India Import Licences: Same-Site Exclusivity and the Single-Agent Structural Risk

1. Key takeaways

According to a textual analysis of the Medical Devices Rules, 2017 (the Nishith Desai analysis of the Medical Devices Rules, 2017 — a third-level source; written confirmation from the CLA is recommended before signing contracts), where a licensee has been permitted to import some products from a given manufacturing site, the remaining products manufactured at that site must mandatorily be licensed to the same licensed importer. In addition, the official CDSCO position is explicit that changing the authorised Indian agent requires a fresh application for the import licence. Together these two provisions form the core constraint of the Indian licence-holding structure, and their combined effect shapes every commercial negotiation between an overseas manufacturer and its Indian partner. The manufacturer can distribute products across multiple agents, but it cannot distribute sites: once one licence holder is on record for a manufacturing site, every other product from that site gravitates to the same licence holder. And because a change of agent is a fresh application rather than an amendment, any deterioration in the agent relationship converts directly into an interruption of imports, with all the supply-chain consequences that entails. Both rules should therefore be priced into the agency agreement before signature, when negotiating leverage still exists, rather than discovered afterwards when it does not.

2. Legal basis

The table below sets out the official FAQ position on agent changes, the documents a successor applicant must file, the site-based exclusivity analysis, and the two official permissions that operate in the opposite direction: multiple agents for one product, and endorsement of multiple sites on one licence.

3. Expert insights

Insight one: the two rules point in opposite directions, and only together do they describe the real constraint. The permission of multiple agents speaks to the same product; the requirement that other products follow the same licence holder speaks to the remaining products of the same site. The combined effect is this: you may distribute products across several agents, but a new product from a given site can only be added under the licence holder that already holds that site on record. This binds the site to the licence holder in a way that no commercial arrangement alone can undo.

Insight two: the price of changing agents is losing the licence. Replacing the AIA is not an amendment or a record update; it is a fresh application. Imports must stop until the new licence issues. An agency dispute therefore translates directly into a supply interruption, which is why the agreement signed on day one matters more than any negotiation conducted after the relationship sours.

Insight three: the successor applicant must use the predecessor’s licence. The new applicant must file a copy of “the import licence already issued to the previous authorised agent” — a requirement that is very hard-edged in practice. If the predecessor will not cooperate, the project is stuck, and no amount of new documentation from the manufacturer alone will unlock it.

Insight four: multiple sites can be endorsed onto a single licence. This gives the manufacturer an important lever: consolidating several manufacturing sites onto one import licence is easier to administer than scattering them across several certificates, and it also makes later changes simpler, since the endorsement structure rather than a set of parallel licences carries the updates.

4. Practical recommendations

• Before signing with an Indian agent, write three things into the agreement. First, the agent must, unconditionally and within N working days after termination of the agreement, provide the import licence copy and the complete technical documentation needed for the new agent’s fresh application.
• Second, the agent must cooperate with site endorsements and must not add models to the licence without authorisation.
• Third, the manufacturer holds a unilateral termination right for agent breach, together with a defined document handover mechanism that operates independently of the agent’s goodwill.
• Without these three clauses, the customer’s position in India is a locked-in state, and every subsequent negotiation starts from the agent’s advantage rather than the manufacturer’s.
• Where the site exclusivity point matters commercially, obtain written confirmation from the CLA before signing, treating the third-level analysis as a working hypothesis rather than settled law.

5. Verification checklist

• □ The agent’s document handover obligation and its time limit are written into the agreement
• □ The manufacturer’s unilateral termination right has been agreed
• □ It has been confirmed that the agent may not add models without authorisation
• □ Whether to consolidate multiple manufacturing sites onto one MD-15 by endorsement has been assessed
• □ Written confirmation on the same-site exclusivity point has been sought from the CLA (third-level source, to be verified)

Regulatory information verified as of October 27, 2026.

How GRZAN can help. GRZAN provides medical device and IVD registration, quality system, authorised representative and local testing support across South Asia, including India. Our team prepares dossiers to CDSCO expectations, manages SUGAM submissions and deficiency responses, and supports post-market vigilance obligations. Business enquiries: info@grzanglobal.com