“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.
PTI