India Pharma: Strong Commercial Opportunities Hampered by Bureaucracy and Poor Policy Planning - Applied Clinical Trials

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India Pharma: Strong Commercial Opportunities Hampered by Bureaucracy and Poor Policy Planning

Source: Company News Release

Business Monitor has just released its latest findings on India’s pharmaceuticals and healthcare sector in its newly-published India Pharmaceuticals & Healthcare Report.

Due to its large population and substantial unmet medical needs, India represents a market with strong commercial opportunities for pharmaceutical firms. However, Business Monitor highlight in their new report that the government is impeding the development of its pharmaceutical sector, mainly due to extensive bureaucracy and poor policy planning. Some of the issues affecting various subsectors in the industry include the regulation of clinical trials, pricing of patented and essential drugs, generally low government involvement in healthcare and foreign direct investments.

Key Trends And Developments in India’s pharmaceuticals market discussed in the report: In December 2013, the Indian government decided to dissolve an inter-ministerial panel that was created to reduce patented drug prices. The panel was formed in 2007 and involved seven members from the Department of Pharmaceuticals (DoP), the National Pharmaceutical Pricing Authority (NPPA), the National Institute of Pharmaceutical Education and Research, the Pharmaceutical Export Promotion Council of India, and the Drug Controller General of India.

In November 2013, the US-based not-for-profit public service organisation, the Initiative for Medicines, Access & Knowledge (I-MAK), filed a pre-grant opposition aiming to prevent Gilead Sciences/Pharmasset (acquired by Gilead in 2012) from gaining a patent in India for sofosbuvir, used in the treatment of hepatitis C (HCV), and which is expected to come to market soon. The move has been welcomed by Médecins Sans Frontières (MSF); the organisation claimed that Gilead is expected to charge US$80,000 for one treatment course of the drug in the US. Even if offered at a fraction of this price in developing countries, MSF argued, the drug will still be priced out of reach.

In September 2013, the US Food and Drug Administration issued an import alert on products manufactured at Ranbaxy's Mohali plant in India until the company complies with US current GMP standards. The agency had identified 'significant cGMP violations' at the facility during inspections in September and December 2012, including the firm's failure to 'adequately investigate manufacturing problems'. During the inspections, the US FDA found a black fibre in a tablet that could be a human hair. In the same press release, the agency restated that Ranbaxy's facilities at Panota Sahib and Dewas 'have been on FDA import alert since 2008'.

BMI Economic View: India's economy staged a cyclical bounce in Q2 FY2013/14 (July-September), with real GDP growth accelerating to 4.8% year-on-year (y-o-y) from 4.4% in the previous quarter. Business Monitor state that while it would be tempting to suggest that the economy can now kick on in the coming quarters, the continued lack of dynamism in investment activity remains a key sticking point. We may have to wait until general elections and monetary easing take place in mid-2014 before seeing a major improvement in investment conditions and, by extension, a sustainable economic recovery.

BMI Political View: In terms of India's investment appeal, Business Monitor believe there is a lot riding on the upcoming general elections scheduled for April-May 2014. However, with nationwide polling only a matter of months away, the outcome remains difficult to predict with much conviction. While India's 60-year-old democracy has withstood the test of poverty, the coming decade will show whether it can stand the test of rising prosperity.

Against a backdrop of economic growth, India's government will need to work even harder to combat poverty and inequality; invest in education and infrastructure; and clamp down on corruption in order to satisfy an increasingly cognisant electorate. Meanwhile, icy relations with neighbouring Pakistan and growing competition with China will continue to dominate India's international agenda. Failure to address these shortcomings could see social disharmony and pockets of fundamentalism continue to ferment at the grassroots level.

Business Monitor is a leading, independent provider of proprietary data, analysis, ratings, rankings and forecasts covering 195 countries and 24 industry sectors. It offers a comprehensive range of products and services designed to help senior executives, analysts and researchers assess and better manage operating risks, and exploit business opportunities.

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