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CDSCO issues draft Clinical Trials Rules, 2018

Nandita Vijay, Bengaluru
Thursday, February 8, 2018, 08:00 Hrs  [IST]

The Central Drugs Standard Control Organization (CDSCO) has issued the draft Clinical Trials Rules, 2018. It applies to all new drugs, investigational new drugs for human use, clinical trial, bioequivalence study, bioavailability study and Ethics Committee. It will come in to force after its final publication in the Official Gazette. This 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 regulations clearly defines features of an academic study, role of central licensing authority, trial protocol, biomedical and health research.
Further it has detailed about clinical trial in relation to a new drug or investigational new drug in human subjects to generate data for discovering or verifying its pharmacological interactions including pharmacodynamics, pharmacokinetic and adverse effects. The objective is to determine the safety, efficacy or tolerance of new drugs, stated the regulatory authority.
In a chapter on authorities and officers, it has explicitly indicated on the delegation of powers of Central Licensing Authority. Here the Drugs Controller General of India, with the prior approval of the central government, can delegate powers of the Central Licensing Authority to any other officer of the Central Drugs Standard Control Organisation not be below the rank of Assistant Drugs Controller.  Now the officers to whom the powers have been delegated under sub-rule (1) would implement all the rules of the Central Licensing Authority.
Under the section on Ethics Committee for clinical trial, bioavailability and bioequivalence study, it calls for a minimum of seven members representing medical science, scientific, non-medical, non-scientific, one lay person and one woman member. Moreover a member of the Ethics Committee will be the Chairperson, who should not be related with the institute or organisation. The EC registration granted is valid for a period of three years.
Any institution or organisation intends to conduct biomedical and health research will need to have an Ethics Committee to oversee the conduct of such research.
The Ethics Committee referred to in rule 15, relating to biomedical and health research will be constituted in accordance with the National Ethical Guidelines for Biomedical and Health Research Involving human participants as specified by the Indian Council of Medical Research and function as per the guidelines.
In case of an application for permission to undertake 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.
The industry says that in view of the early issues of stalling a clinical trials in 2013, the new guidelines have explicitly provided details on conduct, monitoring and audit of human studies.
According to Bharathi Ramesh, director operation , Integrated Global Regulatory Services, the new rule contains 12 chapters and 8 schedules. It goal is to clarify and update the recommendations to implement the guidance . It is most appropriate in the current environment of clinical research where it would encourage and facilitate the systems to improve the quality and efficiency of the clinical investigator.
Moreover the chapter wise information making it a functional guideline. The designation of an officer in the rank of an Assistant drugs controller was not earlier there. The powers to the office of DCGI with sub-rules for the supervisors are all important in the current context of development, she added.


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