New Delhi: Through a recent notification CDSCO has invited stakeholders to submit their views or any objections/ suggestions on the draft New Drugs and Clinical Trials Rules, 2018. The notice also invited the stakeholders to visit CDSCO's office for personal hearing on 22.11.2018

The Ministry of Health and Family Welfare, Government of India had issued Draft rules the New Drugs and Clinical Trials Rules, 2018 vide G.S.R.104(E) dated 1st February 2018. The Draft Rules are available on the website of the Central Drugs Standard Control Organization, of the Ministry of Health and Family Welfare. 45 days time was given to file objections and suggestion to the Draft Rules.

As per the Hon'ble Supreme Court order dated 12.09.2018 in the subject matter; the notice adds that a corrigendum will be issued inviting objection and those who are interested may file their objection to the Draft Rules. Accordingly, a meeting was held in FDA Bhawan on 05.11.2018 with stakeholders. However, some of the parties including the petitioners have requested another date to present their views.

Accordingly, the interested stakeholders are hereby invited to submit their views or any objections/ suggestions on the draft New Drugs and Clinical Trials Rules, 2018 and visit this office for personal hearing on 22.11.2018 at 2:00 PM, Conference Hall, 1st Floor, FDA Bhawan, Kotla Road, ITO, New Delhi-110002.

Read Also: New Clinical Trials Rules 2018 released, check out details

Key highlights of the Draft Rules:

• The Draft Rules are applicable to all new drugs, investigational new drugs for human use, clinical trial, bioequivalence study, bioavailability study, and Ethics Committee.


• Any institution or organization, which intends to conduct a clinical trial or bioavailability study or bioequivalence study, is required to have an Ethics Committee.


• Every such Ethics Committee has to get registration from the Central Licensing Authority.


• No person or institution or organization shall conduct a clinical trial of a new drug or investigational new drug without getting permission from the Authority. If permission granted, will remain valid for a period of two years from the date of its issue unless suspended or cancelled by the Authority.


• An institution or organization has to conduct a clinical trial according to the protocol approved by the registered Ethics Committee.


• If a clinical trial site does not have its own Ethics Committee, the clinical trial at that site may be initiated after getting the protocol approved from the

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  • Institutional Ethics Committee of another trial site or
  
  
  • An independent Ethics Committee constituted under the Draft Rules
  
  
  
  

• In case of termination of any clinical trial, the detailed reasons for such termination should be communicated to the Central Licencing Authority within thirty days of such termination.


• Any report of a serious adverse event occurring during the clinical trial to a subject of the clinical trial, after due analysis, should be forwarded to the Central Licencing Authority, the chairperson of the Ethics Committee and the Institute where the trial has been conducted within fourteen days of its occurrence.


• In case of an injury during a clinical trial to the subject of such trial, complete medical management and compensation should be provided by the firm and details of compensation provided in such cases shall be intimated to the Central Licencing Authority within thirty days of the receipt of recommendations made by Ethics Committee.


• In case of clinical trial related death or permanent disability of any subject of such trial during the trial, compensation shall be provided and details of compensation provided in such cases should be intimated to the Central Licencing Authority within thirty days of receipt of the order issued by the Central Licencing Authority.


• A license has to be obtained by the institutions or organizations for manufacturing or importing new drugs or investigational new drugs or for the manufacture of unapproved active pharmaceutical ingredient for the development of any formulation, for a clinical trial, bioavailability, bioequivalence study etc. under the Rules.


• The institutions or organizations also have to obtain a license to manufacture or import new drugs for sale or for distribution under the Rules.

Find the attachment for the same.

http://www.cdsco.nic.in/writereaddata/Draft CT Rules sent for Publication.pdf