Centre plans to mandate origin labelling for biologics, synthetic drugs
India proposes defining biological products and mandating origin labels on drugs to address dual-route manufacturing and licensing overlaps.
The Indian government is planning to amend the Drugs Rules, 1945, to require pharmaceutical companies to clearly state whether a drug is of biological or synthetic origin, both in licence applications and on product packaging. The move is intended to resolve regulatory ambiguity for medicines that can be manufactured through more than one route.
A key example is semaglutide, used for diabetes and obesity, which can be produced either by chemical synthesis or through biological methods such as recombinant DNA (r-DNA) technology. Currently, the rules do not contain a statutory definition of biological products, which has allowed manufacturers to obtain licences under different categories for the same molecule.
The proposed changes would introduce a formal definition of biological products, aligned with World Health Organization standards, covering vaccines, therapeutic proteins, monoclonal antibodies, enzymes, hormones, and cell and gene therapies. Manufacturers would also be required to label the origin of a drug as synthetic, r-DNA, human, or animal origin.
The Central Drugs Standard Control Organisation (CDSCO) has reportedly received multiple applications from firms seeking to produce both synthetic and r-DNA versions of the same drug at one facility. While Schedule M of the rules permits campaign-based manufacturing with cleaning validation, the lack of a clear definition has created overlaps between Form 28 (for synthetic products) and Form 28D (for biological products).
The Drugs Technical Advisory Board (DTAB), the country's top statutory body on drug-related technical matters, has agreed with the proposals. Industry representatives have noted that the move is about administrative clarity and traceability, as chemically synthesised and biologically expressed drugs differ in impurity profiles and immunogenicity risks. Origin labelling is expected to aid post-market surveillance and align India's framework with US and EU standards.
India's biologics market is estimated at $13.3 billion, against an overall pharmaceutical market of about $60 billion. Demand for semaglutide alone in India is projected to reach $347.5 million by 2035.