SC asks govt expert body to review banned FDC drugs before taking further action
The Supreme Court on Thursday referred 344 fixed combination drugs, also called FDCs, to the government’s Drugs Technical Advisory Board (DTAB) for a fresh review of their safety, efficacy and therapeutic justification before recommending an action.
The recommendations of the DTAB or its expert sub-committee would have to be made to the Central Government within six months, after which the government will act further if and where necessary. The Supreme Court order gives temporary relief to pharmaceutical companies, but the possibility of a ban is still in the air.
The apex Court also clarified that for the exercise of powers under Section 26 (A) of the Drugs and Cosmetics Act, the DTAB need not be mandatorily consulted by the Government in order to be convinced of reasons for banning a medicine. The court remarked that the Government could be justified in declaring a ban if it finds that the drug has been banned in other countries.
The Delhi high court in December 2016 had set aside a government notification that banned 344 FDC drugs, made by combining two or more drugs into a single dose, on the grounds that the statutory Drugs Technical Advisory Board (DTAB) had not been consulted by the Government.
The pharmaceutical companies represented by eminent lawyers such as P Chidambaram, Kapil Sibal and Gopal Subramaniam argued before the court that there were certain perversities and anomalies in the Professor Kokate Committee Report that found these drugs to be “irrational” and “unsafe”, based on which the government banned them.
The Ministry of Health and Family Welfare last year had banned 344 FDCs, estimated to affect around 6,000 brands, after an expert committee declared them unsafe for human health. The drug makers immediately challenged the government’s ban in high courts across the country, with Delhi high court alone receiving over 450 petitions seeking interim relief on their specific brands.
In January this year, the health ministry moved the apex court challenging Delhi high court order that revoked its ban.
The government had previously filed a transfer petition asking for all pending FDC petitions to be transferred to the Supreme Court. In all, the 294 FDCs that were banned way back in 1997 also got transferred to the Supreme Court, after government challenged a stay order by the Madras High Court in 2008.
The Supreme Court on Thursday directed the government to take suitable action. All India Drug Action Network (AIDAN), which was party to the government petition, welcomed the court order.
“The 344 FDCs account for only about 5 percent of the value of total FDCs in India, approximately half of which are considered to be irrational. The Government should proactively take advantage of the space afforded by this order to weed other irrational FDCs in the interest patient safety,” said S Srinivasan, co-convenor of AIDAN.
“The order clears the ground for the Government to rapidly take steps after due consultation with expert bodies or consideration any other information to weed out large numbers of irrational, unscientific and hazardous FDCs that are unjustifiably prevalent in India,” AIDAN said.
The ban had impacted several popular brands, including Corex, D’Cold Total and Vicks Action 500 Extra, among others.