New Delhi :- Pfizer’s cough syrup Corex, which had received a ‘No Objection Certificate’ (NOC) from DCGI in 1995, was brought up as an example during the proceedings.
The Delhi High Court on Thursday asked the government how it banned some combination drugs without taking into consideration data from manufacturers that had the Centre’s approval and using data from manufacturers without approvals instead.
Pfizer’s cough syrup Corex, which had received a ‘No Objection Certificate’ (NOC) from DCGI in 1995, was brought up as an example during the proceedings. The court has extended by another week the stay granted to over 60 pharmaceutical companies that have petitioned the ban on 344 fixed dose combination (FDC) drugs as it continues to hear the government defend its decision.
Around 11 combinations out of the 344 combinations for which firms have moved the court have brands that were approved by the Drug Controller General of India (DCGI), according to a lawyer representing a large drug maker in the matter.
In this case, subsequent manufacturers of the same codeine combination did not need an approval, but Corex’s approval was revoked based on data from the other manufacturers instead of Pfizer, Justice RS Endlaw told government’s counsel, additional solicitor general (ASG) Sanjay Jain. “Obviously, they could not have had data,” he added.
Enough medical literature on the combinations studied by the expert Kokate Committee already existed even if data on approved brands weren’t taken into account,
Speaking on Corex, Jain said that Pfizer had neither come forward with information when the health ministry had put up a public notice on the matter. The company also did not mention that the cough syrup was approved when the Kokate Committee had invited information on approved combinations, he added.
Pfizer had also not approached the government when the ministry had put up a list of FDCs approved by DCGI on its website in 2013, according to Jain. The list did not include Corex’s combination among those that were approved, he said.
“They did not come forward to seek rectification of that list which the approved drugs were mentioned in. After that, Pfizer did not come forward to submit any data before the Committee (either),”
The data collected from the other manufacturers was used to confirm what ingredients were used in the FDCs studied, said Jain.
“Even if Pfizer had come forward, they would not be in a position to give us anything new because it has not conducted any trials as per the records available with DCGI,” he added.
