The Drugs Technical Advisory Board (DTAB) on Friday recommended revoking the ban on pioglitazone — an oral anti-diabetic drug which was banned on June 18.
But the DTAB, which was kept in the dark when the decision to ban was taken, has also recommended that the medicine be sold with a boxed warning (that the drug carries a significant risk of serious or even life-threatening adverse effects).
The recommendations have been sent to the Union Health and Family Welfare Ministry, which will issue the formal orders.
The Ministry banned piogiltazone based on a letter sent in January to the Drug Control General of India (DCGI) by Chennai-based diabetologist Dr. V. Mohan, chairman of Dr. Mohan’s Diabetes Specialities Centre. His letter was based on his observation of eight bladder cancer cases in patients, taking the drug. His data was published only as a ‘letter-to-the-editor’ in the Journal of Association of Physicians of India (JAPI) and hence was never peer reviewed prior to publication.
The expert committee meeting convened on July 11 wanted the ban revoked. The committee was formed when the government was severely criticised by diabetologists for acting in haste and without any study on the matter. India approved pioglitazone more than a decade ago and many thousands are on this drug.
As per records available on the website of the Clinical Trials Registry – India (CTRI), Dr. Mohan’s Centre is one of the participating institutions in five human clinical trials involving MSD’s anti-diabetes Sitaglipitin drug. MSD is the Indian subsidiary of Merck. His Centre is not a part of the sixth trial being conducted in India by MSD. But the company is funding a certificate course run by Dr. Mohan’s Diabetes Education Academy for the last two years.
“There is no conflict of interest at all… [Being a part of the trial has] absolutely not influenced me,” Dr. Mohan told The Hindu. “As a WHO Collaborating Centre for Non-Communicable Diseases, it is our duty to inform the health authorities about possible side effects of drugs.”
“The very fact that the government has placed so many restrictions on its use today shows that the drug does indeed have serious side effects,” he added.