Delhi HC stays centre’s decision to ban 344 fixed dose combinations medicine

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NEW DELHI,Dec1: The Delhi high court on Thursday set aside the Centre’s decision to ban 344 fixed dose combination (FDC) medicines, including well known 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 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.
They had also argued that the ban order was passed without considering clinical data and had termed as “absurd” the government’s claim that it took the decision to ban FDCs on the ground that safer alternatives were available.
The government had banned over 300 FDC drugs on the ground that they involve “risk” to humans and safer alternatives were available.
As per the March 10 notification, “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.”
Defending its stand, the Centre had argued that the FDC medicines are “new drugs” and thus, require licence from Drugs Controller General of India (DCGI) for sale and manufacture.
The government had also said there were no valid licences for making any of the banned FDCs and added it was difficult to implement any action at state level.

However, it had also said that the lack of approval for these FDCs were a secondary issue and the primary focus was that they “lacked safety and efficacy” and thus, “ban was the only answer”.
It had also said that the banned FDCs had no “therapeutic justification”.

AIDAN, which had intervened in the matter, had argued that there were nearly 40,000 FDC drugs in Indian market and since the regulatory control over such medicines was allegedly “illusory”, the Centre’s decision to ban some of them “was the only move”.
Even the Indian Medical Association (IMA) had moved an application seeking intervention in the matter saying it has decided to support the Centre’s decision.

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