Drug Controller General of India (DCGI) may soon allow manufacturing and marketing of 150 FDC drugs and place them under post-marketing surveillance. The move is a sequel to DCGI's softening stand over the FDC issue after the revival of talks between the industry and DCGI's office.

According to sources, the DCGI is weighing options on immediately allowing the industry to manufacture and market around 150 'need for further examination' category drugs on the condition of putting them under pharmacovigilance. If there are any adverse reports against any drug, the same will be withdrawn from the market.

The DCGI's proposal in this regard is a reciprocal action against the industry's offer of voluntarily withdrawing around 110 drugs mostly belonging to 'absurd' and 'banned' categories. The industry is not mincing words to admit that some of the FDC drugs are actually irrational and the industry is ready to voluntarily withdraw them provided the authorities allow them to market the rest.

Sources in the industry said that the industry will wholeheartedly welcome such a move as the industry is hopeful that most of the 'need further examination' drugs are safe and will stand the scrutiny of medical vigilance. A large number of these combination drugs have been in the market not for years but for decades together and there were no reports of any adverse effect of these medicines, sources said.

In fact, ever since former DCGI Dr Venkateshwarlu ordered the withdrawal of the contentious 294 FDC drugs in June last year, the industry has been scouting for such a compromise. In the DCGI-industry meeting held in Chandigarh in October last year, a small scale pharma industry association SPIC had put forward a formula on these lines. But, the then DCGI did not budge from his stand of withdrawing all the drugs from the market.