'Stricter norms in clinical trials will boost foreign investment'

The declining numbers of clinical trials (CT) in India compared to its neighbours, in the last few years has shed light on the quality of research, said experts here Friday, stressing the introduction of stricter norms will pave the way for quality work and more foreign investments.

The clinical research (CR) industry was worth $500 million around a decade back, while the number of approved applications for CT in 2010 was as high as 500.

"In 2013, only 73 trials got approved in India... even less than 100. On the other hand, the same in countries like Korea, Japan, China and Taiwan have been steadily increasing.

"We have to question why our neigbours are doing better quality research," said Ganesh Uchit, therapy lead, global clinical and medical affairs, Pfizer Ltd. at the national seminar on 'Clinical Pharmacology-Bench to Bedside' at the Jadavpur University here.

The Ranjit Roy Chaudhury Committee, an expert panel, was formed by the previous government, to formulate policy and guidelines for approval of new drugs, clinical trials and banning of drugs.

The key recommendations included accreditation to clinical trial centres, investigators and ethics committees, which is slated to be the centerpiece of India's new clinical trial policy.

"Without better regulations, it is difficult to ensure quality. The reason why foreigners will want to invest in India is because of quality and new proposals on regulations will help in that direction.

"Countries like Bangladesh have poor quality control and therefore, it is hard for them to find foreign investment," said Gargi Roychowdhury, head, clinical research, Clinovation Research Pvt. Ltd.

Uchit said sponsors and CR organizations are on a "wait and watch" mode.

"There is turbulence but at the end of it, there is sunshine," said Uchit, stressing on the need to have accountability to all stakeholders including patients involved in the trial.