The Gujarat Food and Drugs Control Administration (FDCA) is seeking expert opinion from state legal department to decide what further course of action can be taken on the controversial FDC issue. The Gujarat FDCA's action comes in the backdrop of pressures from the industry associations demanding to stop all actions against the FDC drugs in the wake of the recent stay order from Madras High Court.
Major pharma industry associations like Indian Drug Manufacturers Association (IDMA) and Confederation of Indian Pharmaceutical Industry (CIPI) have pointed out to the state FDCA that any further action against the FDC drugs would be contempt of court as the Madras High Court has already stayed the DCGI order asking against FDC drugs. The FDCA has forwarded the letters of the associations to the legal department to clarify whether the state government's action on FDC drugs would tantamount to contempt of court.
"We received the letter from the associations while we were planning to cancel the product license for the combination drugs in the DCGI's list. But since it involves a legal issue, we have to clarify whether to go ahead with the action or to wait until a final verdict will come out from the Madras High Court," said a source from Gujarat FDCA. "Yes, we are waiting for opinion from the legal department," confirmed H G Koshia, joint commissioner, Gujarat FDCA, who currently holds charge as licensing officer for pharmaceutical products.
In November 2007, the state FDCA has earlier issued notices to 370 manufacturers who hold around 1,800 licences for combination drugs in the state, ordering stoppage of manufacturing and marketing of the products. In reply to the notice, majority of state drug manufacturers informed the administration that they have stopped marketing and manufacturing of the products. The only duty remains with the FDCA is cancellation of product license of the combinations under dispute, added sources.
Meanwhile, Mona Khandhar IAS, joint secretary with the state health and family welfare department has taken the additional charge of the FDCA, the post which fell vacant in January 2008, with the resignation of Dr S P Adeshara. The government has notified H G Koshia as the licensing officer for drugs for the time being.