The Drug Controller General of India appears to have softened his stand in taking action against FDC drugs at the retail level. Copies of the minutes of the meeting DCGI had with state drug controllers in Chandigarh on October 26 have reached the state drug controllers but it is silent on action to be taken at retail level.

"The minutes of the DCGI-state drug controllers meeting in Chandigarh has reached and it does not mention anything about the action at retail level. Having received the minutes, the state drug controllers have to launch action against combinations classified as absurd, rejected and banned drugs (around 120 FDCs) at the wholesale and carry and forward (C&F) agent levels. The FDA has also to take action against around 150 Need further Examination category FDCs only at the C&F level", a senior official in the Maharashtra Food and Drug Administration (FDA) said.

As per the decision taken at the DCGI-state drug controllers meeting at NIPER in Chandigarh on October 26, 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 manufacturing, C&F agents and also from retail chemists. For the 150 combinations of 'need further examination' category, the DCGI has decided to allow the sale of the drugs which are already with the distributors and chemist shops till its expiry.

Meanwhile, the FDA will start action as per the DCGI order in a day or two. The department is waiting for the haze to clear about the status of the Madras High Court order. The court had on November 12 stayed the DCGI order of stopping production of FDC drugs listed by the DCGI.

"The department is waiting for clarity of the court order whether the order has extra-territorial jurisdiction or not. Since the order stayed by the court is of central government, it might apply to all over India. Once the picture is clear, we will start action", the FDA official said.