The Indian Pharmacopoeia Commission held a two-day National Conference on "Quality and Safety of Biosimilars: Strengthening India's Biopharma SHAKTI Vision" on 10 and 11 September 2026 at the Centre for Cellular and Molecular Platforms (C-CAMP), Bengaluru, attended by 160 participants from regulatory authorities, industry, academia and research organisations.
Its concrete output was the release of an Indian Pharmacopoeia Reference Substance (IPRS) for Enoxaparin Sodium for bioassays — an authenticated reference material against which laboratories can measure the biological activity of a batch. The conference was organised with the Indian Drug Manufacturers' Association, with BIRAC and C-CAMP as Knowledge Partners and the Karnataka Drugs and Pharmaceuticals Manufacturers' Association as Associate Partner.
Why copying a biologic is nothing like copying a tablet
Start with the distinction that the whole subject rests on.
A small-molecule drug — aspirin, paracetamol, metformin — is a defined chemical structure of a few dozen atoms, made by chemical synthesis. Any competent factory following the same route makes exactly the same molecule. That is why a generic can be declared identical to the original, and why approval needs only proof that it behaves the same way in the body.
A biologic is a different kind of object. Insulin, monoclonal antibodies, vaccines, clotting factors and heparins are large molecules — often thousands of atoms, sometimes tens of thousands — produced inside living cells: bacteria, yeast, or cultured mammalian cells engineered to manufacture them. The cell is the factory, and no two cell lines, culture media or purification runs behave identically. Proteins fold into three-dimensional shapes and carry attached sugar chains, and both the folding and the glycosylation pattern affect how the molecule works and how long it lasts in the blood.
The consequence is blunt: a biologic cannot be copied atom for atom. The best that can be achieved is a product highly similar to the reference, with no clinically meaningful differences in quality, safety or efficacy. Hence the regulatory term used in India — a "similar biologic" — and the international term biosimilar. Students working through recombinant DNA and genetics and microbiology will recognise the underlying technology: an engineered gene inserted into a host cell, which then expresses the protein.
| Generic | Biosimilar | |
|---|---|---|
| Source molecule | Small, chemically synthesised | Large, made in living cells |
| Relation to original | Identical | Highly similar, not identical |
| Main evidence required | Bioequivalence study | Extensive analytical comparability, plus clinical data |
| Batch variation | Negligible | Inherent, must be controlled within limits |
| Immune response risk | Low | Must be studied — immunogenicity |
The vocabulary the conference worked in
The technical sessions covered pharmacopoeial standards, critical quality attributes, analytical characterisation, comparability assessment, immunogenicity and pharmacovigilance. Each term has a precise meaning worth carrying.
Critical quality attributes are the measurable properties — purity, potency, glycosylation profile, aggregation — that must stay within defined limits for the product to work safely. Comparability assessment is the structured exercise of proving that the proposed biosimilar matches the reference across those attributes. Immunogenicity is the risk unique to large foreign molecules: the patient's immune system may recognise the protein as foreign and raise antibodies against it, which can neutralise the drug or, rarely, cause harm. Pharmacovigilance is the continuing surveillance of a medicine after it reaches the market, because rare effects appear only at population scale.
What a reference substance is, and why Enoxaparin
Enoxaparin Sodium is a low-molecular-weight heparin — an anticoagulant produced by breaking down unfractionated heparin into shorter fragments. It works by potentiating antithrombin, the body's natural brake on clotting, with its action falling mainly on clotting factor Xa. Clinically it is used to prevent and treat thromboembolic disorders — deep vein thrombosis, pulmonary embolism, and clot risk after surgery or during prolonged immobility. Anyone revising the circulatory system and blood can place it precisely: it does not dissolve an existing clot, it prevents propagation and new clot formation.
Enoxaparin is also a textbook case of why biologics are difficult. It is not one molecule but a mixture of chains of varying length, and the mixture's composition depends on how the parent heparin was cut. Two manufacturers can produce material of the same nominal strength with different biological activity.
Which is why activity must be measured by a bioassay — a test that measures what a substance does in a biological system, rather than what it is chemically. A bioassay only yields a comparable number if every laboratory measures against the same yardstick, and that yardstick is a reference substance: a carefully characterised, authenticated batch with an assigned value. The IPRS for Enoxaparin Sodium for bioassays gives Indian laboratories a domestic standard for exactly this purpose, so that potency results are accurate, consistent and comparable across manufacturers and testing sites. Until now such standards have often had to be imported, which is the specific sense in which this release advances Atmanirbhar Bharat — self-reliance in quality infrastructure rather than in product manufacture.
