Delhi high court dumps govt order banning 344 FDC drugs
01 Dec 2016
The Delhi high court has set aside the central government's decision to ban 344 fixed dose combination (FDC) drugs, including some of the commonly used brands like Corex cough syrup, Vicks Action 500 Extra and D'Cold.
The court pronounced its order after hearing arguments of companies like Pfizer, Glenmark, Procter and Gamble and Cipla.
The court refused to heed the central government's argument that there were no valid licences for making any of the banned FDCs and that decisions were difficult to implement at states level.
The government said the primary issue was that these FDCs "lacked safety and efficacy" and that a, "ban was the only answer". It had also said that the banned drugs had no "therapeutic justification".
Some NGOs like All India Drug Action Network (AIDAN) also argued in favour of the ban over a span of over two months, starting 14 March, but in vain.
The court had on 14 March stayed the centre's 10 March order banning the use of 344 FDC drugs and had made the interim order applicable to all cases filed by pharmaceutical companies thereafter.
The drug companies had argued that the government did not properly apply its 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.
They also argued that the ban order was passed without considering clinical data and termed the government's claim that the decision to ban FDCs was based on the fact that safer alternatives were available, as "absurd"
The government had banned over 300 FDC drugs on the ground that they involve "risk" to humans and safer alternatives were available.
"On the basis of recommendations of an expert committee, the central government is satisfied that it is necessary and expedient in public interest to regulate by way of prohibition of manufacture for sale, sale and distribution for human use of said drugs in the country," the government stated in its 10 March notification.
The centre had argued that the FDC medicines were "new drugs" requiring licence from the Drugs Controller General of India (DCGI) for sale and manufacture.
Intervening in the case, AIDAN, the NGO, had argued that there were nearly 40,000 FDC drugs in Indian market and the use of most of these needed to be regulated.
The NGO also welcomed the government's move to use regulatory control over at least a few dugs, stating it "was the only move".
The Indian Medical Association (IMA) had also moved an application seeking intervention in the matter, saying it has decided to support the centre's decision.
