The Government is open to re-examine the case of anti-diabetes drug pioglitazone and revoke the ban if strong scientific evidences emerge in support of its safety and efficacy, Drug Controller General of India (DCGI) Dr G N Singh informed.
However, he defended the ban of the drug as per the existing system and adverse reactions, and strongly refuted the allegations that it was banned to help some other brands.
“It is not a closed case. We are open-minded in the case of pioglitazone, unlike in the case of the two other banned drugs-- analgin and deanxit. Science is progressing and we are willing to re-examine the ban if the companies concerned or the scientific community come up with scientific evidence to prove its safety and efficacy,” Dr Singh told Pharmabiz.
While indicating that it was kind of 'suspension' of manufacturing more than the blanket ban, the DCGI said the decision to ban drug was taken as per the existing norms. “The Health Ministry had made a written commitment before the Parliamentary panel that any drug banned in more regulated countries would be banned in India also immediately. Pioglitazone is banned in developed countries like Germany and France,” he said.
Apart from this, there were also cases of adverse reports about this anti-diabetes drug under the pharmacovigilance programme in India, further strengthening the case for a ban now, the regulator revealed.
The ban of pioglitazone had raised a storm with the industry leaders questioning the step and there were also allegations that it was banned to help some other existing brands. However, the DCGI strongly denied such allegations as 'totally baseless'.
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. The sudden ban had raised protests from the industry which claimed that it was available in most of the countries across the globe.