India is fast becoming a hot destination not only for medical treatments but for clinical trials as well. Outsourcing of technology has, in a way, changed the landscape of urban India. Now, She is the world leader in bagging outsourced clinical research contracts.

India has two times the market share of the next-in-line, Italy, and four times as much as Spain, the third competitor. But recently, these outsourced trials have raised many an eyebrow.

Changing the Act

The Government of India has liberalized clinical trial procedures by making amendments to Schedule Y of the Drugs and Cosmetics Act. This, many fear, will pave the way for Indians to be used as guinea pigs.Are these fears unfounded or are they based on solid evidence?

In a few years time, India stands to gain humongous amount of foreign exchange through the outsourcing of clinical trials by pharmaceutical companies. But on the other side, the pharmaceutical companies stand to gain immensely. Forty percent of the drug development cost is related to trial-related expenses. Therefore, carrying out these trials in a comparatively poorer nation, like India, will cut down the costs by 60%. 

After the change

The amendment to the Act has removed the "phase lag" between trials. Phase-II trials were initiated in India only after these trials have been completed abroad and the initiation of phase-III trials there. Phase-III trials were allowed in India only after the drugs were marketed abroad. Now phase-II and phase- III trials in India can be held concurrently with the trials abroad.

"It is, therefore, all the more necessary to put in place a set of rules that are more stringent, and ensure that the rights of Indian subjects of trials are given full protection," points out Rajya Sabha member Ms. Brinda Karat in her letter addressed to the Health Minister, Anbumani Ramdoss.

Mr. Ramadoss, reiterates that stringent measures are in place, including provisions for ‘informed’ consent.

However, Ms. Karat points out that the presence of an ‘impartial person’, at the event of an illiterate candidate   signing the consent form, will not actually amount to stringent measure. "You are also no doubt aware that not a single paisa has ever been given to a single patient who has suffered the adverse consequences of trials," Ms.Brinda adds.

Advantages

International clinical trials have several advantages if properly conducted. 

The following are some of the advantages of these drug trials –

• In  the year 2005, contract research in India was estimated  at $100-120m, growing all the while at a rate of 20-25 per cent each year.By the year 2010, it is estimated to hit a target of  1bn US dollars.
• For these trials to be conducted foreign sponsors, including India, must adhere to certain regulations and monitoring in alignment with the  International standards. It would help India to develop its own sets of ‘Good clinical Practice’.
• More regulations are likely to come into force.
• Outsourcing of clinical trials make transfer of technology possible. This would help  in advancing medical research and knowledge to find  better cure for diseases. 
• Clinical infrastructure, in the form of new equipments and research centres, is likely to get a boost.
• The Indian hospitals and doctors get an exposure to a  work discipline  of working meticulously and efficiently.
• It would help  patients with advanced forms of cancers or diseases where there are no treatment options  or  hope for a cure to prolong their survival.
• Clinical trials give new job opportunities to graduates from medical/science disciplines.