Varun Sharma, founder and CEO of NEUVIOR, reflects on the necessitates of the recently forged India-UK pharma trade deal.
The India UK Comprehensive Economic and Trade Agreement became operational on 15 July. That is good news for businesses in both countries. It is also the moment to stop treating tariff reduction as a synonym for market access, especially in pharmaceuticals, medical technology and digital health.
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Medicines and devices do not move from factory to patient through one gate. They move through at least five. A product must qualify for the tariff preference under the rules of origin. It must have the right approval in the destination market. Its manufacturing and quality evidence must withstand inspection. It must meet the terms of any public procurement. Its people, systems and data must be able to operate lawfully across borders.
The agreement changes some of these gates. It does not collapse them.
Consider tariffs first
The Indian schedule places 198 of 226 pharmaceutical tariff lines in immediate staging, four already at zero, with the rest phased over five or ten years. Medical technology receives a more mixed pattern of phased elimination and partial reduction. These preferences matter, but only for products that satisfy the product specific origin rule.
For pharmaceuticals, origin may be established through a tariff classification change, qualifying value content, or a genuine chemical reaction. Simple packaging, relabelling, testing, inspection or certification is not enough. A company using active ingredients, components or contract manufacturing from several countries therefore needs an origin file that matches its real supply chain, not a flag on the final carton.
The regulatory position is important
The agreement contains useful commitments on transparency, standards, conformity assessment and cooperation. Yet the annex does not list medicines legislation or the UK Medical Devices Regulations 2002 for conformity assessment participation. The UK international recognition route for medicines does not list India as a reference regulator. The published MHRA and CDSCO memorandum supported information exchange, but current renewal is unverified and did not create mutual recognition or waive approval or inspection requirements.
The same discipline is needed when discussing procurement. The agreement opens selected central government procurement in India and covers many UK health bodies for qualifying goods above the relevant thresholds. It does not guarantee an NHS contract, extend to every Indian state buyer, or replace product authorisation, tender specifications, value assessment and supplier due diligence.
Professional mobility also has boundaries. Research, computing, testing and consulting roles can benefit from defined business mobility routes. Clinical practice and pharmacy remain subject to domestic licensing. The professional services annex starts a process for possible recognition arrangements. It does not recognise qualifications on day one.
Digital health deserves particular care
The digital trade chapter supports electronic contracts, signatures, identities and paperless processes. It preserves regulator access to source code for enforcement and leaves personal data protection to domestic law. It does not create a new right to transfer patient data between the two countries.
That is why the first practical deliverable should be a public product level five gate implementation evidence ledger. Each row should separate treaty entitlement, published implementation instruction, and evidence a company holds. For every priority SKU it should record origin, destination approval, inspection and quality evidence, covered procurement, and requirements for people and data. Status should be verified, unverified or not applicable, without any signal that implies regulatory approval.
During the first ninety days, trade bodies and regulators should collect anonymised outcomes. How many preference claims were accepted? Where did authentication fail? Which inspections were relied upon or repeated? How long did approvals take? Which covered tenders attracted qualified suppliers? Where did data or professional licensing rules block an otherwise viable project?
This proposal does not ask either regulator to lower a standard. It asks both governments to make the distance between a treaty promise and a compliant product route visible. That matters most to smaller companies. Large groups can assign teams to customs, regulatory affairs, quality, procurement and immigration. An early stage founder must work out how those systems join together before spending scarce capital.
The agreement has created a valuable platform. Its innovation, regulatory practice, technical barriers, procurement and professional services bodies now have a chance to make implementation measurable. Their success should not be judged by the number of meetings held, but by how many compliant products can clear all five gates without confusion, duplicated effort or weakened safeguards.
Tariffs can open a door. For regulated health products, delivery begins only when the whole corridor works reliably.
