Health ministry amends NDCTR to include additional testing methods to assess safety and efficacy of iPSC

New Delhi, March 15, 2023 :

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), the adult cells that are genetically reprogrammed to have an embryonic stem cell-like potential.

Bringing safety and efficacy standard tests for iPSCs into the regulations is expected to help the research and development in the field of regenerative medicines in the country.

The amendment has been made in the third paragraph of the First Schedule, which is about 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 brought in 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 assay, organ chips and micro physiological systems, sophisticated computer modeling, other human biology-based test methods and animal studies.

It may be noted that the Ministry has earlier introduced a draft amendment notification for the same on November 22, 2022, inviting objections and suggestions to persons likely to be affected.

In the final notification, the Ministry said that the objections and suggestions received from the public on the rules has been considered by the Central government.

According to the Broad Stem Cell Research Centre, University of California, iPSCs are derived from skin or blood cells that have been reprogrammed back into an embryonic-like pluripotent state that enables the development of an unlimited source of any type of human cell needed for therapeutic purposes.

“For example, iPSC 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,” it says.

The third paragraph of the First Schedule details the development methodology, with the 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 conduct of clinical trial should be determined taking the aspects such as the characteristics of the new drug or investigational new drug; disease of conditions for which the new drug or investigational new drug is intended to be indicated; duration and exposure in clinical trial subject; and the route of administration.

It also states that for first in human studies the dose should be calculated carefully based on the non-clinical pharmacological, toxicological data generated.

The Ministry stated that the draft rules is published for information of all persons likely to be affected thereby and a notice is given 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 public.

“Objections and suggestions which may be received from any person within the period specified above will be considered by the Central government,” it said, directing that the objections and suggestions shall be addressed to the Under Secretary (Drugs) under the MoHFW or to be sent in the designated email ID.  Pharmabiz