Ban on FDCs: HC asks if legitimacy of approval be considered

The Delhi high court on Wednesday asked the Centre whether the legitimacy of approvals held by pharma companies, challenging the government’s decision to ban 344 fixed drug combinations (FDCs), needs to be considered as this was not given as a reason to ban these medicines.

“You have not prohibited the drugs/FDCs on the ground of legitimacy of their approval. So do we need to go into it? Can we proceed under the premise that approval is not an issue,” Justice Rajiv Sahai Endlaw asked the government.

Additional Solicitor General Sanjay Jain, appearing for the Centre, said the drugs were banned as they had no therapeutic justification and not on the ground of approval but most of these firms did not hold a valid licence to make the FDCs, which were banned by its March 10 notification.

However, senior advocate Colin Gonsalves, appearing for All-India Drug Action Network (AIDAN), contended that the issue of approval has to be gone into. Senior advocate Kapil Sibal, appearing for various drug companies, including Pfizer, said they were not making medicines without approval. “They (government) are free to take action against us if we do not have approval,” he said.

Sibal argued that the legitimacy of approval was the reason for setting up of an expert panel and claimed that the panel had not applied its mind or done its “homework” while recommending a ban on these FDCs.