Is Pioglitazone Safe? Chennai Diabetologist plans to approach SC seeking answers

Chennai: Seeking clarity regarding the safety of pioglitazone, a Chennai-based medical specialist in diabetes is planning to approach the Supreme Court.

The concerned anti-diabetic medication had been banned by DCGI back in June 18, 2013. Later, the Chennai-based doctor had exposed the involvement of diabetologists in this regard to the Health Ministry and exposed the conspiracy by those diabetologists, who had allegedly fabricated the evidence for implementing the ban.

Now approaching the Supreme Court, the doctor is planning to seek a direction to the Union Government to issue direction to the Indian Council of Medical Research (ICMR) for conducting an investigation in the matter and for removing the ambiguity on the safety of pioglitazone.

Back on May 14, 2019, the Ministry of Health and Family Welfare had acted on a complaint by the whistleblower diabetologist, Dr. Mukesh from Mercury Hospital based in Chennai. At that time, the Ministry had issued an order to the ICMR for investigating the allegations of conspiracy by the group of diabetologists. These doctors allegedly had a malafide intention of promoting an alternative agent of the gliptin family after banning pioglitazone.

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As per the latest media report by Pharmabiz, even though the Union Health Ministry had ordered the investigation back in 2019, ICMR has not initiated the prove even after four years. Therefore, citing this delay, the doctor is now planning to approach the Supreme Court for speeding up the investigation process.

While commenting on the matter, Dr Mukesh narrated to the daily about the efforts he had undertaken for sensitizing the government that the drug was a safe and efficacious medicine for treating type 2 diabetes. He also tried to prove that the drug had no risk-factor of bladder cancer, which had earlier been claimed by a group of diabetologists led by a renowned doctor in Tamil Nadu.

Replying to Dr Mukesh, the Union Health Ministry had informed back on May 14, 2019 that a doctor from madras Diabetes Research Foundation in Chennai had written to the Ministry on 30.01.2013 and had raised the concerns of risk of bladder cancer associated with the usage of pioglitazone. 

Referring to this, Dr. Mukesh told the daily that none of the group of diabetologists could prove any case of bladder cancer because of using pioglitazone, even though the complaint letter had reported eight such cases. However, due to the complaint letter, DCGI had banned the drug back on June 18, 2013.

“I am approaching the court seeking to remove the ambiguity on the safety and efficacy of the drug which is in circulation now and is being prescribed and used. It has been in medical use since 1999 and no case of bladder cancer has been reported due to the use of this particular drug from anywhere in the world including India. Even before the ban, or after the revocation of the ban, no case of bladder cancer could be reported by anybody who treats diabetes. So, my question is why the drug controller general of India banned the drug for a period of 43 days from June 18, 2013, and why does the ICMR not initiate investigation on the matter although the union health ministry asked it to do so. The ICMR has to start the investigation because, on behalf of the Government of India, it is their duty to remove the ambiguity on the safety of pioglitazone among doctors and patients. As far as I know the research council is delaying the enquiry for the last four years”, he told the daily.

Dr Mukesh further informed that RTI replies from various authorities did not reveal any positive evidences to prove the allegations of bladder cancer. In fact, Dr. Mukesh had allegedly lodged a complaint against the complainant doctor before the Tamil Nadu Medical Council demanding an enquiry. Even though the complainant doctor had been summoned by the council for explanation, TNMC also did not conduct any investigation in this regard, informed Dr. Mukesh. He further informed that the complainant doctor has sent a legal notice to him for countering the claims of bladder cancer.

Meanwhile, a senior member of TNMC refused to comment on the matter and informed the daily that the drug is now available in the market after DCGI revoked the ban. 

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