Stem Cell Derived Drugs To Be Classified As New Drugs After Latest Amends

The Union health ministry amended substituting cell or stem derived product to be defined as "new drug" under WCTR 2019 or New Drugs, and Clinical Trials Rules 2019. It is for efficient clarity and amenability of such drugs derived using stem cell technologies. This move has been taken considering the term "cell-derived product" is missing in the New Drug definition under NDCT rules that only involves stem cell-derived products.

On February 9, 2021, the central government, through a letter, has given directions as per 33P to all main health secretaries of the States and Union Territories for issuing clarification on stem cell-derived products as per NDCT Rules 2019. The given directions also clarify that all cell-based things are concealed in NDCT rules as per various criteria present in the letter.

All these are based on the commendations of the 84th DTAB in a meeting held on August 27, 2019, and 85th DTAB held on July 29, 2020.

It is also relevant to present here that it was proposed that it is necessary to consider cells or stem derived products rather than only products derived from a stem cell that is appropriate terminology for regulation of such products. Otherwise, the cell-derived products are not covered under the vocabulary "stem cell-derived products".

In a meeting held on March 2, 2021, DCC reflected on the matter and decided to switch the vocabulary "stem cell-derived product" under the definition "New Drugs" that was published under NDCT Rules 2019 with Cells or stem cells derived product". Also in April 2021, DTAB discussed the matter and made an amendment for the definition of "New Drugs" that was published under NDCT Rules 2019.

These rules are the latest addition to the New Drugs and Clinical Trials rules 2021, and they will come into action on the date of their final publication in the Official Gazette.

 

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