A government panel has recommended the continued use of an anti-diabetic compound and a painkiller only a month after the Union health ministry suspended their sale amid concerns about their side effects.
The Drugs Technical Advisory Board (DTAB), a panel of experts that advises the Centre on medicines, has asked the health ministry to revoke the bans on the anti-diabetic pioglitazone and the painkiller analgin, sources said.
“Two drugs labelled by the government as unacceptable only a month ago are about to be described as acceptable,” said a “shocked” Chandra Gulhati, pharmacologist and editor of the Monthly Index of Medical Specialities, India, an independent journal of drugs.
“Indian drug regulators have over the years banned nearly 90 drugs, and virtually all of them based on information about adverse effects from outside India. Why are pioglitazone and analgin being
treated differently?” Gulhati said.
Concerns about pioglitazone emerged after a study in France showed that patients exposed to it have a 1.2-fold increased risk of bladder cancer compared with patients who never took the drug.
France suspended the use of pioglitazone in June 2011, and both US and European drug regulators introduced rules requiring the link to bladder cancer to be explained on drug information leaflets for patient awareness.
Gulhati says he is even more surprised at the recommendation to lift the ban on analgin.
A parliamentary standing committee on health that scrutinised the functions of India’s drug regulators had last year asked the government to examine the rationality of continued marketing of analgin.
The drug has been withdrawn or banned in Australia, Bangladesh, Ireland, Denmark, Malaysia, Pakistan, Saudi Arabia and the US, among other countries.
The health ministry’s June 18 order had cited its “progressive” withdrawal from many countries.
“I’m shocked by the DTAB’s latest decision. It seems they are either trying to use analgin as a smokescreen to push through pioglitazone, or they are trying to openly defy the parliamentary panel,” Gulhati said.
Only time will tell whether lifting the ban is a wise decision or not?