Once again a demand for banning analgin, one of the oldest analgesics marketed and widely used in the country, has come to the fore. This time it is a panel of parliament which has called for the removal of the drug from the Indian market. Analgin has been discarded in many countries several years ago for its side effects whereas its use has increased considerably in India as a pain killer without any medical advice. Reacting to the Panel’s demand, the Central drug authorities have decided to refer the drug to a new drug advisory committee and placed it under pharmacovigilance programme for the time being. The Union Health Ministry said that the issue of rationality and continued marketing of analgin in the country was already examined by DTAB in its 61st meeting held in July 2012 and the board after deliberations recommended that the marketing of the drug may be examined by an expert committee. In the meanwhile, it was decided that the manufacturers of analgin may be directed to market the product giving the full indications approved earlier by DTAB. The DCGI subsequently issued letters to all state drug authorities in September 2012 allowing continued marketing of the drug with full indications printed in the package insert/promotional literatures.
The parliamentary panel is not very happy with the ministry’s decision to refer the matter to an expert panel and the suggestion to place the drug under pharmacovigilence programme. It feels that continued marketing of the drug is a matter of grave concern as it is sold as an OTC drug with no medical supervision. It is the bureaucratic delays and repeated references from one committee to another that has prolonged a much debated decision for several years. By just directing the manufacturers to print the label with full indications on the drug without specifying penal action for violations is not going to help the reported misuse of the drug. By banning the drug, the ministry has no reason to get worried about non availability of this analgesic in the country as there are a large number of alternative analgesics and antipyretics available in the Indian market. Now, if the ministry is not fully convinced about banning the drug, it has to come out with strong scientific justifications to prove its safety and efficacy. It is high time the ministry stopped wavering on this issue and came out with a firm and clear decision.