Anti-diabetes drug Pioglitazone whose sale has been recently suspended by the Union Health Ministry last week might soon be sold in the market but with some rider.
Giving in to the intense pressure from the industry and health professionals, the Ministry has decided to re-examine the case of the drug and revoke its suspension if strong scientific evidences are proved in support of its safety and efficacy.
The sale of the anti-diabetes drug was suspended following cases of adverse reports that its usage could increase the risk of urinary bladder cancer among patients.
The move also comes in the wake of the Government’s commitment to a Parliamentary panel on Health that it plans to suspend sale of medicines that were banned in one of the six major global drug markets for harmful side effects.
AK Panda, Joint Secretary in the Health Ministry, said that the Drug Technical Advisory Board (DTAB) of the Drug Controller General of India (DCGI) would soon meet to review the matter. Depending on its outcome, the fate of the drug will be decided, he said.
“In fact, the drug is not banned but its usage and sale has been suspended till its efficacy is proved. It would be upon the experts of the DTAB whether they would allow its sale or regulate it with new warnings,” said Panda.
Pioglitazone is banned in developed countries like France while Germany has put on “hold” its suspension for some time.
However, the suspension in the Indian market was protested by the industry as well doctors who said that the drug was being consumed by lakhs of patients and also that it was an attempt to help some other brands. The industry also claimed that it was available in most of the countries across the globe.
Pioglitazone is one of the commonly-prescribed medicines. As many as 300 brands are available as single drug as well as in combinations with other drugs such as metformin and glimepiride.