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 the 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 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 to be revoked. The committee was formed when the government was severely criticised by diabetologists for acting in haste and without conducting any scientific study in the country. 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. 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.
“We were involved with all gliptin molecule trials in India… We have worked with all other companies producing gliptin molecules. We have worked with almost all pharma companies. We were involved in 110 trials in the last 20 years… For almost every drug on diabetes available in the country, we would have been one of the trial centres at some point of time.”
Explaining further, he said: “There are four gliptins in the market…we have all the four gliptins in our pharmacy. We make it a policy to stock all the [diabetic] drugs in our pharmacy.”
As per the CTRI records, the first trial to be registered was in August 2009. One trial was registered in June 2010, while three trials were registered last year — one in February and two in September.
Three of the trials are conducted in many countries and India is one of them; two trials are conducted only in India in many centres/institutions.
Chennai-based diabetologist Dr. V. Balaji’s diabetes centre is also one of the sites where one MSD trials for Sitagliptin are being carried out. He evaluated bladder cancer risk in 958 patients on pioglitazone but did not find any “increased risk of bladder-related abnormalities across all treated age groups even after two years of treatment.” His study was published in July in the Indian Journal of Endocrinology and Metabolism.