Pharma cos turn cautious, not to make 294 FDCs despite Madras HC stay
Notwithstanding the Madras High Court's recent stay order which allowed the pharmaceutical companies to manufacture and market the FDC drugs, the manufacturers will not resume production of FDCs in the near future. They are exercising caution and will use the opportunity to liquidate the stocks which are already in the market.
Sources close to the development said that the pharmaceutical companies will not resume production of the 294 FDC drugs immediately which the DCGI had identified and had directed the state drug controllers to withdraw licenses to them. The state drug authorities, acting on DCGI order, had issued notices to the manufacturers of these 294 FDCs and the manufacturing of these FDCs has virtually come to a standstill in the entire country.
"(ii) Pleased to grant an order of stay of all further proceedings of impugned order of the 2nd respondent, so as to enable the petitioner to produce and market FDC drugs pending disposal of the above w.p. nos 34777 to 34781 of 2007 respectively", the court order said. While the 2nd respondent is DCGI, the petitioner is five pharma companies from Pondicherry.
"The manufacturers are exercising caution and will not resume manufacturing of these 294 FDCs till a clearer picture emerges. They do not want to take chances now as it takes several months, even years, to liquidate a product in the market. They will use this opportunity to liquidate the stocks already in the market", a senior industry leader said.
Industry sources said that manufacturing is not the priority of the companies at present. They are worried about the stocks already in the market as hundreds of crore of rupees are at stake. The high court stay could not have come at a more opportune time, as the DCGI had directed the state drug authorities to seize these FDC drugs from the C&F agents, godowns and also from the distributors.
Though pharma companies had pleaded for some time to liquidate the products, the DCGI did not heed to the industry's demands. In fact, the industry was hopeful of a positive response from the DCGI till the DCGI-Industry meeting at NIPER in Chandigarh on October 27. But, the DCGI bluntly asked the companies to withdraw their products from the market by December 31 which was not acceptable to the industry as it wanted at least six months to liquidate the stocks, sources said.