)
Biocon, the publicly-held biotechnology company, has criticised the regulatory framework guiding clinical trials in the country. Coming down heavily on the regulations on clinical research, Kiran Mazumdar-Shaw, CMD, Biocon Ltd, said it was adversely impacting clinical research in the country today.
According to industry sources, the regulations have led to many entities suspending clinical trials and also no new clinical trials are being taken up here.
"This could be detrimental to the pharma sector as drugs need to be tested here locally to find their suitability for the Indian population given the difference in the genetic makeup of Indians," the sources added. "Many of the clinical conditions, hence, may not even have any drugs to treat them," he said.
The Indian Society for Clinical Research (ISCR) in a recent note had said the value and role of clinical research in ensuring better and more effective treatment for several thousands of patients in India was often overlooked.
"It is only through clinical research that we have found and will be able to find newer and better medicines to treat our population and reduce mortality rates for various diseases, including those unique to our part of the world," the ISCR said.
The Government of India-sponsored Working Group on Disease Burden for the 12th Five-Year Plan refers to the triple burden of disease that developing countries, like India, are facing due to communicable diseases, emerging non-communicable diseases related to lifestyles and emerging infectious diseases.
"In the larger context of India's unique healthcare requirements and the growing incidence of endemic diseases and emerging lifestyle diseases, we need clinical research to develop new and effective medicines and vaccines to tackle our mammoth disease burden and unmet medical needs," it said.
India has 16 per cent of the world's population and 20 per cent of the global disease burden and yet, less than 2 per cent of global trials take place here.
"If we have to find better and more cost-effective cures for these diseases in a population that is multi-racial and heterogeneous, it is necessary to conduct clinical research in India," the ISCR added.
It also welcomed a move by a court to consider the 162 cases for which approval has been given by the DCG(I) since the New Drug Advisory Committees were formed in 2011.
