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Thu, 20 Sep 2018

Northeast Today

Govt Bans 328 Drugs over Safety Grounds, Including Saridon

Govt Bans 328 Drugs over Safety Grounds, Including Saridon
September 13
12:13 2018

The government prohibited the manufacture, sale and distribution of 328 Fixed Dose Combination (FDC) drugs for human use with immediate effect on Wednesday. Several popular drugs including painkillers combinations such as Saridon.

It has also restricted the manufacture, sale or distribution of six FDCs subject to certain conditions.

The Ministry of Health and Family Welfare had earlier banned 344 FDCs under section 26 A of the Drugs and Cosmetics Act in 2017. Later, five more FDCs were added to the list.

The matter was contested by several manufacturers in High Courts and the Supreme Court of India.

The SC in 2017 asked the Drugs Technical Advisory Board to examine the matter and present a report on these drugs to the Central Government.

“The Drugs Technical Advisory Board recommended, amongst other things, that there is no therapeutic justification for the ingredients contained in 328 FDCs and that these FDCs may involve risk to human beings. The Board recommended that it is necessary to prohibit the manufacture, sale or distribution of these FDCs under section 26 A of the Drugs and Cosmetics Act, 1940 in the larger public interest,” informed the health ministry.

Another expert committee, appointed by the Centre, also made recommendations in line with those of the Board, calling the drugs “irrational” and cited safety issues and lack of therapeutic justification.

Based on the recommendations of the expert committee and drugs board, the Centre then decided to prohibit the manufacture for sale and distribution for human use of these 328 FDCs in the country.

SOURCE: Zee News

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