Health ministry yet to take any concrete step on banning Analgin

The drug regulatory authorities are yet to take a final decision on banning Analgin, as in the case of several other recommendations made by the Parliamentary Panel that examined the functioning of the Central Drugs Standard Control Organisation (CDSCO). Though the standing committee on health, in its report submitted on April 26 this year, gave just 15 days deadline to decide conclusively on the fate of Analgin which is discarded by many countries, a final decision is yet to be made even after 45 days now. According to sources in the CDSCO, the matter has been in fact referred to the New Drug Advisory Committee which has to take a final call based on the inputs generated from the pharmacovigilance programme. However, the standing committee did not support the action of placing it under the pharmacovigilance, instead asked for concrete action. “The indications are approved by CDSCO, not State Drug Authorities. Hence CDSCO should itself take immediate action for violations. Given the near non-existence pharmacovigilance in the country putting Analgin under so called “focussed pharmacovigilance” is nothing but a dilatory and diversionary move to let the drug be sold in the country to benefit the manufacturer,” the report said. “The Committee, therefore, desires that a decision be taken on this open and shut case without taking refuge behind committees after committees within one month of presentation of this Report. The Committee has noted that there are a very large number of alternative analgesics, antipyretics in the Indian market. With so many countries banning Analgin, not to mention unlawful over-promotion by manufacturers, the CDSCO should be directed to re-examine the rationality of continued marketing of Analgin,” the panel said. “It is a well-known fact that drug manufacturers simply do not submit applications for the approval of new drugs to robust regulators to avoid rejection by other agencies/ countries. It is precisely for this reason that several manufacturers, in spite of the huge potential of marketing drugs in the US, avoid entering the US market. As once a drug is rejected in the US, it becomes highly impossible to get approval even in countries with poor drug regulation. The Committee is also confident that now when the Ministry has adopted, albeit, belatedly this global best practice in drug regulation, it would immediately apply it on two burning cases viz Analgin and Buclizine,” it said. Source:Pharmabiz