Introduction of new drug pricing policy, FDI restrictions, patent protection, and compulsory licensing.

1. Report on
“11th edition of Pharma Summit 2013”
Date: 31st October, 2013 Venue: Hotel The Lalit, Mumbai
Organised by Knowledge Partner Supported By

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The 11th edition of Pharma Summit 2013: a flagship event conducted by CII was held in Mumbai on 31st October 2013. The event saw participations from about 30 executives across pharmaceutical Industry, policy makers, academia, scientists, investors, technologists, and entrepreneurs.
On the backdrop of changing regulatory landscape in India and introduction of new drug pricing policy, FDI restrictions, patent protection, and compulsory licensing; the Indian Pharma Summit 2013 focused on how the Pharma industry can navigate through the regulatory hurdles and chart its strategies for growth.
The occasion was graced by distinguished speakers such as Dr Shri Rajiv Modi, Dr Shri H G Koshia, Dr Shri Hasit Joshipura, Shri J P Parswani, Shri Sujay Shetty, Shri Ninad Karpe; by sharing their knowledge and guiding the audience through their addresses.
The event incorporated CEO’s Interactive roundtables on following themes to set a perspective on the Indian Pharmaceutical Industry:
 India Pharma Inc.: Regulatory Impact on Indian Pharma  India Pharma Inc.: Spotlight on Maharashtra and Health Insurance  India Pharma Inc.: Clinical Trials in India – Regulatory Challenges and Suggestions on the Way Forward  India Pharma Inc.: Improving Sales Force Effectiveness through the Influx of Technology
Shri Ninad Karpe (Chairman, CII Maharashtra State Council) inaugurated the summit and welcomed the audience. In his address he mentioned that Indian pharmaceutical market (IPM) is the third largest market by volume and fourth largest by value across the globe. The Growth of the Industry has been good in the recent past, but is concentrated in a particular zone.
Shri J P Parswani (Executive Director, Cadila Pharmaceuticals Ltd.) briefed about the summit and its objectives. In his address he mentioned that delays in clinical trial approvals, uncertainties over the FDI policy, a uniform code for sales and marketing practices and compulsory licensing have affected growth of the Indian pharmaceutical market (IPM). The slowdown was also evident from the number of new product launches, which has gone down from approximately 1900 in year 2010 to 1700 in year 2012. However he stated that the slowdown provides the sector with an opportunity. “Big data, cloud computing, and networking
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are changing the way business is being done in India”, he said and urged the sectors to adapt to the changes.
A joint CII-PwC report titled, ‘India Pharma Inc: Changing Landscape of Indian Pharma Industry’ was released during the event. The report emphasized on the changing landscape of the Indian pharmaceutical industry, the regulatory hurdles and the emerging technologies to achieve a sustainable and compliant long- term growth.
According to the report, the Indian pharmaceutical market (IPM) which is currently valued at INR 72,069 crore, has experienced a slowdown where its growth has declined from 16.6% in 2012 to 9.8% in 2013. This was attributed to new drug pricing policy and the regulatory interventions over the last year. Additionally, the implementation of the National
Pharmaceutical Pricing Policy 2012 by the Government of India has reportedly eroded margins for retailers and stockists, respectively from 20% and 10% to 16% and 8%.
While suggesting a way out, Shri Sujay Shetty (Partner – India Pharma Life Sciences Leader, PwC India) added that, “The economic environment in India is tougher now than ever before. While pharma companies focus their attention on measures to combat the growth slowdown, they will need to work with the government and other stakeholders to discuss and resolve regulatory challenges. Resolving the impasse with clinical trials is critical both for patients and India's ambition to innovate.”
Dr Shri Rajiv Modi (Chairman - CII Pharma Summit 2013 & CII Gujarat State Council and chairman and Managing Director, Cadila Pharmaceuticals), seconded this fact and added, "India has had an efficient pharmaceutical industry, which has been making affordable drugs not just for the Indian markets but has also been exporting them to the world. The sector is currently experiencing slow growth. Henceforth, both the Indian and foreign companies operating in India will have to device suitable strategies in order to be in the top 10 global markets by 2020."
Highlighting India’s advantage as an attractive destination for clinical trials, Dr Shri H G Khosia (Commissioner, Food and Drug Administration, Government of Gujarat) mentioned, “India is a blessed market with a genetically varied people, which makes it good for clinical trials, but due to PIL (public interest litigations) in court, clinical trials have come down. Hence when a PIL is filed, the sector should counter it by giving the correct picture.”

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The CII-PwC report too emphasized the importance of clinical trials in India. It mentioned that, Clinical trials are an inherent part of the drug development process and cannot be dispensed with. The continuing search for new therapies and cost-effective alternatives to existing therapies will be realised in practice only after comprehensive clinical trials are conducted in India.
Conclusion
In a nutshell, the panel members acknowledged that the clinical research industry need to liaise closely with the government, towards development of regulatory mechanism that allows sound and ethically correct trials which would benefit patients at large across the country.
Other dignitaries who attended the panel discussions included – Shri K V Subramaniam (President & Chief Executive Officer Reliance Life Sciences); Dr Safia Rizvi (Managing Director, UCB India Private Ltd.); Shri Anuj Reddy (Vice President – Business Development, Wockhardt Ltd.); Shri Krishnakumar Sankaranarayanan (Associate Director - Pharma Life Sciences, PwC India).