Weight Loss Drug Semaglutide Boom Pushes India To Consider Defining Biological Medicines

Last Updated:February 06, 2026, 15:39 IST

As peptide-based blockbusters such as semaglutide enter the Indian market, regulators are examining gaps in drug laws governing biological products.

India is moving to formally define ‘biological drugs’ under its medicines law, as the category expands with the launch of some of the world’s top-selling therapies, including anti-obesity and diabetes blockbuster semaglutide, News18 learnt.

The move comes as drug regulators grapple with fast-evolving manufacturing technologies that blur the lines between synthetic medicines and biologically derived products, often produced within the same facility. The Drugs Technical Advisory Board (DTAB) is now set to deliberate on a proposal that seeks to introduce a legal definition of biological products, mandate origin-based labelling, and update legacy schedules under the Drugs Rules, 1945, to reflect modern biologics.

The matter has now been formally placed before the apex drug approval panel, Drugs Technical Advisory Board, with the agenda document concluding that “DTAB may kindly deliberate and give its recommendation in the matter."

If approved, industry experts believe the changes would mark a significant overhaul of India’s biological drug regulation, bringing long-overdue legal clarity at a time when biologics and peptide-based therapies are rapidly reshaping the pharmaceutical landscape. The move is also significant considering India itself is planning to become hub of biological and biosimilar drug making with finance minister Nirmala Sitharaman announcing the “BioShakti Pharma Hub" scheme in the union budget last Sunday.

DTAB to examine gaps as synthetic and biological drugs converge

According to the agenda document accessed by News18, the proposal has been triggered by a growing number of applications received by the Central Drugs Standard Control Organisation, where manufacturers are seeking regulatory approval to produce both synthetic and recombinant products at the same site. The document said that “CDSCO receives multiple applications wherein manufacturers seek permission to manufacture synthetic and r-DNA origin drug products in the same manufacturing facility."

Regulatory agency in the document noted that this convergence has become especially prominent in peptide-based therapies. “Certain peptide-based therapeutic products, such as Semaglutide and similar products are available in both synthetic and r-DNA origin and in injectable as well as oral dosage forms," the agenda paper says, underlining the regulatory complexity such products pose.

While the existing framework allows limited flexibility, the regulator acknowledges that the rules lack clarity on core definitions. “Schedule M of the Drugs Rules, 1945 provides provision for campaign-based manufacturing with appropriate cleaning validation and risk mitigation measures," the document said but adds that “the substantive provisions of the Drugs Rules do not define ‘Biological drugs’."

The absence of a formal definition has also created uncertainty around licensing, particularly when different categories of drugs are produced at the same location. The agenda paper flags that “currently, there are no provisions on licensing overlap between facilities licensed under Form 28 and Form 28D at the same site," raising concerns about regulatory oversight, inspections and compliance.

To address these gaps, the proposal recommends incorporating a definition of “biological products" into both the Drugs Rules and the New Drugs and Clinical Trials (NDCT) Rules, 2019. Citing global standards, it reproduces the World Health Organization’s definition, describing biological products as “a product containing a substance produced by or extracted from biological sources, such as living cells or organisms, and which require complex manufacturing processes and control."

The document further clarifies that “biological products include vaccines, blood and blood components, allergenic, somatic cells gene therapies, tissues, recombinant therapeutic proteins and monoclonal antibodies."

Mandatory labelling coming soon?

In a move aimed at improving transparency, the regulator has also proposed mandatory origin-based labelling. The agenda note states that “mandatory labelling provisions may be introduced to clearly indicate the origin of the drug as ‘Synthetic Origin,’ ‘r-DNA Origin,’ ‘Human Origin,’ or ‘Animal Origin,’ as applicable."

Additionally, the proposal calls for “consequential amendments" to Schedule C and Schedule C1 of the Drugs Rules, 1945, to explicitly include biological-origin products in both parenteral and non-parenteral forms, reflecting the growing diversity of modern biological therapies.

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