The Drugs Technical Advisory Board (DTAB) on 19 July 2013 recommended for revoking the ban on Pioglitazone- an oral anti-diabetic drug which was banned on 18 June 2013.
DTAB also recommended that the medicine should be sold with a boxed warning (that the drug carries a significant risk of serious or even life-threatening adverse effects).
The recommendations were sent to the Union Health and Family Welfare Ministry, which will in turn issue the formal orders.
The Expert Committee meeting convened on 11 July 2013, took the decision of the lifting the ban on Piogltazone.
The Expert Committee under the Chairmanship of Director General of Health Services Jagdish Prasad has constituted when the Government was severely criticised by diabetologists for acting in haste and without conducting any scientific study in the country.
India approved Pioglitazone more than a decade ago and many people are using this drug.
The Ministry banned Piogiltazone based on a letter sent in January 2013 to the Drug Control General of India (DCGI) by the Chennai-based diabetologist Dr. V. Mohan, chairman of Dr. Mohan’s Diabetes Specialities Centre.
The market for Pioglitazone in India is estimated at 700 crore Rupees annually and major players, such as Ranbaxy, Cipla and Sun Pharma, manufacture the drug.
The drug was banned in France in 2010, but it is still using in the US, the UK and other countries, with a warning label.
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