A Parliamentary panel has given one month time to the Government to decide imposing a ban on well-known painkiller Analgin, which is banned world over, but freely available in the country.
“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,” said the panel headed by MP Brajesh Pathak in its report tabled in Parliament recently.
The panel noted that in the India market there were a large number of alternative analgesics, antipyretics, which could replace Analgin. “With so many countries banning Analgin, not to mention unlawful over-promotion by manufacturers, the Drug Controller General of India (DCGI) should be directed to re-examine the rationality of continued marketing of Analgin,” it said.
In its reply, the DCGI said that the National Technical Advisory Board (NTAB) for drugs had recommended that the use of all analgesics with special reference to Analgin should be placed under focused Pharmacovigilance under Pharmacovigilance Programme of India (PvPI). The safety data so collected should be properly analysed to take further suitable action on use of such drugs.
However, refusing to buy the DCGI’s theory, the panel said, “Given the near non-existance 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 panel also expressed unhappiness at the Union Health Ministry’s reply as a reason not to ban risky remedies by stating that “most newer drugs are generally found to be more expensive”. The Committee has been given to understand that there is no provision under Drugs and Cosmetics Rule to take the cost of drugs into consideration while approving or banning drugs.
“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,” it said.