Indian government bans several painkillers, diabetes and antibiotic drugs over safety concerns

• The ban affects an estimated 6,000 brands of ‘fixed dose combination’ drugs.
• A drug review panel deems these drugs potentially toxic.
  
• Popular painkiller Saridon and skin ointment Panderm among those banned.

The government on Wednesday banned the sale and distribution of over 328 ‘fixed dose combination’ drugs and restricted six others over safety concerns, a move that affects an estimated 6,000 brands of such FDC drugs.

Among the brands that have been banned include the popular painkiller Saridon; Panderm, a skin ointment; Diabetes drug Gluconorm PG; and antibiotic drug Lupidiclox, the Times of India reported.

The government had sought to restrict the combination drugs as early as 2010 followed by a review by India’s drug advisory panel, the Drugs Technical Advisory Board, which recommended an outright ban over three years ago. The ban was contested by several drug makers and the matter wound up in courts with the Supreme Court ordering a fresh review by the panel late last year.

‘Irrational’ and ‘unsafe’

The drug review committee deemed these FDC drugs -- which have more than two active ingredients in a single dose -- lacked therapeutic justification and the combinations potentially toxic terming them “irrational” and “unsafe.”

According to estimates by All India Drug Action Network, one of the petitioners behind the ban, the market for unsafe, problematic FDCs in India makes up a quarter of the total pharma market in India valued at ₹1.3 trillion ($14 billion). In a recent statement it noted that the FDCs under scrutiny account for approximately ₹25 billion in sales and “represent only the tip of the iceberg.”

“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.

Indian drug makers body, The Indian Drug Manufacturers’ Association (IDMA) has said it “respects” the verdict as responsible citizens of India, adding it has never advocated “irrational” FDCs but believes in the “advantages of patient convenience and compliance” that these combination drugs provide.