New Delhi, Aug 10, 2010: The number of death occurrences in the clinical trials have increased with each passing year. The information collated have revealed that there were 132 deaths in the year 2007, 288 deaths in the year 2008, 637 deaths in the year 2009 and 462 deaths up to June, in the year 2010.

This information was shared by the Minister of Health & Family Welfare, Mr Ghulam Nabi Azad on  Aug 06, 2010 in the Parliament.
The Minister, while mentioning about the causes of deaths, said “Death may occur during clinical trials due to various reasons. These could be disease-related deaths like cancer, or administration to critical or terminally ill patients, or side effects of unrelated cause. Such deaths are investigated for causal relationship by investigators and by medical experts of the sponsor.”

No company in India can initiate any clinical trial of a new drug, without prior approval from CDSCO, Directorate General of Health Services, Ministry of Health and Family Welfare, Govt. of India. There are a large number of pharmaceutical companies and Clinical Research Organizations (CRO) who seek permission from Central Drugs Standard Control Organisation (CDSCO) to conduct clinical trial in the country, which include GlaxoSmithkline, Johnson & Johnson, Sanofi-Aventis, MSD, Eli Lilly, Novartis, Bristol Myers Sqibb, Bayer Healthcare, Astra Zeneca, Pfizer and Clinical Research Organizations (CROs) like Quintiles, ICON, GVK BIO Siro Clinpharm, Parexel, PRA International PPD, Covance, Omnicare, Kendle.

Clinical trials are permitted in the country as per Rule 122DA, 122DAA, 122DB 122E and Schedule Y of Drugs & Cosmetic Rules. A substantial number of clinical trials were permitted as part of global clinical trials, and local clinical trial for marketing authorization, during the last 3 years. The number of global trials permitted in the years 2007, 2008, 2009 and until June 2010, were 259, 246, 258 and 117 respectively. The number of local clinical trials permitted were 142, 275, 195 and 134 for the respective years of 2007, 2008, 2009 and until June 2010.