SC allows sale of three banned FDC drugs | Fusion - WeRIndia

Last week some 328 FDC drugs had been banned by the central government on the advice of the Drugs Technical Advisory Board (DTAB).

The main reason for banning these drugs as per the government’s notification was that they had “no therapeutic value.”

In this regard, many pharma companies are challenging this decision and some petitions are being filed by the drug manufacturers.

Considering their view, the Supreme Court permitted the sale of Saridon and two other drugs for now.

Initially 349 drugs had been recommended for ban by the DTAB in the month of June. However, 15 drugs were kept outside the purview of the ban as they were approved before 1988.

The Apex Court restrained the government from banning these 15 drugs which have a market value of more than ₹7 billion. Some of them included in these are cough and cold medicine like Phensedyl and Tixylix.

These 349 FDCs were recommended for prohibition for manufacture, sale and distribution by the Health Ministry in March, 2016 through a notification.

However, the pharma companies questioned this ban and took this matter to the Court. The Delhi High Court had rejected the ban.

Hence, the government challenged this matter in the Supreme Court. Then, the Apex Court asked the DTAB for re-examination on this decision in the last December.

As per the directions of the Apex Court, the expert panel of DTAB recommended to ban 328 drugs which do not have any therapeutic value and which may pose risk to humans.

Considering the recommendations of the DTAB, the central government banned these 328 FDC drugs immediately.

However, several pharma companies did not agree with this decision. Hence, they brought this matter again to the Apex Court stating that the government did not give any ‘proper reason’ for the ban but just stated these drugs have ‘no therapeutic value’.

In this scenario, the Apex Court permitted the sale of Saridon and another two drugs for the time being.

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