or aerosols with ms more than 0.1% but not more than 0.75% label (6) |
|
101 |
Homatropine in preparations for external use (except preparations for local ophthalmic use: Schedule 2) |
|
102 |
Hydrocortisone |
|
103 |
Hydrocortisone 17-butyrate |
|
104 |
Hydrocortisone acetate |
|
105 |
Hydrocortisone caprylate |
|
106 |
Hydrocortisone hydrogen succinate |
|
107 |
Hydrocortisone sodium phosphate |
|
108 |
Hydrocortisone sodium succinate |
|
109 |
Hydroxychloroquine sulphate for the prophylaxis of malaria Labelling for malaria prophylaxis |
|
110 |
Hydroxymethylgramicidin in throat lozenges or throat pastilles |
|
111 |
Hyoscine |
|
112 |
Hyoscine butylbromide |
|
113 |
Hyoscine hydrobromide |
|
114 |
Hyoscine methobromide |
|
115 |
Hyoscine methonitrate |
|
116 |
Ibuprofen |
|
117 |
Idoxuridine in preparations for external use (except preparations for local ophthalmic use:Schedule 2) |
|
118 |
Indomethacin |
|
119 |
Ipecacuanha see emetine |
|
120 |
Iron; its salts |
|
121 |
Isoconazole nitrate |
|
122 |
Ketoconazole |
|
123 |
Ketotifen |
|
124 |
L-Histidine hydrochloride used as an ingredient in dietary or nutritional medicines as an amino acid |
|
125 |
Lignocaine |
|
126 |
Lignocaine hydrochloride |
|
127 |
Loperamide hydrochloride |
|
128 |
Loratadine |
|
129 |
Mebendazole |
|
130 |
Mebeverine hydrochloride |
|
131 |
Mefenamic acid |
|
132 |
Mefloquine Hydrochloride |
|
133 |
Mephenesin |
|
134 |
Mepivacaine hydrochloride in preparations for non-parenteral use, (except those intended for local ophthalmic use: Schedule 2) |
|
135 |
Mepyramine maleate |
|
136 |
Metabutethamine hydrochloride in preparations for non-parenteral use, (except preparations for local ophthalmic use) |
|
137 |
Methylephedrine hydrochloride in preparations for internal use with md 30mg and mdd 60mg |
|
138 |
Miconazole |
|
139 |
Miconazole and its salts |
|
140 |
Miconazole nitrate |
|
141 |
Mupirocin |
|
142 |
N-acetylcysteine |
|
143 |
Naphazoline and its salts in nasal sprays or nasal drops not containing liquid paraffin as vehicle and ms 0.05% |
|
144 |
Naphazoline and its salts: (a) in nasal sprays or nasal drops not containing liquid paraffin as vehicle and ms 0.05% |
|
145 |
Naphazoline and its salts: (b) in eye drops and ms 0.015% |
|
146 |
Naphazoline hydrochloride |
|
147 |
Naphazoline nitrate |
|
148 |
Neomycin |
|
149 |
Neomycin palmitate |
|
150 |
Neomycin sulphate |
|
151 |
Neomycin undecanoate |
|
152 |
Niclosamide |
|
153 |
Nitrofurazone |
|
154 |
Nitrofurazone in preparations for external use |
|
155 |
Nystatin |
|
156 |
Orphenadrine and its salts |
|
157 |
Orphenadrine citrate |
|
158 |
Orphenadrine hydrochloride |
|
159 |
Orthocaine in preparations for non-parenteral use, (except those intended for local ophthalmic use: Schedule 2) |
|
160 |
Oxybuprocaine hydrochloride in preparations for non-parenteral use, (except those intended for local ophthalmic use: Schedule 2) |
|
161 |
Oxymetazoline |
|
162 |
Oxytetracycline |
|
163 |
Oxytetracycline calcium |
|
164 |
Oxytetracycline dihydrate |
|
165 |
Oxytetracycline hydrochloride |
|
166 |
Paracetamol label (3) |
|
167 |
