CDSCO
Which CDSCO approval do you actually need?
Drugs, cosmetics and borderline products each follow a different route, a different authority and a different timeline. We start by getting the classification right.
- Authority
- Central Drugs Standard Control Organisation and, for manufacturing licences, the relevant State Licensing Authority
- Governing rules
- Drugs and Cosmetics Act, 1940 with the Drugs Rules, 1945, the Cosmetics Rules, 2020 and the New Drugs and Clinical Trials Rules, 2019
- Typical timeline
- Varies by route, from 45 days to 9 months
CDSCO Licensing Overview: what it involves
The Central Drugs Standard Control Organisation is the national regulator for drugs, cosmetics and medical devices, operating under the Drugs and Cosmetics Act, 1940 and the rules made under it. Some approvals come from CDSCO directly, others from the State Licensing Authority with CDSCO involved in inspection, and a few products that people assume are CDSCO regulated are actually licensed by FSSAI instead.
That classification question is where most projects go wrong. A supplement with a therapeutic claim, a cosmetic with an active pharmaceutical ingredient, or a food product marketed for a medical condition can each land in the wrong regulatory bucket, and correcting it after you have built the plant is expensive. We resolve the classification first, then run the correct filing.
Who needs this
- Manufacturers unsure whether their product is a drug, cosmetic or food
- Importers of cosmetics or drug products into India
- Brands adding an active ingredient to an existing cosmetic range
- Nutraceutical companies whose claims may cross into drug territory
- Businesses setting up a new pharmaceutical or cosmetics manufacturing unit
- Overseas manufacturers needing an Indian authorised agent
Documentation
Documents required
Arrange these and the file moves. We tell you exactly which format each one has to be in, and we draft the technical annexures ourselves.
- Complete product composition with the function of each ingredient
- Intended use, dosage form and proposed claims
- Draft label and marketing material
- Manufacturing process description
- Details of the manufacturing site and its existing licences
- Constitution documents of the applicant entity
- Technical staff qualifications and experience records
How we work
The process, stage by stage
Indicative durations for a file where documents arrive on time. We tell you at the outset which stage is most likely to slip in your case.
- 1
Classification opinion
3 to 7 daysWe assess composition, intended use and claims against the definitions in the Drugs and Cosmetics Act and the FSS Act, and give you a written view on which regulator and which route applies.
- 2
Route and timeline planning
2 to 4 daysOnce the route is fixed we map the full sequence: which authority, which forms, what site readiness is required, what it will cost and how long each stage realistically takes.
- 3
Dossier preparation
2 to 6 weeksWe compile the technical dossier for the applicable route, whether that is a manufacturing licence application, an import registration or a product approval.
- 4
Filing and query management
Route dependentApplications are filed on the relevant CDSCO portal and we handle deficiency letters and queries through to resolution.
- 5
Inspection and grant
Route dependentFor routes involving a site inspection, we prepare the facility and documentation, attend the inspection and close observations.
Questions
Frequently asked questions
How do I know if my product is a drug or a cosmetic?
It turns on composition and intended use together. A product that claims to treat, prevent or cure a condition is generally a drug even if its composition looks cosmetic. A product that only cleanses, beautifies or alters appearance is a cosmetic. Products carrying an active pharmaceutical ingredient need a careful, documented assessment before you commit to a route.
Is CDSCO approval needed for nutraceuticals?
No. Health supplements and nutraceuticals are licensed by FSSAI as food. CDSCO only enters the picture if the product is genuinely a drug by composition or by the claims made for it.
Do overseas manufacturers need an Indian entity?
Not necessarily an entity, but you do need a properly authorised Indian agent or importer holding the relevant licence, who takes on regulatory responsibility for the product in India.
What is the SUGAM portal?
It is CDSCO's online submission system for drug and cosmetic applications. Filings, fee payments, query responses and approvals move through it, and applications are tracked against a single reference number.
Related services
Often taken together with this
CDSCO Cosmetics Import Registration
Register imported cosmetic brands with CDSCO under the Cosmetics Rules, 2020, from authorised agent to COS-2 certificate.
Typical timeline · 3 to 6 months from a complete dossier
Read moreDrug Manufacturing Licence (Form 25 & Form 28)
Form 25 and Form 28 manufacturing licences with revised Schedule M readiness, layouts and inspection support.
Typical timeline · 4 to 9 months including facility readiness
Read moreCosmetics Manufacturing Licence (Form COS-5 to COS-8)
Set up and licence a cosmetics manufacturing unit, from the COS-5 application through to the COS-8 licence.
Typical timeline · 2 to 5 months including facility readiness
Read moreTell us what you are manufacturing. We will tell you what you need.
Share your product category, premises and turnover. You will get a written scope covering the exact licences that apply, the documents to arrange, and a realistic timeline.