Challenges await the new government

The Indian bioscience industry has undergone a lot of stress, given the long drawn process and uncertainty surrounding regulations. With so many litigations pending in courts, the government will have to fight on multiple fronts

hurdles

The new government will be at crossroads over many issues and will have to cross many hurdles to help the industry grow.

From a regulatory stand point, there has been a fair amount of unease in the lifesciences sector in India. The top priority of the government must be to cross the barriers and make the industry confident. Here we look at the top hurdles that the new dispensation will have to cross:

Sustained policymaking
The industry-policymaker-academia relationship will have to be further strengthened. The trust deficit and dis-satisfaction of the industry will have to be removed through continuous deliberations and identification of problem areas. "I expect the new government to spend about 4-5 billion per annum on strengthening the infrastructure in regulation, enforceability of quality controls, IP and also other infrastructure requirements that are currently not in place. There has to be a separate channel at customs for import of all materials related to R&D or atleast a separate cell which can fast track such processes. In addition, it would be useful to have a 5 year policy for S&T. Every single approval needs a clear path of progression with a time line. We need to win back investors to India." Mr PM Murali, president, Association of Biotechnology Led Enterprises said.

Intellectual property
Another big fight where the government will have to step in, is the one between multi-national pharma companies versus home grown companies. The issues on intellectual property rights have caused lot of bad blood between the two. Mr Tapan Ray, independent pharmaceutical industry analyst and consultant, feels that the new government must not give into the pressure of multi-national pharmaceutical companies who might lobby for amendments in the intellectual property rights act. "India is the largest foreign supplier of generic medicines to America, having over 40 percent share in its $ 30 billion generic drug and Over-The-Counter (OTC) product market. Thus, expecting that the Indian government would wilt under pressure, the 2014 ‘Special 301 Report' of the US Trade Representative (USTR) on Intellectual Property Rights (IPR) has retained India on its ‘Priority Watch List', terming the country as violator of the US Patents Law," he wrote in his blog on May 25, 2014.

Streamline regulations
From undefined research guidelines in stem cells and genetically modified crops to a single window regulator, there needs to be clear understanding of the requirements. In case of the clinical trials scenario, where there has been a total blackout for last year (only few approvals), the government will have to seriously address the issues and replace the lack luster style. A balance between the protecting the rights of recruited subjects while providing clear norms for the conduct of trials is the dire need of the hour. At the core of the issue lies the lack of regulations which are stable and do not undergo changes time and again. The requirement of dealing with multiple regulatory authorities, both at the central and state level adds to the complexity of doing business.

Infrastructure development
The Federation of Indian Chambers of Commerce and Industry (FICCI) is of the view that it is important for the coming government to provide support and work towards empowering the entire innovation ecosystem. As per Ms Shobha Mishra Ghosh, senior director, FICCI, "One of the primary mandates of the new Government should be to trigger, transform and tend biotech startups to convert innovative research in public and private sector into viable, competitive products and enterprises. There is a need for partnership between industry and government, especially for the biotechnology sector particularly in vaccines, biosimilars and regenerative medicine, and institutionalizing policies that enable faster market entry at lower costs, without compromising product quality, safety and efficacy. Enhancing innovation and improving market access for biotech products are one of the many defining goals of healthcare reforms.

 

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