Following the reversal on the ban of 344 fixed dose combinations (FDCs) by the Delhi High Court on December 1, 2016, the Karnataka pharma companies are hoping that the government would call on the industry to discuss the way forward.

The FDC ban in March this year was done too quickly and there was no rational behind the move which led the DCGI to issue an immediate embargo on sale of these drugs in March this year, said Dr BR Jagashetty, former National Adviser (Drugs Control) to MoHFW.

Quoting the PharmaLetter news report, which stated “Though the government has already filed an appeal in the Supreme Court against the decision, drug companies are now seeking a reconciliation with the health ministry and are moving towards an out-of-court settlement regarding the vexed issue,” Dr. Jagashetty said that the decision on reversing the DCGI order by the Delhi High Court seems to be mainly on purely administrative or non technical matters.

He further stated that the Delhi High Court could have considered technical and scientific material evidence, if any, produced by the government of India since this ban is mainly because of the irrational combinations which have no therapeutic value. All these 344 FDCs were in the market and were successful in the market going by its acceptance in the healthcare stream as patients responded to positive treatment outcomes with the same. Therefore there are no questions for such a mass ban, he added.

The DCGI decision to withdraw the drugs is based on guidance of the Kokate Committee testimony. But there should have been scientific backing on the possible health hazards given to the industry before hastily withdrawing the FDCs, pointed out Dr. Jagashetty.

According to Sunil Attavar, president, Karnataka Drugs and Pharmaceutical Manufacturers Association (KDPMA), we are all for banning the grossly irrational FDCs. Now that the order is reversed, the government should get together with the industry to find a way forward on these and other combinations that still exist and were not part of the 344 banned drugs list.

Currently, most of the small and medium enterprises in Karnataka have already changed their formulations to DCGI approved combinations, said Attavar. “We are not opposed to weeding out irrational products. But the issue could have been handled better by sensitizing the industry and comprehensive dialogue with all stakeholders. Nobody gains by selling irrational products and the industry had time and again suggested voluntary withdrawal of FDCs, pointed out Harish K Jain, secretary, KDPMA and director, Embiotic Laboratories.