FDCs banned over safety & efficacy concerns: Centre tells HC

Government today told Delhi High Court that the decision to ban 344 fixed dose combination (FDC) drugs was taken keeping in view "safety, efficacy and rationality" of these medicines.
The government, however, clarified before Justice Rajiv Sahai Endlaw that their initial concern was regarding licences being granted by the states for manufacture of FDC drugs, but by the time a final decision was taken, the focus shifted on safety of such medicines.
The submission came in response to the court's observation that the entire exercise of setting up a panel to look into FDCs was undertaken to deal with fresh applications for licences.

The court was hearing over 150 petitions filed by several pharma firms, including Pfizer, Glenmark, Procter and Gamble and Cipla, challenging the government's March 10 notification banning 344 FDCs, a decision which has been stayed by the judge in each case filed before it since March 14.
"My understanding is that the whole exercise was undertaken to deal with fresh applications for licences. If concern would have been of safety, then it (notification) would have said that so many complaints were received from patients and doctors, etc. Instead, the concern appears to be of licensing," the judge said.
To this, Additional Solicitor General (ASG) Sanjay Jain said, "though the initial trigger was approval or licensing by state authorities, by the time a decision was taken, there was complete clarity that concern was safety, efficacy and rationality of these FDCs".

The ASG also said there was no question of "political victimisation" as the decision was implemented irrespective of "face value" of a drug or the company manufacturing it.

He further argued there was no mandatory requirement to consult the Drugs Technical Advisory Board (DTAB) prior to banning the FDCs, as claimed by the companies.
"If DTAB involvement is not required for grant of approval to a drug, then their involvement is not required for banning a drug," he said, adding "the ultimate discretion is with the central government on whether it wants to consult DTAB, except where the Drugs and Cosmetics Act makes it mandatory to involve the Board".

The ASG further contended that the power exercised by the
government under the Act while issuing the notification was "essentially and primarily a legislative function" and only "partially technical" and thus there was no need to consult the DTAB.
During the two-hour long hearing, he also said decision to ban the FDCs, including various cough syrups, was taken in "public interest".
He said a large number of people were getting addicted to the cough syrup as it was being used by them as an intoxicant.
Pfizer, which makes Corex cough syrup, told the court that it gets codeine for its drug from the government and currently had Rs eight crore worth of the ingredient lying with it, adding that if the Centre passes such orders banning FDCs, then the company "will go broke".

Other drug majors argued that as per WHO guidelines, FDCs include both finished formulation of two ingredients like Corex as well as prescribing of the ingredients separately but concurrently.
They said that while the government banned the finished formulation version, the second variety was not banned and this showed "complete non-application of mind".
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 Centre'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.