The Delhi High Court has quashed a government-imposed ban on 344 fixed dose combination (FDC) drugs based on 454 petitions filed by leading Indian drug makers challenging the validity of such a ban.
Major Indian drugs such as Piramal Healthcare’s Saridon, Pfizer’s Corex, D’Cold Total, Vicks Action 500 Extra, Merck India’s Nasivion fell under the list of the banned FDC drugs.
Petitions were filed following government's March 10 notification to ban 344 FDC drugs, which extended to about 6,000 brands, citing health risks and lack of any therapeutic justification.
During the hearings at the Delhi HC, the government has been maintaining that the ban was in public interest as the combination drugs were not safe for health and have been banned in several other countries.
FDC drugs are combinations of two or more active pharmaceutical ingredients in fixed ratios, given in the form of a single dose.
Justice Rajiv Sahai Endlaw on June 2 had reserved the order after hearing regular arguments of companies like Pfizer, Glenmark, Procter and Gamble and Cipla, the central government and some NGOs like All India Drug Action Network (AIDAN) over a span of over two months, starting from March 14.
The court had on March 14 stayed the Centre's March 10 ban on 344 FDC drugs and this interim order was passed in each and every case filed before it thereafter.
During arguments, the drug companies had contended that the government has not properly implemented the powers under section 26A (power to prohibit manufacture of drugs and cosmetics in public interest) of Drugs and Cosmetics Act, under which the ban was ordered.
The FDC ban was the culmination of government instituted Chandrakant Kokate committee in 2014 that would review submissions based on a CDSCO letter dated January 2013 directing all state and Union territory drug controllers asking them to order all the drug manufacturers under their jurisdiction to prove the safety and efficacy of their FDCs within 18 months.
By the end of the 18-month period, in July 2014, the Kokate committee had received over 6,220 applications for consideration.
After examination, the Kokate committee found 963 drugs to be irrational. Acting on the committee’s detailed report, the central government issued a show-cause notice to the manufacturers of these drugs. Once their replies were filed, the committee called on domain expert medical specialists from reputed hospitals such as AIIMS, Safdarjung Hospital, Ram Manohar Lohia Hospital and Maulana Azad Medical College to help assess the drugs.
Even after the second examination, the committee found, in February this year, that the FDCs in question to be medically inappropriate and ineffective. This was soon followed by the 10 March order, in which the central government banned 344 of the 963 drugs. The government stated that the ban was instituted because the drug combinations were “likely to involve risk to human beings” at a time when “safer drugs were available.”