Since January 2013, Indian regulatory authorities have announced a spate of laws and guidelines that will make a huge impact on the clinical trial sector in India.
These changes are the need of hour. If made in a pro-active manner over a period of several years, various stakeholders such as the industry, investigators and ethics committees that these rules impact, will have had adequate time to adapt to them. Instead, these changes have been reactive – in point, a reaction to the Supreme Court’s orders.
Besides, the manner in which they have been made will only serve to make clinical trials in India slow and expensive, compelling sponsors to look at alternatives.
First a list of the significant changes :
- Rules on compensation for clinical trial-related injury or death
- Expert committee to advise CDSCO (the drug regulator’s office) on compensation
- Formula to determine the quantum of compensation in the cases of serious adverse events of deaths occurring during clinical trials
- Registration of ethics committees
- Apex committee and Technical committee to supervise and monitor clinical trials
- Expert committee to formulate policy, guidelines, SOPs for approval of new drugs, clinical trials and banning of drugs
- Audio-video recording of informed consent process
- Regulatory inspections for checking compliance to good clinical practices
- Process for clinical trial approval
- Furnishing of information regarding financial support to investigators
- The Drugs And Cosmetics (Amendment) Bill, 2013
The problem with the law
First, the compensation rules. These apply to all clinical trial-related injuries/deaths, irrespective of whether or not the adverse event is causally linked to the investigational product (IP). One condition is that compensation should be paid if the death / injury has occurred due to the failure of the investigational product (IP).
A clinical trial is a scientific study to assess whether the IP is effective and safe. Hence, it is unlikely that the IP will work in all patients. The quantum of compensation suggested ranges from Rs 4 lakhs to Rs 73 lakhs, with an average of Rs 29 lakhs. The sponsor has to budget for this additional cost. In conditions where the risk of death is high e.g. cancer, heart failure, infarct etc, the cost will go up tremendously.
Second, rules governing ethics committees (ECs). The so called “private” ethics committees (ECs) i.e. independent ECs, have been barred from reviewing / approving clinical trials. Hence, investigators in private clinics, who used to approach such ECs for approval of trials, will not be able to do so. This provision has already reduced the number of clinical trials by over half.
Three, inspections. The CDSCO has inspected over 500 investigators in just 8 months. As compared to the US FDA’s professional approach to inspections, these were announced suddenly and conducted in an intimidating manner. Such an approach will deter even good investigators from participating in clinical trials.
Four, clinical trial approval. Some of the new processes to approve trials such as referring them to a New Drug Advisory Committee, Apex committee and Technical committee have led to uncertainties and delays. An approval can take upto 8 or 9 months. Add to that, the sponsor has to give an undertaking, along with the clinical trial application, that it will market the drug in India after the completion of clinical trial approval.
This means many foreign sponsors, who used to conduct trials in India for the US/European market only, will not be able to do so.
All these rules /guidelines/orders are aimed at protecting the safety and welfare of clinical trial participants and protecting their rights. In fact, some of these such as compensation for trial-related injury, registration of ECs, audio-video recording of consent, and regulatory inspections have been discussed with stakeholders for several years.
As mentioned earlier, stakeholders can adapt if given time. Their rapid pace (over just 8 months) has only succeeded in making the regulatory environment hostile to clinical trials and impacting India’s image as an attractive destination for them.
Dr Arun Bhatt is the President of Mumbai-based clinical research organisation Clininvent Research Private Limited and former medical director Novartis India. He has over three decades of experience in the Indian pharmaceutical industry including as a consultant in pharmaceutical medicine and clinical pharmacology. He is also the founder of Training Resource Academy and Information Nucleus (www.traain.com), a web resource for clinical research professionals, investigator sites, and ethics committees.