The Indian government confirmed that it has revoked the ban on popular anti-diabetes drug pioglitazone though there are a number of riders accompanying the lifting of the ban.
The central government had initially banned the drug last month following concerns over the increased risk of urinary bladder cancer. However after doctors protested against the ban, claiming that it benefits far outweighed the risks, the health ministry confirmed that it will be revoking the ban based on recommendations of the Drug Technical Advisory Board.
However the revocation comes with a number of riders. The ministry asked the manufacturers of the drug to ensure that the packaging, product insert and the promotion literature displays warnings in bold red letters. Pioglitazone should also not be used as a first line of treatment for diabetics and should not be given to patients who have a history of bladder cancer.
The drug should be restricted to the elderly and should only be prescribed after knowing the patients' history. Patients who have been prescribed the drug should also undergo safety reviews after three to six months of the treatment.
"Pioglitazone and all formulations containing Pioglitazone for human use is allowed to be manufactured for sale, sale and distribution subject to the condition that the manufacturers shall mention the following on their package insert and promotional literature of the drug", the government said in a statement.