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The Supreme Court allowed the sale of Saridon, Piriton Expectorant and Dart which were in the list of 328 fixed-dose combination (FDC) drugs banned by the Centre on the ground that there was no justification given for the ingredients contained and they may involve risk to human beings. The bench allowed the Saridonand two other drugs to be sold temporarily as a relief to headaches after the notification issued by the Centre was challenged.
The Ministry of Health and Family Welfare, issued a notification, which prohibited the manufacture and sale of FDCs which has a fixed dose combination of two or more products.
Recommendation of the Drugs Technical Board was relied on by the Centre so as to reach a conclusion that these drugs were not safe for humans. Previously, the Wockhardt, a pharma company moved to Delhi High Court wherein, the ban was challenged but the Bench refused to give relief, as a result the High Court directed the existing stock of drugs to be sold or those already in the distribution channel.
The Centre had banned 344 FDCs in the year 2016 but the Delhi High Court in the year, 2017 lifted the ban which covered the Corex Cough Syrup and Vicks Action 500 Extra, and held that the decision was taken in a haphazard manner without consulting the statutory bodies as made mandatory under the law.
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