India has wide spectrum of diseases (urban lifestyle and tropical) due to its varied environment & a large pool of patients. Many of them have never been treated before uncontaminated' or naive patients and this makes them even more valuable as participants. The past experience has shown that in most of the multi-country trials, patient enrolment is rapid in India. Infectious diseases like multi-drug resistant Tuberculosis, Pneumonia, and Hepatitis B are far more prevalent in India than in west.

The country has a heterogeneous mix of people several gene types such as Caucasians, Mongoloid and Australoids can be found in India. Testing a drug on different ethnic groups can determine how drugs work differently in various racial groups and among other things so if a company is looking for different gene pools in a single location, India stands to gain. Biodiversity of population, involving a wide and varied gene pool that can provide a wealth of information for target identification. It has been calculated that all of the currently known drugs act against only 500 different molecular targets in the body. It has however been estimated that between 5,000 and 10,000 targets actually exist. Genomics will play a greater role in increasing the identification of newer targets.

The fact that India has a huge population, especially in the rural areas, that has had no access to modern medical services may be spreading ripples of concern amongst the country's medical fraternity, as it mirrors the poor penetration of drugs in India. But for global pharma majors, this represents a potential market for clinical trials of a wide range of untested drugs.

India has a talented pool of Clinical Research Professionals, Physicians and Investigator sites eager to take part in GCP trials. Large & fast growing private health care sector makes clinical trials in India very economic.

India has well-defined guidelines for carrying out various phases of clinical trials. These guidelines are in line with the global guidelines on clinical research (ICH-GCP). The various guidelines that govern the conduct of clinical trials in India include:

i) Schedule Y of Drugs and Cosmetics Act, 1940
ii) Ethical Guidelines for Biomedical Research on Human Subjects, 2000 also known as ICMR Code
iii) Good Clinical Practices, 2001

Generally it takes 10-15 years to develop a new drug and the 20-year-clock on a drug patent starts ticking when a new compound is discovered. So the quicker a product can get to market, the speedier the return on investment. The faster a drug is developed, the longer its patent protects it. Even saving a few months on the drug development timelines can mean millions of dollars in sales to a drug company. Conducting Phase III trials in India simultaneously with trials in the west can save companies between two and five years in getting their drugs to market in India and other Asian countries.

At present, the global off-shoring potential in life sciences and healthcare is about $220 billion, with an annual growth rate of 8-10 per cent. India currently corners about $280 million in this sector and can garner about $12 billion of this pie by 2015, according to industry estimates. The overall cost advantage in bringing a drug to market by leveraging India aggressively could be as high as $200 million. Moreover, import duties have been levied on the import of all CT material (drugs), making India a preferred destination for conducting global clinical trials. The present day economic environment is quite favorable for foreign direct investments. Foreign Direct Investment is over US$ 2 billion a year.

India became a member of WTO in 1995 and agreed to adhere to the product patent regime by 2005. This has led to a significant growth in pharmaceutical industry (>15%) and increased stakes of MNCs in Indian operations. As part of TRIPS (Trade Related Intellectual Property Rights) the Pharmaceutical Industry will have the right to patent products as well as processes throughout the world including India. Being a member of GATT / Trips, India will also have a process and product patents that will be consistent with the patent laws prevailing in the most developed countries.

India's credibility has been proved with acceptance of data generated from India, at all International conferences and journals. India has been a part of the many FDA & EMEA registration studies.

The country is renowned for it's prowess in Information Technology. English is a primary language of education and communication among Indians

Existence of one point solution providers like Rejuvendus clinical research makes environment in India very smooth and hassle free for conducting research. Our specialty of being a hub of clinical research physician/ doctors with a nationwide spread is a distinction in itself.