The prospects of clinical research, especially delivering the market driven worldwide clinical research trails , including international bioequivalence studies, started as a pleasant dream in India in the early 2000s. It was ascertained by many experts that by 2012, India would be all set emerge as a global center of excellence for clinical trial.
After implementation of the product patent in India, almost all MNCs have started largeclinical trials here. India provided an increased access to treatment of ingenuous subjects in cancer, asthma, diabetes, BP, tropical infections and degenerative diseases by listing a huge number of sites outside of major markets. Another important factor is an enormous cost saving through economies of scale and cost of labor. Another important requirement is skilled investigators and assisting manpower in trials and IT management, the former being well-trained in good clinical practice and other good practices norms in India.
Until the year 2009, it was a pleasant dream and somewhat smooth in nature, but ever since then there has been a rude wakening to the fact that since then there has been a dramatic fall in successfully conducting and delivering the international CTs outsourced to India. According to some statistics, this drop is up to about 50% in last 4 years.
For a effective conduct of trials, one requires competent, well trained and experienced investigators and resourceful sites. Every individual associated with a clinical trial say it be investigators, supervisors, trial designers, all need a formal training on the required subjects and areas. Unfortunately, there is a big gap in India between theory and practice for success in all these areas.
The lapse in ethics in India though not very frequent, but it should be emphasized for many reasons. Recently Supreme Court of India has criticized the government for being negligent about CT deaths and unauthorized trials and also banned new molecular entity trials under certain conditions .
The apex court further instructed that the government come up with a new regulatory regime for Clinical trials that would reflect the concerns of all stakeholders, including subjects who volunteer to be part of the tests at the risk of adverse health effects and even death.
The good news is that even as this proposal is evolving , recently the Central Drugs Standard Control Organization (CDSCO) has cleared trial licenses for 50 Clinical Trials such that the industries doesn’t come to a standstill.
There are two main reasons why the current system of regulation and control in India is not working very well:
Firstly lack of an evidential and competent review system of new drug applications (NDAs), investigation new drugs (INDs) and abbreviated NDAs (ANDAs). Yet none has seen a first class review report for any submitted NDA or ANDA in India. Whereas in countries such as USA or Canada a review report of an NDA is comparable with an article in a journal of impact factor of say 25.
Developing a review system is not a child’s act. A couple of hours of an NDA meeting participated by a group of even competent experts cannot deliver a quality of document and review thereof. If written-first-class reviews are not produced for each dossier, no long-term credibility and validity of regulatory mechanism will be established.
Secondly, thorough address of issue of quality and documentations. In recent inspections by US-Food and Drug Administration, it was found that Indian sites could have built in better quality in their clinical trials had they been paying more attention to some particular areas. But there is one major advantages in India is that of a high rate of patient recruitment, sometimes the investigation sites focus less on documentation. This need to be corrected as proper documentation is significant in keeping records.
A lot of work needs to be carried out for worldwide clinical studies to flow into India again and to grow to the level of the developed countries. The industry, academia, ethics committees, sponsors and all other stakeholders are ready to be in pace with the government.