New Delhi, July 2 (IANS). The Central Government has amended the Drugs Rules, 1945 to make regulation of modern medical technologies like advanced cell and gene therapy more effective. Under this amendment, cell or stem cell derived products, gene therapy products and xenografts have been included in the purview of the Centrally License Approving Authority (CLAA).
The government says that this step will help in implementing a uniform regulatory regime for these modern medical products across the country and ensure the safety of patients.
According to the government, some important drugs and biological products are already monitored jointly by the licensing agencies of the Central and State Governments under the Drugs and Cosmetics Act. These include vaccines, intravenous (IV) solutions in quantities greater than 100 ml and recombinant DNA-based medicines. Now the scope of this system has been expanded to include new medical technologies.
The government said that the use of cell and stem cell based products is increasing rapidly in modern treatments like regenerative therapy and CAR-T cell therapy. They are used to treat blood cancers such as leukemia and lymphoma. At the same time, gene therapy products are being used in the treatment of genetic diseases and many types of cancer through techniques like gene replacement and gene editing.
Additionally, xenografts are medical products prepared from animal tissues. These include products such as heart valves, which are used for implants in cardiology and orthopedics.
The government says that all these technologies are developing rapidly and are quite complex. In such a situation, strict monitoring is necessary to ensure their safe use and safety of patients. Bringing these products under the ambit of CLAA will lead to better coordination between the Central and State licensing agencies and ensure uniform regulatory standards across the country.
The government believes that this amendment will strengthen India’s regulatory framework at par with global standards. Also, it will promote innovation in the health and life sciences sector and help in safe adoption of modern medical technologies. The government has also issued a detailed Gazette notification in this regard.
–IANS
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