Regulation/Guidelines

Second Amendment in Drugs & Cosmetics Rule, 2013

  • 2nd September, 2013

n the Drugs and Cosmetics Rules, 1945, in Part X-A, after 122Dab, the following rule shall be inserted, namely:-

122 DAC. (1) Permission to conduct clinical trial- The licensing Authority as defined in clause (b) of rule 21, on being satisfied that the data submitted along with application in support of the proposed clinical trial is adequate in all respects, issue permission for conduct of clinical trial, subject to the following conditions, namely:-

a) Clinical trial shall be conducted in compliance with the approved protocols, requirements of Schedule Y annexed to these rules, Good Clinical Practice Guidelines for conduct of clinical trials in India and other applicable regulations

b) Approval of the Ethics Committee shall be obtained before initiation of the study;

c) Clinical trial shall be registered at Clinical trials Registry of India before enrolling the first patient for the study;

d) Annual status report of each clinical trial, as to whether it is ongoing ,completed or terminated, shall be submitted to the Licensing Authority and in case of termination of any clinical trial the detailed reasons for the same shall be communicated to the said Licensing Authority;

e) Any report of serious adverse event occurring during clinical trial to the subject, after due analysis, shall be forwarded within few days of its occurrence as per Appendix XI and in compliance with the procedures prescribed in Schedule Y;

f) In case of an injury or death during the clinical trial to the subject of the clinical trial, the applicant shall provide complete medical management and compensation in the case of trial related injury or death in accordance with rule 122 DAB and the procedures prescribed under Schedule Y, and  the details of compensation provided in such cases shall be intimated to the Licensing Authority within thirty days of the receipt of the order of the said authority;

g) The premises of the Sponsor including their employees, subsidiaries and branches, their agents, contractors and sub-contractors and clinical trial sites be open to inspection by the officers authorized by the Central Drugs Standard Control Organization , who may be accompanied by an officer of the State Drug Control Authority concerned, to verify compliance to the requirement of Schedule Y, Good Clinical Practices guidelines for conduct of clinical trials in India and other applicable regulation;

h) The Sponsor including their employees, subsidiaries and branches, their agents, contractors and sub-contractors and clinical trial sites and the investigator shall allow officers authorised by the Central Drugs Standard Control Organisation ,who may be accompanied by an officer of the State Drug Control Authority concerned, to enter with or without prior notice, any premises of Sponsor including their employees, subsidiaries and branches, their agents, contractors and sub-contractors and clinical trial sites to inspect, search and  seize any record, data, document, books, investigational drugs, etc. related to clinical trials and provide adequate replies to any queries raised by the inspecting authority in relation in relation to the conduct of clinical trial.

(2) Notwithstanding the conditions specified in sub-rule (1), the Licensing Authority, on being satisfied that the data submitted along with the application in support of the proposed clinical trial is adequate in all respect, may also impose such additional conditions for issuance of permission in respect of specific clinical trials, if considered necessary regarding the objective, design, subject population, subject eligibility, assessments, conduct and treatment of such clinical trial.

(3) If any Sponsor including their employees, subsidiaries and branches, their agents, contractors and sub-contractors, Investigators conducting clinical trial and clinical trial sites fail to comply with any of the above conditions, the Licensing Authority, may, after giving an opportunity to show cause why such an order should not be passed by an order in writing stating the reasons thereof;-

a) issue warning letter giving details of deficiency found during the inspection, which might affect the right or well-being of the clinical trial subject or the validity of the study conducted at the site;

b) recommend that study may rejected or discontinued;

c) suspend or cancel the clinical trial permission;

d) Debar theInvestigator(s), Sponsor including their employeessubsidiaries and branches, their agents, contractors and sub-contractors, to conduct any clinical trial in future.

(4) The Sponsor including their employees, subsidiaries and branches, their agents, contractors and sub-contractors and clinical trial Investigators against whom action as mentioned in sub rule (3) has been taken by the Licensing Authority, may within ninety days of the receipt of the copy of the order of the Licensing Authority prefer an appeal to the Central Government and the Central Government may, after giving such appellant an opportunity of being heard,confirm, reverse or modify such order”.