Clinical Trial Opportunities in India Report
India is emerging as a favorable destination for conducting clinical trials, according to a report by PwC India and the US-India Chamber of Commerce (USAIC).
The report titled ‘Opportunities for Clinical Trials in India’ highlights the following facts-
- India’s share in the overall clinical trial is around 3%. However, India accounts for more than 15% of the global burden of most prevalent diseases such as respiratory infections, heart diseases, etc. This shows the unutilized potential of the top pharma sector in India.
- Clinical trials are research studies done on people. Through these, medical, surgical or behavioral interventions are evaluated.
- These tests are governed by the Drugs and Cosmetics Act, 1940, the Indian Council of Medical Research Act, 1956 and the Indian Medicine Central Council Act, 1970.
Clinical Trial Registry-India (CTRI)
- Clinical Trials Registry – India (CTRI) is hosted with the National Medical Statistics Institute of the Indian Council of Medical Research (ICMR).
- CTRI was launched in 2007. It is a free and online public record system for registration of clinical trials conducted in India.
- In addition, CTRI also registers clinical studies being conducted in countries that do not have their own primary registry.
- It was introduced as a voluntary measure. From the year 2009, the Drugs Controller General of India (DCGI) has made trial registration with CTRI mandatory.
- The World Health Organization has recognized CTRI as a primary registry.
Ethical Implications of Clinical Trials
- Due to lack of literacy and fraud by the companies, the consent of the participants is taken without telling the whole truth of such tests.
- Clinical trials are mostly done on the poor. This test often results in them getting treatment that they cannot afford.
Source – Economics Times
