New Delhi: India’s drug quality regulator has convened a meeting with pharmaceutical industry lobbies on 10 June, in a move aimed at quickly resolving differences with drug makers over an order late in 2007 banning nearly 300 so-called fixed drug combinations that sell a combined Rs3,500 crore a year.
Industry associations confirmed the meeting next week but said that they were yet to be briefed on what the compromise formula could be and would react only after hearing out the regulator. The stance of the lobbies has been mostly to persuade the regulator, the office of the drug controller general of India or DCGI, to let these drugs stay on in the market until their safety and efficacy is investigated and then, if required, phase out some of them. Their main opposition is to a “blanket ban” on all the 294 drugs.
Mint had reported on 23 April this year that Surinder Singh, the current DCGI, was looking at a settlement formula with the industry that could involve pulling out some of the combination drugs and allowing the rest to be sold under strict pharmacovigilance, a regulatory process involving post-marketing surveillance to track adverse drug reactions. Such drugs are also referred to as fixed drug combination or FDC medicines.
Singh, who had then indicated a July deadline for reaching an agreement, could not be reached for comment on the coming meeting. “We have been called on 10 June to look at ways to resolve the FDC issue. There was an initial meeting with the DCGI on this over a month ago for reaching an out-of-court settlement,” confirmed P.K. Gupta, co-chairman of the Confederation of Indian Pharmaceutical Industry or CIPI, a lobby of smaller Indian drug makers. “We need to decide which drugs stay and which need to be pulled off.”
After a public interest litigation filed by CIPI in the Madras high court last November, the lobby got a stay order against an order by the previous DCGI, M. Venkateswarlu. The companies had been up in arms against, as one industry executive puts it, “a blanket ban that meant all 294 drugs had to go (initially) and not just the ones that had been found wanting on a safety and efficacy test”.
Other representatives of the Rs70,000 crore Indian pharmaceutical industry confirmed being invited to the meeting. D.G. Shah, secretary general of the Indian Pharmaceutical Alliance, a grouping of big Indian drug makers, suggested that the DCGI ask for drug data from companies on a strict deadline and decide the ones that need to be withdrawn based on that data. Until then, these FDCs should be allowed to continue, he added.
To guard against such situations and ensure patient safety, any new FDC—treated as a new medicine under the Drugs and Cosmetics Act, 1940, the main pharmaceuticals law in India—will need the approval of the DCGI ahead of other such clearances from state drug controllers, Singh had explained in the April interview. Most FDCs in India are sold under approval from state authorities.