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
photo credit here
Things are looking up for generics: the recent approvals and victories
Generic drug manufacturers scored another victory this week. On 5 Sept 2007, the US FDA announced the approval of the first generic versions of GlaxoSmithKline’s Coreg (carvedilol). In total, 14 drug companies were given the go signal to market their Coreg-like generics indicated for the treatment hypertension, heart failure, and left ventricular dysfunction following myocardial infarction.
Last month, the FDA approved the Israeli drug company Teva’s application to market a generic form of Famvir (famciclovir), an antiviral drug used to treat genital herpes. Famvir is a patented product of the pharmaceutical giant Novartis.
Last week, a Swiss court approved the application of the generic manufacturer Mepha to continue the marketing of the generic version of Fosamax (alendronate), a drug indicated for the treatment of osteoporosis developed by Merck, Sharp & Dohme.
Although patent litigations are still ongoing between the major players in the field, the generics companies are already making headways in the pharmaceutical industry. These recent developments will benefit grateful consumers but put the big pharmaceutical companies at a disadvantage.