Concerned over the rampant use of pain killers without medical advice in the country, the Union health ministry will soon constitute an Expert Committee to examine the rationality and continued marketing of Analgin in the country. Besides, the ministry will place the use of all analgesics with special reference to Analgin under focused pharmacovigilance under the Pharmacovigilance Programme of India.
After detailed deliberations, the Drugs Technical Advisory Board (DTAB), the highest authority in the union health ministry on technical matters, in its latest meeting held on July 24 this year has recommended to the Central Drugs Standard Control Organisation (CDSCO) that the continued marketing of the drug may be examined by the Expert Committee in the context of present day knowledge on priority, while the manufacturers of Analgin may be directed to market the product giving the full indications on the label approved earlier by DTAB as: “severe pain or pain due to tumour and also for bringing down the temperature in refractory cases when other anti-pyretics fail to do so.”
The health ministry's action in this regard comes in the wake of the Parliamentary Standing Committee of the Ministry of Health and Family Welfare's 59th report in which it has examined the question of rampant use of pain killers without medical advice. In the report, the committee has observed that there is misuse and overuse of the drug Analgin as it is not labelled properly. The approved indication of the drug is “severe pain or pain due to tumour and also for bringing down the temperature in refractory cases when other anti-pyretics fail to do so.” However, the product inserts of Baralgan-M and Novalgin do not give the full indication on the label.
The DTAB further recommended that the use of all analgesics with special reference to Analgin should be placed under focused pharmacovigilance under Pharmacovigilance Programme of India. The safety data so collected should be properly analysed so that suitable action could be taken on use of the such drugs.