Who Can Act as an Authorised Indian Agent: Eligibility under MD-42

1. Key takeaways

An entity acting as the Authorised Agent of a foreign manufacturer in India must first hold one of three licences in its own name: a manufacturing licence, a wholesale licence, or a Form MD-42 registration certificate (for sale or distribution). In addition, it must be appointed by the foreign manufacturer through a Power of Attorney (PoA). Neither condition can substitute for the other: if either one is missing, the application for Form MD-14 cannot be filed at all.

• Licence in hand first: the agent must already hold a manufacturing licence, a wholesale licence or a Form MD-42 registration certificate before it can support an import application.
• Appointment in writing second: the PoA issued and jointly signed by the foreign manufacturer is a separate and equally mandatory requirement.
• Both together or nothing: an entity with a licence but no PoA, or a PoA but no licence, is not eligible to file Form MD-14.
• Changing the agent means re-applying: once the agent relationship is established, replacing the agent requires a fresh import licence application, so the choice of agent carries a high exit cost.

2. Legal basis

The eligibility rules for the authorised agent are set out in the Medical Devices Rules, 2017 and clarified in the official CDSCO FAQ. The table below consolidates the points that determine who may stand before the Central Licensing Authority as an import applicant.

3. Expert insights

Insight 1: this is a gate of “hold a licence before you can help obtain a licence”. To serve as your Indian agent, the candidate must first possess its own licence. This rule transforms the search for an agent from a purely commercial negotiation into an eligibility screening exercise. A candidate without a licence, however attractive its commercial terms, must first spend time obtaining one, and that lead time belongs to the project schedule. Manufacturers who discover this requirement late tend to compress the agent-selection stage and end up choosing on price rather than on regulatory fitness, which is exactly the wrong order of priorities for a market where the agent sits at the centre of every filing.

Insight 2: groups with pharmaceutical businesses hold a natural advantage. A Form 20B/21B/21C wholesale licence issued under the Drugs and Cosmetics Rules, 1945 can be used directly for devices (CDSCO FAQ Question 143). This means that established Indian pharmaceutical distributors are already legally eligible candidates as device licence holders and do not need to obtain an MD-42 registration certificate first. For a foreign manufacturer, this materially widens the pool of qualified agents: the most experienced distribution organisations in India, many of which have operated for decades under the drug rules, can be engaged without waiting for a fresh registration.

Insight 3: the PoA is a second threshold and cannot be signed on someone else’s behalf. The Power of Attorney must be issued by the overseas manufacturer, jointly signed by both parties, and authenticated by a First Class Judicial Magistrate, the Indian embassy in the country of origin, or an apostille-equivalent authority. If any one of these three steps is missing, the agent’s eligibility to apply is broken. In practice the authentication step is the one most often underestimated, because it involves consular or judicial channels in the manufacturer’s home country and their timelines are outside the project team’s direct control.

Insight 4: the licence-holding structure has a lock-in effect. Changing the authorised agent requires a fresh import licence application (CDSCO official position). Once the agent relationship is established, the cost of exit is therefore very high: the manufacturer cannot simply transfer the import licence to a new agent, but must go through the application cycle again under the new agent’s name. This asymmetry is the single most important commercial fact about the Indian agent model, and it should shape how the agency agreement is drafted from the very first conversation.

4. Practical recommendations

• Screen candidates by licence type before anything else. GRZAN’s first filter when selecting an Indian agent is the type of licence held, and candidates fall into three tiers: those holding a manufacturing licence (the best tier, able to handle both manufacturing and import matters), those holding a drug wholesale licence (the next tier, legally eligible already), and those holding an MD-42 registration certificate (eligible, but with a usually narrower scope of business).
• Negotiate commercial terms only after the eligibility tier is established. Ranking by licence type first prevents an attractive price from masking an ineligible or fragile structure.
• Require licence scans and licence numbers, and complete verification before signing the PoA. Discovering only after the PoA has been signed that the counterparty’s licence has expired is the hardest situation to recover from.
• Confirm the agent’s registered address matches the address on its licence. A mismatch between the two invites questions at the application stage.
• Put document-handover duties for agent changes into the agreement at the outset. Because replacing an agent triggers a new import application, the agreement must define who delivers which documents when the relationship ends.

5. Verification checklist

• □ The candidate agent holds one of: a manufacturing licence, a wholesale licence, or an MD-42 registration certificate
• □ The licence is within its validity period and the licence number can be looked up
• □ The PoA has been jointly signed by both parties and authenticated
• □ The agent’s address is consistent with the address registered on its licence
• □ The agency agreement stipulates the document-handover obligations when the agent is changed

Regulatory information verified as of 27 October 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