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BANNED DRUGS IN INDIA. Dr. Prabhakar Adake Asst. Professor Department of Pharmacology Yenepoya Medical College MANGALORE. Introduction. Drug is a chemical substance used in the treatment, diagnosis, or prevention of disease.
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BANNED DRUGS IN INDIA Dr. PrabhakarAdake Asst. Professor Department of Pharmacology Yenepoya Medical College MANGALORE
Introduction Drug is a chemical substance used in the treatment, diagnosis, or prevention of disease. Efficacy and safety profile of a drug is tested before marketing However, new adverse drug reactions are noticed in general population
Reasons for banning a drug • Irrational Fixed Dose Combination • May cause serious adverse drug reactions • No proven advantage in FDC • High cost
Who will ban the drug in India?? Drug Controller General of India (DCGI) has highest power to extend approval or ban a drug from marketing If a drug is found to have serious ADR, DCGI issues ban order to the manufacturers. And wholesalers are asked not to stock the particular medicine In 2016 DCGI had banned 344 FDC’s.
Summary • Patient safety is ultimate goal • Manufacturers have every reason to sell their products if buyers are there. • If doctors stop prescribing drugs that are harmful or irrational, then manufacturer will stop producing.
References 1. Tripathi K.D., Essentials of Medical Pharmacology 7th ed. Jaypee Brothers 2013 2. Satoskar R.S. & Bhandarkar S.D., Pharmacology and Pharmacotherapeutics, 25th ed. Elsevier 2017.