Many established Indian manufacturers can supply registration dossiers or the core data for one. What they hold varies widely, from a full set of GLP studies to a single batch analysis.
Traders and small formulators usually cannot provide dossiers, because they do not control the process or own the studies. That alone is a reason to deal with the real manufacturer. Our guide to telling a trader from a manufacturer shows how to check.
What a supplier may offer
- Some offer a full dossier in a recognised format, already used for registrations in other countries.
- Some offer chemistry data only: process description, specification, analytical methods and five-batch analysis.
- Some offer data plus support, sending confidential parts directly to your regulator and answering its questions.
- Some give letters of access to studies they own, so you can cite them without receiving a copy.
- Some will help run new studies at a GLP lab, often with costs shared or recovered through orders.
Questions to ask before you rely on it
A dossier is only useful if it fits your regulator and your product. Ask these questions in writing.
- Which studies exist, which lab ran each one, and was each done under GLP?
- In which countries has this dossier supported a registration, and is it still active there?
- Does the five-batch analysis come from the same site and process that will make your order?
- Who owns the studies, and what rights will you receive: a copy, a letter of access or none?
- Will the supplier answer regulator questions, and for how long after approval?
- What exclusivity, if any, applies to your country?
Common gaps
Dossiers are often older than they look. Batch data may come from a process that has since changed, or from a different site. Some studies may have been run in a non-GLP lab and be unacceptable to your regulator. Some suppliers show a summary that lists studies they do not actually own.
Ownership is the most common source of disputes. If a supplier funded a study, it usually owns it. If you fund a new study, agree in writing who owns it and whether the supplier may use it for other buyers. Put this in the supply agreement, not in an email.
You can test a supplier's claims against public registers, as described in checking a supplier's registration history.
Why this ties you to the source
Once your registration names a source, changing supplier can mean new data and a new approval. A supplier knows this. Agree supply continuity, notice periods for process changes and data rights before you file, while you still have a choice of source.
Next step
We check what a manufacturer really holds, compare it with your regulator's needs and audit the site that will make your product. Book a free sourcing review before you commit to a source.