Pioglitazone suspension and its aftermath: A wake up call for the Indian drug regulatory authorities

Pioglitazone, the commonly used antidiabetic drug was placed under suspension in June (June 18, 2013). The suspension was promulgated in the Government gazette.[1] It was not recommended by the Drug Technical Advisory Board (DTAB). There has been no mention of the Pharmacovigilance Program of India (PVPI) reporting suspicious signals for pioglitazone. The medical fraternity debated the appropriateness of the decision. Doctors worried on the lack of affordable replacement for pioglitazone. The pharmaceutical industry was taken aback by the suddenness of the decision. The diabetic population was a mute spectator to this entire event. The backlash from the medical fraternity and pharmaceutical industry was swift. Accusations of improper review and not following the procedures flew thick. The institution of the Drugs Controller General (DCGI), India, was at the center of this backlash. The apex drug regulator’s action of suspending a common and widely used drug looked ill‑informed. A fortnight of heated media discussions and accusations forced the DCGI on the defensive. Finally, the nation was informed that the suspension was being revoked and pioglitazone would now be available again with an updated warning for the patients.[2] In a month, the office of the drug regulator went from being generally regarded as a scientifically oriented body to it being perceived as an ill‑informed, over‑zealous organization.