Steps by CDSCO – GoI to strengthen Clinical Research

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Several steps have been taken by the Government, as follows, to strengthen the clinical trial approval procedures and their monitoring mechanism to ensure that safety, rights and well-being of clinical trial subjects are protected:

  • 12 New Drug Advisory Committees (NDAC) consisting of leading experts mostly from the Government medical colleges and institutes from all over the country have been constituted to advise the Central Drugs Standard Control Organisation (CDSCO) in matters related to approval of clinical trials and new drugs. Fresh applications of clinical trial proposals of new drug substances excluding investigational new drugs (INDs) are being evaluated by these Committees.
  • For INDs, two separate expert committees have similarly been constituted. Applications of Investigational New Drugs (IND) i.e., New Drug Substances which have never earlier been used in human beings are evaluated by an IND Committee, chaired by the Director General, Indian Council of Medical Research (ICMR). Similarly, for medical devices, six Medical Device Advisory Committees (MDAC) have been constituted.
  • Registration of clinical trial in ICMR’s registry at has been made mandatory.
  • Guidelines for conducting inspection of clinical trial sites and sponsor / Clinical Research Organizations (CROs) have been prepared.
  • Proposals to amend the toxicity study data requirements for approval of clinical trial / new drugs to make it harmonized with the international guidelines have been approved by Drugs Technical Advisory Board (DTAB).
  • It has been made mandatory that Ethical Review Boards across the country are registered with the CDSCO and follow regulations laid down by the DCGI’s Office.



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