Observing that India's life science industry is poised for spectacular growth and international participation, Corporate America has sought major reforms in the country's health sector including foreign direct investment and global collaboration in life sciences.
In a pre-budget memorandum, submitted to the Union Finance Minister, P Chidambaram, the US India Business Council (USIBC) has said it was concerned over the several recent policy initiatives of the Indian Government in this regard.
"Over the past year, Indian Government has issued several policies, decisions, and draft rules related to merger activity, price controls on patent medicines, clinical trials, and intellectual property, that if implemented, would severely limit FDI in the pharmaceutical, medical device, and biotechnology sectors. FDI and global collaboration in life sciences is essential for a thriving, robust Indian healthcare sector," USIBC has said in its pre-budget memorandum to Chidambaram.
USIBC said the industry has several serious concerns regarding intellectual property.
Over the past year, at least four patents for drugs varying from asthma and hepatitis C to cancer treatments were revoked along with the compulsory license (CL) that was issued in March.
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"This trend sends concerns to investors not only in the life sciences sector but other innovative industries as well," it said, but noted that recent efforts in support of the Draft National Intellectual Policy are a step in the right direction.
Welcoming the government for agreeing to support a market-based formula for the National Pharmaceutical Pricing Policy, USIBC in its memorandum urged New Delhi to work with all stakeholders to provide a predictable and transparent framework for any price controls placed on medical devices.
"We also request support for a separate regulatory framework for medical devices and greater industry dialogue with regard to the regulation of such devices," the memorandum said.
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It urged the Finance Minister to dedicate significant resources to increase healthcare access.
"Realising that healthcare is just as much about the availability of doctors and hospitals and health insurance as much as it is about affordable medicines and access to cutting edge technology, we encourage the GOI to achieve its goal of contributing 2.5 percent of GDP to healthcare, which was outlined in the 12th Five Year Plan," USIBC said.
"We believe expansion of price controls or greater use of compulsory licenses is detrimental to the improvement of access to healthcare in India; rather, the Government should work with industry to advance comprehensive reforms and sustainable solutions to address India's healthcare concerns," USIBC said.