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Medicines and Related Substances Control Act, 1965 (Act No. 101 of 1965)

Regulations

General Regulations

Schedules

Annexure 1 : Classes of Medicines in categories A and D (human complementary medicine)

 

Annexure 1

 

Classes of Medicines in categories A and D (human complementary medicine)

 

 

1. Central nervous system stimulants
1.1 Central analeptics.
1.2 Psychoanaleptics (antidepressants).
1.3 Special antidepressant combinations.
1.4 Respiratory stimulants.
1.5 Hallucinogenic medicines.
1.6 Other central nervous system  stimulants.

 

2. Central nervous system depressants
2.1 Anaesthetics.
2.2 Sedatives, hypnotics.
2.3 Barbiturates.
2.4 Non-barbiturates.
2.5 Anticonvulsants, including anti-epileptics.
2.6 Tranquillisers.
2.6.1 Phenothiazines and their derivatives.
2.6.2 Rauwolfia: Alkaloids and combinations.
2.6.3 Diphenylmethane and its derivatives.
2.6.4 Alkyl diols and their derivatives.
2.6.5 Miscellaneous structures.
2.7 Antipyretics or antipyretic and anti-inflammatory analgesics.
2.8 Analgesic combinations.
2.9 Other analgesics.
2.10 Centrally acting muscle relaxants.
2.11 Other medicines acting on the central nervous system
2.12 Depressants.

 

3. Connective Tissue Medicines
3.1 Antirheumatics (anti-inflammatory agents).
3.2 Non-hormonal preparations.
3.3 Anti-gout preparations.
3.4 Combinations with corticosteroids.
3.5 Others.

 

4. Local anaesthetics

 

5. Medicines affecting autonomic function
5.1 Adrenomimetics (sympathomimetics).
5.2 Adrenolytics (sympatholytics).
5.3 Cholinomimetics (cholinergics).
5.4 Cholinolytics ( anticholinergics).
5.4.1 Anti-Parkinsonism preparations.
5.4.2 General.
5.5 Ganglion blockers.
5.6 Histamine.
5.7 Antihistaminics, anti-emetics and antivertigo preparations.
5.7.1 Antihistaminics.
5.7.2 Anti-emetics and antivertigo preparations.
5.8 Preparations for the common cold including nasal decongestants.
5.9 Hydroxytryptamine (serotonin).
5.10 Serotonin antagonists.
5.11 Others.

 

6. Cardiac medicines
6.1 Cardiac stimulants.
6.2 Cardiac depressants.
6.3 Cardiac glycosides.
6.4 Antidysrhythmics /conduction modifying medicines.
6.5 Others.

 

7. Vascular medicines
7.1 Vasodilators, hypotensive, antihypertensive medicines include other antihypertensive medicines e.g. ACE-inhibitors, ARBs, RAAS, etc]
7.1.1 Rauwolfia and combinations.
7.1.2 Rauwolfia: Diuretic combinations.
7.1.3 Other hypotensives.
7.1.4 Vasodilators - coronary and other medicines used in angina pectoris.
7.1.5 Vasodilators - peripheral.
7.2 Vasoconstrictors, pressor medicines.
7.3 Migraine preparations.
7.4 Lipotropic agents.
7.5 Serum-cholesterol reducers.
7.6 Others.

 

8. Medicines acting on blood and haemopoietic system
8.1 Coagulants, haemostatics.
8.2 Anticoagulants.
8.3 Erythropoietics (haematinics).
8.4 Plasma expanders.
8.5 Others.

 

9. Medicines against alcoholism

 

10. Medicines acting on respiratory system
10.1 Antitussives and expectorants.
10.2 Bronchodilators.
10.2.1 inhalants.
10.3 Others.

 

11. Medicines acting on gastro- intestinal tract
11.1 Digestants.
11.2 Gastro- intestinal antispasmodics and cholinolytics (anticholinergics).
11.3 Anorexigenics.
11.4 Antacids.
11.4.1 Acid neutralisers.
11.4.2 Acid neutralisers with antispasmodics.
11.4.3 Other.
11.5 Laxatives.
11.6 Lubricants and faecal softeners.
11.7 Cholagogues.
11.8 Suppositories and anal ointments.
11.9 Antidiarrhoeals.
11.9.1 Antidiarrhoeals in combination with anti-infective agents.
11.9.2 Special combinations.
11.10 Others.

 

12. Anthelmintics, bilharzia medicines, filaricides, etc.

 

13. Dermatological preparations
13.1 Antiseptics, disinfectants and cleansing agents.
13.2 Antiscabies medicines.
13.3 Surface anaesthetics.
13.4 Antipruritics.
13.4.1 Corticosteroids with or without anti-infective agents.
13.4.2 Emollients and protectives.
13.5 Rubefacients.
13.6 Counterirritants.
13.7 Keratolytics.
13.8 Special combinations.
13.8.1 Preparations for psoriasis.
13.8.2 Fungicides.
13.9 Radiation protectants.
13.10 Melanin inhibitors and stimulants.
13.11 Acne preparations.
13.12 Others.

