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A foreign customer does not automatically make an Indian pharma or clinical-research supply an export of services under GST. Export treatment is available only when all five conditions in section 2(6) of the Integrated Goods and Services Tax Act, 2017 (IGST Act) are satisfied, including a place of supply outside India. For research performed in India on samples or reference materials supplied by an overseas sponsor, the place-of-supply rule can be decisive.
Companies should document the actual service, contracting chain, sample movements, payment route and relationship between the parties before issuing a zero-rated invoice. The position also needs to be checked against any amendment that may have been enacted and commenced after the government’s 9 October 2026 proposal concerning section 13(3)(a).
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The five cumulative conditions for export of services
Section 2(6) of the IGST Act defines an export of services as a supply meeting five requirements at the same time. A foreign contract, an overseas customer or receipt in foreign currency proves only one part of the fact pattern; none of those facts alone establishes export status.
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|---|---|---|
| Supplier in India | The legal entity making the supply is located in India for GST purposes. | GST registration, incorporation records and the actual supplier named in the contract and invoice. |
| Recipient outside India | The contractual recipient receiving the service is located outside India. | Executed agreement, purchase order, foreign registration details and customer master data. |
| Place of supply outside India | The applicable section 13 rule places the service outside India. | Service description, work location, sample-flow records and a written place-of-supply analysis. |
| Permitted payment | Consideration is received in convertible foreign exchange or in Indian rupees where the Reserve Bank of India permits that route. | Bank advice, foreign-inward-remittance evidence or records supporting an RBI-permitted rupee receipt. |
| No distinct-person relationship | The supplier and recipient are not merely establishments of the same person treated as distinct persons under the IGST Act. | Group structure, branch and fixed-establishment analysis, and intercompany documentation. |
Failure of any single condition means the supply does not qualify as an export of services. The GST consequences then differ from those for a zero-rated export, so the analysis should be completed for each service line rather than for the customer relationship as a whole.
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Why place of supply is difficult for pharma R&D and clinical research
The default rule in section 13(2)
For a cross-border service where both supplier and recipient are outside the same country, section 13(2) generally places the supply at the location of the recipient. If an Indian company supplies a service to a foreign recipient and no special rule applies, this default can support a place of supply outside India.
The goods-and-samples rule in section 13(3)(a)
Section 13(3)(a) has provided a special rule for services supplied in respect of goods that the recipient must make physically available to the supplier. In that situation, the place of supply is generally where the service is actually performed. A foreign sponsor sending reference materials, compounds, biological samples or other goods to an Indian laboratory can therefore create a materially different result from a service delivered entirely from the Indian provider’s own resources.
The legal question is not simply whether a parcel crossed a border. Identify the goods, who supplied them, whether the recipient was required to make them available, and how they were used in the contracted service. Keep chain-of-custody records, import or transfer documents, sample logs and protocols that connect the materials to the relevant work order.
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| Fact pattern | Rule to examine | Issue that can change the result |
|---|---|---|
| Indian laboratory performs testing on a foreign sponsor’s physical samples delivered to India. | Section 13(3)(a) may apply while it remains in force. | Whether the samples are goods made physically available by the recipient and where the testing is actually performed. |
| Indian CRO performs study design, data analysis or regulatory support using its own systems and information supplied electronically. | Start with section 13(2), then test any more specific rule. | The precise service supplied and whether another statutory exception applies. |
| Indian company arranges investigators or another laboratory but does not undertake the underlying service itself. | Examine the intermediary rule in addition to the general rule. | Whether the company supplies its own principal service or facilitates another person’s supply. |
Services discussed in the GST Council policy record
The GST Council’s 37th-meeting agenda discussed pharmaceutical R&D carried out in India using reference materials made available by foreign recipients. The examples included integrated discovery and development; processing and testing; in-vivo and assay evaluation; drug metabolism and pharmacokinetics research; safety assessment and toxicology; analytical testing; bioequivalence and bioavailability studies; and clinical trials. The agenda shows why physical availability under section 13(3)(a) became a policy issue. It is historical policy material, not a substitute for applying the law in force on the date of the supply.
Separate the service supplied from the project’s label
Calling a contract a “clinical trial,” “contract research,” “testing,” or “R&D” does not determine GST treatment. Break the statement of work into supplies and identify the entity responsible for each one.
- Laboratory and analytical work: Identify each assay, stability test, bioequivalence test or analytical report, the materials used and the facility where the work occurs.
- In-vivo, toxicology and safety studies: Record who provides test articles, animals, protocols and facilities, and whether the Indian entity supplies the study itself or only coordinates another provider.
- Clinical-trial operations: Separate sponsor management, investigator or site services, patient-facing activities, monitoring, data management and statistical analysis where different entities perform them.
- Discovery and development support: Distinguish original scientific work from project management, procurement, regulatory support or access to another supplier’s service.
One master agreement can contain several supplies with different place-of-supply outcomes. The invoice, work order and tax analysis should be granular enough to show which conclusion applies to which deliverable.
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Apply the intermediary test to the contracting chain
What section 2(13) asks
Section 2(13) defines an intermediary around arranging or facilitating a supply between two or more persons. It excludes a person who supplies the relevant goods or services on its own account. The commercial title of the company is not determinative.
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One free scan finds every outdated or missing driver and matches the right update for your exact hardware.Free scan · exact hardware matchCBIC Circular 107/26/2019-GST states that intermediary status depends on the facts and circumstances and on identifying the principal or main supply. A CRO that undertakes the contracted research with its own personnel, facilities and responsibility is factually different from an entity that merely introduces a sponsor to investigators and earns a fee for arranging their work.