Phenacaine in preparations for non-parenteral use, (except those intended for local ophthalmic use) |
|
168 |
Phenazone |
|
169 |
Phenazone and derivatives |
|
170 |
Phenazone salicylate |
|
171 |
Phenindamine tartrate |
|
172 |
Pheniramine maleate |
|
173 |
Phenylephrine hydrochloride |
|
174 |
Piperazine & its salts |
|
175 |
Piroxicam |
|
176 |
Pizotifen |
|
177 |
Pizotifen hydrogen maleate |
|
178 |
Podophyllum resin in ointments or impregnated plasters for external use with ms 20% |
|
179 |
Polymyxin B sulphate |
|
180 |
Polyvinyl alcohol |
|
181 |
Potassium chloride |
|
182 |
Potassium chloride (except injectable Schedule 2) |
|
183 |
Potassium citrate |
|
184 |
Prilocaine hydrochloride in preparations for non-parenteral use, (except those intended for local ophthalmic use: Schedule 2) |
|
185 |
Proguanil hydrochloride for prophylaxis of malaria Labelling for malaria prophylaxis |
|
186 |
Proxymetacaine hydrochloride in preparations for non-parenteral use (except those intended for local ophthalmic use: Schedule 2) |
|
187 |
Pseodophedrine sulphate in preparations for internal use with md 60mg and mdd 180mg |
|
188 |
Pseudoephedrine and its salts (except in preparations for internal use with md 60mg and mdd 180mg Schedule 3) |
|
189 |
Pseudoephrine hydrochloride |
|
190 |
Pseudoephrine sulphate |
|
191 |
Pyrantel and its salts |
|
192 |
Pyrantel embonate |
|
193 |
Pyrantel tartrate |
|
194 |
Quinine and its salts (except in preparations for internal use md 100mg (calculated as base) and mdd 300mg (calculated as base) Schedule 3) |
|
195 |
Ranitidine hydrochloride |
|
196 |
Salbutamol |
|
197 |
Salbutamol sulphate |
|
198 |
Sildenafil |
|
199 |
Siver sulphadiazine |
|
200 |
Sodium apolate in preparations for external use |
|
201 |
Sodium arsenite in preparations for internal and external use and ms 0.013% |
|
202 |
Sodium cromoglycate |
|
203 |
Sodium fluoride: |
|
204 |
Sodium fluoride:(a) in preparations for use in the prevention of dental caries, other than dentifrices, in the form of: |
|
205 |
Sodium fluoride:(ii) mouth rinses other than those for daily use and ms 0.2% |
|
206 |
Sodium fluoride:(iii) mouth rinses for daily use and ms 0.05% |
|
207 |
Streptodornase in preparations for external use |
|
208 |
Streptokinase in preparations for external use |
|
209 |
Sulconazole in preparations for external use, (except vaginal use Schedule 2) |
|
210 |
Sulphacetamide |
|
211 |
Sulphacetamide sodium |
|
212 |
Terbinafine |
|
213 |
Terfenadine |
|
214 |
Tetracycline |
|
215 |
Tetracycline hydrochloride |
|
216 |
Tetracycline phosphate complex |
|
217 |
Tetrahydrozoline |
|
218 |
Tetryzoline Hydrochloride |
|
219 |
Theophylline |
|
220 |
Thiabendazole |
|
221 |
Tildenafil |
|
222 |
Tinidazole |
|
223 |
Tioconazole |
|
224 |
Tyrothricin in throat lozenges or throat pastilles |
|
225 |
Vardenafil |
|
226 |
Zinc Bacitracin |
|
(4) SCHEDULE 4 MEDICINES |
|
|
NO. |
NAME OF THE MEDICINE |
|
1 |
8-Hydroxyquinoline |
|
2 |
Aluminium and its salts |
|
3 |
Alverine Citrate |
|
4 |
Amino Acids |
|
5 |
Ammonium Chloride |
|
6 |
Amyl-M-Cresol |
|
7 |
Aniseed Oil |
|
8 |
Arachis Oil |
|
9 |
Ascorbic acid in preparations for non-parenteral use |
