A panel of Parliament members has called for banning Analgin, discarded in many countries but continued to be marketed in India. The authorities, however, want to have it examined by the new drug advisory committee and placed it under pharmacovigilance programme.

“The continued marketing of Analgin, discarded the world over, is a matter of grave concern for the Committee. Analgin is not listed in the National List of Essential Medicines (NLEM). Bureaucratic delays, repetitive references from one committee to another can do nothing but hurt patients. The Committee also feels that merely requesting State Drug Authorities to direct manufacturers to label the drug Analgin as approved by CDSCO without exemplary, penal action for documented violations is itself an act of negligence,” according to the recent report by the Parliamentary Standing Committee on Health.

While briefing the panel, the Health Ministry said the issue of rationality and continued marketing of Analgin in the country was examined by DTAB in its 61st meeting held on 24th July 2012. The board after deliberations recommended that the continued marketing of the drug may be examined by expert committee in the context of present day knowledge while the manufacturers of Analgin may be directed to market the product giving the full indications approved earlier by DTAB as under:

"Severe pain or pain due to tumour and also for bringing down the temperature in refractory cases when other antipyretics fail to do so".

“The board further recommended that the use of all analgesics with special reference to Analgin should be placed under focused Pharmacovigilance Programme of India (PvPI). The safety data so collected should be properly analyzed to take further suitable action on use of such drugs. Based on recommendations of the board, the DCG(I) has issued letters to all State Drug Controllers on 13. 09. 2012 requesting them to direct the manufacturers of Analgin formulations to market the drug mentioning the above indications in the package insert/promotional literature of Analgin formulation. Further, as per the recommendations, all analgesics with special reference to Analgin have been placed under focused PvPI. The continued marketing of Analgin will also be referred to NDAC for examination. The DCG(l) has been adequately sensitized in this regard,” the Ministry told the panel.

However, the panel wanted an immediate and concrete decision at the earliest. “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 to 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.