The real impact of the Drug Controller General of India's (DCGI) campaign against 294 FDCs will be felt at the retail level in some days from now. The state drug departments are waiting for the minutes of the meeting of DCGI-state drug controllers held on October 26-27 to commence seizing operations of combination drugs from over 5 lakh chemist shops across the country.
Sources said the state drug authorities are waiting for the formal letter from the DCGI office in Delhi to initiate action at the retail level. Though the state drug authorities have already issued 'stop production' orders for all the 294 FDC drugs to the drug manufacturers, the real heat of the DCGI action will be felt only when the action at the retail level starts, as there are still plenty of stocks in the market from C&F level to the retail chemist shops.
As per the decision taken at the DCGI-state drug controllers meeting at NIPER in Chandigarh on October 26-27, the state drug authorities have to ensure that all the brands of the 120 FDC drugs falling under the category of Absurd, Rejected and Banned have to be removed from all levels from manufacturing to C&F agents to the shelves of lakh of medical retail outlets of the country. For the 150 'need further examination' category drugs, the DCGI has decided to allow the sale of the drugs which are already with the distributors and chemist shops till its expiry.
"We are ready for the action and are waiting for the minutes of the meeting. We will not take any action unless we get something in black and white", a senior FDA official said. The DCGI letter is expected any time now. The market will feel the real heat of the DCGI action once the drug authorities start action at the retail level, he added.
Interestingly, the state drug authorities of the central Indian states are yet to receive the minutes of the meeting of the DCGI-state drug controllers meeting held in Goa on September 24. The meeting was part of the DCGI's regional level state drug controllers meeting to convince them about the need to weed out irrational combination drugs from the pharmaceutical market in the country.