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Honourable Dr. G. N. Singh, Drug Controller General of India presented a Momento by our Director Mr. Syed S. Abbas & Principal Advisor Mr. Vinod Arora on the launch of our Computer System Validation (CSV) programme

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Increase in clinical trials in India after a span of five years

Increase in clinical trials in India after a span of five years

There has been an increase in clinical trials in India after a span of five years as suggested by the data. DCGI approved 17 clinical trials in India in 2013 which went to 97 in 2017, more than 400% jump in five years. According to the regulators and domain experts the rise has happened due to introduction of scientific and balanced guidelines that suit all stakeholders, however activists are of different opinion when it comes to monitoring of trials in India.

Although there has been an increase in the trials but it is nowhere as compared to the pre-2013 period. Data suggests that DCGI approved 253 trials in 2012, 283 trials in 2011 and 529 trials in 2010.

A PIL plea was filed by the Swasthya Adhikar Manch in the Supreme Court in February 2012, which raised an alert over lack of consent and compensation to the patients being one of the irregularities amongst many raised in Supreme Court. In January 2013, a gazette notification was released by the Ministry of Health and Family Welfare determining the eligibility for compensation which eventually led to many pharmaceutical companies to conduct trials outside India. According to Suneela Thatte, board member of the Indian Society of Clinical Research, a clinical research professionals’ association, “The clause of compensation was open to misuse and could act as an inducement for participation in the trial as it called for free medical management in terms of injury to the clinical trial subject. There was no distinction made between study related injury or non-related injury.”

According to DCGI Dr. S. Eswara Reddy, along with the above mention compensation related clause some other clauses were also introduced such as “investigators could not undertake more than three trials, to be conducted only in government hospitals, the site of trials should be 50-bed hospitals, etc. “However now 50% of the trials can be conducted in private hospitals, there is no restriction of three trials per investigator and a formula for calculating financial compensation has been derived.”