India May Soon Revoke Ban on Diabetes Drug Pioglitazone

July 23, 2013

The Indian government's suspension of the diabetes drug pioglitazone may soon be revoked if the government follows the advice of the Drug Technical Advisory Board (DTAB) there. The DTAB met July 19 and recommended that pioglitazone be put back on the market in India, albeit with a boxed warning about bladder cancer.

The decision by the Indian government to suspend the manufacture, sale, and distribution of pioglitazone, citing concerns over adverse effects, particularly bladder cancer, came out of the blue last month, and was widely criticized by doctors and others there, as reported by Medscape Medical News.

Since then, a meeting of doctors on July 12 resulted in the referral of the matter to the DTAB. The DTAB recommended the ban be lifted when it met on July 19, according to numerous reports in the Indian press.

Despite repeated attempts to contact the drugs controller general of India (DCGI), Dr. G.N. Singh, and other government officials in an attempt to ascertain whether it will accept the advice of the DTAB and revoke the ban, so far no one could be reached for comment.

The secretary general of the Indian Pharmaceutical Alliance (which represents 19 research-based national pharmaceutical companies), Beilib D.G. Shah, told Medscape Medical News, "The DTAB is an advisory body. The government may or may not accept its advice. Current indications are that it may accept the recommendations."

Ban Due to Letter About 8 Cases of Bladder Cancer

The pioglitazone ban has received much coverage in the media in India. According to several reports, it was first invoked because of a letter sent to Dr. Singh earlier this year.

That letter came from a diabetologist, Padma Shri V. Mohan, MD, from Dr. Mohan's Diabetes Specialities Centre, Chennai, and cited 8 cases of bladder cancer in patients who had been taking pioglitazone.

There were accusations in some of the media coverage that the motivation behind this correspondence was the fact that Dr. Mohan had received funding from Merck, Sharpe & Dohme, the Indian subsidiary of Merck, whose newer diabetes drug sitagliptin (Januvia) stands to gain if pioglitazone is unavailable.

But Dr. Mohan has strenuously denied this. He told the Indian Express, "I had written that letter in good faith, in the interest of my patients and not to benefit some drug company. It is the duty of the DCGI to commission a study."

He also said that it's incorrect to state that the gliptins (dipeptidyl peptidase-4 inhibitors) — of which sitagliptin is one example — are a direct replacement for pioglitazone. "It is incorrect to assume that if pioglitazone is not available, it will be replaced by a gliptin. Moreover, there are several other antidiabetes drugs on the market apart from gliptins, some of which are even less expensive than pioglitazone," he told the Economic Times.

Dr. Mohan's data were published as a letter to the editor in the Journal of the Association of Physicians of India and "hence [were] never peer reviewed prior to publication," the Hindu newspaper notes.

The same report adds that another Chennai-based diabetes doctor, Vijayam Balaji, MD, from Dr. Balaji Diabetes Care Centre, evaluated bladder-cancer risk in 958 patients receiving pioglitazone but did not find any increased risk across all age groups, even after 2 years of treatment. That study was published this month in the Indian Journal of Endocrinology and Metabolism.

Mixed Reaction to Pioglitazone Suspension

Regardless of the reasoning behind the ban, there was criticism that the Indian government did not follow due process in enacting the suspension.

Those who dispute the ban state that pioglitazone had been on the market for over a decade in India and is still available in the United States, United Kingdom, and many other Western markets. They also argue that pioglitazone is cheap and particularly effective for Indians with diabetes, who have a lot of insulin resistance . According to the International Diabetes Federation, more than 60 million adults in India have diabetes.

Critics also point out that pioglitazone is endorsed and recommended for diabetes management by many respected organizations, including the American Diabetes Association, the European Association for the Study of Diabetes, and the International Diabetes Federation.

However, others believe the suspension should stay in place, citing the fact that France banned pioglitazone because of the bladder-cancer risk. Archana Sarda, MD, from Sarda Centre for Diabetes and Selfcare, Aurangabad, Maharashtra, told the Times of India that pioglitazone has "significant side- effects." Thorough research "should be conducted in India. The ultimate bottom line should be the safety of patients," he said.

And Dr. Mohan himself told the Hindu, "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."

Yet others feel there is a middle ground somewhere.

Mangala Borkar, MD, from the Government Medical College and Hospital, Aurangabad, told the Times of India: "Pioglitazone is a good antidiabetic drug, especially for our country, where insulin resistance is common. But heavy doses of the drug should be avoided." Dr. Borkar said pioglitazone should only be "a third or fourth option" and should be used "only if necessary and in small doses."

A final decision from the Indian government on this issue is expected shortly.


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