India’s pharmaceutical regulatory framework could see an important change with proposed amendments to the Drugs Rules, 1945. The Centre is considering requirements for pharmaceutical companies to clearly distinguish biological medicines from synthetic drugs during the licensing process as well as on product packaging.
Classification of Biological and Synthetic Medicines
The issue becomes particularly relevant for molecules such as semaglutide, which can be produced through different manufacturing routes, including chemical synthesis and recombinant DNA methods. Under the existing framework, the absence of a statutory definition for biological products can create ambiguity around how such products are classified and licensed.
Proposed Changes and Regulatory Clarity
The proposed changes would require companies to declare the origin of a biological product, including whether it is of synthetic, recombinant DNA, human or animal origin, where applicable. Beyond classification, clearer identification could have implications for traceability, post-market surveillance and adverse-event investigations, while also bringing the framework closer to regulatory practices followed in the US and Europe.
Quality and Product Origin
Hari Kiran Chereddi, Founder, MD & CEO, HRV Pharma, also highlights why the distinction matters from a quality perspective. Chemical and r-DNA products are not automatically interchangeable and can differ in impurity profiles, immunogenicity considerations and quality-control requirements. Clearer regulatory definitions could therefore provide greater visibility into the nature and origin of the medicines reaching the market.
Read the full story in Mint.
