New Drugs and Clinical Trials Rules, 2019 of India

– a brief summary for Clinical Research professionals

This article is intended as a short summary of the recently published “New Drugs and Clinical Trials Rules, 2019” by the Min. of Health and Family Welfare, Govt. of India on 19 Mar 2019

The whole gazette publication runs into 240+ pages, with the English part alone taking up 100+ pages. As a result, not every detail published in the New Drugs and Clinical Trials Rules, 2019 (“New CT Rules, 2019”) can be elicited here. Nor can the legal nuances be elaborated on a point-by-point basis due to the volume of the content of the New CT Rules, 2019. However, this article aims to provide a crisp outline of the changes that have been made to the New CT Rules from the earlier one (New Drugs and Clinical Trials Rules, 2018) – chiefly to aid clinical researchers to quickly identify these changes and implement them at their respective workplaces.

  1. The one big highlight under changes from the old rules, is point no. 2 – “Definitions”, under Chapter I – Preliminary. More so, under the definitions, the New CT Rules, 2019 now defines academic clinical trials as follows: “academic clinical trial” means a clinical trial of a drug already approved for a certain claim and initiated by any investigator, academic or research institution for a new indication or new route of administration or new dose or new dosage form, where the results of such a trial are intended to be used only for academic or research purposes and not for seeking approval of the Central Licencing Authority or regulatory authority of any country for marketing or commercial purpose
  2. To be honest, the whole section of “Definitions” is huge a value addition, since this section – at the very beginning, clarifies what the Govt. / Regulatory Authority mean by the jargons that are used in India, in the clinical research and development space
  3. New terminology – “Central Licencing Authority (CLA)” introduced. CLA has a host of responsibilities, while also being the sole custodian of executionary powers for conduct of clinical trials in India. By creating this role of CLA, the Govt. has in a way decentralized power and has also provided all other stakeholders, a single window or a single point of contact – who is both approachable and accountable! Chapter II of the New CT Rules is dedicated to Authorities and Officers – just to drive home the point of powers, responsibilities and accountability
  4. Chapter III – Ethics Committee for Clinical Trial, Bioavailability and Bioequivalence Study has been elaborated more, with special emphasis on:
    • Constitution of Ethics Committee for clinical trials this talks clearly on the membership of the ECs
    • Registration of Ethics Committee relating to clinical trials, bioavailability and bioequivalence study this clarifies the requirements for “registration of ECs” under the CLA (no longer just “ACCREDITATION”) and the CLA’s scrutiny of the compliance to the registration requirements by ECs. Renewal of EC registration is also called out now
    • Validity period of registration of Ethics Committee for clinical trial (05 years – changed from the earlier period of 03 years)
    • Functions of Ethics Committee with a major addition that mandates every EC to perform “ongoing review of the clinical trials for which it has accorded approval…” and on communication requirements with CLA when SAEs occur. Another highlight of this section is the point on CLA’s authority to inspect EC with or without prior notice regarding it’s functioning and compliance with regulations & guidelines
    • Maintenance of records by Ethics Committee for clinical trial for a period of 05 years after completion of every clinical trial or bioavailability or bioequivalence study (archival of records by EC). A comprehensive list of types of documents that covers the entire gambit of all aspects of EC, is published here and proves quite handy
  5. Chapter IV – Ethics Committee for Biomedical and Health Research is a welcome addition that aims to fork out special considerations for clinical research that does not come under the purview of the traditional ‘clinical research / trials industry’. While overall the contents / requirements are similar to chapter III, this chapter is slightly less stringent and designed to favour the academia. The other highlight of this section, though purely administrative in nature, is that as per the gazette notification’s special clarification, this chapter will only be effective from mid-SEP 2019 onwards
  6. Chapter V – Clinical Trial, Bioavailability and Bioequivalence Study of New Drugs and Investigational New Drugs Part A of this chapter is significant for one addition – clarifying that no permission to conduct Academic Clinical Trials from CLA where:
    • the clinical trial in respect of the permitted drug formulation is intended solely for academic research purposes for a new indication or new route of administration or new dose or new dosage form; and
    • the clinical trial referred to in clause (i) has been initiated after prior approval by the Ethics Committee for clinical trial; and
    • the observations generated from such clinical trial are not required to be submitted to the Central Licencing Authority; and
    • the observations of such clinical trial are not used for promotional purposes.
  7. Chapter VI – Compensation talks about the timelines, requirements and modalities to report Serious Adverse Events and the roles of the stakeholders in deciding & disbursing the amount of compensation for injury or death – the role of the CLA and the EC in accordance to the type of clinical trials (‘sponsored’ and ‘academic’). The notable change here is that for academic trials, the compensation amount is to be decided by the EC while the CLA decides this based on the EC’s recommendation for all other types (read as ‘sponsored’) clinical trials
  8. Similar to the ICH-GCP (R2) requirement of “Monitoring Plan”, a similar requirement is now mentioned in the New CT Rules, 2019 – under Contents of the Proposed Protocol for conducting Clinical Trialsas follows: “Study monitoring and supervision: A description of study monitoring policies and procedures should be provided along with the proposed frequency of site monitoring visits, and who is expected to perform monitoring
  9. The New CT Rules, 2019 also has officially added a more structured and much-sought after channel of communication between the sponsor and the CLA. Specifically, the terms Pre-submission meeting and Post-submission meeting, which clarify in detail about these meetings, role of CLA & sponsor (as applicant), what information can be sought or will be provided, expected outcome and timelines of decisions arising from these meetings.
  10. There is an addition to the Responsibilities of the Sponsor in the New CT Rules, 2019 that states: “The sponsor shall provide post-trial access of the investigational drug by giving the drug free of cost to the trial subject as per directions of the Central Licencing Authority in special circumstances on the recommendations of the investigator and the ethics committee and written consent of the patient in accordance with rule 27”

There are many more changes in the New CT Rules, 2019 when compared to the previously existing regulations for conduct of clinical trials in India. However, in the author’s perspective, the above points stand out in terms of being path-breaking and contemporary with global regulations & guidelines. Readers are encouraged to exercise their wisdom and refer to the entire gazette notification on “New Drugs and Clinical Trials, 2019” published by the Ministry of Health and Family Welfare, Government of India, while applying to their line of work.


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