Pune: Experts demand stricter regulations for clinical trials in India

While speaking at the first national seminar on ‘Clinical Trial of Drugs: Regulations and Challenges,’ experts stated that much work needs to be done to ensure safe and ethical drug trails in the country. This seminar was organised in Pune

Pune: Experts demand stricter regulations for clinical trials in India

At the conference arranged on Wednesday, experts conveyed that unregulated research in clinical trials has triggered ethical issues of the violation of human rights. The seminar was conducted by the Indian Law Society’s Law College, Pune, in association with Swasthya Adhikar Manch, which is an NGO in Indore that works in the field of clinical trials in India.

The experts raised the subject of the unethical drugs trails which is a grave matter of concern. Various experts working in the field of clinical trials, health activists, law students, and victims of clinical trials were among those who participated in this workshop.

The prevailing ambiguity over the rules and regulations governing such trials, are giving leeway to multi-national companies to engage in unethical and illegal conditions, experts explained.

India is a global hub for clinical trials for pharmaceutical companies located in developed countries, because of the modest cost for conducting trials, availability of an ignorant population, coupled with poorly regulated legal framework.


Speaking at the event, Sanjay Parekh, an advocate in the Supreme Court, who is pleading a case, said, “There is no law on how to enrol subject for clinical trials. Also, if something happens to the subject, there is no binding on the trial company to inform about the relative of the subject about it. The doctor should be independent of the sponsor for the trial, but the law does not ensure this. There are many grey areas on how to regulate documentation of treatment during a clinical trial. Contract Research Organisation (CRO), which works as a middlemen in clinical trials should be banned.”

While Amulya Nidhi, conveynor of Swasthya Adhikar Manch, said, “Swasthya Adhikar Manch has filed a PIL in the Supreme Court. We expect that Supreme Court will come up with directives, which will help in protecting the human rights of those who would undergo trials in future and who have undergone them in the past.”

Pradeep Gehlot, one of the victims of a drug trial from Indore, who was present at the seminar, said, “I was yet to finish my college studies, when my father died due to the drug trial. The entire house’s responsibility was upon him. Even after more than 15 years of his death, the case is still pending in the court and we are yet to receive any sort of remuneration.”

Amitav Guha, national working committee member of Centre of Indian Trade Unions, who has been working on legal issues in drug trial and pharmaceutical companies, said, “There are bio pharmaceuticals whose drug trials need special regulations, but they are not there in our country. From molecular medicines, the research is now shifting to the field of bio pharmaceuticals. Since the USA, has made its laws strict, many multi-national companies are flocking to India for drug trials. It is need of the hour to make the laws strong in order to protect the health-related rights of people.”

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