Boston, MA -- (SBWIRE) -- 08/24/2012 -- BMI View: India's pharmaceutical regulator should drop its requirement for local clinical trials in order for a new medicine to receive approval. The country does not have the necessary number of trained professionals to effectively monitor the costly and timely process. Patients would benefit from more rapidly introduced pharmaceuticals, and drugmakers would also see higher commercial upside if the requirement was withdrawn. Like most other emerging markets, India should follow the guidance of regulatory agencies in developed states, namely the US Food and Drug Administration and the European Medicines Agency. If a country insists on local clinical trials ahead of approval, it must have the resources to do so as the Japanese Ministry of Health, Labour and Welfare does.
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Headline Expenditure Projections
- Pharmaceuticals: INR730bn (US$15.6bn) in 2011 to INR846bn (US$17.4bn) in 2012; +15.9% in local currency terms and +11.5% in US dollar terms. Our forecast is unchanged from Q212.
- Healthcare: INR3,353bn (US$71.8bn) in 2011 to INR3,748bn (US$77.3bn) in 2012; +11.8% in local currency terms and +7.6% in US dollar terms. Our forecast is unchanged from Q212.
- Medical devices: INR139bn (US$3.0bn) in 2011 to INR156bn (US$3.2bn) in 2012; +12.2% in local currency terms and +8.0% in US dollar terms. Our forecast is unchanged from Q212.
Risk/Reward Rating: India's Pharmaceutical Risk/Reward Rating (RRR) score has dropped from 56.0 in Q212 to 54.4 in Q312 due to falls in its industry risks and country risks scores. As a result, India's position on the proprietary ranking system is now 10th out of 18 countries, falling a position behind New Zealand.
Key Trends And Developments
- In May 2012, the upper house of the Indian parliament, Rajya Sabha, strongly criticised the operations of the Central Drugs Standard Control Organisation. It cited several shortcomings, including understaffing, lack of qualifications among key personnel, acting in the interests of commercial entities, approval of medicines that are banned in other markets, substandard postmarketing surveillance activities, and a failure to demand local clinical trials for drugs to be approved.
- The Indian Controller General of Patents Designs and Trademarks granted its first compulsory licence for a patented pharmaceutical in March 2012. Local firm Natco Pharma is now allowed to sell the anti-cancer agent sorafenib, which is the active ingredient in Germany based Bayer's Nexavar in return for a 6% royalty to the originator. Bayer was 'disappointed with the decision' and launched an appeal in May 2012.
- In March 2012, Roche planned to introduce two cheap cancer drugs to the Indian market. The strategy comes after the Indian government confirmed it would take patent exclusivity rights away from companies who employed pricing strategies that put drugs out of reach for most citizens in the country.
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