Map every participant
- Name the foreign sponsor or affiliate that signs the contract and is obliged to pay.
- Identify the Indian entity issuing the invoice and accepting responsibility for the deliverables.
- List investigators, hospitals, laboratories, sites and sub-contractors, including the agreements under which they work.
- For each deliverable, state who performs it, who controls the method and quality, who bears re-performance risk and who owns the resulting report or data.
- Check whether the Indian company invoices a bundled service on its own account or separately charges for arranging another party’s supply.
The contracting chain described in an advance-ruling record involving a CRO and investigator or site arrangements illustrates why these details matter. A conclusion for one relationship cannot automatically be transferred to every CRO model.
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A foreign customer, foreign currency and a foreign contract are not enough
Check the actual recipient and distinct-person status
Confirm that the customer named in the contract is the recipient of the service, not an Indian branch, project office or another establishment of the same legal person. The fifth condition in section 2(6) excludes supplies between establishments of a distinct person. Group companies also require careful analysis: common ownership alone is not the complete test, but a branch or establishment relationship can be decisive.
Check the payment condition separately
Receipt in convertible foreign exchange is one route, while receipt in Indian rupees can qualify where permitted by the RBI. Retain the banking evidence and the documentation supporting the permitted rupee route. Payment evidence cannot cure a place-of-supply failure.
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What the October 2026 policy proposal means today
A PIB FAQ posted on 9 October 2026 says the government intends to omit section 13(3)(a). The stated policy effect would be to bring services such as testing, repair, R&D and clinical trials under the section 13(2) recipient-location default rule.
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The available record does not establish that an amendment has passed, received assent, been published in the Gazette or commenced. Treat the FAQ as a proposed or intended change unless those legal steps are verified. Before applying the older section 13(3)(a) analysis to a current or future supply, check the enacted text, the Gazette notification and the commencement date. The operative date, not the announcement date, determines which rule governs a supply.
A practical eligibility review, step by step
- Describe the precise service. Attach the statement of work, protocol and deliverable list. Avoid relying on a broad label such as “CRO services.”
- Identify the supplier. Match the legal entity performing the work to its GST registration, contract and invoice.
- Confirm the recipient and location. Verify the contracting party, its establishment and the entity that uses and pays for the service.
- Map the work and materials. Record where people, facilities, data, samples and other goods are located, and whether the recipient must make any goods physically available in India.
- Choose the place-of-supply rule. Start with section 13(2), test section 13(3)(a) or another specific rule where relevant, and separately analyze any intermediary characterization.
- Test the remaining export conditions. Review payment currency or permitted rupee receipt and the distinct-person restriction.
- Check the law’s operative date. Verify any 2026 amendment through enacted text, Gazette publication and commencement before finalizing the position.
- Document the conclusion. Keep a contemporaneous memo linking each statutory condition to contracts, sample records, banking evidence and organizational documents.
Invoices, LUT or bond and refund records
Once the supply qualifies and the chosen export route is available, use the export-related invoice endorsement prescribed by the current invoice rules: the wording differs depending on whether the supply is made on payment of IGST or without payment under a bond or letter of undertaking (LUT). Do not use a generic “export” description that omits the required route.
For supplies exported without payment under bond or LUT, CBIC refund rules set out export-turnover calculations for services. Maintain invoices, agreements, bank realization evidence, LUT or bond records, return workings and the documents supporting the value and timing of the service. Eligibility, filing mechanics and the available refund route depend on the rules applicable during the relevant tax period.
What advance rulings and industry submissions can—and cannot—show
GST Council records identify advance-ruling proceedings involving Asiatic Clinical Research Private Limited in Karnataka and Cliantha Research Limited in Maharashtra. These matters show that clinical research supplied to foreign clients has been examined in concrete fact patterns. An advance ruling is fact-specific and should not be treated as a universal answer for every CRO, laboratory or sponsor arrangement.
The 2019 GST Council agenda reproduced an Association of Biotechnology Led Enterprises (ABLE) submission estimating an industry impact of ₹170 crore per year. That figure is an industry-submitted estimate in a policy proposal, not an independently validated government statistic. It may explain the policy concern, but it does not determine whether an individual supply is an export.
Quick Recap
Common failure points and corrective action
- “The customer is overseas, so the supply is zero-rated.” Rebuild the analysis from all five section 2(6) conditions.
- Ignoring physical samples. Add sample ownership, availability, location and use to the place-of-supply memo.
- Calling a coordinator a CRO service provider. Compare the contract, invoice and actual conduct against the intermediary definition.
- Using a group-company address as proof of a foreign recipient. Check whether the recipient is a distinct establishment of the same person.
- Assuming foreign-currency receipt cures every defect. Treat payment as one condition, not conclusive evidence of export status.
- Relying on the October 2026 FAQ as enacted law. Verify the amendment, Gazette publication and commencement date.
- Generalizing an advance ruling. Compare the ruling’s contracts, parties, samples and deliverables with the company’s own facts.
- Using the wrong invoice or refund route. Reconcile the endorsement, LUT or bond, returns and refund computation with the rules for the relevant period.
Decision checklist for the finance and tax file
- What exact service is being supplied, and which legal entity supplies it?
- Who contracts with the Indian provider, who receives the deliverable and where is that recipient located?
- Are samples or other goods physically made available in India by the recipient?
- Where is the service actually performed under the applicable section 13 rule?
- Is the provider supplying its own service or arranging another person’s supply?
- Are supplier and recipient merely establishments of a distinct person?
- Was consideration received in convertible foreign exchange or an RBI-permitted Indian-rupee route?
- Which law, invoice wording, LUT or bond requirement and refund rule was in force on the supply date?
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