Today’s edit page of The Indian Express has my column on the Indian drugs regulator’s decision to ban pioglitazone, an anti-diabetes drug reportedly taken by 30 lakh patients. I have argued that India is paying for its historically casual attitude to pharmacovigilance or tracking drug safety. Continue reading
There is some debate on whether the Indian regulatory agency ought to have banned anti-diabetes drug pioglitazone given the large diabetic population in India.
The decision to ban is a correct and proactive step considering the harm that it may cause in patients who have been taking the drug for over two years.
Since hardly any meaningful pharmacovigilance (drug safety) data arises in India from pharmaceutical companies, the Indian regulatory agency has had to rely on studies and data received from other countries to take this important step. This, I have tried to explain below in detail. Continue reading