NEWS
Flip flop policy over pioglitazone licence causes media storm in India

BMJ 2013;347:f4937

India’s ministry of health and family welfare has revoked the ban that it placed on the antidiabetes drug pioglitazone just six weeks ago because of the drug’s association with bladder cancer.1

The Drug Technical Advisory Board, through the Gazette of India, recommended revoking the ban after reviewing the evidence, and imposed various conditions for the use of pioglitazone.2 It recommends, for example, that pioglitazone should not be used as a first line treatment for diabetes.

The ban and the subsequent reversal of the policy have caused a media storm in India, with many commentators demanding clear processes for drug licensing that are based on scientific evaluation of the evidence.

Jaykaran, assistant professor of pharmacology at the Government Medical College in Surat, Gujarat, said, “The whole process of banning first and revoking later is shocking. This shows how incompetent the system is. Drug control authorities in India are hardly aware about evidence based medicine and seem to rely mostly on [the] personal opinions of some clinicians.”

The ban on pioglitazone was apparently triggered by a letter after a noted Indian diabetologist and Padmashree awardee (the fourth highest civilian award in India) wrote to the prime minister’s office detailing the risk of bladder cancer with pioglitazone use.3

Clinicians are also puzzled about the clinical safeguards imposed by the drug control agency. These require prescribers to review the safety of pioglitazone every three to six months and to keep only those patients who are deriving a benefit from the drug on it.

Rakesh Biswas, professor of medicine at People’s College of Medical Sciences, Bhopal, told the BMJ, “Are the prescribers expected to order a cystoscopy every three months to screen for bladder cancer? Also, pioglitazone is often given in combination with other oral hypoglycaemic [drugs] so it would be difficult to decide on whether to continue or discontinue pioglitazone solely based on the patient’s overall blood sugar control as one may not know for sure which of the drugs (pioglitazone or metformin or sulfonylurea) are actually working.”

The requirement for manufacturers to mention various safeguards on their package insert and promotional literature of the drug is also being questioned.

Jaykaran told the BMJ, “Clinical decisions regarding drug prescription in India mainly depend on information about the drug given by medical representatives. No medical representative is going to focus on things mentioned in [the] Gazette.
Clinicians in India are usually poor at assessing evidence and don’t have much time and interest in prescribing drugs based on guidelines or box warnings so this Gazette is going to have limited implications.”

Biswas added that “the guidelines mentioned in the gazette are unrealistic and it may not be possible to maintain safeguards by either CDSCO (the drug control agency in India) or the treating physician.”

Notes
Cite this as: BMJ 2013;347:

G Mohan.