|
10 |
Benzoic Acid |
|
11 |
Benzydamine Hydrochloride |
|
12 |
Benzyl Benzoate |
|
13 |
Bisacodyl |
|
14 |
Boric acid |
|
15 |
Caffeine |
|
16 |
Calcium and its salts |
|
17 |
Camphor |
|
18 |
Carbon tetrachloride |
|
19 |
Carboxymethylcellulose Sodium |
|
20 |
Castor Oil |
|
21 |
Cetalkonium Chloride |
|
22 |
Cetrimide |
|
23 |
Cetylpyridinium Chloride |
|
24 |
Chlorbutol |
|
25 |
Chlorhexidine: |
|
26 |
Chlorhexidine:(a) for external use (except vaginal use: Schedule 3) |
|
27 |
Chlorhexidine: (b) in preparations for mouth wash and for use in the prevention of dental caries |
|
28 |
Cinnamon Oil |
|
29 |
Coal Tar |
|
30 |
Crotamiton |
|
31 |
Dimethicone |
|
32 |
Docusate Sodium |
|
33 |
Eucalyptus Oil |
|
34 |
Folic acid in preparations for internal use and mdd 200 micrograms |
|
35 |
Gentian Violet |
|
36 |
Glycerol |
|
37 |
Guaifenesin |
|
38 |
Hexachlorophene: in preparations for external use and: |
|
39 |
Hexachlorophene: in preparations for external use and:(a) in soaps with ms 0.1% label (6) |
|
40 |
Hexachlorophene: in preparations for external use and:(b) in aerosols with ms 0.1% label (6) |
|
41 |
Hexachlorophene: in preparations for external use and:(c) in medicines other than soaps or aerosols with ms 0.1% label (6) |
|
42 |
Hydroxyquinoline sulfate |
|
43 |
Ichthammol |
|
44 |
Kaolin |
|
45 |
Lactulose |
|
46 |
Liquid Paraffin |
|
47 |
Magaldrate |
|
48 |
Magnesium and its salts |
|
49 |
Magnesium trisilicate |
|
50 |
Menthol |
|
51 |
Methyl Salicylate |
|
52 |
Monosulfiram |
|
53 |
Oral Rehydration Salts |
|
54 |
Paracetamol in tablet preparations with ms 500mg and not more than 30 tablets label (3) |
|
55 |
Pectin |
|
56 |
Phenol |
|
57 |
Phenolphthalein |
|
58 |
Podophyllum Indian |
|
59 |
Podophyllum resin |
|
60 |
Potassium hydroxyquinoline sulfate |
|
61 |
Povidone-Iodine |
|
62 |
Pyridoxine |
|
63 |
Salicylic Acid |
|
64 |
Selenium Sulphide |
|
65 |
Sennosides A – B |
|
66 |
Simethicone |
|
67 |
Sodium Bicarbonate |
|
68 |
Sodium Chloride |
|
69 |
Sodium fluoride in dentifrices and ms 0.33% |
|
70 |
Sodium monofluorophosphate in dentifrices and ms 1.14% |
|
71 |
Stannous fluoride in dentifrices and ms 0.62% |
|
72 |
Tartaric Acid |
|
73 |
Trace Elements (except for parenteral use Schedule 2) |
|
74 |
Turpentine Oil |
|
75 |
Undecenoic Acid |
|
76 |
Urea |
|
77 |
Vitamin A in: :(a) preparations for internal use with mdd 7500 iu Vitamin A (2250 mcg Retinol equivalent) |
|
78 |
Vitamin A in: (b) preparations for external use |
|
79 |
Vitamin A acetate in: (a) preparations for internal use with mdd equivalent to 7500 iu Vitamin A (2250 mcg Retinol equivalent) |
|
80 |
Vitamin A acetate in: (b) preparations for external use |
|
81 |
Vitamin A palmitate in: (a) preparations for internal use with mdd equivalent to 7500 iu Vitamin A (2250 mcg Retinol equivalent) |
|
82 |
Vitamin A palmitate in: (b) preparations for external use |
|
83 |
Vitamin D in:(a) preparations for internal use with mdd 10 mcg |
|
84 |
Vitamin D in:(b) preparations for external use |
|
85 |
Vitamins, mixed in non-parenteral preparations |
|
86 |
Zinc Chloride |
|
87 |
Zinc Oxide |
