The agent holds the licence.
The distributor holds the relationship.
Most manufacturers appoint one Indian company to be both, because setting up a second relationship feels like extra work. It is also the single most common reason a weak channel partner turns into a licence problem a year later.
Should our India Authorized Agent and our distributor be the same company?
Not by default. The Authorized Agent is the entity CDSCO holds responsible for your import licence; the distributor is whoever sells the product to Indian buyers. Combining the two in one company is legal and widely done, but it means a distributor you want to drop is also the company your import licence is filed under, and swapping it means a fresh filing. Keeping one agent above several distributors avoids that without adding a second licensed relationship.
By Tanveer Sinngh, Founder at Montazzo · What does each role actually hold?
Two jobs get conflated into one appointment letter constantly, and they answer to different masters.
| Question | Authorized Agent | Distributor |
|---|---|---|
| Who appoints them | The foreign manufacturer, by a Power of Attorney naming one Indian entity. | The manufacturer or the agent, by a commercial distribution agreement. |
| What they must already hold | A wholesale drug licence (Form 20B or 21B) or a registration certificate in Form MD-42, before they can apply for anything. | Nothing, as a baseline. No licence is required to sign a distribution agreement. |
| What they file | Form MD-14, the import licence application, naming the device and the manufacturer. | Nothing with CDSCO. Purchase orders, invoices, delivery. |
| What gets issued in their name | Form MD-15, the import licence itself. Customs checks it at every clearance. | Nothing. A distributor without its own licence is not on any CDSCO document. |
| What happens if you replace them | The old MD-15 does not move with them and does not transfer to anyone. The new agent files a fresh MD-14 from the beginning. | You sign a new distribution agreement. Nothing changes at CDSCO. |
| Who customs and CDSCO actually contact | Them, by name, for the life of the licence. | Nobody, unless they are also the agent. |
The row that matters most is the fifth one. It is the entire reason this page exists.
Why combining the two roles creates a hostage problem
When one company holds both the import licence and the buyer relationships, discipline becomes expensive. A distributor who is underperforming, carrying a competing line, or simply uninterested in your product costs you a normal commercial headache almost everywhere else in the world. In India, if that same company is also your Authorized Agent, removing them does not end with a terminated contract. It ends with your product having no valid import licence at all, until a new agent is appointed and the MD-14 to MD-15 sequence runs again from zero.
A notice period, a termination clause and a well-drafted agreement help with the commercial side of the exit. None of them shorten the regulatory side, because the licence is not a contractual asset you can assign between parties. It is tied to the agent CDSCO has on file, and CDSCO does not move it for you. The practical effect is that a weak partner you combined both roles into gets leverage over you that a weak partner in a separated structure never would.
The structure that avoids it
The fix is not necessarily to avoid combining the roles in every case, it is to decide on purpose rather than by default, and the most common fix in practice is simpler than switching to a wholly neutral agent: appoint one Authorized Agent, and run multiple distributors underneath them.
- One agent, several regional distributors. The agent's job stays narrow: hold the MD-42 or wholesale licence, hold the POA, file and maintain the MD-15. None of that changes when you add, drop or renegotiate a distributor in Mumbai, Chennai or Delhi NCR, because the distributors are not named on the import licence. This is the structure most practitioners recommend by default, precisely because it separates the regulatory relationship you rarely want to touch from the commercial relationships you expect to actively manage.
- A fully neutral regulatory-only agent. Some manufacturers go further and appoint a compliance-focused firm as agent, with zero commercial role, specifically so the agent has no incentive to favour one distributor over another and no stake in sales volume. This usually costs a flat retainer rather than a margin, and it is worth the extra relationship in categories where you expect to change channel partners often.
- One company, both roles. Still the fastest to set up, and it remains the right call when you have one trusted partner, a small single-city rollout, or no appetite yet for managing two relationships. Go in with the hostage risk named rather than discovered.
What you should not do is combine the roles by accident, which is what happens when a distributor offers to "handle the paperwork too" and nobody asks what that paperwork actually ties them to.
What actually happens if you do need to change your agent
The mechanics, so there are no surprises mid-process. The outgoing agent's Power of Attorney is revoked and a fresh POA is executed for the incoming agent. CDSCO's own FAQ guidance on the Medical Device Rules states that any change requires a fresh Power of Attorney together with an undertaking from the authorized agent, filed as part of the new application rather than as an amendment to the old one. The incoming agent must already hold its own MD-42 or wholesale licence before anything can be filed, exactly as the first agent did. A new MD-14 is submitted and a new MD-15 is issued. The previous import licence is not transferred, amended or handed over between agents; CDSCO treats it as a new application in every respect.
Build the timeline for this into any decision to switch. An import licence that has to be refiled from scratch is not a same-week fix, and a device with an expired or unfiled licence cannot clear customs in the interim. The planning window for this move should start the day you decide the current agent is wrong, not the day the relationship actually ends.
An MD-15 import licence runs for five years from the date it is issued. Renewal puts you back in front of CDSCO regardless of whether you change anything, which makes it a natural, low-friction point to review whether your current agent and distributor structure is still the one you want, rather than revisiting the question mid-term under pressure from a channel problem.
What Montazzo runs, and what it does not
We do not hold MD-42, MD-15, a Form 20B or 21B wholesale licence, or any CDSCO registration. We do not accept a Power of Attorney from a manufacturer, file Form MD-14, or appear on any import licence. We are also not your distributor: we do not take title to goods, hold inventory, or invoice your buyers on our own paper.
What we do is help you work out which structure fits your category and risk tolerance, then run the commercial side regardless of how you set up the regulatory one: screening candidate distributors (see the distributor search and screen), and generating the demand that makes any structure worth having. For the full regulatory versus commercial split in medical devices specifically, read selling medical devices in India. For the wider set of entry routes, start at selling your product in India.
FAQ
Questions about agent and distributor structure in India
Yes. It is legal and it is the most common setup for a first market entry, mainly because it is faster to appoint one company than two. The cost is that the same company then holds both your import licence and your buyer relationships, so replacing them for commercial reasons also forces you to refile for a new import licence. It is a reasonable choice for a small or single-city rollout; it is a risk worth naming on purpose for anything bigger.
Only if the distributor is also your Authorized Agent. If the two roles are separate, the import licence is tied to the agent, not the distributor, so swapping a distributor for commercial reasons has no effect at CDSCO whatsoever. This is the main reason to separate the roles in the first place: it lets you fix a channel problem without touching your regulatory filing.
Yes, and it is the structure most practitioners recommend by default. One agent holds the licence and the Power of Attorney; any number of regional distributors can be appointed, replaced or added under it, in different cities, with different exclusivity terms, without any of those changes reaching CDSCO. This is usually the simplest way to get the benefit of separating the roles without appointing a fully neutral third-party agent.
The outgoing agent's Power of Attorney is revoked, a fresh Power of Attorney and undertaking is executed for the incoming agent, the incoming agent must already hold its own MD-42 or wholesale licence, and a new Form MD-14 is filed from the beginning. CDSCO does not transfer the existing MD-15 between agents. Budget the same lead time as a first-time application, and plan for a gap in your ability to import during the transition.
No. A distributor with no licence or registration of its own can sell perfectly legally, provided someone else, the Authorized Agent, holds the import licence the product was cleared under. The licence requirement under Rule 34 attaches to whoever files the import application, not to every company that touches the product commercially afterward.
No, and we never will. We are a commercial demand generation and sales team. If you need an Authorized Agent, that is a licensed regulatory role and you should appoint a firm or counsel that holds the right registration for it. We will tell you honestly where that boundary sits and work alongside whoever you appoint.
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