Walk into any oncology department at a major Indian hospital and you will find medicines from Germany, the United States, Switzerland, Japan, and the United Kingdom sitting alongside domestically manufactured generics. For most patients and their families, this raises a perfectly reasonable question: why is this medicine coming from abroad? Why isn’t it made here?

The answer is more interesting — and more layered — than most people expect. It is not simply a matter of cost, or capability, or regulatory preference. It reflects the reality of how pharmaceutical innovation, manufacturing investment, and global supply chains actually work. As a licensed medicine distributor in Delhi and pharmaceutical distributor in Delhi, A.K. Pharma sources and supplies many of the specialty imported medicines discussed in this article to hospitals and pharmacies across India.

Innovation Happens Before Manufacturing

The most fundamental reason some medicines are imported rather than manufactured in India is that they were invented, developed, and first brought to market by companies based in other countries — and the manufacturing infrastructure for those medicines was built where the companies are.

Take Tevimbra (Tislelizumab), a PD-1 checkpoint inhibitor developed by BeiGene in China and the United States for oesophageal and gastric cancers. By the time it received regulatory approval and reached Indian hospitals, the manufacturing infrastructure — cell culture facilities, purification processes, fill-finish production, cold chain logistics — was already established internationally. Similarly, Elahere (Mirvetuximab Soravtansine) for ovarian cancer was developed by ImmunoGen (now AbbVie) in the United States, with manufacturing infrastructure built to serve global markets from US-based facilities.

Building a parallel manufacturing infrastructure in India for the same molecules requires years of investment, technology transfer, regulatory validation, and commercial justification that may or may not exist depending on the size of the patient population and the commercial return available in the Indian market. This is not a failure of Indian pharmaceutical capability — India is one of the world’s largest producers of generic medicines — but a consequence of where innovation happens and where manufacturing investment follows it.

Biologics Are Fundamentally Different to Manufacture

Most of the specialty medicines that Indian hospitals import are biologics — monoclonal antibodies, antibody-drug conjugates, fusion proteins, and similar large-molecule therapies. Biologics present a manufacturing challenge that is categorically different from manufacturing conventional small-molecule tablets or capsules.

A conventional medicine like Capecite (Capecitabine) is made through chemical synthesis — a process that follows defined chemical reactions and produces identical molecules every time when done correctly. The recipe is transferable. A generic manufacturer who understands the chemistry can replicate the process.

A biologic like Dupixent (Dupilumab) — used for atopic dermatitis and asthma — is not synthesised chemically. It is produced by living cells in large bioreactors under tightly controlled conditions. The resulting molecule is extraordinarily complex: a monoclonal antibody has a molecular weight roughly 1,000 times greater than a small-molecule drug, with structural features including glycosylation patterns that vary depending on the exact cell line, culture conditions, and manufacturing environment.

This is why building a biologic manufacturing facility requires hundreds of millions of dollars in capital investment, highly specialised scientific expertise, and years of regulatory validation before a single vial can be produced commercially. For medicines like Soliris (Eculizumab) — a complement inhibitor for rare blood disorders used by small patient populations — the Indian market alone does not justify that investment.

Patent Protection Restricts Generic Manufacturing

When a pharmaceutical company invents a new medicine, it receives patent protection — typically 20 years from the date of filing — that gives it the exclusive right to manufacture and sell that medicine in countries where the patent is registered. India is a signatory to the TRIPS agreement, which means that a medicine patented by a US or European company also has patent protection in India.

Many of the specialty medicines imported into Indian hospitals are still under patent protection. Mounjaro (Tirzepatide) for diabetes and obesity management, Lormalzi (Donanemab) for Alzheimer’s disease, Brukinsa (Zanubrutinib) for blood cancers, and Evenity (Romosozumab) for osteoporosis are all recent approvals under active patent protection — meaning Indian manufacturers cannot legally produce generic versions until those patents expire.

When patents do expire, Indian manufacturers have demonstrated repeatedly that they can move quickly. Capecite (Capecitabine), Cytodrox (Hydroxyurea), and Bdparib (Rucaparib) are examples of Indian-manufactured generics for medicines that were once exclusively imported. The same pattern will play out for today’s patented specialty medicines as their protection periods end.

Technology Transfer Takes Time

Even when a company decides it wants to manufacture a medicine in India — or license Indian manufacturers to do so — the process of transferring manufacturing technology is not simple or fast.

For a biologic, technology transfer involves sharing the specific cell lines used in production, the exact culture media and process parameters, the purification and quality control methodologies, and the analytical testing methods used to verify the final product. Each must be validated at the receiving facility, and the entire process must satisfy both the original manufacturer’s quality standards and regulatory requirements of every market the medicine will be sold in.

This is why several medicines on A.K. Pharma’s range exist in both originator and Indian-manufactured versions. Denorange (Denosumab) is the Indian-manufactured version of the originator Prolia (Denosumab) — same active ingredient, same mechanism, but domestically produced through a completed technology transfer. Similarly, Bdenza (Enzalutamide) is the Indian generic of Xtandi, and Capecite (Capecitabine) is the Indian generic of Xeloda. But for newer molecules like Koselugo (Selumetinib) for neurofibromatosis or Retevmo (Selpercatinib) for RET-altered cancers, that technology transfer has not happened yet — and import remains the only route.

