India: Health Ministry Releases Draft New Drug & Clinical Trial Rule 2018

The Ministry of Health and Family Welfare of Government of India has released draft Clinical Trial (CT) Rules 2018, which will come in force after its final publication in the Official Gazette. The new rules have been drafted after consultation with the Drugs Technical Advisory Board (DTAB) and 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 CT 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 (DCGI), with the prior approval of the central government, can delegate all or any of the powers of the Central Licensing Authority (CLA) to any other Officer of the Central Drugs Standard Control Organization (CDSCO) not below the rank of Assistant Drugs Controller (ADI). The officers to whom the powers have been delegated under sub-rule (1) would implement all or any of the rules of the CLA.

The DCGI may designate any officer not below the rank of Assistant Drugs Controller as Controlling Officer and will assign the areas and powers of the Controlling Officer through an order. The Controlling Officer will then supervise the work of subordinate officers and will exercise powers and perform functions which may be assigned to that Officer.

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.


Ethics Committee (EC) and Central Licensing Authority (CLA):

  • Any institution or organization, which intends to conduct CT or bioavailability study or bioequivalence study, is required to have an Ethics Committee (EC). Every such EC has to get registration from the CLA and must have a minimum of seven members from Medical Science, Scientific, Non-medical, Non- scientific, and layperson and a woman member. A member of the EC will be the Chairperson, who should not be related in any manner with the institute or the organization. The registration of EC will be valid for a period of three years.
  • No person or institution or organization shall conduct a CT of a new drug or investigational new drug without getting permission from the CLA. If granted, permission will remain valid for a period of two years from the date of its issue unless suspended or canceled by the Authority.
  • However, there shall be no permission required from CLA for conducting an academic CT for any drug in the following circumstances:
    1. The CT drug formulation is intended solely for academic research purposes,
    2. The CT has been approved by the EC,
    3. The observations of such CT are not required to be submitted to the CLA; and
    4. The observations of such CT are not used for promotional purposes.
  • If a CT site does not have its own EC, the CT at that site may be initiated after getting the protocol approved from the Institutional Ethics Committee of another trial site or an independent EC constituted under the Draft Rules.
  • In case of termination of any CT, the detailed reasons for such termination should be communicated to the CLA within thirty days of such termination.
  • Any report of a serious adverse event occurring during the CT to a subject of the CT, after due analysis, should be forwarded to the CLA, the chairperson of the EC and the Institute where the CT has been conducted within fourteen days of its occurrence.
  • In case of an injury during a CT 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 CLA within thirty days of the receipt of recommendations made by EC.
  • In case of a CT related death or permanent disability of any subject during the trial, compensation shall be provided within thirty days of receipt of the order issued by the CLA. Whereas, the details of compensation provided in such cases should be intimated to the CLA

New Drugs or Investigational New Drugs:

  • 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 CT, bioavailability, bioequivalence study etc.
  • The institutions or organizations have to also obtain a license to manufacture or import new drugs for sale or for distribution under the Rules.

Bioavailability and Bioequivalence study:

  • No bioavailability or bioequivalence study of any new drug or investigational new drug shall be conducted in human subjects by any person or institution or organization except in accordance with the permission granted by the CLA and EC.
  • The work of every bioavailability or bioequivalence study center shall be overseen by an EC. Whereas, any officer authorized by the CLA, who may, if considered necessary, be accompanied by an officer authorized by the State licensing authority, may enter with or without prior notice to premises and bioavailability or bioequivalence study center to inspect, search or seize, any record, statistical result, document, investigational drug and other related material and reply to queries raised by the inspecting authority in relation to the conduct of such bioavailability or bioequivalence study.


  • The investigator shall be responsible for the conduct of the trial according to the Standard operating procedures (SOP) and the Good Clinical Practices (GCP) Guidelines. SOP are required to be documented and maintained by the investigators for the tasks performed by them.
  • The investigator should ensure that adequate medical care is provided to the participant in case of any adverse events. In case of serious adverse events, the investigator shall report to all authorities like CLA, EC and sponsor within twenty-four hours of their occurrence.
  • The investigator shall provide all essential information of CT to the trial subject through informed consent process including information of sponsors and compensation in case of trial related injury or death.


  • The CT sponsor is responsible for implementing and maintaining quality assurance systems to ensure that the CT is conducted and data generated, documented and reported in compliance with the protocol and GCP.
  • Sponsors are required to submit a status report on the CT to the CLA at prescribed periodicity.
  • In case a serious adverse event occurs at trial site, the sponsor, after due analysis, shall forward SAE report to the CLA, shall make payment for medical management of the subject and also provide financial compensation for the CT related injury or death.
  • The sponsor shall provide post-trial access of the investigational drug by giving the drug free of cost to the trial subject as per the directions of the CLA; in special circumstances on the recommendations of the investigator and the ethics committee and written consent of the patient.

Informed Consent:

  • In all trials, a freely given, informed, written consent is required to be obtained from each study subject. The Investigator must provide information about the study verbally as well as using a patient information sheet, in a language that is non-technical and understandable by the study subject.
  • Where a subject is not able to give informed consent (e.g. an unconscious person or a minor or those suffering from severe mental illness or disability), the same may be obtained from a legally acceptable representative or in the presence of impartial witness.
  • In case of CT on pediatrics, the subjects are legally unable to provide written informed consent, the consent should be obtained from the parent or legal guardian. Where appropriate, pediatric participants should additionally assent to enroll in the study.
  • An audio-video recording of the informed consent process in case of vulnerable subjects, CT of New Chemical Entity or New Molecular Entity including procedure of providing information to the subject and his understanding on such consent, shall be maintained by the investigator for record. It is provided that in case of clinical trial of anti-HIV and anti-leprosy drugs, only audio recording of the informed consent process of individual subject including the procedure of providing information to the subject and his understanding on such consent shall be maintained by the investigator for record.


The proposed draft clinical trial rules cover the full spectrum of clinical trial activities, from ethics committees and manufacturing permissions to inspections and injury compensation. Publication of the draft rules marks an important step in India's attempts to codify its approach towards clinical trials. These draft rules are also an attempt to recover from the regulatory problems that had throttled the clinical trial industry. With these proposed new regulations the clinical trial industry should revive in the country. The draft is currently open to receive comments from industry/ stakeholders for 45 days.

The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.

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