India can have its clinical research regulation in place only by early 2015. It will take another eight to 12 months for the regulatory bodies in the country to formulate the final guidelines. The uncertainty is expected to prevail and revenue generation pressures will only intensify, Arun Bhatt, executive committee member, ISCR and president Clinivent Research Pvt. Ltd told Pharmabiz on the sidelines of the 7th annual ISCR conference being held in Bengaluru.

According to Dr Bhatt, the regulatory reforms needed to be carefully formulated and expert committees were working on it. After Prof. Ranjit Roy Chaudhury report was submitted, norms for compensation, informed consent, audit on ethics committee and standard operating procedures for clinical trial approvals came in. We also saw the permission to conduct five human studies slowly trickling in. Nothing much could be expected in the next few months and the clinical research industry would need to brace itself to put up with the tough times. The permission to conduct five trials also  slowly trickled in. It would take a while to beat the uncertain environment and revival of growth,” he added.

Over the last one year, the sector received the jolt. All clinical research lab expansions were put on hold. Small, unwieldy and fly by night operators vanished from the scene. It was challenge for the large and medium sized companies to endure, said Dr Bhatt adding that most global majors and large Indian CROs were surviving so far on the on-going global multi-centric trials.

India is losing out on the access to latest drugs. International institutions like the NIH in US, MRC in the UK and CIHR, Canada and Welcomme Trust have pulled out clinical trial projects in India. These institutes funded large projects which was a huge support for the sector. Now going by the efforts by the Union government to put the sector back on track, NIH announced its intentions to assist in  one trial at a time, said Dr Prem Pais, professor of Medicine and head division of Clinical Research and Training.

All these global institutes were closely watching the regulatory clearances and would make a comeback to India only if the human study approval timelines were definite, said Dr Pais.

The irony is that the Indian regulators have declared 2014 as the Patient and Animal Safety Year. ISCR with its 200 members is committed to ensure trials protect the rights and safety of patients, said Suneela Thatte, president ISCR adding that clinical research which was critical to finding new and better treatment was at the  crossroads. Much of the trials were now conducted outside India leading to a decline in the growth of sector.

India has 16 per cent of the world’s population and 20 per cent of the global disease burden and yet, less than 1.5 per cent of global trials take place in India. The share of global and Indian companies conducting trials in India is 50:50.

The murky regulatory environment has affected India’s clinical research turnover by over 50 per cent and estimated to be $450 million, noted Dr Suresh Menon, executive committee member, ISCR, who also chairs the ISCR Regulatory Council.