|
88 |
Zinc sulphate in non-parenteral preparations (except in preparations for local ophthalmic use:Schedule 2) |
|
NOTES |
|
Explanation of abbreviations and other phrases used in lists of medicines |
|
md: (maximum dose) i.e. the maximum quantity of the drug or substance that is contained in the amount of a medicinal product which is recommended to be taken or administered at any one time. |
|
mdd: (maximum daily dose) i.e. the maximum quantity of the substance that is contained in the amount of a medicinal product which is recommended to be taken or administered in any period of 24 hours. |
|
ms: (maximum strength) i.e. either or, if so specified, both of the following: |
|
(a) the maximum quantity of the substance by weight or volume that is contained in the dosage unit of a medicinal product; or |
|
(b) the maximum percentage of the substance contained in a medicinal product calculated in terms of w/w, w/v, v/w or v/v, as appropriate. |
| external use: means for application to the skin, teeth, mucosa of the mouth, throat, nose, eye, ear, vagina or anal canal when a local action only is necessary and extensive systemic absorption is unlikely to occur. |
|
N.B. The following are not regarded as for external use: throat sprays, throat pastilles, throat lozenges, throat tablets, nasal drops, nasal sprays, nasal inhalations or teething preparations. |
|
oral use: means administration through the mouth. |
|
parenteral administration: means administration by breach of the skin or mucous membrane. |
(reg. 47)
|
Precursor chemicals in Tables I and II of the 1988 Convention |
|
Table I |
|
Acetic anhydride |
|
N-Acetylanthranilic acid |
|
Ephedrine |
|
Ergometrine |
|
Ergotamine |
|
Isosafrole |
|
Lysergic acid |
|
3,4-Methylenedioxyphenyl-2-propanone |
|
Norephedrine |
|
Phenylacetic acid |
|
alpha-Phenylacetoacetonitrile |
|
1-Phenyl-2-propanone |
|
Piperonal |
|
Potassium permanganate |
|
Pseudoephedrine |
|
Safrole |
|
Note: The salts of the substances are listed in the table whenever the existence of such salts is possible. |
|
Table II |
|
Acetone |
|
Anthranilic acid |
|
Ethyl ether |
|
Hydrochloric acid |
|
Methyl ethyl ketone |
|
Piperidine |
|
Sulphuric acid |
|
Toluene |
|
Note: The salts of the substances listed in the table whenever the existence of such salts is possible. |
(reg. 69)
|
Amphetamine |
|
Brolamphetamine (DOB, Bromo-STP) |
|
Bufotenine (N, N-Dimethylserotonin) |
|
Cannabis |
|
Cocaine |
|
Coca Leaf |
|
Cathinone |
|
DET or 3-[2-(diethylamino) ethyl] indole |
|
Dexamphetamine |
|
DMA or (+ or -)-2,5-dimethoxy-alpha-methylphenethylamine |
|
DMT or 3-[2-(dimethylamino) ethyl] indole |
|
DOET or (+ or -)-4-ethyl-2,5-dimethoxy-alpha-phenethylamine |
|
Ecgonine |
|
Eticyclidine (PCE) |
|
Fentanyl analogues (unless listed in another Schedule): acetyl-alpha-methyl-fentanyl alpha- methyl-fentanyl alpha-methyl-fentanyl-acetanilide alpha-methyl-thiofentanyl beta-hydroxy- fentanyl |
|
3-methyl-thiofentanyl |
|
3-methyl-fentanyl and its cis- and trans- isomeric forms thiofentanyl para-flurofentanyl |
|
Harmaline |
|
Harmine |
|
Heroin (diacetylmorphine) |
|
(+)-lysergide (LSD, LSD-25) |
