Good Clinical Practices, 2001
1. SPEED
For almost all drug companies, speed is of essence. Typically 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.
2. PATIENT ENROLMENT
India certainly has plenty of patients. Every 6th patient in world is from India. The past experience has shown that in most of the
multi-country trials, patient enrolment is rapid in India. Many of them have never been treated before and this makes them even more valuable as participants.
3. WIDE SPECTRUM OF DISEASE
Apart from the sheer numbers of patients, there are other compelling reasons why multinational drug companies are looking to India to test new drugs. Diseases like multi-drug resistant pneumonia, hepatitis B, diabetes and some cancers are far more prevalent in India than in west. Also testing a drug on different ethnic groups can determine how drugs work differently in various racial groups and among other things, whether different dosages are required in different ethnic populations.
4. ECONOMY
Clinical trials in India are economic. The overall cost advantage in bringing a drug to market by leveraging India aggressively could be as high as $200 million. Moreover, import duties have been levied on the import of all CT material (drugs), making India a preferred destination for conducting global clinical trials.
5. QUALITY OF DATA
The acceptance of data generated from India at all major conferences and journals proves its credibility. India has been a part of the many FDA & EMEA registration studies.
6. ECONOMIC ENVIRONMENT
The present day economic environment is quite favorable for foreign direct investments. Foreign Direct Investment is over US$ 2 billion a year.
7. ALIGNMENT WITH GATT/TRIPS/WTO
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.
8. INFRASTRUCTURE
India has a talented pool of Clinical Research Professionals and Investigator sites eager to take part in GCP trials. India’s IT strength can be leveraged to gain competitive advantage in the clinical research arena, including data management.
9. PROFICIENCY IN ENGLISH LANGUAGE
The proficiency of Indian Investigators and research professionals in English language is an added advantage for all medical and
scientific communications.
