MNCs still bullish on India R&D

Even as some major global pharmaceutical majors like Novartis say India's patent laws are weak and a hurdle to their investment plans for the country, at least a dozen large-scale companies have chosen the country as a safe haven for investment in drug research and development (R&D) since January 2005, when the Indian Patent Act was amended.

The companies include Allergan, Eisai Pharma, Dupont, Astra Zeneca, Johnson & Johnson, Bristol-Myers Squibb, Pliva, Ratiopharm, Nektar Therapeutics, Sigma Aldrich and Teva. 
 

HEALTHY DOSES
Company	Area of focus	Investment
Allergan Inc	Inflammatory, infection,  urological indications	$3-5 million
Eisai  Pharmaceuticals	API processes	$120 million  (including mfg plants)
Dupont	Molecular biology,  bio-informatics and  polymer synthesis	$23 million
Ratiopharm GmbH	Basic processes	$36 million  (in two phases)
Teva	Basic processes	$3-4 million
AstraZeneca	TB & NCE research,  process & development	$15 million
BMS -Syngene	Basic drug discovery	N/A
Pliva	Basic studies for generics	$1 million
Nektar Therapeutics	Pre-clinical and bio- analytical development	$10 million

Industry sources pointed out that although the investments by these companies in the country were not as large as the high-end ones by companies like Astra Zeneca, Wyeth, Novartis, Roche, J&J and GSK in China and Singapore, the number of projects and partnerships with local companies were higher in India.

A senior industry analyst, who preferred not to be identified, said the hype created by Novartis on Glivec, the anti-cancer drug for which a patent was rejected by the Indian patenting authorities, was unlikely to influence the business plans of other multinationals.

"The global industry now realises it cannot ignore either China or India as the pharmaceutical industry dynamics are now shifting towards these countries, mainly because of the large pool of talent, human resources and cost-effectiveness," he said.

Noted Ajit V Dangi, director general of the Organisation of Pharmaceutical Producers of India (OPPI), a grouping of 75 multinational pharmaceutical companies operating in India, "Some companies may be concerned about issues like data exclusivity, which is allowed in about 40-50 countries but not in India. Similarly, Section 3 (d) of the Patent Act lacks clarity and this also may be a concern. But that need not deter them from investing in India as there are other factors involved while taking business decisions."

At least 10 OPPI members are conducting large-scale clinical trials in India. Further, many other members were engaged in contract research and contract manufacturing business with Indian partners, like the Ranbaxy-GSK and Suven-Eli Lilly drug discovery alliances, he said.

"Opportunities in India are tremendous especially in the clinical development of drugs and concerns on IP protection can be addressed. Our Indian drug development centre will be an important hub for drug R&D efforts, integrated with other research activities in different parts of the world," Paul Stoffels, chairman, research and development of pharmaceutical group, Johnson & Johnson, had said during a recent visit.

J&J is investing about Rs 37 crore to expand its recently renovated Analytical and Pharmaceutical Development Centre (APDC) in Mumbai, in addition to Rs 36 crore spent recently on renovation.

According to AstraZeneca India sources, it is the only multinational company in India focused on discovering novel drugs or therapies for tuberculosis.

Astra Zeneca also opened a US $ 15 million process and development laboratory in Bangalore in March, this year, mainly to take up new chemical entity (NCE) research.