Global pharmaceutical R&D is on the rise and is expected to grow by more than 10% during the next five years in conjunction with US-FDA requirements for more detailed and larger patient-based trials.
Our country's 1000 million population, a highly skilled medical fraternity, some world-class medical institutions and the quintessential "cost advantage" make many of us buoyant about harnessing India's potential as a global hub for clinical research.
Broadly speaking there are two kinds of sponsors pursuing clinical research in India: those who have to submit the data to "developing" regulatory authorities" - including Indian CDSCO and those who need the data for "evolved" regulatory agencies like those of ICH member countries.
The present state of grossly inadequate regulatory intervention in clinical trials has unfortunately seeded a pseudo-GCP culture in the country. Most stakeholders -sponsors and investigators alike - are completely oblivious of GCP fundamentals and yet claim compliance with it.
Hospitals with meagre documentation systems pass off as impressive sites for clinical research because they have a huge patient turnout. Sponsors feel that busier clinicians need to be honoured with prestigious clinical trials even when they are fully aware that these hard-pressed-for-time doctors will not be able to do justice to the trials which demand extensive documentation. Investigators eloquently explain why informed consent is not relevant in Indian context. SOPs are talked about but are almost non-existent at sponsor sites, investigator sites as well as at most laboratories. Yet, each one of them swears by GCP. Importantly, the data generated by these teams is good-enough to obtain regulatory clearances in India because CDSCO is woefully understaffed.
In the current professional ethos - there is no incentive for GCP compliance in India since regulatory enforcement is seen as feeble. In fact compliance with GCP has a strong disincentive: it costs to comply and yet it slows down the pace of clinical trials by enforcing disciplined operations.
Fortunately, the Mashelkar Committee (1999) report on pharmaceutical R&D identified clinical research as one of the most important areas with immense growth potential in the country. CDSCO planned a strategic intervention to improve the situation. One of its first measures was to release Indian GCP guidelines, which conveyed its seriousness to make progress in this regard. Together with ICMR's "Ethical Guidelines for Biomedical Research on Human Subjects" the basic framework for appropriate regulatory intervention in clinical research started shaping up. A completely overhauled Schedule Y - likely to be released within days - will bring Indian clinical research regulations at par with contemporary global levels. A revision of Indian GCP guidelines based on the amended Schedule Y and initiation of National Pharmacovigilance Programme will complete a major phase of Government's initiative in this regard.
Mashelkar Committee on drug regulatory matters (2003) is expected to further strengthen the regulatory mechanisms by recommending augmentation and reinforcement of CDSCO staff. Hopefully, in near future, CDSCO will have adequate expert staff to evaluate the clinical data and carry out inspections of investigator and sponsor sites to ensure compliance with statutes and GCP.
Meanwhile, the GCP chasm has to be sincerely addressed if worthwhile clinical data has to be generated in India for submission to "evolved" regulatory agencies, and sponsors and CROs need to perform a major role in this regard since they will be the primary beneficiaries.
Ethics, written SOPs, documentation, ADR management and audits are some of the critical areas that will have to be addressed in India.
Indian sponsors will have to demonstrate that they have appropriate systems in place to discharge their duties and to verity that their systems work. There is a pressing need in India for adequate systems that facilitate and support the reporting of scientific misconduct either by self-reporting or by 'whistleblowing'. A sub-investigator or a monitor who raises genuine concerns about some important issue of policy, practice or standard (including negligence, fraud or deliberate misconduct) within an institution and who may publicly allege wrongdoing must be protected from victimization. Possibilities for misconduct stem from the potential for paternalism, self-protection, self-promotion and diminished accountability that arises in powerful communities of shard knowledge and understanding such as medical profession. While the majority of the Indian medical professionals have a commendable record in this respect, the 'club culture' does exist with several examples of malpractice in institutions having come to light in recent years. It remains a major concern that an unknown number of cases of research misconduct never become public knowledge because of impasses resulting from psychological and sociological difficulties for the concerned whistleblower, as well as occasional examples of undue deference to the medical profession, medical self-protection and/or a breakdown of institutional accountability.