# Bulk drug and formulation import registration, Form 40 to Form 41

Source: https://saideeppharma.com/services/import-registration-form-41/
Provider: Saideep Pharma Solution, Ghaziabad, Uttar Pradesh, India
Last reviewed: 2026-08-23

Importing a drug into India takes two separate approvals, not one. The overseas manufacturing site and its products are first registered with CDSCO by applying in Form 40, which yields a registration certificate in Form 41. Only once Form 41 is in hand can the importer apply for the import licence in Form 8, granted in Form 10.

## Forms and terms referenced

- **Form 40**: Application to register an overseas site and its drugs
- **Form 41**: Registration certificate granted by CDSCO
- **Form 8 / 8A**: Application for an import licence
- **Form 10 / 10A**: The import licence itself

## Why this is two steps and not one

Companies routinely treat registration and licensing as a single filing, budget one timeline for both, and then discover halfway through that the second application cannot even be lodged until the first is granted. That mistake costs a full cycle.

The registration certificate in Form 41 attaches to the overseas manufacturing premises and the specific drugs listed on it. The import licence in Form 10 attaches to the Indian agent who will bring the goods in. Different applicant, different form, different fee head.

We assist in preparing both packages in parallel so the licence application is signed and ready to lodge the day the registration certificate is issued.

## What goes into the Form 40 package

The substance of the application is the Plant Master File and the Product Master File. The Plant Master File describes the manufacturing site, its layout, utilities, quality systems and personnel. The Product Master File covers each drug being registered: composition, specifications, manufacturing process, container closure system, stability data and analytical methods.

Alongside those sit the power of attorney from the manufacturer to the Indian agent, a free sale certificate or equivalent from the country of origin, a current GMP certificate, and the prescribed fee.

Registration certificates run for three years from issue unless suspended or cancelled, so renewal planning starts well before expiry rather than at it.

## Where these applications usually stall

Free sale certificates that are not legalised or apostilled in the form CDSCO accepts. Plant master files written for a European inspector and never adapted. Stability data that does not cover the climatic zone India sits in. Powers of attorney executed in favour of the wrong entity.

None of these are hard problems. They are just expensive to discover after submission rather than before it.

## What you need to supply

- Power of attorney from the overseas manufacturer to the Indian agent
- Plant Master File covering the manufacturing site
- Product Master File for each drug being registered
- Free sale certificate or certificate of pharmaceutical product from the country of origin
- Current GMP certificate for the site
- Copy of the Indian agent's manufacturing or sale licence
- Stability data appropriate to the Indian climatic zone

## Questions we get asked

**What is the difference between Form 41 registration and an import licence?**

They are two separate steps. Form 40 is the application to register the overseas manufacturing site and its products, and Form 41 is the registration certificate that comes back. Only once you hold the Form 41 can you apply for the import licence itself, in Form 8 or Form 8A, which is granted in Form 10 or 10A.

**How long is a Form 41 registration certificate valid?**

A registration certificate is ordinarily valid for three years from the date of issue unless it is suspended or cancelled earlier. Because renewal turns on the site's continued GMP status, we recommend starting the renewal file at least six months before expiry.

**Can I add a new product to an existing Form 41?**

Yes. Adding a drug to a site already registered is an endorsement rather than a fresh registration, which is a materially lighter filing. It still needs a complete Product Master File for the new drug and the prescribed fee.

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