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India-Japan pharmaceutical collaboration: The way forward
Senior officials of the Department of Commerce and over 100 pharmaceutical companies will showcase the giant strides taken by the pharma sector at the 'Brand India Pharma' show at the Interphex and Inpharma trade show in Tokyo from July 2 to 4, 2014.

The industry standard shows are perceived as an appropriate platform to connect with the Japanese market and showcase the best manufacturing and research capabilities of Indian Pharmaceutical market.

The Indian official delegation to the pharma trade exhibition is led by Rajeev Kher, Commerce Secretary, while the industry delegation is headed by Habil Khorakiwala, Past President, FICCI and Chairman, Wockhardt Ltd. The other officers accompanying the Commerce Secretary are the Joint Secretary, DOC Asit Tripathy and Director, DOC Sanjeet Singh, acoording to a FICCI statement.

The 'Brand India Pharma' campaign of the Government of India is a significant initiative armed at highlighting the value proposition that the Indian pharma sector presents to the global market. The global launch of Brand India Pharma took place on March 21, 2012 in Tokyo. The campaign was a significant initiative under the aegis of the Department of Commerce, Government of India, to highlight the value proposition that Brand India Pharma presents today for, Globally.

While there is a huge potential in the regulated markets, the developments of the last three to four years have demonstrated the necessity for diversification. This new dimension of India's strategy coincides with developments in Japan. Given the heavy pressure on the health requirements, especially its aging population, Japan, which is a US$ 119 billion market, of which generics constitute 11%, has decided to enlarge its generics portfolio.

Japan today represents an opportunity for the Indian pharmaceutical industry. India's CEPA with Japan, which is a conscious agreement to mutually increase cooperation in the pharma sector, an element of this is the fact that Japan has extended national treatment to Indian companies.

Parallely, India is recognized for its role in the public health sector, which comprises three elements, namely:

1.Coverage of a wide expanse of health profile;

2.Indian medicines are very affordable

3. Quality of Indian medicines is recognized.

For example, India, with a 35 per cent share, ranks the highest in terms of filings of (Drug Master File) DMF filed with USFDA. 25% of the manufacturing sites registered with EDQM are from India.

The Government and industry in India propose sustaining the Brand India Pharma campaign in Japan at two levels:

1. Formal Government to Government level wherein we are proposing materialisation of commitments made by India and Japan under CEPA to develop into a roadmap for cooperation and dialogue. The Indian government is keen to enter into a dialogue with its counterparts and this will also include inviting Japanese to invest in Indian greenfield projects.

2. Business-to-business level where the Indian government would support its exporters to locate market opportunities and invite Japanese buyers for first hand insights of the regulatory regimes and manufacturing capacities in India.

India would also like to inform the Japanese regulatory agencies about Indian regulations so that mutual confidence on quality is assured. This is because India realises Japan is a quality conscious market and respects the same.

India is a producer of high-quality affordable medicines and a leading supplier to both developed and developing nations across the globe. Interesting facts on the successes and achievements of the Indian pharma industry would prove to be an eye opener for some - Eight out of top 25 generic companies across the world are from India; every third tablet produced in the world is made in India; every third child in the world is getting Indian vaccines; India has the highest number of USFDA facilities outside US and many more.

The domestic pharma market is estimated to touch US$49 billion by 2020. The projected human resource requirement to match this growth is estimated at 21,50,000 by 2020.

The Government of India has taken a series of measures to meet the projected demand of pharma professionals in the future. The Department of Pharmaceuticals has projected an investment Rs 3,000 crore (US$ 478.4 million) to set up 10 more National Institute of Pharmaceutical Education and Research (NIPER) over the next few years to strengthen the human resource base.

Clinical Research Education and Management Academy (CREMA) is another institute, which exclusively provides courses specific to clinical research and healthcare management. It is amongst the first institutions dedicated to promoting high quality clinical research & healthcare management education.

Scholarships programmes are awarded to the meritorious students, which help inculcate a competitive spirit amongst students pursuing higher education.

The introduction of Pharm D programme along with the revised framework of Indian pharmacy education is expected to ensure quality human resources meeting global standards.

This huge growth in generics production has seen the country become a hotbed of manufacturing innovation - India has over 3400 DMFs registered with USFDA. After considerable amount of Success in Para 4 filings (first to file generics) with over 30 such filings between 2009-2011, India's Pharmaceutical industry is now looking at developing super Generics. This requires filing a product under section 505 (b) (2) of USFDA.

A successful filing may fetch 3 to 5 years of Patent protection. Some of the market research reports puts the global market in the calendar year 2013 at $15 billion for this differential generics popularly termed as super Generics.

With the world's pharmaceutical development manufacturing base moving to India - there are 546 US FDA approved company sites (second only to the US), 23 companies holding 1100 authorisations with UK's MHRA, and 166 companies together hold over 1100 CEPs (Certificates of Suitability) from EDQM - coupled with the rise in supergenerics, the country's next natural step is to use its world leading development expertise in the creation of new chemical entities.

Recognising this opportunity, the Government of India is putting in place supportive initiatives with the goal of cementing the country's position as the 'pharmacy of the world' and creating a global innovation hub. With generics predicted to rise to 35% of global pharmaceutical market value by 2016 (some $400bn+), and with an CAGR growth rate of 22% amongst Indian generics exports during the last five years ending FY 2014 Comparing very favorably with the average of 10% the Government is forecasting much of this revenue will be reinvested across the country in new research- leading to a steady pipeline of future drug targets.

Steps have also been taken to streamline procedures covering development of new drug molecules and clinical research- including two schemes 'New Millennium Indian Technology Leadership Initiative' and the 'Drugs and Pharmaceuticals Research Programme', which has been specially targeted at drugs and pharmaceutical research.

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