Who should hold your Indian import licence?

Every imported medical device and IVD sold in India needs an Indian licence holder. A foreign manufacturer cannot hold the import licence itself. It must appoint an Indian Authorised Agent.

That agent holds a wholesale licence, files the import application (Form MD-14) and holds the import licence (Form MD-15).¹ So the real question is not whether someone in India holds your licence. It is who holds it, and on what terms.

Route 1: your own subsidiary

A subsidiary gives you full control. The licence sits inside your own group. You set prices, choose customers and keep the data.

The cost is time and fixed overhead. You need an Indian company, directors, a wholesale licence, a warehouse, finance staff and a sales team. For a manufacturer testing India with a few product lines, that is a large commitment before the first order. A subsidiary makes most sense once Indian revenue is proven.

Route 2: a conventional distributor as agent

This is the most common route. A distributor registers your products, holds the licence and sells.

It is fast and cheap to start. The risks appear later. The licence is in the distributor’s name, and you may never see the filings. Customer relationships, price history and tender records sit with the distributor.

If the relationship ends, registering again through a new agent can take months. During that gap, your customers may move to a competitor.

Route 3: a specialist agent-distributor, with transparency in the contract

The third route keeps the speed of a distributor and adds the controls a subsidiary would give you. The agent holds the licence, because Indian rules require it. The agreement ensures you are never in the dark.

This route works best for manufacturers who want to test India properly before they invest in a local company.

Three terms that keep you informed

Whichever partner you choose, put these terms into the agreement.

1. Ownership of your files. State that the technical documentation, Device Master File and Plant Master File remain your property. The agent may use them only for your registration.
2. Copies of filings. Require copies of every filing, every CDSCO query and response, and the licence itself, within a fixed number of days.
3. Regular market reporting. Agree monthly reporting on sales volumes, pipeline and market developments.

Questions to ask any prospective agent

• Do you hold a current wholesale licence? What is its number?
• Who prepares the dossier, and who answers CDSCO queries?
• How do you handle long hospital payment terms and collections?

A serious partner will answer all three in writing.