The government is set to revoke the suspension order on anti-diabetes drug pioglitazone, imposed late last month.
However, pharmaceutical companies selling the drug will be required to carry a box warning indicating the possible risk of bladder cancer.
The decision was taken in a meeting of the government’s highest advisory body on drugs, the Drugs Technical Advisory Board (DTAB), on July 19, after strong opposition from the industry as well as the medical fraternity emphasising the need of the drug for patients in the country.
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.
“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,” said Dr Singh.
The ban :
Last month, the government had suspended manufacturing and sale of pioglitazone in India after V Mohan, a prominent diabetologist from Chennai, wrote to the Prime Minister’s Office highlighting the risks attached to the drug.
The government had recently suspended the sale of pioglitazone in India after around seven cases of adverse effects of the drug causing potential risk of bladder cancer were reported in Chennai.
However, there are no other such cases reported in India.
The drug, which is used by 3-4 million patients in India, is banned in France. However, in countries such as the US and the UK, the medicine is sold with a boxed warning on the label.
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.