Last Updated on October 2, 2024 by The Health Master
New Drugs and Clinical Trials Rules, 2019
Download notification No. GSR 175(E) dt 09-03-2023, the link is given below: The Union health ministry has amended the New Drugs and Clinical Trials Rules (NDCTR), 2019 to include additional testing methods under the non-clinical studies to assess the safety and efficacy of induced pluripotent stem cells (iPSC) vide notification No. GSR 175(E) dt 09-03-2023.
These cells are adult cells genetically reprogrammed to have an embryonic stem cell-like potential.
The inclusion of safety and efficacy standard tests for iPSCs is expected to aid research and development in the field of regenerative medicines in India.
Updates to the NDCTR, 2019
The amendment has been made in the third paragraph of the First Schedule, which outlines the general principles and practices for clinical trials under the NDCTR, 2019.
The clause (b) of the sub-paragraph (1) of the paragraph suggested that the detailed requirements of non-clinical studies have been specified in the Second Schedule of the Rules.
The Ministry has made the amendment to substitute the clause with two sub clauses.
The first sub-clause states that the general requirements of non-clinical studies have been specified in the second schedule.
However, the second sub-clause adds that the non-clinical testing methods to assess the safety and efficacy of a new drug or investigational new drug will include:
- Cell-based assays
- Organ chips and microphysiological systems
- Sophisticated computer modeling
- Other human biology-based test methods and animal studies
The Ministry had released a draft amendment notification on November 22, 2022, inviting objections and suggestions from those likely to be affected.
The final notification, which considers the objections and suggestions received from the public on the rules, has been issued by the Central government.
iPSCs and their therapeutic benefits
According to the Broad Stem Cell Research Centre at the University of California, iPSCs can be derived from skin or blood cells that are reprogrammed back into an embryonic-like pluripotent state.
This state enables the development of an unlimited source of any type of human cell needed for therapeutic purposes.
iPSCs can be prodded into becoming beta islet cells to treat diabetes, blood cells to create new blood free of cancer cells for a leukemia patient, or neurons to treat neurological disorders.
Requirements of non-clinical studies
The third paragraph of the First Schedule details the development methodology, with sub-paragraph (1) elaborating the requirements of non-clinical studies.
It states that the nature of non-clinical studies and their timing in respect of the conduct of clinical trials should be determined by taking into consideration aspects such as:
- Characteristics of the new drug or investigational new drug
- Disease or conditions for which the new drug or investigational new drug is intended to be indicated
- Duration and exposure in clinical trial subjects
- Route of administration
It also states that for first-in-human studies, the dose should be calculated carefully based on the non-clinical pharmacological and toxicological data generated.
Draft rules published for public comments
The Ministry has published the draft rules for information for all persons likely to be affected.
The Ministry has also given notice that the said draft rules shall be taken into consideration on or after the expiry of a period of 15 days from the date on which the copies of the draft rules in the Gazette of India are made available to the public.
The objections and suggestions shall be addressed to the Under Secretary (Drugs) under the MoHFW or sent to the designated email ID.
Forms: All types of Clinical Trials
Schedules: All types of Clinical Trials
Notifications: New Drugs, FDC, Clinical Trial
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