|
MDMA or (+ or -)-N, alpha-dimethyl-3,4-(methylenedioxy)-phenethylamine |
|
Mecloqualone |
|
Mescaline |
|
Methaqualone |
|
4-methylaminorex |
|
MMDA or 2-methoxy-alpha-methyl-4,5 (methylenedioxy) phenethylamine |
|
N-ethyl MDA or (+ or -)-N-ethyl-alpha-methyl-3,4-(methyIenedioxy) phenethylamine |
|
N-hydroxy MDA or (+ or-)-N- [alpha-methyl-3,4 (methylene-dioxy) phenethyl) hydroxylamine |
|
Opium |
|
Parahexyl |
|
Pethidine analogues: |
|
1-methyl-4-phenyl-4-propionoxy-piperidine (MPPP) |
|
1-methyl-4-phenyl-2,5,6-tetrahydropieridine (MPTP) |
|
1-phenylethyl-4-phenyl-4-acetyloxy-piperidine (PEPAP) |
|
PMA |
|
Poppy straw concentrate |
|
Psilocine or psilotsin |
|
Psilocybine |
|
Rolicyclidine (PHP, PCPY) |
|
STP, DOM or 2,5-dimethoxy-alpha,4-dimethylphenelhylamine |
|
Tenamfetamine (MDA) |
|
Tenocyclidine (TCP) |
|
Tetrahydrocannabinol |
|
TMA or (+ or -)-3,4,5-trimethoxy-alpha-methylphenethylamine |
|
All preparations and mixtures of the following unless specifically excluded or unless listed in another Schedule: |
|
(i) the isomers of substances above, where existence of such isomers is possible; |
|
(ii) the esters and ethers of such substances and of the isomers referred to above or isomers of such esters and ethers, where the existence of such esters, ethers and isomers is possible; |
|
(iii) the salts of such substances and of the isomers referred to in (i), and the salts of the esters, ethers and isomers referred to in (ii), where the existence of such salts is possible; |
|
(iv) the isomers of any of the salts referred to in (iii), where the existence of such isomers is possible. |
(regs. 3, 5, 9, 11, 16, 17, 18, 19, 20, 21, 22, 24, 26, 27, 28, 32, 50, 54, 55, 60, 61, 64 and 66)
<OB:FO:”_14BF8A77E481A36″,5.45972,7.06667; SD:255,255,255><OB:FO:”_FF109A77E481A36″,5.45972,7.72014; SD:255,255,255><OB:FO:”_204AE2A77E481A37″,5.45972,7.72014; SD:255,255,255><OB:FO:”_305895A77E481A37″,5.45972,7.10972; SD:255,255,255><OB:FO:”_3F82D0A77E481A37″,5.45972,7.92361; SD:255,255,255><OB:FO:”_4F9B85A77E481A38″,5.45972,1.85972; SD:255,255,255><OB:FO:”_54C790A77E481A38″,5.45972,7.76319; SD:255,255,255><OB:FO:”_659B4BA77E481A38″,5.46389,7.94583; SD:255,255,255><OB:FO:”_772096A77E481A39″,5.45972,7.94306; SD:255,255,255><OB:FO:”_884AEAA77E481A39″,5.45972,7.94306; SD:255,255,255><OB:FO:”_99AFD4A77E481A39″,5.45972,7.94306; SD:255,255,255><OB:FO:”_AB0832A77E481A3A”,5.45972,7.94306; SD:255,255,255><OB:FO:”_BCF678A77E481A3A”,5.45972,7.94306; SD:255,255,255><OB:FO:”_CDFB4CA77E481A3A”,5.45972,7.94306; SD:255,255,255><OB:FO:”_DE9174A77E481A3B”,5.25347,4.69306; SD:255,255,255><OB:FO:”_E812F9A77E481A3B”,5.25347,5.70694; SD:255,255,255><OB:FO:”_F384FEA77E481A3B”,5.25347,7.84653; SD:255,255,255><OB:FO:”_102FA4AA77E481B0″,5.25347,6.99306; SD:255,255,255><OB:FO:”_1105056A77E481B0″,5.34028,2.64653; SD:255,255,255><OB:FO:”_115CD8BA77E481B0″,5.34028,5.65972; SD:255,255,255><OB:FO:”_121D9E0A77E481B0″,5.34028,7.97986; SD:255,255,255><OB:FO:”_1311EC6A77E481B1″,5.34028,1.39028; SD:255,255,255><OB:FO:”_13421A6A77E481B1″,5.34028,7.38681; SD:255,255,255><OB:FO:”_14347C2A77E481B1″,5.34028,7.80972; SD:255,255,255><