Here’s why the Supreme Court has exempted Saridon from the ban on FDCs

• The Supreme Court has ordered a fresh enquiry of banned combination drugs after repeated reviews and recommendations from India’s drug advisory panel.
  
• The Court announced its decision while hearing a plea from drug manufacturers Piramal Healthcare, GlaxoSmithkline and Juggat Pharma who have challenged the ban.
  
• India’s drug advisory panel has said these drug combinations could be potentially toxic to consumers and lack therapeutic justification.
  

A week after the government banned the sale and distribution of over 328 ‘fixed dose combination’ drugs including several painkillers over safety concerns, the Supreme Court has lifted the ban on popular painkiller Saridon and two other drugs citing a technicality.

A Supreme Court bench announced its decision while hearing a plea from drug manufacturers Piramal Healthcare, GlaxoSmithkline and Juggat Pharma who claimed their combination drugs should be allowed as they were first manufactured and granted regulatory clearance before 1988, the cut-off year for the government’s current ban.

Earlier this month, the Supreme Court had directed the government to conduct yet another enquiry to evaluate the safety of at least 15 fixed dose combination drugs that were reportedly manufactured before 1988. It was not immediately clear if Saridon, Piriton expectorant and Dart, the other two drugs granted relief by the court, would still be subject to fresh safety tests.

The Supreme Court ordered the fresh enquiry of these combination drugs after repeated reviews and recommendations from India’s drug advisory panel, the Drugs Technical Advisory Board, which has said these drug combinations could be potentially toxic to consumers and lacked therapeutic justification. The most recent ban came three years after the panel had cited similar concerns recommending an outright ban before being ordered to conduct another review by the Supreme Court late last year.

A pharmaceutical trade group, the Federation of Pharma Entrepreneurs, representing makers of FDCs affected by the ban has claimed the government and the safety review panel have not followed due process in instituting the ban. Pharma companies have also contended the Drug Technical Advisory Board’s review report behind the ban was never given to them.

A long battle

The government on its part has been seeking to ban these combination drugs -- which contain two or more active ingredients -- for nearly a decade. The review and recommendations have been ongoing for years with India’s Drugs Technical Advisory Board behind these repeated recommendations.

According to estimates by All India Drug Action Network, one of the petitioners behind the ban, problematic FDCs in India makes up a quarter of the total pharma market in India valued at ₹1.3 trillion ($14 billion)

“The people of India have been made the consumers of unsafe medicines for too long and this is one step towards rectifying the grave situation of a pharma market brimming with innumerable irrational FDCs,” the drug network said in a recent statement.