Review on anti-diabetic drug ban

A month after the Union Health Ministry banned a popular and cheap anti-diabetic drug pioglitazone citing bladder cancer risks, a technical panel is all set to review the decision following protests from a section of doctors, who wanted to continue with the medicine.

The Drug Technical Advisory Board (DTAB) headed by Jagdish Prasad, Director-General of Health Services in the ministry, will analyse the opinion of various doctors and options adopted by other global regulators on Friday before taking any decision on the drug.

Pioglitazone was banned because its long-term use may cause urinary bladder cancer. The medicine is prohibited for use in France and Germany whereas in the USA and UK, it is sold with a “black box warning.” It was banned by the ministry after Chennai-based veteran diabetologist V Mohan wrote to the Drugs Controller General of India (DCGI) in January pointing out eight cases of bladder cancer among patients using pioglitazone.

The letter was preceded by a scientific correspondence in the December 2012 issue of “Journal of the Association of Physicians in India” by Mohan and seven other doctors from southern and western India, who reported those eight cases. “The purpose of my letter was improving the pharmacovigilence, which is non-existent in India. Since the time I wrote to DCGI, there are five-six new cases of bladder cancer among pioglitazone users. But in the absence of a proper pharmacovigilence programme, we don't know how many users are developing cancer,” Mohan told Deccan Herald.

Every drug regulator has a strong pharmacovigilence section, which keeps an eye on how a particular drug is behaving when it is being used by a large number of patients.Along with the letter he also attached his own JAPI correspondence and at least four major studies from Canada, the UK and France in which adverse effect of the medicine was demonstrated by following up thousands of patients. Mohan said he was to receive a reply to his letter. But the ministry banned the drug last month, giving rise to protests from many doctors who were prescribing the medicine to their patients.

Many of them claimed an alternative drug, Sitaglptin, is also expensive.

While doctors refer to individual cases of pioglitazone users, there are no large-scale scientific studies on the medicine's long-term side effects in India.