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India regulatory affairs

Regulatory work for
manufacturers and sponsors

Schedule M compliance documentation for Indian manufacturers, origin and registration work for exporters, and independent representation for sponsors filing with the Central Drugs Standard Control Organisation. We do not run trials and we do not distribute product, so we have no interest in your file beyond getting it right.

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For Indian manufacturers

Quality compliance and export

Revised Schedule M has applied since 1 January 2026 and inspections are running. Most of the cost of compliance is engineering; the other half is documentation, and that is the half we do. For exporters, we work on rules of origin and destination-market registration.

Schedule M gap assessment
Your site read against the revised schedule, with the gaps listed in the order an inspector will find them, and a remediation plan behind it.
The quality system on paper
Pharmaceutical quality system, quality risk management, product quality review, site master file, validation protocols and the data-integrity framework the schedule now requires.
Inspection readiness
Mock inspection preparation and document-control review, for sites expecting an audit rather than answering one.
Rules of origin
Whether a product qualifies for preference under an agreement, tested against that agreement’s own rule — and the costing file that proves it. Since 15 July 2026 origin under the United Kingdom agreement is self-certified, which means the exporter carries five years of audit exposure.
Gulf registration
The United Arab Emirates and Oman agreements give a 90-day route for products already approved by a reference regulator. The qualifying lists differ between the two, and which of your products qualify is worth establishing before you file.
Keeping registrations current
Variations when a site, specification or supplier changes, and renewals to each market’s own timetable.
How we price. Fixed fee per engagement, quoted in writing before work begins, and it does not move unless the scope does. Fees exclusive of GST.

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

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.