Updated on 29 August 2013
The NIH shocker
Meanwhile, in the wake of this amendment, the National Institute of Health (NIH) in the US, presented a shocker for the country, when it suspended almost 40 ongoing clinical trials in India. Expressing concern about the new regulations, the NIH said that it looks forward to hearing clarifications from India on the important issue. Following the footsteps of the NIH, several private sector players from the US and Canada withdrew their clinical trials from India, claiming that the amendment could lead to "unreasonable claims" by subject-patients. Furthermore, industry experts, who participated in the US-India Bio-Pharma and Health Care Summit 2013 in Boston, US, also said that the current policy and environment in the country was not conducive to conduct clinical trials.
McKinsey's 2013 report that was prepared for the USA India Chamber of Commerce identified that India's clinical trial policies were the biggest hurdles in the country's booming pharma sector. "While both global and Indian industry leaders opine that India's intellectual property (IP) scenario needs to be addressed and clarified, they have highlighted that it is in fact the clinical trials infrastructure and policy that are the biggest obstacles for India to meet its potential of driving R&D innovation at a large scale," the report said.
The Indian Society for Clinical Research (ISCR), which represents pharmaceutical companies that sponsor trials and contract research organizations (CROs), has asked for more clarity and stability in the regulations. "We need more clarity and stability in the regulatory environment along with an assurance that the regulations will be implemented in a hassle free manner. However, there is a need to clarify that fall in the number of clinical trials is true not just for global majors. Several biopharma companies in India are also moving their trials to locations outside of India, which is unfortunate," said Ms Suneela Thatte, president, ISCR. She emphasized that it is not the overall regulatory environment but the uncertainty and unpredictability of some of the irrational clauses in the compensation guidelines that lead to delays in approvals and thus are a cause of concern for the industry. Specifying one such clause, the ISCR head said that, "One of the clauses calls for financial compensation to be paid over and above costs of medical management in the event of a trial-related illness. However, there is no clarity on what constitutes trial-related injury."
"We must also make a distinction between death of a patient during a clinical trial and death due to clinical trial. Patients who participate in clinical trials already have a disease that may either be mild or be serious. The death of a patient in a clinical trial could be due to various reasons, including a natural progression of the disease, emergence of new diseases, age-related disorders, or an unrelated complication. Patients, who participate in a clinical trial, receive greater degree of medical care than they would have under regular treatment because of the high level of investigations and patient management that a clinical study protocol requires," she explained.
Even as the amendments to the regulation are being clarified and implemented, the clinical research industry is praying for a silver lining, which could save the industry from doldrum.