The Ministry of Health and Family Welfare has issued the draft New Drugs and Clinical Trials Rules, 2018

The Ministry of Health and Family Welfare has issued the draft New Drugs and Clinical Trials Rules, 2018

February 7, 2018 Healthcare, OPS, Pharmaceuticals, states 0

The Ministry of Health and Family Welfare (“Ministry”) has, in supersession of Part XA and Schedule Y of the Drugs and Cosmetics Rules, 1945 (“Rules”) and after consultation with the Drugs Technical Advisory Board, issued the draft New Drugs and Clinical Trials Rules, 2018 (“Draft Rules”), inviting objections and suggestions from all persons likely to be affected by the Draft Rules, within a period of forty five days from the date on which copies of the Gazette of India containing these Draft Rules are made available to the public.

Such objections or suggestions may be

  • addressed to the Under Secretary (Drugs), Ministry of Health and Family Welfare, Government of India, Room No. 414 A, ‘D’ Wing, Nirman Bhawan, New Delhi – 110011 or
  • sent on email at

Key highlights of the Draft Rules:

  • Every such Ethics Committee has to get registration from the Central Licencing Authority (“Authority”) i.e. the Drugs Controller General of India.
  • 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 organisation, which intends to conduct clinical trial or bioavailability study or bioequivalence study, is required to have an Ethics Committee.
  • No person or institution or organisation shall conduct clinical trial of a new drug or investigational new drug without getting permission from the Authority.

Such permission, if granted, shall remain valid for a period of two years from the date of its issue, unless suspended or cancelled by the Authority.

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

However, where 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

  (a) institutional Ethics Committee of another trial site or

  (b) an independent Ethics Committee constituted under the Draft Rules

  • A licence has to be obtained by the institutions or organisations for manufacturing or importing new drugs or investigational new drugs or for manufacture of unapproved active pharmaceutical ingredient for development of any formulation, for clinical trial, bioavailability, bioequivalence study etc. under the Rules.
  • The institutions or organisations also have to obtain a licence to manufacture or import new drugs for sale or for distribution under the Rules.

Please refer to the hyperlinked source for the Draft Rules.

Source: Ministry of Health and Family Welfare

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