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A passage to India

Increasing numbers of pharma companies are heading east to conduct clinical trials and set up R&D facilities in India, attracted by a skilled and English-speaking workforce.

It's a small world. Not so long ago, a simple telephone call to your bank put you through to the branch on your local high street. Now it's more likely to involve a long-distance connection to a call centre in India.

Increasing numbers of banks and insurance companies are heading east, attracted by a largely untapped, skilled and English-speaking workforce. Pharmaceutical companies are following suit, with more and more firms conducting clinical trials and setting up R&D facilities in India.

Research conducted last year by clinical research consultancy Oxygen Healthcare estimated that 1 per cent of global clinical trials are currently conducted in India. This figure, the research suggested, could increase to 10 per cent in the next five years and the country has the potential to be the premier destination for conducting global clinical trials.

The pharma giants are already one step ahead, with Juerg Haelelfinger, deputy director of Roche's pharmaceutical division, reasoning that “no big pharmaceutical company can afford not to be present in India”.

New arrivals
Many big pharma firms have already arrived on Indian soil. Roche has committed over 10m Swiss Francs to its Indian operations and Pfizer has doubled its R&D spending in India to $13m. Eli Lilly and Novartis are also expanding their R&D operations in the country.

Last month, AstraZeneca laid the foundations for an R&D facility in Bangalore. The facility forms part of AstraZeneca's $10m investment in India and the company hopes that its Indian operations will “play a crucial role in taking the discovery phase of research to bringing drugs to the market”.

GlaxoSmithKline is also eager to grab a piece of the action. Its vaccines business, GSK Biologicals, has vowed to make India its global hub for clinical R&D and plans to conduct four clinical trials in India this year.

“We are now significantly increasing investments on clinical R&D and have every intention to make India a global centre for clinical trials,” confirms Sanjoy K Datta, South Asia director of clinical R&D and medical affairs at GSK Biologicals.

Legal implications
Pharma's attraction to India has been boosted by last year's confirmation from the Indian government that it would, for the first time, honour its pledge to the World Health Organisation and recognise the patents of foreign drugs.

Previously, India had refused to recognise pharmaceutical patents and a number of its pharmaceutical companies have created profitable businesses by copying foreign drugs using a different manufacturing process to the original product.

India's government had agreed to recognise the patents from January 1 this year but the changes are still waiting to be confirmed by parliament. There are fears that the Communist Party of India could oppose the deal but India's commerce and industry minister, Kamal Nath, is confident that the regulations will be pushed through later this month.

Dr David Kingston, head of pharma development operations for the Asia Pacific region at Roche reveals that a tightening of the laws means that Roche can now invest its operations in the country.

“We are planning to increase the number of clinical studies performed in India following the passing of the patent law by the Indian parliament,” he says. “For doctors and patients in India this allows earlier access to new therapies and gives them an opportunity to participate in building the knowledge about potential medicines.”

However, concerns remain. Maxine Taylor, former director of corporate affairs at Eli Lilly admits that the main challenge pharma faces when operating in India is intellectual property protection. “This is being closely scrutinised and could hinder further investment by the industry unless progress continues to be made,” she reveals.

Kingston adds: “In order to fully benefit from Indian involvement in our global trials, timelines for regulatory approval of these studies need to improve.”

Saving the pennies
Beyond regulation, it is no surprise that India is such a mouth-watering prospect for pharma firms.

Cost is, undoubtedly, a major factor. “The cost of trials continues to escalate in much of Europe, the US and Japan, whereas in India, as in many other areas of business, pricing is highly competitive,” says Taylor.

Sunil Shah, director of Oxygen Healthcare, agrees: “Companies in India operate on about a third of the cost-base to Western companies.”

Recruiting patients for clinical trials is also a huge bonus, as India has a huge population with many untreated patients who are currently taking no other medication.

“India provides access to patients with diseases common to Europe and North America, as well as tropical diseases,” says Alan Boyce, vice president of Europe for Kendle.

“In addition, the training and experience gained in Western countries by many investigators has resulted in closer alignment to international standards in clinical research.”

Looking forward
It is clear that India has a bright future in pharmaceuticals and is ready to open its doors to big pharma. Shah concludes: “India will undoubtedly become a world leader of global research for the drug industries and this sector is likely to follow the massive success the country has had with regards to information technology.”

The Author
Beth Brooks is web journalist for PMLive.com

2nd September 2008

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