ACCESS · QUALITY · HOPE
India regulatory affairs

Independent of the
vendor running your study

A sponsor without an Indian entity files through one. If that party is your contract research organisation or your importer, you have put a commercial counterparty on your own regulatory file. We take the filing role and nothing else — no trials run, no product distributed, no competing interest in what your study finds.

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For sponsors outside India

Clinical trials in India

We are appointed as the sponsor’s representative and deal with the regulator on its behalf, from the first application through to the queries that follow.

Represent you to CDSCO
Named as your authorised representative, dealing with the Central Drugs Standard Control Organisation directly, under written authorisation and defined scope.
File the trial application
The clinical trial application prepared and filed, the regulatory pathway agreed before the dossier is assembled, and every query answered through to approval.
Clear the ethics committees
Submission packages prepared for each site’s registered ethics committee and the correspondence carried to approval.
Import your investigational product
Licence applications for the import of investigational product, and the local safety reporting that runs alongside the trial.
Read a protocol for India
What India will require of your protocol, established before you select a site or fix a budget.
Choose and audit your CRO
We select and oversee contract research organisations on your behalf. We are not one, so we audit one without a conflict.

Why the filing party should not also be the vendor. Indian regulatory permissions are granted for fixed terms and renewed — an import licence for investigational product runs three years — and changing the party named on a file means re-filing it. That makes the choice durable, which is precisely why it should not be made for convenience. A contract research organisation that is also your regulatory face has an interest in the scope of your study. We do not run trials and we do not distribute product, so we have none.

For Indian manufacturers

Schedule M and market entry abroad

The revised Schedule M compliance date passed on 31 December 2025 and inspections are running. Most of the cost of compliance is engineering. The other half is documentation, and that is the half we do.

Gap assessment
Your site read against the revised schedule, with the gaps listed in the order an inspector will find them.
The documentation set
Site master file, quality manual, validation protocols and the standard operating procedures the schedule requires, prepared to be used rather than filed.
The RPTUAS application
Assistance runs at 20% of eligible investment for units under ₹50 crore turnover, capped at ₹2 crore, and consultancy is an eligible cost. We prepare the application as part of the engagement. The national allocation is limited and it is worth applying early.
Inspection readiness
Mock inspection preparation and document-control review, for sites expecting an audit rather than responding to one.
Market entry abroad
Dossier and filing strategy for the United States, Canada, the European Union, the United Kingdom and the Gulf — worked per destination market rather than as one submission repeated.
Keeping it approved
Variations when a site, specification or supplier changes, and renewals to each market’s own timetable.
How we price. Fixed fee per dossier, per market — not by the hour. A written quote before any work begins, and it does not move unless the scope does. Fees are quoted exclusive of GST.

We do not bill for time spent understanding your product.
Reference

India’s pharmaceutical exports, in published data

A compilation of India’s pharmaceutical export, patent and destination data, drawn from official statistical sources and public filings. Sources, bases and as-of dates are set out on the data and sources page.

Speak to us

We represent sponsors before the Indian regulator and take Indian generics into the United States, Canada, the European Union and the United Kingdom. Tell us about the product or the protocol and we will tell you what it takes.

Write to us directly at enquiries@worldmeds.org.