Rajya Sabha MP Dr Kanimozhi NVN Somu has raised serious concerns about the increasing number of dubious drug trials taking place in India. In a meeting with Union Health Minister JP Nadda next week, Dr Somu intends to bring this issue to the forefront, presenting evidence of these unethical practices.
Dr Somu’s decision to highlight this alarming trend stems from her deep concern for the potential impact on the nation’s healthcare system. As a doctor herself, she understands the dangers these trials pose to patient safety and the damage they inflict on public trust in healthcare professionals.
Earlier this week, during the ongoing Parliament session, Dr Somu discussed a report by the Ethical Committee of the National Institute of Virology (NIV) that detailed the rising number of dubious drug trials in India. She expressed serious concerns about the lack of sufficient oversight and quality control measures in clinical trials conducted within the country. Dr Somu pointed to a recent case where a pharmaceutical company appealed to the Drug Controller General of India (DCGI) to address serious gaps in clinical trials aimed at developing a biosimilar product for breast cancer treatment.
During her speech in the Rajya Sabha, Dr Somu emphasized the crucial role of the genuineness of the original product, considered the gold standard, in clinical trials. Any doubt about its authenticity could compromise the integrity of the entire trial and cast doubt on the effectiveness of the biosimilar being tested.
Dr Somu highlighted the mandatory requirement for pharmaceutical companies to register with the Central Trial Registry of India before conducting clinical trials. She alleged that certain trials had been conducted four months before the gold standard drug was procured from the original manufacturer, raising further concerns.
Furthermore, Dr Somu mentioned that the same pharmaceutical company had made significant contributions through electoral bonds. Data reveals that 35 pharmaceutical corporations in India have donated approximately 1,000 crore in electoral bonds to political parties, primarily those in power at both the central and state levels. Worryingly, at least seven of these corporations were under investigation for using substandard drugs at the time of their donations.
Dr Somu urged the Union government to prioritize the well-being of innocent citizens by taking a strong stance against those conducting dubious and unethical drug trials. She stressed the importance of safeguarding the integrity of medical research and ensuring the safety and trust of patients.
