What was the urgency to ban over 300 FDC drugs, HC asks govt

New Delhi: What was the urgency for banning the manufacture and sale of over 300 fixed dose combination medicines and how can the approval of Drug Controller General of India (DCGI) be disregarded completely, Delhi High Court asked the government on Monday.

Justice Rajiv Sahai Endlaw also sought an explanation from the concerned ministry on the issue, saying they must have opted for some standard procedures before granting licences to the pharma companies.

"What were the standard procedures adopted by you (government) during grant of licence and what was the urgency which led to withdrawal of the same," the court asked the Centre's counsel while hearing over 180 pleas challenging the government's decision to ban 344 fixed dose combinations (FDCs).

"How can approval of DCGI be disregarded entirely? You will have to state what changes occurred thereafter (post- approval) for disregarding. Else there is one expert panel on Monday and Tuesday there will be another. There is no reason appearing from your (government's) arguments as to what happened that a drug which received DCGI approval has now been banned," the court observed.

In his response, Additional Solicitor General (ASG) Sanjay Jain said under the Drugs and Cosmetic Act, the government can disregard the approval given by DCGI and say that a FDC or drug has to be prohibited.

"Grant of approval does not restrain government from taking action under section 26A (power to prohibit manufacture of drugs and cosmetics in public interest) of the Act. Earlier also, more than 90 DCGI approved drugs were banned," he said.

ASG was responding to the contentions of pharma companies like Pfizer, Glenmark, Procter and Gamble and Cipla, that there were three categories of drugs mentioned under section 26A which are "harmful, boastful and those that lack therapeutic justification."

They had said the powers under the provision to allow prohibition of drugs that are harmful, restricting "boastful" claims about medicines and regulation of those that lack therapeutic justification.

The drug firms had said that as per government's expert panel, all banned FDCs fell in the third category and hence should have been regulated by saying which ingredient of a combination was not required or in what dosage. They claimed the government has not properly implemented the powers under section 26A of the Act.

The court was hearing the petitions by the pharma companies challenging the government's March 10 notification banning 344 FDCs, a decision which has been stayed by the judge in each case filed before him since March 14.

The government on March 31 had said the decision to ban 344 FDCs was taken keeping in view "safety, efficacy and rationality" of these medicines.

It had then clarified that their initial concern was regarding licences being granted by states for manufacture of FDC drugs, but by the time a final decision was taken, the focus shifted on safety of such medicines. Earlier, the drug firms had argued that the Centre's ban on the 344 FDCs was taken without considering clinical data.

The companies had also termed as "absurd" the government's claim that it took the decision to ban the FDCs on the ground that safer alternatives were available.

Pursuant to the court's interim stay order, some well- known medicines on which the ban on sale was lifted were Pfizer's Corex cough syrup, P&G's Vicks Action 500 extra, Reckitt Benckiser's D'Cold, Piramal's Saridon and Glenmark's Ascoril and Alex cough syrups.

The March 10 notification says, "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."