OB:FO:”_152A440A77E481B1″,5.34028,5.92639; SD:255,255,255><OB:FO:”_15EBAFBA77E481B1″,5.34028,7.87986; SD:255,255,255><OB:FO:”_16E77F1A77E481B2″,5.34028,7.39306; SD:255,255,255><OB:FO:”_17D1ED5A77E481B2″,5.34028,4.61319; SD:255,255,255><OB:FO:”_186AB6CA77E481B2″,5.34028,7.69028; SD:255,255,255><OB:FO:”_1962738A77E481B3″,5.34028,6.37986; SD:255,255,255><OB:FO:”_1A2F161A77E481B3″,5.45972,7.88333; SD:255,255,255><OB:FO:”_1B27BC9A77E481B3″,5.45972,3.17361; SD:255,255,255><OB:FO:”_1B9B504A77E481B3″,5.45972,7.92986; SD:255,255,255><OB:FO:”_1C9E262A77E481B4″,5.45972,8.15972; SD:255,255,255><OB:FO:”_1DA6E1EA77E481B4″,5.45972,7.74028; SD:255,255,255><OB:FO:”_1EA1C66A77E481B4″,5.45972,8.25; SD:255,255,255><OB:FO:”_1FB4210A77E481B5″,5.45972,7.94028; SD:255,255,255><OB:FO:”_20B23ACA77E481B5″,5.45972,6.4; SD:255,255,255><OB:FO:”_21853F6A77E481B5″,5.45972,7.83681; SD:255,255,255><OB:FO:”_227F7F0A77E481B5″,5.45972,6.70972; SD:255,255,255><OB:FO:”_235AEEEA77E481B6″,5.45972,5.45347; SD:255,255,255><OB:FO:”_24094A3A77E481B6″,5.45972,3.35; SD:255,255,255><OB:FO:”_24819F0A77E481B6″,5.45972,7.62986; SD:255,255,255><OB:FO:”_257045AA77E481B6″,5.45972,1.28681; SD:255,255,255><OB:FO:”_25A6872A77E481B6″,5.45972,7.75972; SD:255,255,255><OB:FO:”_269E3B4A77E481B7″,5.45972,2.20694; SD:255,255,255><OB:FO:”_26EC2F8A77E481B7″,5.45972,4.88333; SD:255,255,255><OB:FO:”_2799EDFA77E481B7″,5.45972,7.37639; SD:255,255,255><OB:FO:”_288437BA77E481B7″,5.45972,1.57361; SD:255,255,255><OB:FO:”_28C68B1A77E481B7″,5.45972,4.93681; SD:255,255,255><OB:FO:”_296B864A77E481B8″,5.45972,7.48681; SD:255,255,255><OB:FO:”_2A695E4A77E481B8″,5.45972,7.98333; SD:255,255,255><OB:FO:”_2B706FAA77E481B8″,5.45972,6.12361; SD:255,255,255><OB:FO:”_2C4D463A77E481B8″,5.45972,8.12361; SD:255,255,255><OB:FO:”_2D5EC77A77E481B9″,5.45972,8.12361; SD:255,255,255><OB:FO:”_2E75AA9A77E481B9″,5.45972,7.67014; SD:255,255,255><OB:FO:”_2F81BEBA77E481B9″,5.45972,7.92986; SD:255,255,255><OB:FO:”_30945E1A77E481BA”,5.45972,7.56667; SD:255,255,255><OB:FO:”_31867E7A77E481BA”,5.46389,3.3; SD:255,255,255><OB:FO:”_3200D96A77E481BA”,5.45972,7.73681; SD:255,255,255><OB:FO:”_32FEE3AA77E481BB”,5.45972,6.83333; SD:255,255,255><OB:FO:”_33E1E40A77E481BB”,5.45972,8.05; SD:255,255,255><OB:FO:”_34EFBC0A77E481BB”,5.45972,7.59028; SD:255,255,255><OB:FO:”_35E04E6A77E481BB”,5.31667,4.19306; SD:255,255,255><OB:FO:”_366DDCDA77E481BC”,5.31667,6.19028; SD:255,255,255><OB:FO:”_3730EBAA77E481BC”,5.31667,4.37639; SD:255,255,255><OB:FO:”_37C7499A77E481BD”,5.31667,7.74028; SD:255,255,255><OB:FO:”_38C8DB9A77E481BE”,5.31667,7.87986; SD:255,255,255><OB:FO:”_39C5EA9A77E481BF”,5.31667,4.37361; SD:255,255,255><OB:FO:”_3A54BD4A77E481B10″,5.31667,7.62639; SD:255,255,255><OB:FO:”_3B3F652A77E481B10″,5.31667,7.62639; SD:255,255,255><OB:FO:”_3C2F522A77E481B11″,5.31667,7.62639; SD:255,255,255><OB:FO:”_3D1F534A77E481B11″,5.31667,6.12361; SD:255,255,255><OB:FO:”_3DE2C63A77E481B12″,5.31667,6.12361; SD:255,255,255><OB:FO:”_3EA4FE2A77E481B12″,5.31667,6.87639; SD:255,255,255><OB:FO:”_3F7A156A77E481B12″,5.31667,3.87639; SD:255,255,255
<OB:FO:”_48453A77E49A24NEW”,5.31319,7.69028; SD:255,255,255