Some Medicines Serve Very Small Patient Populations

A rare disease medicine used by a few thousand patients across India presents a fundamentally different commercial calculation than a diabetes medicine used by tens of millions. Building domestic manufacturing capacity for a rare disease treatment requires the same capital investment as for a common medicine, but spread across a much smaller patient population — making the per-unit economics extremely challenging.

This is why medicines like Soliris (Eculizumab) for PNH, aHUS, and myasthenia gravis, Beyfortus (Nirsevimab) for RSV prevention in infants, and Lormalzi (Donanemab) for early Alzheimer’s disease remain imported. The patient volumes that would justify domestic manufacturing simply do not exist for most of these conditions, and the global patient volume is concentrated in markets where the medicine was originally developed.

Cold Chain Requirements Add Complexity

Even for medicines where domestic manufacturing might be commercially viable, the cold chain requirements of biologics create an additional barrier. Most imported specialty biologics require continuous refrigeration between 2°C and 8°C from the point of manufacture through to the moment of administration.

Medicines like Dupixent (Dupilumab), Tishtha (Nivolumab), Xolair (Omalizumab), Praluent (Alirocumab), and Luprodex (Leuprolide Acetate) all require maintained cold chain throughout import, storage, and last-mile delivery to the hospital. Domestic manufacturing would still require the same cold chain infrastructure for distribution — so the manufacturing argument and the distribution argument are to some extent separable. A medicine can be domestically manufactured and still require the same cold chain expertise to reach the patient.

This is why sourcing specialty imported and biologic medicines through a licensed medicine distributor in Delhi with verified cold chain infrastructure matters as much as the manufacturing question — the medicine’s integrity depends on that chain being unbroken regardless of where it was made.

What This Means for Indian Patients

The practical consequence of all these factors is that a significant and growing number of the most clinically important medicines for cancer, rare diseases, autoimmune conditions, and neurological disorders are, and will remain, imported into India for the foreseeable future.

This creates two distinct challenges:

Access through verified channels: Imported specialty medicines must reach patients through licensed pharmaceutical distributors who maintain cold chain, documentation, and authenticity verification. A.K. Pharma supplies genuine imported medicines across oncology, immunology, bone health, heart medicines, and anti-infectives to hospitals and pharmacies across India with complete batch documentation and cold chain compliance for every shipment.

Access through patient programs: For medicines not yet commercially available in India, or where market pricing is prohibitive, the Named Patient Program and Patient Assistance Program pathways exist specifically to bridge these gaps. Medicines like Retevmo (Selpercatinib) — not yet commercially available in India — are accessible through the Named Patient Program for patients whose oncologist has identified them as clinically appropriate.

The Direction of Travel

India’s domestic biopharmaceutical manufacturing capacity is growing. The government’s Production Linked Incentive scheme for pharmaceuticals specifically targets biopharmaceuticals and complex medicines, recognising that India’s long-term interest lies in building domestic capability in these categories.

Several Indian companies — including Biocon, Dr. Reddy’s, and BDR Pharmaceuticals — have already made this transition for some molecules. Bdparib (Rucaparib), Bdenza (Enzalutamide), and Denorange (Denosumab) are all Indian-manufactured generics of medicines that were once exclusively imported — representing the pattern that will play out over the next decade for many of today’s imported specialty medicines as their patents expire.

But for the newest wave of medicines — Truqap (Capivasertib), Cibinqo (Abrocitinib), Spexib (Ceritinib), Rahika (Capmatinib), and Pagenax (Brolucizumab) — domestic manufacturing is a long-term aspiration rather than a near-term reality. In the meantime, the imported medicine supply chain, and the pharmaceutical distribution companies that make it work, remains the essential link between global pharmaceutical innovation and Indian patients who need it.

Why A.K. Pharma Is the Right Partner for Imported Medicine Access in Delhi

For hospitals and pharmacies navigating India’s imported medicine supply chain, the choice of distributor is not a minor operational decision — it is a clinical one. A medicine that arrives with broken cold chain or unverifiable provenance carries risk that no procurement saving can justify. A.K. Pharma has operated as a licensed imported medicine distributor in Delhi and pharmaceutical distributor in Delhi for 25 years — maintaining direct manufacturer relationships, certified cold chain infrastructure, and complete batch documentation across every shipment. As one of Delhi’s most trusted pharmaceutical distribution companies, A.K. Pharma supplies genuine imported medicines across cancer, immunology, bone health, and specialty anti-infectives to hospitals across India — and supports Named Patient Program access for medicines not yet commercially available here. Contact us at 011 4172 6999 or visit akpharma.in.

Disclaimer: This article is intended for general informational and educational purposes only and does not constitute medical or clinical advice. All treatment decisions should be made by a qualified healthcare professional. A.K. Pharma is a licensed medicine distributor and does not provide clinical guidance.