Government brings stem cell, gene therapies under Central licensing ambit

Under the Drugs and Cosmetics Act, certain drugs and biological products are under joint regulatory supervision of the Central and State regulators. These include vaccines, large volume parenterals and r-DNA based medicines.

Govt brings stem cell, gene therapies under Central licensing ambitXenografts are animal tissue-derived products, such as heart valves, which are being used in cardiology.(Credit: Unsplash)

The Central government on Thursday amended the Drugs Rules, 1945, bringing stem cell derived products, gene therapeutic products and xenografts under the ambit of the Centrally Licensed Approving Authority (CLAA) framework to enhance regulatory oversight of new and emerging therapies.

Under the Drugs and Cosmetics Act, certain drugs and biological products are under joint regulatory supervision of the Central and State regulators. These include vaccines, large volume parenterals and r-DNA based medicines.

With this amendment, this set is being expanded to cover additional emerging technologies, the health ministry said in a statement.

Cell and genetic therapies are complex and rapidly evolving fields with several cutting-edge cancer treatments, including the Chimeric Antigen Receptor T-cell therapy (CAR-T). With high costs of the patented therapies, many Indian companies are making their own immunotherapy to treat blood cancer.

Genetic therapies are used to treat genetic disorders and various types of cancers. Xenografts are animal tissue-derived products, such as heart valves, which are being used in cardiology.

“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 in a statement. This will help in quicker adoption of newer technologies, it said.

Anonna Dutt is a Principal Correspondent who writes primarily on health at the Indian Express. She reports on myriad topics ranging from the growing burden of non-communicable diseases such as diabetes and hypertension to the problems with pervasive infectious conditions. She reported on the government’s management of the Covid-19 pandemic and closely followed the vaccination programme. Her stories have resulted in the city government investing in high-end tests for the poor and acknowledging errors in their official reports. Dutt also takes a keen interest in the country’s space programme and has written on key missions like Chandrayaan 2 and 3, Aditya L1, and Gaganyaan. She was among the first batch of eleven media fellows with RBM Partnership to End Malaria. She was also selected to participate in the short-term programme on early childhood reporting at Columbia University’s Dart Centre. Dutt has a Bachelor’s Degree from the Symbiosis Institute of Media and Communication, Pune and a PG Diploma from the Asian College of Journalism, Chennai. She started her reporting career with the Hindustan Times. When not at work, she tries to appease the Duolingo owl with her French skills and sometimes takes to the dance floor. ... Read More

 

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