Centre brings Stem Cell, Gene Therapies and Xenografts under stricter licensing framework
The amendment will increase regulatory rigour for emerging technologies and reinforcing India's regulatory framework in line with scientific advancements and global best practices
In a significant step towards strengthening the regulatory oversight of advanced and emerging medical technologies, the Central Government has amended the Drugs Rules, 1945, to bring Cell or Stem Cell derived products, Gene therapeutic products and Xenografts under the ambit of the Centrally Licence Approving Authority (CLAA) framework.
The amendment will increase regulatory rigour for emerging technologies and reinforcing India's regulatory framework in line with scientific advancements and global best practices. CLAS oversees the import of all medical devices, authorizes clinical trials, and approves the manufacture of high-risk
Under the Drugs and Cosmetics Act, certain specified categories of critical drugs and biological products are under the joint regulatory supervision of the Central and State regulators. These include vaccines, and r-DNA based medicines. This set is being expanded with this amendment to cover additional emerging technologies.
Cell- or Stem Cell-derived products which include stem cell-based regenerative treatments, CAR-T cell therapies have seen increasing use in treatment of blood cancers such as leukemias and lymphomas. Gene therapeutic products such as gene replacement and gene editing products have found use in treating genetic disorders and various types of cancers. Xenografts are animal tissue-derived products such as heart valves which can be transplanted into humans. These have use in cardiology and orthopedics.
Since these technologies represent highly complex, specialized and rapidly evolving areas of medical science, they need enhanced regulatory scrutiny to ensure patient safety.
The Health Ministry said that inclusion of stem cell derived products, gene therapeutic products and Xenografts products under the CLAA framework will facilitate a system of joint oversight by the Central and State Licensing Authorities, thereby ensuring uniformity in regulatory standards across the country.
