India Made the US Zero-Tariff List for Specialty Drugs: The Insurance Build-Out for ADC, Plasma, Cell and Gene Therapy Exporters

The US pharmaceutical tariff regime under Section 232 has two faces for Indian exporters. The first, covered in this blog in August, is the 100% duty on patented drugs that took effect on 29 September 2026 at 12:01 a.m. ET for importers without a qualifying route to a lower rate. The second arrived a week earlier.

According to a trade alert published by Andersen and A.N. Deringer on 23 September 2026, the Commerce Department's Bureau of Industry and Security issued guidance on 21 September 2026 clarifying how the tariffs under Proclamation 11020 apply. The guidance lists specialty categories that may qualify for a 0% rate, and India is on the list of eligible countries.

The categories named in that alert are:

• orphan-only drugs
• radiopharmaceuticals
• blood-derived (plasma) therapies
• fertility drugs
• cell and gene therapies
• antibody-drug conjugates (ADCs)
• chemical, biological, radiological and nuclear (CBRN) countermeasures
• veterinary products

For an Indian company making or contract-manufacturing anything on that list, the US market may now be cheaper to reach than it is for a competitor shipping the same kind of product from a non-eligible country. That is a commercial opening. It is also a change in the risk profile of the business, and the insurance programme has to follow it.

The first thing to get right is that the 0% treatment does not attach to an exporter. Per an IAAN Express report of 29 September 2026, applications are assessed product by product and reviewed with the US Trade Representative and the Department of Health and Human Services. Patented medicines that fall outside the specialty categories can still face the full 100% duty. Generics are not subject to it.

That has two consequences for risk managers.

Your US book will be mixed

A CDMO with an ADC conjugation line and a small-molecule API block may find one product cleared at 0%, another still pending, and a third at 100%. Revenue projections, US customer contracts and insured values built on an assumption of blanket zero-duty access will be wrong for part of the book.

Pending status is a commercial risk in itself

Until a product is confirmed, the importer of record carries uncertainty about the landed cost. Buyers manage that uncertainty by delaying orders, asking suppliers to share any duty, or switching sources. The trade credit questions raised in our earlier piece on the Section 232 deadline for API makers and CDMOs apply to any product still waiting on a decision.

Most Indian pharmaceutical insurance programmes were designed around generics: high volume, modest unit value, ambient or simple cold-chain storage, and well-understood product liability exposure. Specialty biologics break almost every one of those assumptions.

1. Value per consignment is far higher. A single air shipment of plasma-derived product, ADC drug substance or a cell therapy batch can carry a value many times that of a typical generic consignment. Cargo limits sized on generic shipments will be inadequate.
2. The product is unforgiving about temperature. Many biologics need tight refrigerated ranges, some need frozen or cryogenic storage, and a short excursion can make an entire batch unusable even though nothing is visibly damaged.
3. Patient populations are smaller and sicker. Orphan drugs, cell and gene therapies and radiopharmaceuticals are used in serious conditions. A defect can cause severe harm, and US juries assess damages accordingly.
4. Recall is harder. Biologics depend on a manufacturing process that is itself part of the product. A contamination or process deviation can implicate multiple lots and trigger regulatory scrutiny of the whole line.

The rest of this post works through each cover line in that order: cargo, stock, liability, clinical trials and recall.

A standard marine cargo policy on Institute Cargo Clauses responds to physical loss or damage. A batch that arrives intact but has drifted outside its validated temperature range has not obviously suffered physical damage in the sense the wording expects, and many cargo policies exclude loss caused by temperature variation unless it follows a named event such as breakdown of refrigerating machinery.

Specialty exporters should be asking for:

• Temperature deviation cover written expressly into the open cover, triggered by an excursion outside the validated range recorded on data loggers, without needing a mechanical breakdown or a casualty to the conveyance.
• Per-consignment limits sized to the highest-value single shipment, including the case where several high-value lots travel on the same flight.
• Clarity on valuation. Whether cover is on cost, invoice value or a selling-price basis matters more for a product priced well above its cost of goods.
• Packaging and logger conditions that match how you actually ship. If the policy requires validated packaging and continuous logging, every lane has to meet that, including the last leg in the US.
• Delay and rejection. Rejection by a regulator at entry and loss from delay are often excluded. Understand the gap before relying on the policy for a time-critical cell therapy shipment.

