Drug, cosmetic & medical device licensing.
Map the relevant central or state approval route to the product and activity.
The right support.
With the details in view.
Health-related products do not share one licence route. Classify the product and determine whether the business imports, manufactures, distributes or sells it, then identify central and state responsibilities. Technical evidence, qualified personnel, premises and quality-system records vary with the product category and activity.
First, establish what applies
These are activity-specific checks, not a standard package for every business. Product classification, premises, capacity and state rules determine what applies.
What the scoped work can cover
- Product and activity classification review
- Route-specific technical and premises checklist
- Application and post-approval obligations plan
The documents.
A clearer starting point.
Use this as a preparation list for the initial review. The final checklist is confirmed against the applicant, service route, location and current authority requirements.
- 01
Entity, applicant authorisation, premises and existing licence records
- 02
Product composition, intended use, labels and applicable risk or product classification
- 03
Manufacturer and site information, technical dossier and quality-system records where required
- 04
Responsible technical personnel qualifications and appointment records where applicable
- 05
Testing, overseas approvals and manufacturer authorisation relevant to the selected route
Share sensitive records only through an agreed secure channel after the engagement is confirmed. Do not send passwords, OTPs or signing keys.
One step.
Then the next.
A clear sequence, with room to resolve the details that are specific to your business.
- 01
Classify the product and activity
Distinguish drug, cosmetic and device routes, including applicable risk and intended-use factors.
- 02
Map the competent authority
Review central or state licensing responsibility and the current application requirements.
- 03
Review the technical file
Organise the dossier, premises, personnel and quality evidence with relevant specialists.
- 04
Coordinate application follow-up
Prepare the agreed submission and responses, then review licence conditions and ongoing records.
Scope, fees and timing are agreed after review. Document readiness, professional review and any authority queries affect the schedule. Statutory charges, testing, execution and other third-party costs are identified where relevant.
Keep the next
responsibility in view.
Maintain quality and traceability records and review changes, licence conditions, reporting and retention or renewal obligations for the actual product route.
Explore obligations beyond your core businessGood questions.
Useful answers.
01Can the same licence cover cosmetics and medical devices?+
Do not assume so. Product classification and activity determine the relevant approval route and scope.
02Are foreign approvals sufficient for Indian sales?+
Foreign approvals may support a dossier but do not automatically replace Indian registration or licensing requirements.
03Does registration approve every advertising claim?+
No. Labels, intended uses, promotional claims and product changes need their own compliance review.