Govt to amend New Drugs and Clinical Trials Rules to add cell derived products as new drugs

New Delhi: Through a recent notification, in order to amend the New Drugs and Clinical Trials Rules, 2019, the Ministry of Health and Family Welfare has issued a draft suggesting to add cell-derived products under the definition of a new drug.

Cell-based human medicinal products (CBMPs) may contain autologous or allogeneic cells, and may or may not include genetically modified cells, as well as cells that have been linked with a device, a scaffold, or a mesh.

The New Drugs and Clinical Trials Rules, 2019, rule 2, sub-rule (1), clause (w), sub-clause (v), states that a new drug is a vaccine, recombinant Deoxyribonucleic Acid (r-DNA) derived product, living modified organism, monoclonal anti-body, stem cell derived product, gene therapeutic product, or xenograft intended to be used as a drug.

However, in the draft rules, the Ministry has proposed that in the New Drugs and Clinical Trials Rules, 2019, in rule 2, under sub-rule (1), in clause (w), in sub-clause (v), for the words "stem cell derived products", the words "cell or stem cell derived product" shall be substituted.

The government has released a draft of certain rules to amend the New Drugs and Clinical Trials Rules, 2019, which the Central Government proposes to make, in exercise of the powers conferred by sub-section (1) of section 12 and sub-section (1) of section 33 of the Drugs and Cosmetics Act, 1940 (23 of 1940), and in consultation with the Drugs Technical Advisory Board is hereby published for information of all persons likely to be affected thereby and notice is hereby given that the said draft rules shall be taken into consideration on or after the expiry of a period of forty-five days from the date on which the copies of the Gazette of India containing these draft rules are made available to the public.

Further, the gazette notification stated that objections and suggestions which may be received from any person within the period specified above will be considered by the Central Government.

"Objections and suggestions, if any, may be addressed to the Under Secretary (Drugs), Ministry of Health and Family Welfare, Government of India, Room No. 434, C Wing, Nirman Bhavan, New Delhi -110011 or emailed at drugsdiv-mohfw@gov.in." the notification added.

As per the proposed amendment;

"1. (1) These rules may be called the New Drugs and Clinical Trials (......Amendment) Rules, 2021.

    (2) They shall come into force on the date of their final publication in the Official Gazette.

2. In the New Drugs and Clinical Trials Rules, 2019, in rule 2, under sub-rule (1), in clause (w), in sub-clause (v), for the words "stem cell derived products", the words "cell or stem cell derived product" shall be substituted."

To view the Gazette notification, click on the link below: