The Union Health Ministry, which recently banned three drugs including popular pain killer analgin, has overlooked the recommendations by the Drug Technical Advisory Board (DTAB), the highest decision making body on the technical matters, and the New Drug Advisory Committee in the case of analgin, if the minutes of the DTAB were any indication.
The controversial drug, which is banned in several countries including the developed markets, was placed first under the focused pharmacovigilance programme and later referred to the NDAC (Neurology and Psychiatry). After going through reports, the DTAB held on May 16, however felt that there was no sufficient ground for a ban.
However, the Union Health Ministry went ahead to ban the manufacturing and sale of three drugs including analgin last week. It is learnt that the regulatory authorities overlooked the recommendations by the DTAB in accordance with its stand that any drug banned in the developed countries like USA, UK, EU, Australia, Japan and Canada etc. would be put under ban in India also.
The NDAC which has examined the issue of continued marketing of analgin in the country has also recommended that there was no adequate data on Indian population in support of either ban of the drug or allow the continued marketing of the drug in the country. It rather suggested suspension of manufacturing.
“However, considering the issues related to the safety aspect of the drug and regulatory actions in many other countries and the fact that alternate analgesics are available, committee recommended that the marketing of the drug in the country should be put under the suspension and the firm should be asked to generate adequate data in Indian scenario to consider the matter further,” according to the minutes of the DTAB meeting.
“The DTAB, however, opined that the drug is being marketed in some European countries and there are no adequate reports of adverse effect of the drug which may warrant prohibition of the drug in the country at present juncture,” the minutes said.
The issue of continued marketing of analgin came up for discussion at the DTAB in July 24. The panel felt that “the criteria of banning a drug should not be solely on the basis of its prohibition in certain countries but also on the basis of its safety, efficacy and context of its usages permitted in the country.”
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 (“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 had also 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.
Based on recommendations of the board, the DCG(I) issued letters to all State Drug Controllers on September 13, 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.
The Parliamentary Panel on Health, which last year sharply came down on the functioning of the CDSCO, has strongly called for the ban of analgin. “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. The indications are approved by CDSCO, not State Drug Authorities. Hence CDSCO should itself take immediate action for violations,” the panel said in its action taken report on the original recommendations.
“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 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,” said the report submitted in April this year.