CDSCO regulatory consultancy for pharmaceuticals, devices and cosmetics
CDSCO is India's central drug regulator. It approves new drugs, clinical trials, notified medical devices and imported cosmetics for the entire country. Saideep assists in preparing, filing and following through on CDSCO applications for manufacturers and importers across pharmaceuticals, APIs, medical devices, cosmetics and food, from strategy through to licence in hand.
| SUGAM | CDSCO online submission portal |
|---|---|
| NSWS | National Single Window System |
Where we work
Pharmaceutical formulations and active pharmaceutical ingredients, including import registration, new drug applications and fixed dose combinations under the New Drugs and Clinical Trials Rules, 2019. Medical devices across all four risk classes under the Medical Devices Rules, 2017. Cosmetics under the Cosmetics Rules, 2020. Food and nutraceutical products under FSSAI.
Several of our clients sit across two of those rule books at once. A nutraceutical with a borderline claim, or a device that carries a drug component, needs someone who has read both.
How we actually work a file
Every engagement opens with a gap assessment. We read what you already hold against the rules that apply today and send back a written list of what is missing, what has gone stale, and what will draw a query letter.
That document is useful to you whether or not you go further with us. Most of the delay in Indian regulatory filing is not review time. It is the round trip between a deficiency letter and a company scrambling to produce a document it should have had ready at submission.
What you need to supply
- Company incorporation and constitution documents
- Existing licences, registration certificates and their renewal status
- Site master file or plant master file, if one exists
- Product list with composition and intended claims
- Any deficiency letters received on earlier filings
Questions we get asked
Do I need a consultant, or can I file with CDSCO directly?
You can file directly. Companies with a standing regulatory affairs team often do. Consultants earn their fee where the category is unfamiliar, where a previous filing drew queries, or where the applicant is an overseas manufacturer who needs an Indian authorised agent to hold the licence.
Which portal are CDSCO applications submitted through?
Most CDSCO applications are submitted through the SUGAM portal, and an increasing number of approvals are routed through the National Single Window System. Both need a registered account, a valid digital signature and fees paid against the correct head before an application can be lodged.
Can an overseas manufacturer apply in its own name?
An overseas manufacturer can apply through its Indian subsidiary company, which holds the licence and lodges the application on the manufacturer's behalf. Where there is no subsidiary in India, the application is made through an authorised agent in India instead. The registration certificate for the overseas site is granted in the manufacturer's name.
This page is orientation, not advice on your specific product. Statutory periods, fee schedules and compliance deadlines change. Confirm the current position before you plan around it. Last reviewed 23 August 2026.