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)
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Annexure 1

 

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

 

 

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

 

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

 

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

 

4.Local anaesthetics

 

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

 

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

 

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

 

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

 

9.Medicines against alcoholism

 

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

 

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

 

12.Anthelmintics, bilharzia medicines, filaricides, etc.

 

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

 

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

 

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

 

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

 

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

 

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

 

19.Oxytocics

 

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

 

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

 

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

 

23.Amino-acids

 

24.Mineral substitutes, electrolytes and trace elements

 

25.Special foods
25.1Infant 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
30.1Antibodies.
30.2Antigens.
30.3Blood fractions.
30.4Probiotics.
30.5Others.

 

31.Enzymatic preparations

 

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

 

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

 

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

 

[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]