Who regulates what
India's drug regulation is distributed across several bodies, and papers regularly test which one does which job.
| Body | Role |
|---|---|
| Indian Pharmacopoeia Commission (IPC) | Autonomous institution under the Ministry of Health and Family Welfare, at Ghaziabad, set up in 2009. Publishes the Indian Pharmacopoeia (ninth edition IP 2022; tenth edition IP 2026), the official book of drug standards, and issues IPRS reference substances. Hosts the National Coordination Centre of the Pharmacovigilance Programme of India |
| CDSCO | Central Drugs Standard Control Organisation — the national drug regulator, headed by the Drugs Controller General of India, which approves new drugs and biologics |
| National Institute of Biologicals | At Noida; testing and lot release of vaccines and biological products |
| BIRAC | Biotechnology Industry Research Assistance Council, under the Department of Biotechnology; funds and supports biotech innovation |
| C-CAMP | Centre for Cellular and Molecular Platforms, Bengaluru; a research and innovation hub |
The Indian Pharmacopoeia carries statutory force under the Drugs and Cosmetics Act, 1940: a drug sold in India that claims to meet IP standards must actually meet them. Its ninth edition, IP 2022, took effect from 1 December 2022, and the tenth edition carries the year 2026.
The rulebook for biosimilars is the Guidelines on Similar Biologics, issued jointly by CDSCO and the Department of Biotechnology in 2012 and revised in 2016. A further revision was put out for consultation in 2025, moving India towards the international trend of relying more on analytical and pharmacokinetic evidence and less on large confirmatory clinical trials and animal testing where the laboratory comparison is strong enough to carry the case.
Speaking at the conference, Dr V. Kalaiselvan, Secretary-cum-Scientific Director of the IPC, pressed the case for stronger pharmacopoeial standards, reliable analytical evaluation, safety monitoring and regulatory cooperation, and for aligning Indian practice with evolving international expectations. Technical sessions drew experts from the IPC, State Licensing Authorities, the WHO, the United States Pharmacopeia, the National Institute of Biologicals, IDMA, BIRAC and C-CAMP.
Why this is a strategic subject, not a niche one
India is among the world's largest suppliers of generic medicines by volume and a major supplier of vaccines — the reason the phrase "pharmacy of the world" is used without embarrassment. But that position was built on small molecules, where the barrier to entry is chemistry. The frontier of modern medicine has moved to biologics: the monoclonal antibodies used in cancer and autoimmune disease, the modern insulins, the clotting factors. These are the drugs that cost lakhs per course.
Biosimilars are what bring those prices down. When a biosimilar trastuzumab or insulin glargine enters a market, the cost of therapy typically falls sharply, and a treatment that was rationed becomes available. That only works if the copies are genuinely trustworthy — and trust is built from exactly the unglamorous infrastructure this conference was about: reference substances, validated bioassays, published standards and post-marketing surveillance. A single quality failure in an exported biosimilar would damage the standing of the whole sector.
There is also a plain strategic dimension. Domestic capacity to characterise, test and certify biologics means India does not depend on foreign laboratories to verify its own medicines — the same self-reliance argument that applies to munitions, semiconductors and satellite launch, applied to the health system.
🔑 Revision block
The event. IPC two-day National Conference on "Quality and Safety of Biosimilars: Strengthening India's Biopharma SHAKTI Vision", 10-11 September 2026, at C-CAMP, Bengaluru; 160 participants.
The output. Indian Pharmacopoeia Reference Substance (IPRS) for Enoxaparin Sodium for bioassays.
Organisers. IPC with IDMA; Knowledge Partners BIRAC and C-CAMP; Associate Partner KDPMA. Addressed by Dr V. Kalaiselvan, Secretary-cum-Scientific Director, IPC.
The core concept. Biologics are made in living cells and cannot be copied exactly — hence similar biologic / biosimilar, never "generic". Generics are chemically identical; biosimilars are highly similar.
Key terms. Critical quality attributes; comparability assessment; immunogenicity; pharmacovigilance; bioassay — a test of biological activity, not chemical identity.
Enoxaparin Sodium. A low-molecular-weight heparin, anticoagulant, acts through antithrombin mainly on factor Xa, used against thromboembolic disorders such as deep vein thrombosis and pulmonary embolism.
IPC. Autonomous body under the Ministry of Health and Family Welfare, at Ghaziabad, set up in 2009; publishes the Indian Pharmacopoeia — ninth edition IP 2022, effective 1 December 2022, tenth edition IP 2026 — and hosts the National Coordination Centre of the Pharmacovigilance Programme of India.
