Order of the Supreme Court of India regarding the Draft Drugs and Clinical Trials Rules 2018, 12/09/2018
Order of the Supreme Court of India in the matter of Swasthya Adhikar Manch & Others Vs Union of India & Others dated 12/09/2018 regarding Draft Drugs and Clinical Trials Rules 2018. The Government of India has issued Drugs and Clinical Trials Rules, 2018 in February, 2018. The Draft Rules are available on the website of the Ministry of Health and Family Welfare. 45 days time was given to file objections to the Draft Rules.
Supreme Court observed that none of the petitioners/applicants have filed any objections to these Rules. Counsel appearing on behalf of the Union of India says that a corrigendum will be issued inviting objections within a period of 30 days. Those who are interested may file their objections to the Draft Rules. Further the Counsel states that many objections/suggestions have already been received. Supreme Court asks the counsel for the Union of India that to the extent possible, those who have raised objections and made suggestions may be given a hearing so that the Rules can be finalized once and for all since it pertains to the health of the people of the country and pertains to clinical trials.