Tamil Nadu MP raises concern over questionable trials of breast cancer drug in India

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Raising the issue of increasing cases of questionable drug trials in India, Rajya Sabha MP Dr Kanimozhi NVN Somu said that she will discuss the issue in a meeting with Union Health Minister JP Nadda.

Dr. Kanimozhi NVN Somu said, “I will strongly raise this issue with all the documented evidence of this suspicious act in the meeting with the Health Minister of India next week.” Livemint,

When asked why he raised this topic, he explained, “I have chosen to highlight the worrying issue of questionable drug trials because of its profound impact on our healthcare sector. As a doctor, I am deeply concerned about how these incidents not only threaten patient safety but also undermine public confidence in healthcare professionals. Such unethical practices cast doubt on our entire profession, which is why it is important to address this issue to maintain the credibility of medical research and ensure the safety and trust of our patients.”

Dr Kanimozhi, while speaking in the Rajya Sabha earlier this week during the ongoing session of Parliament, had discussed the report of the National Institute of Virology (NIV) ethics committee regarding the rising cases of questionable drug trials in India.

He also raised concerns about the monitoring and quality control of clinical trials being conducted in the country and said that a pharmaceutical company had recently appealed to the Drugs Controller General of India (DCGI) to look into serious deficiencies in clinical trials for developing biosimilar products for the treatment of breast cancer.

During his speech in the Rajya Sabha, he said that the most important factor in clinical trials is the authenticity of the original product, which is considered the gold standard. Any doubt about the authenticity of the gold standard raises doubts about the integrity of the entire trial and the efficacy of the biosimilar copy being tested.

He said a company would have to register with the Central Trial Registry of India to conduct clinical trials.

He said the allegation is that the testing was done four months before the purchase of the gold standard medicine from the original manufacturer.

He said that this pharmaceutical company has contributed a lot through electoral bonds. According to the data, 35 pharmaceutical companies in India have donated about Rs 1.5 crore. Rs 1,000 crore was given to political parties in the form of electoral bonds, primarily those in power at both the Centre and the state. When these corporations bought the bonds, at least seven of them were under investigation for using substandard drugs.

He urged the Central Government not to play with the lives of innocent people by supporting and facilitating dubious, unethical drug testing entities in the country.

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Published: July 25, 2024, 03:49 PM IST

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