Other bodies. CDSCO under the DCGI — national drug regulator. National Institute of Biologicals, Noida — testing and lot release of biologicals. BIRAC — under the Department of Biotechnology.
The rulebook. Guidelines on Similar Biologics, CDSCO with the Department of Biotechnology, 2012, revised 2016, further revision consulted on in 2025.
🎯 Practice MCQs
Q1. A biosimilar differs from a generic drug principally because: (a) It is always more expensive (b) It cannot be made chemically identical to the reference product (c) It requires no regulatory approval (d) It is administered only orally → (b) — biologics are produced in living cells.
Q2. Enoxaparin Sodium is: (a) An antibiotic (b) A low-molecular-weight heparin used as an anticoagulant (c) An antiviral (d) A monoclonal antibody used in cancer therapy → (b).
Q3. The Indian Pharmacopoeia Commission is headquartered at: (a) New Delhi (b) Ghaziabad (c) Noida (d) Hyderabad → (b), under the Ministry of Health and Family Welfare.
Q4. The September 2026 biosimilars conference was held at C-CAMP in: (a) Hyderabad (b) Pune (c) Bengaluru (d) Chennai → (c).
Q5. A "bioassay" measures: (a) The chemical formula of a substance (b) The biological activity of a substance in a living system (c) The shelf life of a formulation (d) The melting point of a compound → (b).
Q6. Testing and lot release of vaccines and biologicals in India is the role of the: (a) IPC (b) BIRAC (c) National Institute of Biologicals, Noida (d) ICMR → (c).
Q7. India's national drug regulator, CDSCO, is headed by the: (a) Director General of Health Services (b) Drugs Controller General of India (c) Secretary, Department of Pharmaceuticals (d) Chairman, IPC → (b).
Q8. "Immunogenicity", in the context of biologics, refers to: (a) The drug's ability to kill bacteria (b) The patient's immune system raising a response against the drug molecule (c) The vaccine's shelf stability (d) The rate of absorption from the gut → (b).
Q9. Enoxaparin exerts its anticoagulant effect mainly by acting through antithrombin on: (a) Platelets directly (b) Clotting factor Xa (c) Fibrinogen (d) Vitamin K → (b).
Q10. The Guidelines on Similar Biologics in India were first issued in: (a) 2008 (b) 2012 (c) 2016 (d) 2019 → (b) — and revised in 2016.
Q11. BIRAC functions under which department? (a) Department of Pharmaceuticals (b) Department of Biotechnology (c) Department of Science and Technology (d) Department of Health Research → (b).
Q12. Consider the following: 1. The Indian Pharmacopoeia is the official book of drug standards recognised under the Drugs and Cosmetics Act, 1940. 2. A reference substance is needed so that potency measured in different laboratories is comparable. (a) 1 only (b) 2 only (c) Both (d) Neither → (c).
📋 How this gets asked (PYQ pattern)
Science-and-technology items in NDA papers approach this territory from four sides. The concept item asks what distinguishes a biosimilar from a generic, or what a bioassay measures — pure conceptual clarity, no memorisation needed. The institution item matches an organisation to its function and headquarters, rotating IPC at Ghaziabad, CDSCO under the DCGI, the National Institute of Biologicals at Noida, ICMR and BIRAC; the common error is assigning drug approval to the IPC, which sets standards rather than granting licences. The drug-class item asks what a named substance does — heparin and warfarin as anticoagulants, streptokinase as a clot-buster, insulin as a hormone. The physiology item comes through the blood chapter, on clotting factors, antithrombin and the role of vitamin K.
The fresh 2026 hook is the IPRS for Enoxaparin Sodium and the Biopharma SHAKTI framing, most likely as a statement pair asking what a biosimilar is and which body issues pharmacopoeial reference substances. We describe the recurring pattern here, not any exact past question.
Preparing for NDA? Biology and technology questions reward candidates who understand the mechanism rather than memorise the name, and this topic is a clean example. Build the base with our NDA biology hub, follow the daily NDA current affairs, and prepare with our faculty in the upcoming Cavalier courses in Delhi.
✍️ Written by Maj Sunil Chopra — Co-founder and faculty at The Cavalier, mentoring NDA and SSB aspirants. Reviewed by the Cavalier Faculty Desk. The Cavalier, founded by ex-Army officers, has trained NDA/CDS/SSB aspirants since 2001 (Facebook · YouTube).
Source: PIB / Ministry of Health and Family Welfare, 11 September 2026. Biologic and biosimilar science, the pharmacology of enoxaparin and the roles of IPC, CDSCO, NIB and BIRAC cross-verified with regulatory and independent scientific sources.