Chennai: Member of Parliament (Rajya Sabha) Kanimozhi N.V.N. Somu urged the Union government to take stringent action on all those involved in unethical practices in clinical trials.
Citing an issue raised by the Ethical Committee of National Institute of Virology about the rising cases of dubious drug trials in India, she said it would have serious repercussions on the whole healthcare sector. This also raised questions about monitoring and quality control of clinical studies in the country, she said in the Rajya Sabha. Dr. Kanimozhi noted that recently, the Drug Controller General of India received an appeal to investigate the critical gaps in clinical trials by a pharma company, to develop a biosimilar product for treatment of breast cancer.
All clinical trials have to be registered with the Central Trial Registry of India for a company to conduct trials, she said, adding that the most important factor in such trials is the genuineness of the original product which is considered the gold standard. Any doubt about the authenticity of the gold standard is bound to give misgivings about the integrity of the whole trial and the effectiveness of the biosimilar copy being tested.
She said that there was an allegation of trials being conducted four months before the procurement of the gold standard drug from the original manufacturer.
She pointed out that the same pharma company had made a substantially large contribution through electoral bonds. Data showed that 35 pharma companies in India have contributed nearly Rs 1,000 crore to political parties (mostly to the party in power in both Centre and States) through electoral bonds. Of these, at least seven companies were being investigated for poor quality drugs when they purchased the bonds.
She urged the Union government not to play with the lives of innocent people by supporting and facilitating those who conduct dubious unethical drug trials in the country.
