Dr Renu Razdan, chief operating officer, Max Neeman International, New Delhi
Clinical research industry has been in news a lot lately, and not entirely for good reasons. Although the concerns of civil society regarding the safety and ethicality of clinical trials are not ill-founded, we cannot undermine the indispensability of this field of research for our country, both as a science and as an industry. Annual global turnover of Clinical Research industry is $500 billion in which India has a share of $500 million. Even as a small part of the global business, it has brought much needed revenue to our country. But most significantly it has opened the gates for entry of many life-changing and life-saving drugs into our country. India with its large population of diverse ethnicities, modern infrastructure and trained manpower has been a lucrative choice for pharmaceutical companies.
In India, clinical trials for drugs have been conducted since 1988 when Schedule Y of Drugs and Cosmetic Act became effective. In 2002, the number of trials was 40-50 trials (Centerwatch August 2003). Over last several years the number has increased. In 2009, CDSCO permitted 453 trials (258 global and 195 local). This was mainly due to Indian government making effective regulations - Schedule Y 2005 - and ethical and scientific guidelines - Indian Good Clinical Practice (GCP) and ICMR ethical guidelines- for clinical research. These regulations and guidelines are in line with international regulations and International Conference on Harmonisation GCP guidelines. These statutory requirements improved the quality of Indian clinical trials and made the data acceptable to international regulatory agencies.
This growth of clinical research activity has been of immense benefit to India. Few of the key facts that prove that are:
The quality of Indian trials is at par with global standards. Since 2005, USFDA has conducted inspections at 30 Indian investigator sites. There have been no serious non-compliance issues at any of the sites. The data from Indian trials have been accepted by US FDA and European Medicines Agency.
Although there have been some media reports of cases of non-compliance to regulations and guidelines, majority of clinical trials are conducted in compliance with national and international scientific and ethical norms. These deviations point to an urgent need for regulation inspections and training and accreditation of the Indian investigator sites.
Unfortunately, the regulatory response to such media reports has been reactive, making the e-regulatory approval process for clinical trials slow and uncertain. There is also a lack of transparency and consistency which is a cause of concern for the clinical research professionals in the country.