From Tech to Biotech to Pharmaceuticals: Outsourcing to India
India has been the center of outsourcing activity in the IT industry. Expectedly, biotechnology followed suit. The southern state of Karnataka is home to 55% of all biotech companies in India. Its capital, Bangalore has the largest biocluster in India, hosting 158 of 320 biotech companies in the country [1]. And then came the pharmaceutical industry. According to the March 2007 CanTech Biotech report, India is fast becoming the new favourite outsourcing destination of big drug companies.
India’s Drugs and Cosmetics Rules used to be rather restrictive, requiring that clinical trials conducted in India should be one phase behind those conducted in other countries. This requirement was invalidated in 2005 by a new law allowing trials to be in-sync with the rest of the world [2]. With the new ruling, drug development experienced rapid growth. Hundreds of millions of US dollars are spent in the conduct of clinical trials in India every year by some of the biggest names in the industry. So what makes India so attractive to the pharmaceutical industry? Aside, from the low cost, India has the following advantages:
- English is spoken by a large proportion of the Indian population, overcoming language barriers encountered in other BRIC* countries.
- India is home to well-trained doctors and other medical and research personnel.·
- India’s population is characterized by high genetic diversity, making it the ideal pool from which to recruit subjects.
Rapid growth does not come without problems. There are major concerns over “abuse and misconduct” [2,3]. Noncompliance with GCP and poor pharmacovigilance are not uncommon. Monitoring and auditing CROs in foreign countries is not an easy task for regulatory agencies like US FDA and EMEA. India’s regulatory bodies themselves are said to be understaffed and unprepared for this rapid surge in business [2,3].
* BRIC = the emerging economies of Brazil, Russia, India, and
China
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