It is not news that clinical research in India has been withering. The year 2013 saw a precipitous drop in the number of clinical trials conducted in India, and 2014 was been little better. As regulators attempt to resuscitate a clinical trial industry that is vital to India’s role as a global leader of scientific innovation, the Drugs and Cosmetics (Amendment) Bill, 2013, imposing unnecessary penal consequences on trial investigators, is still pending before the Rajya Sabha. The risk of such penalties will force investigators to quit conducting clinical research, pushing the industry to an almost certain economic death and depriving patients across India of any chance of obtaining potentially life-saving experimental treatments. Now that the government has announced its commitment to national economic progress, it is imperative that the government does not proceed with this Bill.
Under section 4ZE of the Bill, any clinical researcher (including the sponsor, institution or the investigator and anyone who works on their behalf) who fails to conduct a clinical trial in accordance with “the conditions of permission” imposed by the central licensing authority would be punishable with a minimum of two years imprisonment and a fine of R5 lakh. Any researcher who fails to provide compensation to a subject suffering a trial-related injury shall be punishable with “imprisonment which may extend to two years and a fine which shall not be less than twice the amount of the compensation.”
Prominent researchers have expressed that they will stop conducting clinical trials if section 4ZE and its counterparts become law. They believe that such penal provisions will lead to arbitrary prosecution. In their eyes, the risk of an unfounded two-year prison sentence is simply too high.
Dilip G Shah, the secretary general of the Indian Pharmaceutical Alliance, agrees with these researchers. He stated during his November 2013 deposition before the Committee on Health and Family Welfare that “the penal provisions are without adequate safeguards and prone to abuse.” He also stated his belief that the penal provisions would discourage foreign and domestic investment in the pharmaceutical industry.
The concerns of investigators and Shah have merit. The Bill treats investigators who intentionally ignore central licensing authority requirements no differently from investigators who are committed to ethical practices but have incorrectly and unknowingly misinterpreted the often ambiguous clinical trial conditions imposed by the central licensing authority. Misinterpretation by well-intentioned practitioners will likely be a common occurrence because the language of protocols and corresponding “conditions of permission” are vague to apply to a variety of trial events and research participation conditions.
To prevent the mass exodus of investigators from the clinical trial industry, to resuscitate India’s dying clinical trials industry, and to ensure that patients can choose to access new, cutting-edge potential therapies, the Bill containing these proposed penal provisions should not be revived in the new session. If there is to be a new Bill—the need for which is not exactly clear—then it should reflect a more fair and rational policy. Instead of imposing strict liability, the penal provisions should require that prosecutors demonstrate wilful misconduct or intentionality on the part of an investigator. Further, prosecution should be reserved only for material violations of approved study designs, when those violations directly cause harm to participants. Finally, any revised penal provisions should avoid the use of minimum mandatory penalties. Such penalties prevent the judicial system from imposing sentences that reflect the unique culpability—or lack of culpability—of each individual defendant.
Such amendments will focus prosecutors’ limited resources upon the investigators who are truly bad actors. If an investigator is non-compliant due to simple interpretation errors, he or she should be offered additional clinical trials training and education—not prison. The previous government is being criticised for acting unwisely and precipitously in many aspects of the regulations affecting clinical trials in India. The regulations have strangled clinical research in India and have deprived the citizens of India of any chance to enrol in clinical trials of potential life-saving therapies. Indian patients and the Indian economy have been hurt, and deserve better. The time has come for more rational, more measured and more productive policies, and we should start by burying this Bill, once and for all.
(Assisted by Alishan Naqvee, partner, LexCounsel Law Offices; Abhijeet Das, associate, LexCounsel Law Offices; and Amish Shah, legal fellow, Harvard MRCT)
The author is co-chair, Multi-Regional Clinical Trials Center at Harvard University, and partner, Ropes & Gray LLP