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Government bans 328 Fixed Dose Combinations including Saridon

FDCs are two or more drugs combined into a single dosage form, in a fixed ratio. 

Edited by: India TV News Desk New Delhi Published on: September 13, 2018 13:56 IST
Govt bans 328 Fixed Dose Combinations
Image Source : PTI

Govt bans 328 Fixed Dose Combinations 

The manufacturing of 328 Fixed Dose Combinations (FDCs) drugs, including popular painkiller Saridon, was on Wednesday prohibited by the Ministry of Health and Family Welfare. The ministry announced the prohibition of any kind of sale or distribution of the drugs for human use.

The ministry in a statement said it has restricted the manufacture, sale or distribution of six FDCs subject to certain conditions.

FDCs are two or more drugs combined into a single dosage form, in a fixed ratio.

The manufacture for sale and distribution of 349 FDCs was earlier banned by the Centre in March 2016. The manufacturers affected by the move however, had challenged it in high courts and the Supreme Court.

The matter was examined by the Drugs Technical Advisory Board (DTAB), complying with Supreme Court judgement in December 2017.

The board in its reports to the Centre, had recommended prohibiting the FDCs.

There was no therapeutic justification for the ingredients contained in them, the board said, adding these FDCs may involve risk to human beings.

Similar observations were earlier made by an expert committee appointed by the Centre.

The Ministry of Health and Family Welfare prohibited the FDCs through a gazette notification after considering the recommendations of DTAB and the expert committee.

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