New Delhi, July 2 -- Advanced biological treatment products, including recombinant-DNA medicines, stem-cell-based products, gene-therapy-related materials and xenografts - organs or tissues from animals such as pigs to humans - will now be regulated by the government, said officials from the Health Ministry on Thursday.
The oversight was introduced through amendments to Drugs Rules, 1945, now called Drugs (Eighth Amendment) Rules, 2026, and was notified earlier this week on June 29.
The official statement from the Ministry noted that these emerging technologies are finding growing use in treatment for blood cancers, various cardiology and orthopaedic ailments, and require strict regulatory scrutiny to ensure patient safety owing to their ...