India has always been a destination for its low labour costs and that is one of the reasons why the pharmaceutical sector has fared well  in the foreign markets.  But, as the country moves towards product patents, a new dimension is added to this phenomenon of low-cost sourcing which is particularly relevant to the pharmaceutical sector - clinical trials.

A clinical trial is the "D" of pharmaceutical research and development (R&D). It essentially involves testing a new drug in select categories of people. It is done after the particular drug has cleared laboratory tests on animals and shows definitive  therapeutic properties. Clinical trials are the most time consuming   in the  R&D life of a drug and, at times, it can take up 8-10 years before the drug is finally cleared for sale.

There are three distinct phases in clinical trials. A phase 1 trial is conducted on a small group of normal human beings to evaluate the safety of the drug. Phase 2 is to test the effectiveness of the drug against a particular illness or disease and covers 100-300 human subjects. Phase 2 of the trial could typically last for around two years.

Phase 3, the final stage of the clinical trial process, is done on a large group of patients at multi-centric locations. In this phase, results of the phase 2 trials are re-affirmed on a population base of over 10,000.

India offers two kinds of benefits to pharma companies who want to cut costs on research and development. One, the country has an excellent doctor population with international exposure and  a stint in government hospitals and public health centres. In fact, India has the second largest pool of qualified doctors, next only to the US. Even in the US, it is believed, one out of every six doctors is an Indian.

Some of these doctors with wide clinical experience can be trained to become investigators. This presents the drug companies to tap their expertise in treating diseases, which are region-specific -- such as malaria, typhoid, etc, -- and life-style associated diseases -- such as cancer, hypertension, and diabetes.

But more importantly, since the time taken for clinical development is 8-10 years, it leads to a valuable loss in revenues due to diminished market exclusivity in a 20-year patent-protected scenario.

According to Richa Chandra, vice president - clinical research, Pfizer India, faster patient enrolment would help reduce the time lag to take the drug into the market. "With 8-10 years going into clinical research, if this time can be squeezed by even a year or so, it is definitely an advantage.", she stated.

The growing competition in Europe and the US for rapid inclusion of adequate number of patients has actually led to a shortfall of available patients. India, with a huge population base and a wide spectrum of diseases and endemic zones, can provide a much needed alternative.

Then there is the cost advantage for all the periphery expenses associated with clinical trials and patient monitoring such as CT scans, blood tests and X-rays, which are cheaper in India as compared to US and Europe.

Recently, Nicholas Piramal India Ltd, carried out clinical trials of a drug to treat visceral leishmaniasis, a disease more prevalent in the tropics. The company managed to reduce costs by a quarter. The trials were conducted in four north Indian states as per US FDA guidelines and were monitored by international clinical research organisation Quintiles.