Delhi High Court sets aside ban on 344 fixed dose combination drugs

New Delhi: The Delhi high court on Thursday set aside the Union government’s ban on 344 fixed dose combination (FDC) medicines that it had said lacked therapeutic efficacy. The decision came after  six months of hearing more than 400 petitions filed by drugmakers against it.

The 344 drugs also included well-known brands like Corex cough syrup, Vicks Action 500 extra and several anti-diabetes medications. The court said that the government’s decision was  taken in a “haphazard manner.”

Justice Rajiv Sahai Endlaw allowed 454 petitions moved by various pharma and healthcare majors, like Pfizer, Glenmark, Procter and Gamble and Cipla, challenging the government’s March 10 notification banning the FDCs, saying the decision was taken by the Centre without following procedure prescribed in the Drugs and Cosmetics Act.

The court had from March 14 onwards stayed the operation of the Centre’s decision with regard to medicines of several pharma majors.

The court on Thursday said that proceedings till issuance of the notification of March 10, 2016, “do not suggest there was any grave urgency.”

It also said that the power under Section 26A (power to prohibit manufacture of drugs and cosmetics in public interest) of Drugs and Cosmetics Act cannot be exercised in public interest except when a drug poses a risk to consumers.

During the hearing in the case, the drug companies had contended that the government has not properly implemented the powers under Section 26A, 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).

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”.

Some of the well-known medicines on which the ban on sale has been lifted include Pfizer’s Corex cough syrup, Glaxo’s Piriton expectorant and Crocin Cold, P&G’s Vicks Action 500 extra, Reckitt’s D’Cold, Piramal’s Saridon, Glenmark’s Ascoril and Alex cough syrups, Abbott’s Phensedyl cough syrup and Alembic’s Glycodin cough syrup.