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ICMR to hear petitioner Dr Mukesh on antidiabetic drug pioglitazone
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Peethaambaran Kunnathoor, Chennai
January 04 , 2025
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In compliance with the directions of the Madras High Court to the Indian Council of Medical Research (ICMR) on July 29, 2024, the ICMR has called up Dr B Muhesh, a diabetologist at Mercury Hospital in Chennai, to hear his version on the petition he filed with the court against a group of diabetologists alleging their involvement behind the ban on the anti-diabetic drug, pioglitazone by Government of India on June 18, 2013.
The medical council has wanted the petitioner diabetologist to appear for the hearing on January 10, 2025 at ICMR office in New Delhi at 11 am on his own expenses, and file the supporting documents before January 3. It has been informed to him that the hearing is restricted only to the subject matter of the case.
Dr Mukesh informed Pharmabiz that he would appear before the council on the particular day physically and submit all documents beforehand as advised by the research council. He says that there was a criminal conspiracy behind the ban of pioglitazone in the Indian market.
Pioglitazone, the drug to treat type 2 diabetes mellitus (T2DM), was banned by the Government of India on June 18, 2013 citing reason that the drug had adverse effects, particularly a risk factor for bladder cancer in patients. However, the government later revoked the blanket ban on the drug and its formulations on July 31, 2013 due to a complaint given by Dr B Mukesh as well as voices raised by various diabetologists and pharma industries in the country. The drug was under suspension in India for 44 days in 2013.
In March 2016, Dr Mukesh made a complaint with the Union health ministry urging the government to conduct an enquiry over the reasons for putting ban on the drug, accordingly the health ministry wanted the ICMR to take necessary actions on the matter related to the complaint of Dr Mukesh. But, according to Dr Mukesh, the research council was lackadaisical in taking steps in finding out the veracity of the claim of the group of doctors who recommended for the ban and to hear the counter version of Dr Mukesh.
Finally, in 2023, Dr Mukesh approached the Madras High Court seeking a direction to the research council to implement the order of the Union health ministry. The Union health ministry, ICMR and the diabetologist who made recommendations to the government for banning the drug, were the respondents in the case. After hearing the two parties, the court gave a direction to ICMR to hear the versions of the petitioner and of the opposite party, as well as of experts from the scientific community, in the case related to the use of the antidiabetic drug.
The court found that since the matter was earlier referred to the research council by the Union health ministry, it is their duty to do the needful without any delay. The court had given 12 weeks time to ICMR to reach a conclusion. Accordingly, the council has now wanted Dr Mukesh to appear at the council office to hear his version on the matter. It is learnt that the council will hear the version of the opposite parties also in the matter.
Dr Mukesh’s allegation was that the Drug Controller General of India (DCGI) banned the drug in 2013 based on a letter written to the Government of India by a Tamil Nadu based doctor specialized in diabetes treatment, a Padmashree awardee. He said the particular diabetologist sent the letter to the government in January 2013 with recommendations to ban pioglitazone in the Indian market citing reasons that use of the drug caused urinary bladder cancer in patients. Countering his claims, Dr Mukesh argued that pioglitazone was an effective and affordable drug, and raised the allegation that the recommendation for banning the drug was made with a malicious intention to deliberately promote some alternative agent of the gliptin family in place of pioglitazone.
The antidiabetic drug pioglitazone hydrochloride was approved by CDSCO on 17.10.2010 as an adjunct to diet and exercise to improve glycaemic control in patients with type 2 diabetes. Subsequently, fixed dose combinations of pioglitazone with other drugs were also approved in the country.
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