<OB:FO:”_4100C65A77E481B13″,5.31667,7.78681; SD:255,255,255><OB:FO:”_41F8BB7A77E481B13″,5.31667,7.78681; SD:255,255,255><OB:FO:”_42F3CF3A77E481B13″,5.31667,6.92014; SD:255,255,255><OB:FO:”_43D030DA77E481B13″,5.31667,6.74306; SD:255,255,255><OB:FO:”_44A4677A77E481B14″,5.31667,5.4; SD:255,255,255><OB:FO:”_45536B2A77E481B14″,5.31667,7.89653; SD:255,255,255><OB:FO:”_465246AA77E481B14″,5.31667,8.05; SD:255,255,255><OB:FO:”_475632EA77E481B14″,5.04306,8.05; SD:255,255,255
<OB:FO:”_483FDF4A77E481B15″,5.15625,1.86458; SD:255,255,255
(reg. 2)
(As published in the Authority’s Website)
|
Human: |
|
1. Botswana Quality Registration Guidelines (reg. 3, reg. 67) |
|
2. Botswana Bioequivalence/Interchangeability Guidelines (reg. 3) |
|
3. Botswana Variation Guideline (reg. 11 and reg. 12) |
|
4. Botswana Renewal Guideline (reg. 5) |
|
5. SADC Registration Guidelines for Human Medicines (reg. 3) |
|
6. WHO Prequalification Guidelines (reg. 3) |
|
7. WHO Biosimilars Guidelines (reg. 3) |
|
8. WHO Variation Guidelines (reg. 11 and reg. 12) |
|
9. EMA Variation Guidelines (reg. 11, reg. 12) |
|
10. ICH Guidelines (reg. 3, reg. 11 and reg. 12) |
|
11. US FDA Guidelines (reg. 3, reg. 11 and reg. 12) |
|
12. EMA Scientific Guidelines for Human Medicines (reg. 3, reg. 11 and reg. 12) |
|
13. EMA Scientific Guidelines on Biological Human Medicines (reg. 3 and reg. 11) |
|
14. Guidelines for donation of unregistered medicines (reg. 10) |
|
15. SADC Product Information Guidelines |
|
16. Minister’s Guidelines on Dispensing and Prescribing of Medicines |
|
Veterinary: |
|
1. Veterinary Medicines Registration Guidelines |
|
Complementary Medicines |
|
1. Botswana Complementary Medicines Registration Guidelines (reg. 66) |
|
2. Botswana Complementary Medicines Variation Guidelines (reg. 66) |
|
3. Botswana Complementary Medicines Renewal Guidelines (reg. 66) |
|
Cosmetics: |
|
1. Botswana Cosmetics Registration Guidelines (regs. 60, reg. 61, 62, 63, 64 and reg. 65) |
|
Inspections and Licensing Guidelines |
|
1. Guidelines for licensing pharmacy operations (reg. 16, 17, 18, 19, 20, 24, 25, 26, 54 and 55) |
|
2. Guidelines for dispensaries in surgeries and Institutional dispensaries (regs. 21, 22, 23, 24, 54 and 55) |
|
3. Guidelines for licensing medicines wholesale operation (regs. 19, 20, 24, 25, 26, 54 and 55) |
|
4. WHO GMP Guidelines (regs. 17, 18, 24, 25, 26, 54 and 55) |
|
5. WHO GCP Inspections Guideline (reg. 55 and 57) |
|
6. Guideline for licensing Veterinary Medicinal Products Retailing (Veterinary Regulations) |
|
Import and export: |
|
1. Import and Export Guidelines (regs. 26, 27, 28, 29, 50, 51, 52 and 53) |
|
Clinical Trials: |
|
1. Botswana Guidelines for Clinical Trials (regs. 55, 56, 57, 58 and 59) |
|
Pharmacovigilance: |
|
1. Pharmacovigilance Guidelines |
|
Advertising and Promotion: |
|
1. Advertising and Promotion Guidelines |
MEDICINES AND RELATED SUBSTANCES (PROHIBITION OF USE OF CERTAIN MEDICINES IN ANIMALS) ORDER
(section 50(3))
(19th April, 2024)
ARRANGEMENT OF PARAGRAPHS
PARAGRAPH
1. Citation
2. Prohibition of use of certain medicines in animals
3. Revocation of Statutory Instrument No. 76 of 2020
S.I. 50, 2024.
