Diabetes Drug Bladder Cancer Risk Debate: Madras HC Orders Expert Review on Pioglitazone, Sitagliptin Safety

The ruling came in a writ petition filed by Dr B. Mukesh, a practicing medical doctor, who challenged an order issued by the Indian Council of Medical Research (ICMR) in February 2025.

The case marked the second round of litigation between the parties, following an earlier High Court directive requiring ICMR to hear all stakeholders on the petitioner’s complaint. Dr Mukesh alleged that Pioglitazone, a widely used and affordable anti-diabetic drug costing about ₹4 per tablet, was wrongly portrayed as unsafe on the grounds that it caused bladder cancer, leading to its replacement with Sitagliptin, a drug priced nearly ten times higher.

It was noted that the doctor sought to espouse the cause of the general public by drawing the attention of the Court to the medicine prescribed for treating diabetes and by seeking action against the opposite doctor for recommending a wrong medicine for the treatment of diabetes. The Court noted that the doctor is a practicing medical professional and that the opposite doctor also serves as Chairman of the Madras Diabetes Research Foundation.

According to the petitioner, the opinion linking Pioglitazone to serious side effects was propagated by Dr V. Mohan, Chairman of the Madras Diabetes Research Foundation, resulting in regulatory decisions that benefited private pharmaceutical companies at the cost of patient affordability. He further alleged that his complaints, including those alleging false propaganda and criminal conspiracy, were not examined fairly and that the inquiry conducted by ICMR failed to comply with earlier court directions, as different authorities heard the petitioner and the third respondent separately.

The respondents, including the Union Ministry of Health and ICMR, defended their actions by stating that Pioglitazone had faced bans in countries such as France and Germany and that regulatory decisions in India were taken on the side of caution.

They clarified that the ban in India was only temporary, lasting six weeks, and was subsequently revoked after review. The authorities maintained that due process was followed and denied any wrongdoing or bias in the decision-making process.

Justice M. Dhandapani, however, made it clear that the judiciary was not the forum to decide complex medical questions. The Court observed,

“This Court does not possess any expertise to go into the factual aspect as to which drug is beneficial for the treatment of diabetes.”

Stressing the need for an institutional and expert-led resolution, the High Court disposed of the writ petition with a direction to the Centre to form a team of experts to go into this aspect as it concerns public health.

Further, the court order stated,

"The team of experts shall enquire the petitioner and the third respondent (V.Mohan Petitioner(s) Chiarman, Madras Diabetes Research Foundation) on the same day. The experts shall give their opinion about both the drugs and recommend the drug that is suitable for consumption by the diabetes patients in our country.

The said exercise shall be completed within a period of three months from the date of receipt of a copy of this order. The first respondent (Ministry of Health and Family Welfare, Government Of India) is directed to ensure that the order of this Court is implemented in a strict manner since it involves public health and also Crores of diabetes patients in this country."