Ban lifted, diabetes drug will now come with warning

Mumbai, 2 Aug 2013: Following a series of protests from doctors across the country, the Ministry of Health and Family Welfare has after several rounds of meetings finally revoked the June 18 ban on the antidiabetic drug pioglitazone. An insulin sensitiser, the drug is considered by experts to be the most effective of its kind, provided it is administered in the correct dosage. The lifting of the ban will bring relief to over 35 lakh diabetes patients across the country who were left to either switch to insulin or opt for costlier (yet less effective) drugs. The ministry's notification issued on July 31 states that while the central government was of the opinion that the use of pioglitazone involved risk to human life, the DTAB examined the issue and suggested that the drug should not be banned. Conditions for sale With the ban lifted, pioglitazone will once again be available on the market, albeit with certain conditions. The central government has now made it mandatory for its manufacturers to include literature in the packaging to warn users of the drug's potential risks. The central government has also stated that pioglitazone and its other formulations should not be used as a first line of treatment for diabetes, and that the manufacturer should print a warning box on the packaging, warning of its risks for those with active bladder cancer, ongoing chemotherapy and other such conditions. The drug is banned in France. In the Unites States, it is sold with a black box warning - a type of alert on packaging of certain prescription drugs. Following its ban in India, medical experts had termed it a "hasty step" and had been protesting against. "I would say that it is a blessing in disguise as the drug is back with a black-box warning. This will ensure that it is used judiciously and that patients will not lose out on its benefits," said diabetologist Dr Rajiv Kovil. More benefits than risks France was the first country to ban Pioglitazone, in June 2011, and doctors believe that the Indian government followed suit blindly. The drug has been linked to bladder cancer and other side effects such as water retention, anemia and even heart failure. But experts say that its benefits outweigh the risks.

Mumbai Mirror