Ban on anti-diabetes drug Pioglitazone to go
New Delhi: The popular anti-diabetes drug Pioglitazone would soon be available in the market as the Union Health Ministry has decided to revoke the ban on its sale and manufacture with some riders.
The drug, used by lakhs of diabetes patients in the country, would be sold with a warning and would not be used as the first line of treatment.
The drug was banned by the Ministry on June 18.
A notification lifting the ban will be issued soon, official sources said.
Drug makers would also have to put insertions inside the packaging along with a warning outside giving the harmful effects of the drug. The Ministry will also ask medical practitioners not to use the drug on aged patients and that it be used in case they feel it is necessary, they said.
The drug is feared to cause cancer of the bladder though medical studies to confirm this are not available.
The Ministry decided to revoke the ban after recommendations from the Drug Technical Advisory Board.
The relook on the ban came after the government went on the backfoot following criticism from pharma industry and medical fraternity for the "hasty" decision bypassing the Board.
The drug was being used by lakhs of people in India and was much cheaper than its alternatives.
The Ministry had imposed a ban on the drug, suspending manufacture, sale and distribution of Pioglitazone and all formulations containing it.
The Ministry went back on its decision after it was pointed out that there was no scientific data to prove the link of the drug to urinary bladder cancer.
The Drug Advisory panel while recommending the lifting of the ban, asked the drug regulator to carry out such studies in this regard.
The government had banned the drug earlier without consulting the Drug Technical Advisory Board (DTAB).
Pioglitazone is banned in France but sold in the US and Europe with a warning. India will also have such a warning on the drug now.
Officials said the ban was reviewed in the interest of patients who use the drug as it is cheaper but some conditions have been imposed keeping in mind the patient safety.
The Ministry had earlier banned the drug after recommendations from the Central Drugs Standard Control Organisation (CDSCO).
A Chennai-based doctor, V Mohan, had petitioned the drug controller general to ban Pioglitazone after eight cases of adverse effects of the drug causing potential risk of urinary bladder cancer were reported in the southern city.
He, however, later said he did not have scientific data to prove that. Mohan courted controversy as his Diabetes Education Academy is running a certificate course which has been funded by a drug major for the past two years.