Health ministry to review ban on Pioglitazone tomorrow

In the wake of opposition from industry and medical fraternity to the ban on anti-diabetes drug Pioglitazone, Health Ministry's Drug Technical Advisory Board (DTAB) will review the decision in its meeting tomorrow.
The government is on the back-foot after hue and cry from pharma companies and medical fraternity against the "hasty" decision of the Health Ministry and is now planning to revoke the decision to ban marketing of the drug, sources said.
The Health Ministry had suspended manufacture, sale and distribution of Pioglitazone and all formulations containing it last month due to its possible link to urinary bladder cancer. Pioglitazone is banned in France but sold in the US and Europe with a warning.

However, doctors across the country claim there has been no proper study to ascertain the ill-effects of Pioglitazone and alternative drugs are much costlier.
The Drug Controller said the ban is being reviewed in the interest of patients who use the drug as it is cheaper but insisted that patient safety is foremost in the mind of the ministry.
Sources said the Ministry had banned the drug after a recommendation from the Central Drugs Standard Control Organisation (CDSCO).

A Chennai-based doctor had petitioned the drug controller general to ban Pioglitazone after eight cases of adverse effects of the drug causing potential risk of urinary bladder cancer were reported in the southern city.

The government took cognisance of the concern and banned the drug on June 18 without consulting the Drug Technical Advisory Board (DTAB).
After protests from doctors, experts were called to take a review on July 11 and the matter was referred to the Drug Advisory Board.
The Indian Pharmaceutical Alliance also hit out at the Health Ministry's ban on Pioglitazone, saying it was done "without following due process and scientific enquiry".
The industry is expected to present its case in favour of the drug supported by scientific data and facts in DTAB meeting tomorrow, sources said.
The said instead of a blanket ban, there could be a boxed warning on packaging of the drug, cautioning patients about its possible side effects, as is done in some developed countries.