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18 Sep 2014

Drug Regulations in India

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Drug Regulations in India
1. Medicinal products in India are regulated by Central Drugs Standard Control (CDSCO) Organization under Ministry of Health and Family Welfare, headed by Directorate General of Health Services (DGHS).
2. CDSCO regulates the Pharmaceutical Products through Drugs Controller General of India (DCGI).
3. Export of pharmaceutical products controlled by Pharmaceutical Export Promotion Council (Pharmexcil) setup by Ministry of Commerce & Industry, Government of India.
4. Production and standard of indigenous and imported drugs are regulated by the Drugs & Cosmetics Act.
5. As per the Drugs and Cosmetics Act there are following categories of drugs:
Schedule C and Schedule C1 drugs – Drugs derived from biological origin and other related special products.
Schedule G drugs – List of drugs for which consumers are advised to take it under medical supervision.
Schedule H drugs – List of drugs which can be sold only under the prescription of a Regd. Medical Practitioner.
Schedule X drugs – List of some Narcotic drugs.
6. There are special provisions for Vaccines, serums etc. (Sch. F), condoms (Sch. R ), Cosmetics (Sch. S), Disinfectant Fluids (Sch. O) etc.
7. National Pharmaceutical Pricing Authority (NPPA) regulates prices of drugs and formulations through a regulation Drugs Prices Control Order (DPCO) under Essential Commodities Act.
8. Advertisement and Marketing to some extent, is regulated by Drugs & Magic Remedies (Objectionable Advertisement) Act and Schedule J of Drugs and Cosmetics Act.
9. Production and Distribution of Narcotic and Psychotropic substances are controlled by Narcotic Drugs and Psychotropic Substances Act.
10. In India, there is no official list of Over the Counter (OTC) Drugs is available, but some drugs are exempted from some provisions of the Drugs and Cosmetics Act on stipulated conditions. Those are available in Schedule K.
11. Conditions of a Pharmacy where drugs are prepared in accordance to a prescription are described in Schedule N.
12. Good Manufacturing Practices are described in Schedule M.
13. There are separate Provisions for Homoeopathic drugs, Ayurvedic etc. Drugs, Cosmetics.

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