Though the ban on the anti-diabetic drug pioglitazone has been revoked, city chemists said it would take 15 days to one month before the drug is available once again at medical stores.
This means that the 35 lakh diabetics in India who, according to various doctors’ associations, were consuming this drug, will have to wait.
The union health ministry had banned the drug on July 18 for its association with various health risks, it but revoked the ban on July 31 on the condition that the drug would be sold in new packing with a warning about its side effects.
Some of the health risks associated with drug include increased risk of cardiovascular diseases, bladder cancer and weight gain.
The ban led to protests by doctors and patients, who said the ministry’s decision had been hasty and soon after, the ban was removed unconditionally.
More than 95% diabetic patients in India suffer from type 2 diabetes and doctors said insulin resistance is a major complication.
Insulin resistance is more common in Asian Indians, so glitazones have been more popular in India, said doctors
The low cost of the drug is a big reason for its popularity.
In India, the drug costs R1 to R4 per tablet.
The drug has an estimated annual market of R700 crore Pioglitazone is used to improve glucose control in adults with type 2 diabetes.
It allows internal insulin to work in the body,doctors said.
The US FDA approved pioglitazone, in 1999, to treat type 2 diabetes mellitus.
It is usually prescribed as second- or third-line treatment in diabetic patients
Pioglitazone was banned in France in 2011 was removed conditionally.
“As per the notification, the drug can be sold only if it carries the warning literature,” said Damji Pallan from Retail Drug and Chemist Association (RDCA), Mumbai.
“The stock we have does not have the necessary warnings so we are waiting for manufacturing companies to take back the stock and repackage it,” Pallan said.
Before the ban, around 5,000 strips of pioglitazone drug were sold on a monthly basis at a chemist store, according to the RDCA.
“With warnings on boxes, initiating new patients on this drug will be difficult. But those patients who have been on pioglitazone are waiting to get back on the drug,” said a diabetologist, requesting anonymity.
“As a result of the ban, many patients who were on pioglitazone have switched to other drugs or insulin,” said Dr Rajiv Kovil, diabetologist.
“They will have to continue with the alternatives prescribed until the drug with the prescribed warning arrives,” he added.