New Delhi: The clinical trials of 162 new chemical entities will continue to be on the hold as Supreme Court on Monday said that the technical committee and the apex committee will examine the benefits of these trials for the country.
A bench of Justice R M Lodha and Justice Shiva Kirti Singh said that 157 new chemical entities, which were cleared for clinical trials in December 31, 2012, would be reviewed by the two apex committees.
Reviewing the clearance for clinical trials of 157 new chemical entities by the National Drugs Advisory Committee and the Drug Controller General of India, the court said the technical and apex committees would look into the assessment of risk vs benefits to the patients, innovation vis-a-vis existing therapeutic options and the unmet medical needs of the country. [Source]
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