In a big blow to the central government's efforts to phase out irrational combination drugs from the pharmaceutical market of the country, the Madras High Court has stayed the DCGI order invoking section 33(p) of the Drugs & Cosmetics Act, 1940. The court stayed the order on a petition filed by Confederation of Indian Pharmaceutical Industries (CIPI).

According to sources, the Madras High Court has stayed the Drug Controller General of India's (DCGI) order invoking the 33(p) of the Drugs & Cosmetics Act, 1940. The court allowed the stay after hearing the CIPI counsel for over half an hour, who argued that instead of making any attempt to vacate the court stay on FDC issue, the DCGI is countering the industry by enacting section 33(p).

The DCGI had invoked section 33(p) of the Drugs & Cosmetics Act, 1940 on November 28 under which the DCGI directive to the state drug authorities would become binding. The decision to invoke section 33(p) was taken in the wake of the successive stay orders of the Madras High Court on the DCGI order asking the state drug controllers to act against the FDC drugs.

The DCGI and the Industry have been at loggerheads for some time ever since the DCGI's decision to remove irrational combination drugs from the market in June this year. Apart from immediately stopping production of 294 combination drugs, which included more than 1000 brands, identified by the DCIGI, the DCGI had asked the industry to withdraw the products from the market immediately. Though the industry was somewhat willing to stop production of the contentious combination drugs, it has been crying coarse over the DCGI's diktat to withdraw products which already in the market. Apart from more than Rs 3000 crore rupees, their reputation was also at stake.

The court stay on invocation of 33(p) will be a big relief to the CIPI members, because the state drug authorities would have left with no choice but to implement the DCGI order as section 33(p) is binding in nature. As per the DCGI order, the state drug authorities have to launch action against combinations classified as absurd, rejected and banned drugs (around 120 FDCs) at the wholesale and C&F agent levels and have also to take action against around 150 Need further Examination category FDCs at the C&F level which would have resulted in thousands of crores of rupees of loss to the industry.