Guest guest Posted February 24, 2011 Report Share Posted February 24, 2011 Dear members, Corrective measures The system of screening the drug combinations that are already licensed and are moving in the market, is a new concept. This is being practised in many developed and developing countries, including India .The role of Indian Council of Medical Research (ICMR) may be explored with respect to new combinations, as well as the guidelines of the USFDA, WHO and ICH may be followed to obtain results. With the assistance of WHO, the DCGI keeps a continuous monitoring of any drug withdrawn in any other country (on the ground of lack of sufficient evidence of its safety or effectiveness in context of present knowledge). If any such drug or its combinations is marketed in the country, a decision to withdraw the drug or its combinations from the market is taken care of by the pharmacovigilance committee in the country that takes into consideration the evidence of any reported adverse effect of the drug indicated, the availability of safer and economic substitutes of the drug or its combination and the benefit risk ratio. In India, once the recommendations by the drugs consultative committee are approved by the drug technical advisory board (the highest technical body under Drugs and Cosmetics Act), the government can take appropriate measures against such formulations. Regards, Dr. Sonali Pimpalkhute Lecturer, Pharmacology GMC, Nagpur Quote Link to comment Share on other sites More sharing options...
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