How can test for safety of FDC be different from test for

The Delhi High Court today asked the Centre how the test for determining safety and efficacy of a fixed dose combination (FDC) drug can be different from the test for grant of approval to the medicine.
The query was raised by Justice Rajiv Sahai Endlaw while dealing with nearly 300 petitions filed by drug majors challenging the government's March 10 decision to ban 344 FDC medicines, a decision which has been stayed by the judge in each case filed before him since March 14.
"Can test for approval be different from test for safety and efficacy? Can approval be denied by the committee when power to approve was with DCGI?" the court asked Additional Solicitor General (ASG) Sanjay Jain.

The queries were made pursuant to the ASG's submission that the Kokate committee set up by the government had not gone into approvals and instead had looked into the safety and efficacy of FDCs. He also said that grant of approvals was done by Drug Controller General of India (DCGI).
The court then asked DCGI as to what was the procedure followed by it after it receives an application seeking approval for a FDC and directed it to file its standard operating procedures on the next date of hearing, May 19.
During the hearing, the court observed that the government had the liberty to take action against those manufacturing FDC drugs without approval but the Centre "chose to act under a different procedure" by "throwing away statutory provisions and appointing an expert committee".

It also noted that DCGI was granting approval "only as a formality" because the panel has cleared it and asked "how do you justify that the panel is applying its mind and not DCGI?"

"Obviously, there is some difficulty in saying they (FDCs) do not have approval and then banning them on that ground," it added.
The court also said that the "only question" that has to be answered is whether the ban was enforced by the appropriate authority.
Concluding his arguments, the ASG also said that that the
court can speak to the head of the expert panel if it so desired.

Pharma companies like Pfizer, Glenmark, Procter and Gamble and Cipla, have contended in their pleas 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.
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 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 that "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.