Balaram Gajra, Ph.D., is an associate professor at the Department of Pharmaceutics and Pharmaceutical Technology, Ramanbhai Patel College of Pharmacy, Charotar University of Science and Technology, Changa, India.
On June 18, 2013, the Indian government banned the highest selling and lowest costing antidiabetic drug, pioglitazone. The reason cited for the ban is its adverse effects, particularly bladder cancer. Surprisingly, the ban was revoked on July 31, with the following conditions:
1. The drug should not be used as the first-line therapy for diabetes.
2. The manufacturer should place distinct boxed warnings in bold red letters stating that the drug should not be prescribed to patients if they are at risk for bladder cancer, have a prior history of bladder cancer, or if they suffer from uninvestigated hematuria.
3. Review of safety and efficacy, known risk factors of bladder cancer, and the risk to elderly patients should also be mentioned as a boxed warning in bold red letters.
There are more than 60 million diabetic patients in India, and over 3 million of them use pioglitazone. The drug currently has a market of over $150 million USD. The revocation of the ban on pioglitazone is a true benefit for the diabetic patients in India, who would otherwise have to rely on either insulin or the costlier version of the drug.
Pharmaceutical experts in India say that the ban was a sudden decision by the Indian government who did not consult with the Drug Technical Advisory Board (DTAB), a committee of officials operating under the auspices of the Drugs and Cosmetics Act, 1940, of India. According to the Gazette of Government of India, after the ban on pioglitazone, DTAB came into action and decided to advise the government to revoke the ban with the conditions mentioned above.
Pioglitazone is currently banned in France and Germany, whereas the United States and Europe sell it with a boxed warning. Both the ban and revocation were not based on specific studies undertaken by the government or any other agency.
It is still a matter of debate that the decision to revoke the ban is because of due diligence by the government of India.
Do you think the ban on pioglitazone should have been revoked? How can we better administer drug warnings in collaboration with the government?
More About the Author
Balaram Gajra, Ph.D., received his master’s degree from the Department of Pharmaceutics, Indian Institute of Technology, Banaras Hindu University (IIT-BHU), Varanasi, India, and his doctorate from Kachchh University.