Even as confusion prevails over the jurisdiction of the Madras High Court's stay order on the DCGI order asking the state drug controllers to take necessary action on FDC drugs, the Small Scale Industries Pharma Association (SSIPA), Aurangabad, has urged the Maharashtra Food and Drugs Administration (FDA) to stop implementation of the DCGI order in Maharashtra.
In a memorandum, the SSIPA said, "Five manufacturers of Pondicherry have filed writ petitions against licensing authority, Pondicherry and DCGI, New Delhi in Madras High Court. In which, High Court Madras has granted stay order to DCGI's order dated 8-10-07 and also issued notices returnable in 8 weeks. So, SSI Pharma Association, Aurangabad, request you that order of DCGI dated 8.10.07 should not be implemented as per Madras High Court order, for the time being."
The Maharashtra FDA has already implemented the first part of the controversial DCGI order in which it has ordered to the drug manufacturers of the state to stop manufacturing of all the 294 FDC drugs. As per information emanating from the FDA, the manufacturers have fully complied with the order and have stopped production of these contentious FDC drugs.
It was making preparations to initiate action against these contentious medicines already in the market. In the next course of action, the FDA will initiate action against absurd, rejected and banned drugs (around 120 FDCs) at the wholesale and C&F agent level. The FDA will also take action against around 150 Need further Examination category FDC drugs at the C&F level.
The manufacturers are more worried about the next course of action of the DCGI order as hundreds of crore of rupees of medicines are already in the market at different levels, C&F agents, distributors and retailers.
As they have already stopped manufacturing of these FDCs, the manufacturers wanted to use the Madras High Court stay as an opportunity to liquidate the stocks already in the market.