The Drug Controller General of India (DCGI) is yet to take a decision on banning the controversial FDCs or approaching the court to vacate the interim stay granted by the High Court of Himachal Pradesh on the DCGI directive to file safety and efficacy data on FDC drugs approved by the State Licensing Authorities before October 1, 2012.

“We are still to get the order of the High Court. After going through the order, we will discuss and take suitable action accordingly,” DCGI Dr G N Singh said in response to the HC order. He refused to further disclose whether the government will try to get the stay vacated and go ahead with the plan to treat the FDCs as illegal.

However, sources in the Health Ministry indicated that the Government would not rush to a hasty decision as the matter was brought to the courts in different States and only interim stay was granted now.

The Himachal HC on September 27 had granted the stay on the directive by the DCGI issued in July, after a member of Himachal Drug Manufacturers Association approached the court. The petitioner claimed that some of these FDCs under question were being used for decades and no adverse impacts were recorded yet, proving their safety and efficacy.

Meanwhile, the Haryana Pharmaceutical Manufacturers Association (HPMA) has also moved Punjab and Haryana High Court challenging the same order. The Punjab Drug Manufacturers Association has also joined as a party in the case.

The DCGI, through his order, had asked the manufacturers to submit safety and efficacy data of FDC drugs approved by the state drug controllers before October 1, 2012 without the DCGI nod. The last date for submitting the efficacy data of SLA - approved FDCs to the DCGI office has ended on September 30, 2013.

Dr Singh, talking to Pharmabiz, also refused to disclose details on how many companies had submitted the required data on the FDCs before the end of deadline of September 30.

As per the DCGI order, if the manufacturers failed to submit the data before the deadline, these FDCs will would be considered for being prohibited for manufacture and marketing in the country. “In case the applications of such FDCs are not submitted by any manufacturer by September 30, it will be presumed “that they are not willing to prove the safety and efficacy of such FDCs before the office of the DCGI,” the DCGI order to the state licensing authorities (SLAs) said.