DCGI to revoke diabetes drug ban?
Drug Controller General of India Dr G.N. Singh’s decision to suspend anti-diabetes drug Pioglitazone may be revoked. Less than a week after it was suspended, the DCGI said that he may withdraw the suspension of the drug if there is enough science based explanation regarding its benefits.
The Indian drug manufacturers who are slated to meet Dr Singh, will take up the issue during their meeting. “We are open to the discussion regarding this drug. If there is enough data explaining its benefits we will revoke the suspension. The drug has been suspended after safety issues were raised. However, keeping in view the benefit-risk ratio we may withdraw the decision to suspend the drug,” Dr G.N. Singh told this newspaper.
The ministry of health and family welfare had suspended the manufacture and sale of Pioglitazone under Section 26A of the Drugs and Cosmetics Act, 1940 with immediate effect, through a notification issued on June 18.
While the drug is sold in US with a boxed warning. The warning emphasises that it may cause or worsen heart failure, and its use for over a year may be associated with an increased risk of bladder cancer. So far, only France has taken it off the shelves.
The “sudden and abrupt” suspension of the drug in India has disappointed the medical experts. Calling the suspension “unreasonable” Dr Anoop Misra, chairman, Fortis-C-DOC Centre of Excellence for Diabetes and Metabolic Diseases said that it’s a very useful drug; apt for the Indian population.
“I feel, this drug if judiciously used, is quite beneficial to the Indian population. The drug is cheap and largely does not have side effects. Only few studies have shown that it caused bladder cancer. In certain conditions it should be avoided but banning it completely is a wrong decision.”
Dr Misra added that if Pioglitazone is banned, medical experts will be left with very little choice but to prescribe more expnsive drugs.
“If this drug is banned, we will have to go for expensive drugs like Januvia Galvis etc. Pioglitazone on the other hand is a cheap drug, the movement we go to the third line drugs, the money spent on them will be enormous, Dr Misra said.
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