Supreme Court of India on 21 October 2013 ruled that the clinical trials of 162 new chemical entities will continue to be on hold. The court added that 157 new chemical entities which were cleared for clinical trials on 31 December 2012, would be reviewed by the two apex committees. The technical and apex committees would look into the assessment of risk versus benefits to the patients, innovation through existing therapeutic options and the unmet medical needs of the country. The committees will ascertain whether the new chemical entities that are being put to clinical trials are actually required in the country.
The court gave the judgment after 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 next hearing of the matter will take place on16 December 2013.