The number of clinical trials of new drugs and vaccines on human beings approved by the Central Drugs Standard Control Organisation (CDSCO) has come down significantly during the last three years, thanks to the strict regulatory measures taken by the drug authorities to curb irregularities in the clinical trials in the country.
According to data available with the Union health ministry, the number of clinical trials approved by the CDSCO has come down by more than 50 percent from 529 in the year 2010 to 253 in 2012. In 2010, the CDSCO received a total of 546 applications for conducting clinical trials in the country, of which 529 were given permission by the CDSCO.
But, the number of applications received by the CDSCO for conducting clinical trials nosedived from 546 in 2010 to just 306 in 2011. After screening the 306 applications, the drug authorities gave permission to conduct 283 clinical trials in the year 2011. Though there has been a spurt in the number of applications received by the CDSCO in 2012, the number of clinical trial permissions granted by the authorities came down drastically. Out of a total application for 480 clinical trials, the CDCSO granted permission to only 253 trials in 2012.
According to sources, the sharp slide in the number of clinical trials approved by the DCGI was due to the several steps taken by the drug authorities to strengthen the clinical trial approval procedures and monitoring mechanism for clinical trials.
In this regard, the union health ministry had constituted 12 New Drug Advisory Committees (NDACs) consisting of leading experts from the government medical colleges, institutes from all over the country to advise CDSCO in matters related to approval of clinical trials and new drugs. Besides, the ministry had put in a mechanism under which applications of Investigational New Drugs (IND), new drug substances which have never earlier been used in human beings, are evaluated by the IND committee, chaired by the Director General, Indian Council of Medical Research (ICMR).
Moreover, the ministry had made the registration of clinical trial with Clinical Trial Registry of India (CTRI) mandatory way back in June 2009.