IIHMR NEWS VIEWSThe following article is in response to the article titled 'Indian policy on clinical research restrictive: US Pharma companies' published in NDTV Profit on 15/02/14

IIHMR is not surprised by the views expressed by the American pharma companies and their advocacy groups stating alleged restrictive India policies on clinical research, saying such policies are harming the companies. It further adds that as a result not only is the health of the Indian people and the Indian economy suffering, but US (and Indian) companies are unable to conduct lifesaving biomedical research and global health is suffering.

IIHMR views it differently in view of the concerns on the safety of patients expressed by the Supreme Court of India with the directives to Indian regulator to allow clinical trials only when safeguards of patients are adequately addressed. Pharmaceutical companies are always in hurry to bring a new drug in the market with less focus on addressing safety of the patients. Recent withdrawal of Roficoxib and Validicoxib and may such drugs have sufficiently demonstrated that although safety concerns were known to the companies who brought these drugs in market, yet the hided it while submitting clinical trial data for market authorization. Keeping in view the lower literacy rate of people in India, the directives of the Supreme Court does not appear unjustified and looking at strong views expressed by the patient groups NGOs, it is very difficult for the Government to overturn the Supreme Court judgment through Legislative process, especially when general elections are round the corner.

The so called restrictive policies on clinical research, is not restrictive towards transnational companies, but Indian companies are also facing the similar challenge. Similarly, the concerns expressed by American Advocacy group on not protecting ever greening of patented biopharmaceutical products are also required to be viewed in open patient-oriented perspective to protect public health by improving access to medicines. IIHMR feels that the Indian Patent Act is fully TRIPS Agreement compliant and is in true spirit of Doha Declaration on rights of member states to protect public health. American Advocacy group is trying to push TRIPS Plus provision on which there is no general agreement in the WTO and Indian Government has already made it clear that it is ready to face all such IP related disputes at the WTO disputes resolving panel. Instead of availing these available remedies, the American advocacy group is trying promote pressure tactics by lobbying.

(For more information on IIHMR, please visit IIHMR Jaipur Website)