Our detailed guide on pharmaceutical cold chain insurance risks covers the excursion clauses in more depth. The specialty export change does not alter the principle, it raises the stakes on each shipment.

High-value product spends time sitting in Indian plants, bonded warehouses and third-party cold stores before it leaves. A fire policy covers the building and stock against named perils, but the more frequent loss for a biologics maker is spoilage after a refrigeration failure, a power cut or a controller fault.

That exposure sits with deterioration of stock cover, usually written alongside machinery breakdown on the refrigeration plant. Our post on deterioration of stock insurance for cold storage sets out how the trigger, the waiting period and the sum insured interact. For a specialty exporter, three adjustments are worth making:

• Reset the sum insured to peak stock value in the run-up to US shipments, not average stock value, and use a declaration basis if values swing.
• Check that the waiting period before cover attaches is shorter than the time it takes your product to go out of specification.
• Make sure the policy names every location where finished product or drug substance sits, including third-party cold stores and airport facilities.

If you are a CDMO holding a client's material, confirm who insures it. Contracts often leave it vague, and the client's own policy may exclude property in the care of a contractor.

The zero tariff makes it cheaper to ship specialty therapies to American patients. Every product that reaches them extends the exporter's exposure to US product liability law, and specialty products sit at the severe end of that exposure.

Product liability tower

Indian pharma companies typically buy US product liability through a global programme with local admitted policies where required. Our guide to global product liability coverage for Indian pharma explains the structure. For a specialty exporter the questions to reopen are:

• Is the limit sized for a biologic or orphan therapy used in seriously ill patients, or is it a generic-era limit carried forward?
• Does the policy cover the company as a contract manufacturer as well as a marketing authorisation holder? A CDMO's liability often arises through indemnities in its supply agreement, so the contractual liability extension and the vendor arrangements matter.
• Are biologics, gene therapies or specific product classes excluded or sub-limited? Some wordings carry exclusions that were never relevant to a generics book.
• Does the defence cost provision sit inside or outside the limit? US defence costs on a complex product claim can consume a large share of a limit.

Clinical trials

Clinical supply shipped to US sites under the new non-commercial heading still carries liability for harm to trial participants. Sponsors and CDMOs supplying them should confirm that clinical trial liability limits meet US site and sponsor requirements and that the policy covers trials run outside India. Our post on clinical trial insurance for Indian pharma and CROs covers the domestic side.

A recall of a specialty biologic is costly for reasons unrelated to the volume shipped. Lot values are high, replacement may take months because the process cannot simply be rerun, and patients on chronic therapy need continuity of supply. Recall costs and lost gross profit can exceed the direct value of the recalled units.

Product liability policies generally exclude the cost of recalling the insured's own product. That gap is filled by product recall or contamination cover, which can pay for notification, retrieval, destruction and, depending on the wording, replacement and lost profit. Our overview of global product recall coverage for Indian exporters explains the structure.

Points to settle before the first zero-tariff shipment lands:

1. Does the trigger cover a recall ordered or requested by a US regulator, as well as a voluntary recall?
2. Is third-party recall expense covered, so a CDMO can recover what its client spends recalling a finished product that contains its material?
3. Does the policy exclude gene therapy, cell therapy or other advanced therapies?
4. How does the cover handle a process deviation affecting several lots in different markets at once?

The commercial upside of the 21 September guidance depends on product approvals that are still being worked through. The insurance changes can start now.

1. List every US-bound product by tariff status. Cleared at 0%, pending, outside the specialty categories, or generic. Share the list with your broker so cover follows the product mix rather than a single assumption.
2. Re-size cargo limits per shipment. Use the highest single consignment value, not annual turnover divided by shipments, and add temperature deviation cover expressly.
3. Reset stock values in storage. Peak values, every location, deterioration of stock in place.
4. Reopen the product liability programme. Limits, exclusions for biologics and advanced therapies, contractual liability for CDMO indemnities, and how defence costs are treated.
5. Close the recall gap. Either buy recall cover or renegotiate supply-agreement indemnities you cannot insure.
6. Classify clinical supply correctly. Use HTSUS 9903.04.70 where it applies and confirm clinical trial liability for US sites.

Specialty products carry more value and more severity per unit than the generics book most Indian programmes were built on. An insurance programme built for generics will not cover a specialty book properly.