Maharashtra FDA may ignore Madras HC stay, to commence action on FDC drugs
Although the Madras High Court stayed the DCGI directive on irrational combinations, the Maharashtra Food and Drugs Administration is all set to implement the order in letter and spirit.
The state FDA Commissioner Dhanraj Khamatkar said that the DCGI order will be implemented in the state. "I have not received any copy of the Madras High Court order. In fact, I am not aware of it. We will implement the DCGI order against the FDC drugs in the state", he said.
The Madras high court, acting on a petition filed by five pharma companies in Pondicherry, had granted a stay on the DCGI order. The court had once again allowed stay a few days ago acting on another petition filed by the Federation of South Indian Pharma Manufacturers Association, an association of thousands of pharma companies in south India.
Acting on the DCGI order dated 8-10-07, the FDA had issued notices to the drug manufacturers to stop manufacturing of the 294 contentious FDC combination drugs and the manufacturers should be complying with the FDA notice.
At a meeting of the state drug controllers in Chandigarh on October 26, the DCGI also asked the state drug authorities to expedite action against the FDC drugs that are in the market. As per the decision taken at the meeting, the state drug authorities were 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 lakhs of medical retail outlets of the country. For the around 150 'need further examination' category drugs, the DCGI had decided to allow the sale of the drugs which are already with the distributors and chemist shops till its expiry.
Despite this decision on October 26, the FDA waited for the minutes of the meeting to initiate further action. When the minutes of the meeting reached the FDA, the Madras high court had delivered its stay order.
As per the minutes of that meeting, the FDA was to immediately initiate action against absurd, rejected and banned drugs (around 120 FDCs) at the wholesale and C&F agent level. The FDA was also to take action against around 150 Need further Examination category FDCs at the C&F level".
In the light of the Madras high court order, the state drug administrations in the north and central India were going slow on the DCGI order. Though most of the state drug departments had already issued notices to the drug manufacturers to stop manufacturing, they were yet to take the initiative to return the stocks already in the market.