India's Health Ministry adds cell-derived products under new drug definition

The Indian government is looking to amend the New Drugs and Clinical Trial Rules, 2019, act to enable manufacturing of unapproved new drugs while they are still under development.

Through a recent notification, the Ministry of Health and Family Welfare has issued a draft suggesting the addition of cell-derived products under the definition of a new drug, along with stem cell-derived products. This is in tune with the regulator’s efforts to be ahead with the new drug research and development trends in the industry.

Cell-based human medicinal products may contain autologous or allogeneic cells, and may or may not include genetically modified cells.

In the rules, under the definition of new drugs, the government has the provision for a ‘vaccine, recombinant deoxyribonucleic acid (r-DNA) derived product, living modified organism, monoclonal antibody, stem cell derived product, gene therapeutic product or xenografts, intended to be used as drug' to be considered as new drug.

The Ministry has amended this rule, and for the words 'stem cell-derived products,' the words 'cell or stem cell-derived product,' are substituted. The rule is to be called the New Drugs and Clinical Trials (Amendment) Rules, 2022.

The Indian Council of Medical Research and the Department of Biotechnology have framed the National Guidelines for Gene Therapy Product Development and Clinical Trials, referring to the US Food and Drug Administration and European Union guidelines.