In a positive step towards a possible out-of-court settlement on the fixed dose combination (FDC) issue, the Confederation of Indian Pharmaceutical Industries (CIPI) has asked its members to voluntarily withdraw absurd, banned and rejected categories of combination drugs from the market. However, the Confederation did not spell out any timeframe to do so.
The CIPI's action on the eve of its meeting with the new DCGI holds significance as this move may give out a positive signal to the authorities about the intention of the pharma industry that it is not against removing irrational and absurd drugs from the market. A CIPI delegation is scheduled to meet the new DCGI Dr Surinder Singh in Delhi some time next week to discuss the FDC issue.
The CIPI leaders already had an informal meeting with the DCGI last week when he was in Chennai in connection with the FDC case pending in Madras High Court. The court had granted stay to the CIPI in the FDC case and the issue is sub judice. The DCGI had a sitting with the lawyer who is arguing the case for the government.
The CIPI, which represents more than 3,000 small pharma companies spread across country, did not specify any combination drugs that have to be withdrawn voluntarily by its members. "I have asked the members to identify themselves the absurd drugs produced by them and to withdraw them. It is now up to them to act on the issue", CIPI chairman T Jaishankar said.
The sources said that identifying such irrational drugs may not be a big problem for the drug companies as the former DCGI Dr Venkateshwarlu had already issued a list of 294 drugs classifying them into several categories of banned, rejected, absurd and need further examination. "Some members of the CIPI are of the view that the SSIs should not continue to manufacture these absurd drugs, especially when the new DCGI has expressed his 'interactive approach' with the industry", sources said.
Without mincing words he said that the CIPI leaders also know that there are a number of absurd combinations among the 294 combination drugs identified by the former DCGI. In fact, in the DCGI-Industry meeting at Chandigarh, some SSI leaders had asked the former DCGI that if he allowed permission to the 'need further examination' drugs, the industry will agree for withdrawing all the other category drugs in the 294 list. But the former DCGI did not budge from his stand, which led the industry to knock at the door of justice.