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Business News/ Companies / News/  India’s pharma competitiveness score drops
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India’s pharma competitiveness score drops

India scores low on almost all metrics except for partial step-ups on two counts: scientific capabilities and infrastructure, and clinical research conditions and framework

The ranking is part of the third edition of the Biopharmaceutical Competitiveness Survey commissioned by the Pharmaceutical Research and Manufacturers of America and executed by the Pugatch Consilium. Photo: APPremium
The ranking is part of the third edition of the Biopharmaceutical Competitiveness Survey commissioned by the Pharmaceutical Research and Manufacturers of America and executed by the Pugatch Consilium. Photo: AP

New Delhi: India has been ranked No. 19 in a 28-nation survey of biomedical investment attractiveness of countries, with an overall score of 59 out of 100. The US, UK and Switzerland lead, with the US at No. 1 with a score of 86.

India’s score slipped a point from a year ago.

The ranking is part of the third edition of the Biopharmaceutical Competitiveness Survey (BCI) commissioned by the Pharmaceutical Research and Manufacturers of America and executed by the Pugatch Consilium. It looks at biomedical innovation and its influencers, like intellectual property protection for investments in the sector.

The survey categorizes countries into two—“mature" markets like the US, UK and Germany, and “newcomers" like India, China and Brazil.

Five metrics were used to determine rankings: scientific capabilities and infrastructure; clinical research conditions and framework; regulatory system; market access and financing; and effective intellectual property protections.

India scores low on almost all metrics except for partial step-ups on two counts: scientific capabilities and infrastructure, and clinical research conditions and framework.

“India’s IP regime, including Section 3(d) requiring biopharmaceutical inventions to show ‘enhanced efficacy’, continues to affect its investment environment and has inspired look-alike bills in Brazil, Indonesia and South Africa, where executives also noted barriers to investment as a result of gaps in IP protection," the report states.

The BCI report says policies aimed at incentivizing research and development in novel areas and targeting particular areas of unmet need, such as rare diseases or personalized medicine, tend to be more consistently present across mature markets.

Mature markets also seek to provide a highly streamlined regulatory framework, advanced intellectual property protection and favourable tax conditions (with some exceptions), the report advances. Interestingly, Singapore with a score of 85—placed in the newcomers category—is only a point behind the US, which is a mature market.

India’s patent rules mandate the need to show enhanced efficacy of a product claiming to be a novel innovation in order to be patented. While pharmaceutical companies have battled to remove this clause, claiming that it can be seen as a form of incremental innovation and hence “novel", the government has not backed down from its stance.

“Compulsory licensing is akin to a nuclear threat for potential investors in the biopharmaceutical sector. You only have to use it once to make investors wary of spending on novel drug innovation," Meir Perez Pugatch, managing director of Pugatch Consilium, told Mint.

Only one compulsory licence has been issued till date in India—to domestic generic drug maker Natco for Bayer AG’s anti-cancer drug Nexavar—which resulted in a 97% price reduction.

As per the provisions of compulsory licensing under the Indian Patents Act, the central government can only exercise its power “under circumstances of national emergency or in circumstances of extreme urgency or in case of public non-commercial use".

On regulatory challenges plaguing innovation and investment, the report argues that delaying harmonization with global standards will consequently downgrade markets’ attractiveness from the perspective of executives—and that is something that India should be careful about.

“Local executives indicate that India’s current draft biosimilar guidelines deviate from WHO (World Health Organization) guidelines and international standards in several areas (including in relation to the scope and timing of clinical trials and criteria for reference products and manufacturing sites) and if implemented as such could detract from India’s investment competitiveness," said the report.

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Published: 06 Oct 2016, 12:11 AM IST
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