The government has banned popular painkiller Nimesulide above 100 mg in tablets and syrup forms with immediate effect. A notification from the Ministry of Health and Family Welfare said that the government is satisfied that it is necessary and expedient in the public interest to prohibit Nimesulide above 100 mg in the country for human use.
“In exercise of the powers conferred by section 26A of the Drugs and Cosmetics Act, 1940, and after consultation with the Drugs Technical Advisory Board (DTAB), the central government hereby prohibits the manufacture, sale and distribution of all oral formulations of the following drug (Nimesulide), with immediate effect,” the notification said.
Section 26A grants powers to the central government to regulate, restrict, or prohibit the manufacture, sale, and distribution of any drug or cosmetic if it poses risks to humans or animals without necessarily consulting with DTAB.
Industry Impact
As of November, the annual sales of drugs containing Nimesulide in both single-drug formulation and fixed-dose combination stood at Rs 489 crore, according to healthcare research firm Pharmarack. Over the past three years, the drug has reported compounded annual growth rate (CAGR) of 8.4%. Nimesulide is currently sold across hundreds of SKUs – in strengths of 50mg, 100mg and 200mg – by different pharma companies, including Sun Pharma, Dr Reddy’s, Lupin, Cipla, Intas and Zydus.
Safety Audit
The ban has come after the central government asked the Indian Council of Medical Research (ICMR) last year to assess the drug’s safety concerns in adults, specifically analysing liver safety concerns. After consultation with DTAB, ICMR recommended banning all formulations above 100 mg in addition to mandating a “black box” warning on products containing this specific drug.
Experts said that the decision is unfair to the trade and businesses, especially because the safety concerns around Nimesulide are widely known for a long time. “Even though the government has the right to take such decisions in the public interest, the industry is going to suffer from the immediate ban. The negative effects of the drugs have not been discovered recently, and the government is mulling potential ban since last year. It would have been fair if the government had given a window to the manufacturers and distributors to exhaust their current inventory, considering that it’s a top-selling medicine in the country,” said Anay Shukla, founding partner at Arogya Legal.
In 2011, Nimesulide was banned for children (under 12) use followed by its prohibition for veterinary use in February this year.
