PHARM.D

                                                                      BANNED DRUGS A number of individual drugs as well as fixed  dose  combinations are banned in India. Drugs undergo rigorous  testing  before they are introduced into the market. They are first tested in animals and then in human beings during clinical trials.  The efficacy as well as  safety  profiles  of the drug are tested.   In spite of this, some adverse effects of drugs appear only after the drug is used in the general population.  These adverse effects are detected though a process of regular monitoring after the drug is released called  pharmacovigilance .  If the adverse effects are severe or the risks of using the drug outweigh the benefits, or if the drug is ineffec...

               Propoxyphene Withdrawn From US Market Allison Gandey  The US Food and Drug Administration (FDA) has asked that propoxyphene, sold under the brand names Darvon and Darvocet by Xanodyne Pharmaceuticals, be removed from the US market. The decision will also affect generic manufacturers and the makers of propoxyphene-containing products. New clinical data showing that the drug puts patients at risk for potentially serious or even fatal heart rhythm abnormalities has prompted regulators to act. An estimated 10 million patients have used these products. At a press conference today, John Jenkins, MD, director of the Office of New Drugs, said the new numbers tipped the risk–benefit ratio against the drug. The withdrawal will include brand name, generic, and all propoxyphene-containing products. "For the first time, we now have data showing that the standard therapeutic dose of propoxyphene can b...

India's Drug Technical Advisory Board (DTAB) has decided to ban two controversial drugs — Gatifloxacine and Tegaserod — because of their side-effects. The decision was taken by DTAB's sub-committee headed by Dr Y K Gupta from AIIMS which met on Thursday. DTAB, however, could not make up its mind on the third controversial drug Deanxit and said, "More data is needed on the drug's side-effects." Confirming this to TOI, drug controller general of India Dr Surinder Singh said, "Gatifloxacine and Tegaserod will be withdrawn from the market in two weeks' time." Jointly, Gatifloxacine, Tegaserod and Deanxit do business of around Rs 70 crore annually in India. But for some time, there have been concerns on their safety. Gatifloxacine is used as an antibiotic. But according to Dr Singh, this drug is known to shoot up and also dip blood sugar levels. Drug expert Dr C M Gulati had told TOI that it is known to cause heart movement abnormality. Tegas...

                          LIST OF DRUGS BANNED FOR MARKETING IN INDIA The Government of India vide notifications published in the Gazette of India vide G.S.R. No. 578 (E) dated 23/07/1983 and subsequent amendments, made under Section 26 A of Drugs and Cosmetics Act, 1940 has prohibited the manufacture, sale and distribution of the following categories of fixed dose combinations which do not have any therapeutic justification or are likely to involve risk to human beings: G.S.R. No. 578 (E) dt 23-07-1983 1. Amidopyrine. 2. Fixed dose combinations of vitamins with anti-inflammatory agents and tranquilizers. 3. Fixed dose combinations of Atropine and Analgesic and Antipyretics. 4. Fixed dose combinations of Strychnine and Caffeine in tonics. 5. Fixed dose combinations of Yohimbine and Strychnine with Testosterone and Vitamins. 6. Fixed dose combinations ...