New Delhi: The Ministry of Health has released draft rules 2018 for Clinical trials that will be called as New Drugs and Clinical trials Rules, 2018 and It will come in to force after its final publication in the Official Gazette.
The new rules have been drafted after consultation with the Drugs Technical Advisory Board and will be under Part XA and Schedule Y of the Drugs and Cosmetics Rules, 1945, and section 12 and 33 of the Drugs and Cosmetics Act, 1940.
The new rule contains 12 chapters and 8 schedules and will be applicable to all new drugs, investigational new drugs for human use, clinical trial, bioequivalence study, bioavailability study, and Ethics Committee.
The new regulations clearly define features of an academic study, the role of central licensing authority, trial protocol, biomedical and health research.
According to the new rules, the clinical trial in relation to a new drug or investigational new drug in humans has to generate data for discovering or verifying its pharmacological interactions including pharmacodynamics, pharmacokinetic and adverse effects in order to determine the safety, efficacy or tolerance of new drugs.
As per the new rules the Drugs Controller General of India, with the prior approval of the central government, can delegate all or any of powers of the Central Licencing Authority to any other Officer of the Central Drugs Standard Control Organisation not below the rank of Assistant Drugs Controller. The officers to whom the powers have been delegated under sub-rule (1) would implement all or any of the rules of the Central Licensing Authority.
the Drugs Controller General of India will designate any officer not below the rank of Assistant Drugs Controller as Controlling Officer and will specify the areas and powers of the Controlling Officer through an order. The Controlling Officer, designated under sub-rule (1) will supervise the work of subordinate officers and will exercise powers and perform functions which may be assigned to that Officer.
The new rules clearly state that any institution or organization intends to conduct clinical trial or bioavailability study or bioequivalence study will be required to have an Ethics Committee
The Ethics Committee can apply for registration with the Central Licensing Authority and must have a minimum of seven members from Medical Science, Scientific, Non-medical, Non-scientific, One layperson, and one woman member. A member of the Ethics Committee will be the Chairperson, who should not be related in any manner with the institute or organization. The registration of Ethics Committee will be valid for a period of three years.
In case of an application for permission to undertake a clinical trial of a new drug formulation, which is already approved in the country, no pharmaceutical & clinical data is required to be submitted provided the trial is proposed to be conducted with a new drug manufactured/imported by a firm.
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 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 canceled 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
- 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.