Even as the DCGI's counter affidavit to vacate the stay on his order against FDC drugs is pending in the Madras High Court, the drug manufacturers in the country have started manufacturing the contentious 294 FDC drugs, but in small batches which can be liquidated in a month's time.

According to sources, a large number of drug manufacturers in the country have resumed manufacturing the controversial 294 fixed dose combination (FDC) drugs on the assumption that the court may take more time to settle the issue. But the companies are not resorting to mass production and are manufacturing only on requirement. Though it is almost a month since the DCGI filed his counter affidavit for vacating the stay, the court is yet to take up the case.

"Why should we lose business? I am receiving a number of calls from the industry people asking me whether to resume production or not. I am advising them to start production in small quantities that can be liquidated in a month's time", a senior pharma association leader said.

By producing small batches based on the requirement, the industry is playing it safe. The idea of producing small quantity is that if there is any adverse comment from the court, the companies should be able to liquidate the products in a short time.

Even after three successive stay orders on the DCGI orders, there was fear and confusion among the drug manufacturers on the issue of resuming production of the contentious FDC drugs. Though the court has given some temporary reprieve to the industry in the form of stay orders, nobody in the industry in fact wanted to antagonise the DCGI by resuming production. Rather than resuming production of the contentious products, the pharma companies stressed on liquidating the products already in the market.

The pharma companies had stopped production of the contentious 294 FDC drugs ever since the DCGI directed the state drug control departments in June, 2007 to withdraw manufacturing licences issued by them for 'irrational' combination drugs during the last 10 years. Ever since the controversial order, the drug companies were running amok to liquidate their stocks which were at different levels of sale rather than manufacturing more products.

But as the issue lingered on with the DCGI adamant on his stance, some pharma companies moved Madras HC which stayed the DCGI order on November 11.

The DCGI has to get three stay orders vacated by the court. In the first case on November 11, the court had stayed the DCGI order on a petition filed by five pharma companies in Pondicherry. As the stay order was limited to only five companies, the court was moved again by the pharma association, Federation of South Indian Pharmaceutical Manufacturers Associations (FSIPMA).

To counter these two stay orders, the DCGI decided to invoke section 33(p) of the Drugs & Cosmetics Act, 1940 under which the DCGI directive to the state drug authorities will become binding. The CIPI contested this order in the court and got a stay.