Ban on sale of anti-diabetic medicine revoked

Medicine will be sold with a warning on packages

Ban on sale of anti-diabetic medicine revoked

The Union Health Ministry on Wednesday revoked the suspension on the sale of a top-selling anti-diabetic medicine, which was banned last month for adverse side-effects.

The prohibition on the sale of pioglitazone – an anti-diabetic medicine with Rs 830 crore market in India – was lifted following the recommendation of an expert group, sources told Deccan Herald. A formal gazette notification is expected in a day or two.

The medicine, sources said, would be allowed to be sold in India with a warning on the package as well as a information booklet, which will list out the long-term risk of using the medicine.

Doctors would be advised not to prescribe pioglitazone as a first-line drug against diabetes, but to use it as second or third line medicine, said a Health Ministry official.
India does not have any surveillance mechanism to check what medicines doctors are prescribing and if a rational drug use regime is being followed.

Pioglitazone was banned by the Union Health Ministry on June 18 because of its potential to cause bladder cancer in the long run. In the last one month, there is no new study to establish its safety.

But Drug Technical Advisory Board suggested withdrawal of the ban after a section of doctors approached the government with their personal experience. In India, pioglitazone products has an annual sale of almost Rs 830 crores, out of which Rs 540 crore worth market is of a fixed dose combination (FDC) of pioglitazone with metformin and glimepiride. 

Another FDC of pioglitazone with metformin and glibenclamide is worth Rs 60 crores. Such combinations are not permitted in the developed world.

Comments (+)