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Date posted: November 2, 2012

Ramesh Shankar, Mumbai

Even as the fixed dose combination (FDC) issue, triggered by the withdrawal of licences to 294 irrational FDCs by the then DCGI way back in 2007, still lingers on in Madras High Court, the Union health ministry is preparing another long list of irrational FDCs which will be withdrawn from the market in the near future, it is learnt.

According to sources, the ministry has already prepared a list of around 200 irrational FDCs and the list will soon be issued to the state drug licensing authorities, directing them to withdraw licences issued to these drugs by them during the last some years. Most of the atrovastatin combinations, rabeprazole combinations, paracetamol combinations and multivitamin combinations will be withdrawn from the market, sources said.

Though the ministry can itself ban the irrational FDCs in public interest under Section 26A of the Drugs and Cosmetics Act (D&C Act), the ministry is contemplating to issue directions under Section 33(P) of the D&C Act to the state governments, asking the states to direct the drug licensing authorities in their states to remove the irrational and unauthorized FDCs from the market for which licenses were earlier granted by the state drug licensing authorities without prior approval from the DCGI. Under section 33(P) of the D&C Act, it is mandatory for the states to follow the directions issued by the central government.

The health ministry’s knee-jerk action on this issue comes in the backdrop of the recent report of the Parliamentary Standing Committee on Health. The panel, which came down heavily on the functioning of the CDSCO, had also made critical comments on the FDCs, while calling for “a clear, transparent policy for approving FDCs based on scientific principles.” The Committee expressed its view that those unauthorized FDCs that pose risk to patients and communities such as a combination of two antibacterial need to be withdrawn immediately due to danger of developing resistance that affects the entire populations.

Earlier in 2007, the then DCGI Dr Venkateshwarlu had prepared a list of 294 irrational FDCs and had directed the state drug authorities to withdraw licences issued to them. But, the issue courted controversies when the manufacturers moved Madras High Court challenging the DCGI order. The issue is still sub-judice. [Source]

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