Regulatory control over FDCs illusory: NGO tells HC

The Delhi High Court was today told by an NGO that there were nearly 40,000 fixed dose combination (FDC) drugs in Indian market and since the regulatory control over such medicines was allegedly "illusory", the Centre's decision to ban some of them "was the only move".
The NGO, All India Drug Action Network (AIDAN), told Justice Rajiv Sahai Endlaw that once a FDC has been found to be unsafe by the experts, it has to be banned.
It also submitted before the court that prior to grant of licence for manufacturing a FDC, approval has to be sought not only from Drugs Controller General of India (DGCI) but also from the state licensing authorities and thus, the pharma companies making such medicines did not have a valid licence for it.

Additional Solicitor General Sanjay Jain, appearing for the Centre and DGCI, disagreed with this argument of AIDAN which has supported the central government's March 10 decision to ban 344 FDC medicines, a decision which has been stayed by the court in each case filed before it.
The court was of the view that AIDAN's arguments that the licences of the pharma companies to make the FDCs was not valid was not an issue raised before it as lack of valid licences was not the reason for the Centre's ban.
The court was hearing nearly 300 petitions filed by drug majors, including Pfizer, Glenmark, Procter and Gamble and Cipla, challenging the Centre's ban.

AIDAN argued that the state authorities were also expected to test the safety and efficacy of FDCs but they did not do so and added that many of the drug companies did not provide the safety data either to DGCI or to the state authorities.
The NGO also argued that since the manufacturing facilities of the companies were in different states and since the state licensing authorities were a necessary party, these petitions ought to be transferred to the High Courts concerned.
The court, however, did not agree with this line of argument. It listed the matter for further hearing on May 26.