This Order may be cited as the Medicines and Related Substances (Prohibition of Use of Certain Medicines in Animals) Order.
2. Prohibition of use of certain medicines in animals
Any person who uses in animals, any substance in the first column, commits an offence and is liable to the penalty set out under section 50(4) of the Act—
|
Substance |
Exception |
|
Amantadine |
|
|
Aristolochia spp. and preparations thereof |
|
|
Baloxavir marboxil |
|
|
Carbapenems |
|
|
Carboxypenicillins |
|
|
Ceftaroline |
|
|
Ceftobiprole |
|
|
Celgosivir |
|
|
Chloramphenicol |
Animals not intended to produce food |
|
Chlorfenvinphos |
Animals not intended to produce food |
|
Chloroform |
|
|
Chlorpromazine |
Animals not intended to produce food |
|
Clenbuterol |
Animals not intended to produce food |
|
Colchicine |
Animals not intended to produce food |
|
Colistin |
|
|
Combinations of cephalosporins |
|
|
Dapsone |
|
|
Diclofenac |
|
|
Dichlorophen |
|
|
Dimetridazole |
|
|
Diminazine |
Treatment of biliary fever in canines |
|
Eravacycline |
|
|
Estradiol 17 ß |
Animals not intended to produce food, treatment of pyopmetra, fetal maceration or mummification in cattle |
|
Favipiravir |
|
|
Fidaxomicin |
|
|
Fipronil |
|
|
Galidesivir |
|
|
Gentian violet (in food or feed of all |
|
|
Glycopeptides |
|
|
Glycopeptides- all agents, including vancomycin |
Animals not intended to produce food |
|
Glycylcyclines |
|
|
Isoflupredone |
Animals not intended to produce food |
|
Lactimidomycin |
|
|
Laninamivir |
|
|
Lipopeptides |
|
|
Methisazone/metisazone Molnupiravir |
|
|
Monobactams |
|
|
Nitazoxanide |
|
|
Nitrofurans (including furazolidone) |
Animals not intended to produce food |
|
Nitroimidazoles – all agents, including Dimetridazole, ipronidazole, metronidazole |
Small animal medicine |
|
Omadacycline |
|
|
Oseltamivir |
|
|
Oxazolidinones |
|
|
Penems |
|
|
Peramivir |
|
|
Phenylbutazone |
Equids not intended for slaughter |
|
Piperazine |
Equids not intended for slaughter |
|
Phosphonic acid derivates |
|
|
Plazomicin |
|
|
Resorantel |
|
|
Ribavirin |
|
|
Rimantadine |
|
|
Ronidazole |
|
|
Siderophore cephalosporins |
|
|
Tizoxanide |
|
|
Triazavirin |
|
|
Umifenovir |
|
|
Ureidopencillins |
|
|
Zanamivir |
|
3. Revocation of Statutory Instrument No. 76 of 2020
Statutory Instrument No. 76 of 2020 is hereby revoked.