Lack of clarity about the recent clinical trial regulations is hampering new research projects, pushing some of them to other countries, stated experts at the Fortis Healthcare clinical trials workshop.

The Department of Academics and Research, Fortis Healthcare headed by Prof Upendra Kaul, organized a one of its kind workshop to bring together all key stakeholders on one platform, generate a discussions and raise the issues that need to be clarified or ironed out.

The event supported by JK Risk Managers and Insurance Brokers Limited, highlighted on compensation issues in clinical trial industry. The objective was to create a more open and conducive environment and to let the policy makers realize the progress made in executing new trials and some of the issues which are still of concern so that clarifications are made in this regard.

“India offers a very lucrative environment for clinical trials with a large English educated young population including scientists and researchers. It also offers significant cost advantage as compared to developed and other emerging economies, 40- 60% lower than in developed countries and around 10- 20% lower than emerging economies. Indian companies have already proven its capabilities in discovering and developing drug candidate molecules and they are highly capable in research and development particularly in drug discovery. Given the concerns raised globally about practices in clinical trials, Indian authorities have rightly revised their guidelines to make the process more transparent. We as stakeholders need to make sure that there is absolute clarity about the new guidelines, efficiency in execution and rectification of lingering concerns so that crucial clinical trials go on smoothly,” said Dr Kaul.

 India has 3–4 million scientists, 500 investigators, 572,000 doctors, 43,322 hospitals and dispensaries and about 8.7 lakh beds including both private and public. A number of contract research organisations, pharma companies from developed countries forging R&D alliances with Indian companies because they offer quality and cost-effective services in medicinal chemistry, formulation development, and toxicology areas. These alliances are also giving preclinical candidates or clinical candidates proof of concept in humans, he added.

The speakers included senior members of regulatory body (DCGI), Dy.Drug Controller General A K Pradhan, sponsors of clinical trials like Astra Zeneca, Boehringer Ingelheim, Medtronics, Boston Scientific, Biotronik and St Jude, besides CROs like Quintiles, Max Neeman etc and representatives from insurance companies like ICICI Lombard, New India Insurance, and Oriental Insurance etc.

The clinical aspects were brought to light by senior doctors from the Fortis chain of hospitals including reputed medical oncologist Dr Vinod Raina and  Dr Shamsher Dwivedi, neurologist. Other experts included Prof Ranjit Roy Chaudhury, head, expert committee to formulate policy and. guidelines for approval of new clinical trials, Dr S K Gupta - Director & Dean, Institute of Clinical Research (India); and legal officials including Dr B T Kaul, chairman, Delhi Judicial Academy.