 

14. Preparations for treatment of wounds
14.1 Wound disinfectants.
14.2 Wound dressings.
14.3 Others.

 

15. Ophthalmic preparations
15.1 Ophthalmic preparations with antibiotics and/or sulphonamides.
15.2 Ophthalmic preparations with corticosteroids.
15.3 Combination antibiotics.
15.4 Others.

 

16. Ear, nose and throat preparations
16.1 Nasal decongestants.
16.2 Aural preparations.
16.3 Surface anaesthetics.
16.4 Naso- pharyngeal and bucco-pharyngeal antiseptics.
16.5 Others.

 

17. Medicines acting on muscular system
17.1 Peripherally acting muscle relaxants.
17.2 Muscle activators.
17.3 Others.

 

18. Medicines acting on reno-urinary and genital system
18.1 Diuretics.
18.2 Antidiuretics.
18.3 Ion-exchange preparations.
18.4 Urolitholytics.
18.5 Urinary tract antiseptics.
18.6 Vaginal preparations.
18.7 Contraceptive preparations.
18.8 Ovulation controlling agents.
18.9 Uterine antispasmodics.
18.10 Others.

 

19. Oxytocics

 

20. Antimicrobial (chemotherapeutic) agents
20.1 Antibiotics and antibiotic combinations.
20.1.1 Broad and medium spectrum antibiotics.
20.1.2 Penicillins.
20.1.3 Penicillin- streptomycin combinations.
20.1.4 Antibiotic-sulphonamide combinations.
20.1.5 Streptomycin and combinations.
20.1.6 Topical antibiotics.
20.1.7 Antifungal antibiotics.
20.2 Other than antibiotics.
20.2.1 Sulphonamides.
20.2.2 Fungicides.
20.2.3 Tuberculostatics.
20.2.4 Leprostatics.
20.2.5 Germicides.
20.2.6 Medicines against protozoa.
20.2.7 Spirochaeticides.
20.2.8 Antiviral agents.
20.3 Others.

 

21. Hormones, antihormones and oral hypoglycaemics
21.1 Insulin preparations.
21.2 Oral hypoglycaemics.
21.3 Thyroid preparations.
21.4 Parathyroid preparations.
21.5 Corticosteroids.
21.5.1 Corticosteroids and analogues.
21.5.2 Analgesic combinations.
21.5.3 Anti-infective combinations.
21.6 Anabolic steroids.
21.7 Male sex hormones.
21.8 Female sex hormones.
21.8.1 Oestrogens.
21.8.2 Progesterones with or without oestrogens.
21.9 Androgen-oestrogen combinations.
21.10 Trophic hormones.
21.11 Hyperglycaemic hormones.
21.12 Hormone inhibitors.
21.13 Others.

 

22. Vitamins
22.1 Multivitamins and multivitamins with minerals.
22.1.1 Vitamins for paediatric use.
22.1.2 Vitamins for prenatal use.
22.1.3 Vitamins for geriatric use.
22.1.4 Vitamin B- complex with Vitamin C.
22.2 Others.

 

23. Amino-acids

 

24. Mineral substitutes, electrolytes and trace elements

 

25. Special foods
25.1 Infant foods and other formulae, excluding foods used solely as a substitute for human milk.

 

26. Cytostatic agents

 

27. Chelating agents (versenates) as heavy metal antidotes

 

28. Contrast media

 

29. Diagnostic agents

 

30. Biologicals
30.1 Antibodies.
30.2 Antigens.
30.3 Blood fractions.
30.4 Probiotics.
30.5 Others.

 

31. Enzymatic preparations

 

32. Other substances or agents
32.1 Tonics.
32.3 Slimming preparations.
32.4 Water for injection.
32.5 Artificial tear and contact lens solutions.
32.6 Preparations of boracic acid, borax and zinc, starch and boracic powder.
32.7 Topical applications of delousing agents.
32.8 Topical applications of insect repellents.
32.9 Intra-uterine devices.
32.10 Dental preparations.
32.11 Solutions for haemo- or peritoneal dialysis.
32.12 Preparations for which the expressions "medicated ", "medicinal", "for medical use" or expressions with similar connotations are used.
32.13 Preparations intended to promote hair growth.
32.14 Sales packs containing two or more medicines with different indications.
32.15 Radiopharmaceuticals.
32.16 Others.

 

33. Complementary Medicines: Discipline- Specific Traditional Claims
33.1 Aromatherapy
33.2 Homeopathy
33.3 Ayurveda
33.4 Traditional Chinese Medicine
33.5 Unani Medicine
33.6 Western Herbal Medicine
33.7 Combination Product
33.8 Other Herbal

 

34. Complementary Medicines: Health Supplements
34.1 Amino acids
34.2 Aminosaccharides
34.3 Animal Extracts, Products and Derivatives
34.4 Carotenoids
34.5 Enzymes
34.6 Fats, Oils and Fatty Acids
34.7 Minerals
34.8 Polyphenols (including Bioflavonoids)
34.9 Probiotics
34.10 Saccharides (including prebiotics)
34.11 Vitamins
34.12 Multiple substance formulation
34.13 Other

 

[Annexure 1(Class 33.3) substituted by section 4 of the General Regulations made in terms of the Medicines and Related Substances Act, 1965, Amendment, 2023, Notice No. R. 3343, GG48475, dated 28 April 2023]