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India’s health ministry bans pioglitazone, metamizole, and flupentixol-melitracen

BMJ 2013; 347 doi: https://doi.org/10.1136/bmj.f4366 (Published 05 July 2013) Cite this as: BMJ 2013;347:f4366

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  1. Soumyadeep Bhaumik
  1. 1Kolkata

India’s ministry of health and family welfare has banned the popular diabetes drug pioglitazone, the painkiller metamizole, and the psychiatric combination flupentixol with melitracen with immediate effect, because it said that their use was “likely to involve risk to human beings.”

The move is a response to a report from a parliamentary standing committee in April that criticised the ministry for failing to withdraw several drugs with questionable safety profiles and lack of evidence of effectiveness.1 The report highlighted problems with metamizole and the combination, though it did not mention pioglitazone.

An estimated three million people in India use pioglitazone, a market worth about Rs7bn (£80m; €90m; $120m).2 However, its use has been associated with an increased risk of bladder cancer.3

Jaykaran, assistant professor of pharmacology at the Government Medical College, Surat, Gujarat, told the BMJ, “I think this a good and proactive step by the Indian government. There is no credible agency in the government sector that critically evaluates available literature to know the safety profile of drugs, hence it is better to ban drugs that are already banned in some other countries over safety concerns.”

France and Germany banned pioglitazone in 2011, but it is available in the United States and the rest of Europe with warnings.

The Indian Pharmaceutical Alliance, which represents the interests of the industry, opposes the withdrawal of pioglitazone. It said in a statement, “Patients who were adequately controlled on treatments costing Rs4-8 per day are being pushed towards costlier medication.”

Metamizole has been banned in Sweden since 1974, the US since 1977, and many other countries because of the increased risk of agranulocytosis.

Flupentixol with melitracen, which is produced by a Danish company and marketed as Deanxit, is banned by the Danish Medical Association. Indian laws prevent marketing of a drug that is not approved for use in its country of origin. Deanxit is also banned in the US, the UK, Ireland, Canada, Japan, and Australia.

Notes

Cite this as: BMJ 2013;347:f4366

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