Health Ministry appeals to transfer all FDC cases to Supreme Court.

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The Union health ministry has moved Supreme Court, praying it to club and transfer all the petitions pending in various High Courts in the country filed by a large number of pharma companies and associations against the ministry’s ban on 344 fixed dose combination (FDC) drugs in March this year.

According to sources, the ministry’s move in this regard is to avoid any kind of ambiguity on the issue that could arise from differing verdicts that might come from different High Courts as the case is pending in around 10 High Courts including Delhi High Court where the case has already been heard and an order is expected any time. It its petition, the ministry has requested the Supreme Court that all cases against the ban order being heard in High Courts across the country should be transferred to Supreme Court and be heard as a single case.

Earlier on March 12, 2016, the Union health ministry had prohibited 344 FDC drugs, taking the pharma industry by surprise. Several major multinational companies and Indian companies were affected by the ban of these FDC drugs including widely sold pain-killers, anti-diabetics and respiratory therapies. Subsequently, hundreds of petitions were filed by the drug makers in various High Courts against the health ministry’s prohibition order.

The ministry prohibited the 344 FDC drugs for human use under section 26 A of Drugs and Cosmetics Act (D&C Act) 1940 as the government felt that the use of these drugs are likely to involve risk to human beings whereas safer alternatives to the said drug are available. The government’s decision to ban these drugs was based on the recommendations of an Expert Committee constituted by the ministry some time back.

The matter has been examined by an Expert Committee appointed by the Central Government and the said Expert Committee recommended to the Central Government that the said drug is found to have no therapeutic justification, the ministry had said.

Source: 1


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