How Can DCGI Approved Drugs Be Banned: HC Asks Govt

New Delhi

How can a medicine approved by the drug control authority be banned, Delhi High Court asked today, as the government said mere approval does not restrain it from taking action.

"How can approval of Drug Controller General of India (DCGI) be disregarded entirely? You will have to state what changes occured thereafter (post-approval) for disregarding. Else there is one expert panel today and tomorrow there will be another.

"There is no reason appearing from your report as to what happened that a drug which received DCGI approval has now been banned," Justice Rajiv Sahai Endlaw told the government while hearing over 180 pleas challenging the government's decision to ban 344 fixed dose combinations (FDCs).

Additional Solicitor General (ASG) Sanjay Jain said that under the 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.

Pharma companies like Pfizer, Glenmark, Procter and Gamble and Cipla, told the court that there were three categories of drugs mentioned under section 26A which are "harmful, boastful and those that lack therapeutic justification."

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

The firms said that as per the government's expert panel, all banned FDCs fell in the third category and hence they should have been regulated by saying which ingredient of a combination was not required or if needed then in what dosage.

They claimed the government has not properly implemented the powers under section 26A of the Act.

The court asked the pharma companies to "crystallise" the issues that need to be discussed and give them to the ASG so that he can address arguments on those points on the next date of hearing on April 18.

It asked the companies to give broad parameters and questions which are generally applicable to all of them, irrespective of the licences they hold, and clarified that commercial concerns of the pharma companies was not a factor.

"What if some drug is dangerous? Therefore, it (commercial concerns) is of no weightage," the court said.

The court was hearing the petitions by 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."

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