Indian government bans three medicines owing to health risks

The Indian government has banned three popular medicines – anti-diabetes drug pioglitazone, painkiller analgin and anti-depressant deanxit – as the result of health risks associated with them, according to the Times of India.

It is believed that pioglitazone can cause heart failure and increases the risk of bladder cancer, while analgin has already been discarded across the globe on grounds of patient safety. Deanxit is viewed as a harmful combination, which has been long banned in Denmark, its country of origin.

The decision comes in the wake of a strong stand taken by the Indian government on suspending marketing of all drugs prohibited for sale in other countries including the US, UK, EU and Australia.

The ministry of health and family welfare has suspended with immediate effect the manufacture and sale of all three drugs under Section 26A of the Drugs and Cosmetics Act, 1940.

The decision to ban pioglitazone and its combinations will hit the Rs 700-crore market for such drugs and have an adverse impact on companies including Abbott, Sun Pharma, USV, Lupin, Ranbaxy and Wockhardt.

The decision to ban pioglitazone and its combinations will hit the Rs 700-crore market for such drugs

Pioglitazone combination is a bigger market than standard pioglitazone, which has posted double-digit growth, with more than 30 companies marketing it.

Analgin is a relatively small market with brands such as Baralgan and Novalgin (Sanofi Aventis), as most companies fearing a ban have already pulled out from the market, industry experts said.

The third drug, a combination of Flupenthixol and Melitracen sold as Deanxit (Lundbeck), Placida (Mankind), Franxit (Intas) and Restfull (Lupin) is facing a ban because deanxit is prohibited for sale in Denmark and the combination is not sold in major countries.

Under the Drugs and Cosmetic Rule 30-B, the import and marketing of any drug prohibited in the country of origin is banned in India.

The family of 'glitazones', used for blood glucose lowering properties, has been controversial since the beginning, with many drugs under the class having already been banned globally, and in India, the Times of India said. Three years ago, another drug from this family, rosiglitazone, marketed by a number of companies including GSK India, was banned, following a decision taken in Europe.

France has already taken pioglitazone off the shelves, while in the US it is sold with a boxed warning.

Doctors in India said in a study last year that more robust data on the use of pioglitazone was needed. Until then, the patient should be adequately informed about adverse effects and the drug should be used in as small a dose as possible, with careful monitoring and follow up.