After almost six months since the DCGI started his movement to weed out irrational fixed combination drugs (FDCs) from the pharma market of the country, things are back to square one as the pharmaceutical distributors, emboldened by the successive stay orders on DCGI order on FDC drugs, have once again started placing orders for the FDC drugs.
"The distributors have started again placing orders for the FDC drugs. We have also received the orders yesterday evening for two drugs for which the distributors had earlier stopped placing orders in the wake of DCGI action", a top official of a prominent Mumbai-based pharma company said.
Sources said, the companies will first clear all the products lying at the godowns. They will resume production of these medicines only after a clearer picture emerges in a week or two as the DCGI is preparing to file the counter affidavit to vacate the stay in Madras high court.
The distributors had some time back stopped putting orders for the FDC drugs to the manufacturers when the state drug authorities, acting on the DCGI order, started taking action against the FDC drugs. The DCGI had identified 294 FDCs for withdrawal of licenses by the state drug controllers. The state drug authorities had first asked all the manufacturers to immediately stop production of all the 294 combination drugs, which accounted for more than 1000 brands.
Around six months back in June this year, the DCGI had issued orders to the state drug controllers to withdraw licenses to 294 FDCs which the state drug authorities had given to the manufacturers over a period of around two decades. When the state drug authorities expressed unwillingness to act on his orders, the DCGI had to literally browbeat them to fall in line. After the manufacturers stopped production of these drugs, the DCGI had directed the state authorities to withdraw the products from C&F agents, godowns and distributors. But by the time the state drug authorities started taking actions, the cornered pharma companies knocked at the doors of the court and got stay on all the action on FDC.
Meanwhile, the Confederation of India Pharma Industries (CIPI) has sent letters to the state drug controllers asking them to take cognisance of the court stay order before taking further action on FDC drugs. The CIPI letter might also have emboldened the pharma distributors to place orders once again.