New Drug Approval in India (CDSCO)
Before a new drug can be imported or made for sale in India, the Central Licencing Authority at CDSCO must grant permission under the New Drugs and Clinical Trials Rules, 2019. Importers file Form CT-18 and manufacturers file Form CT-21, and the rules give CDSCO 90 working days to decide. We handle the application file, the SUGAM portal filing and the follow-up with CDSCO.
What it is
New drug approval is the permission CDSCO gives before a drug that is new to India can be sold here. “New” is a wide word. It covers a molecule never approved in India. It also covers an approved drug with a new claim, indication, dosage form or strength, a first-time fixed-dose combination, and a modified-release version of an existing drug.
Here is the catch: a Baddi or Faridabad formulation unit planning a sustained-release tablet of a common molecule often assumes it only needs a state licence. It does not. The sustained-release form is a new drug, and CDSCO permission comes first.
The law sits in the Drugs and Cosmetics Act, 1940 and Chapter X of the New Drugs and Clinical Trials Rules, 2019 (NDCT Rules). The deciding body is the Central Licencing Authority, which is the Drugs Controller General of India at CDSCO, New Delhi. Applications go through the SUGAM portal, and CDSCO may refer the data to a Subject Expert Committee before deciding.
Who it applies to
Importers of a new drug
A holder of a valid wholesale licence under the Drugs and Cosmetics Rules, 1945 can apply in Form CT-18 to import a new drug for sale or distribution. It can be an API or a finished formulation.
Indian manufacturers
A company that already holds a drug manufacturing licence can apply in Form CT-21 to make a new drug for sale, including a generic of a drug still “new” in India.
Changes to an approved drug
A new indication, route, strength, dosage form or combination of approved drugs counts as a new drug. It needs fresh permission even if the molecule is already sold here.
Why it matters
No permission, no licence
The state will not add a new drug to your drug manufacturing licence, and CDSCO will not issue an import licence for it, until the permission is in hand.
A complete file saves months
Gaps in stability data, bioequivalence data or labelling lead to queries, and each query waits on your reply. A complete dossier keeps the file moving.
The four-year window
Most new drugs stay “new” for four years after first approval. Some categories stay new forever, so every later applicant needs CDSCO permission too.
Documents required
Licences and identity
- Wholesale licence (for import) or drug manufacturing licence (for manufacture)
- Company documents and authorised signatory
- SUGAM portal login and Bharatkosh fee challan
Product data (Second Schedule)
- Chemical, pharmaceutical and manufacturing information
- Stability data and specifications
- Animal pharmacology and toxicology data, where required
- Clinical trial data, or bioequivalence data for a drug already approved in India
Labelling and approvals abroad
- Proposed prescribing information, label and carton text
- Regulatory status in other countries, with approval copies
- Periodic safety update reports, where the drug is already marketed abroad
- Undertaking for a Phase IV trial, if a local trial waiver is sought
How it works
Confirm it is a new drug and pick the route
We check the product against the definition, settle the form (CT-18 or CT-21) and see whether a Rule 101 waiver fits. If you only need samples for testing first, a CDSCO test licence comes before this.
Build the dossier to the CDSCO checklist
Your technical team or the foreign manufacturer supplies the scientific data. We arrange it to the checklist, chase the gaps and prepare the forms and undertakings.
File on SUGAM and pay the fee
We file on the SUGAM portal and pay the Sixth Schedule fee through Bharatkosh. For a first-in-India molecule, a paid pre-submission meeting can settle the data needs first.
Reply to queries and face the committee
CDSCO may raise queries or refer the file to a Subject Expert Committee. We draft replies with your team and prepare the presentation if the committee calls you.
Receive the permission and get licensed
Import permission comes in Form CT-19 (API) or CT-20 (formulation). Manufacturing permission comes in Form CT-22 (API) or CT-23 (formulation). Then we move straight to the import licence for the drug or the state endorsement.
Timelines
Decision on CT-18 or CT-21
The Central Licencing Authority is to grant or refuse permission within 90 working days of receiving the application.
Clinical trial, if one is needed
A trial application is decided within 90 working days, or 30 working days for a drug discovered and being developed in India for manufacture and marketing here.
New drug status
Four years from first approval for most new drugs; permanent for vaccines, r-DNA products, monoclonal antibodies, stem cell and gene therapy products, xenografts and modified-release forms.
Local clinical trial waiver under Rule 101
Rule 101 lets the Central Licencing Authority, with Central Government approval, name countries whose approvals can support a waiver of the local trial. By an order of August 2024, those countries are the USA, UK, Japan, Australia, Canada and the European Union.
| Category | Waiver possible if approved in a listed country? |
|---|---|
| Orphan drugs for rare diseases | Yes |
| Gene and cellular therapy products | Yes |
| New drugs for pandemic situations | Yes |
| New drugs for special defence use | Yes |
| Drugs with a significant therapeutic advance over current care | Yes |
In practice, the waiver is not automatic. Each request is examined by the Drugs Controller General or a Subject Expert Committee, and the applicant gives a written undertaking to run a Phase IV trial in India. A Delhi importer of a rare-disease drug approved in Japan can seek the waiver, but still files full data and commits to the Phase IV study.
What happens if you sell without approval
Goods held at the port
Without the permission, no import licence can be issued for the product, so the port drug officers will not clear it.
Sale treated as unlawful
Making or selling a new drug without permission breaches the Drugs and Cosmetics Act, 1940 and can lead to seizure, licence suspension and prosecution.
A second round costs time
A refused file means more data and a fresh application. Getting the dossier right the first time is cheaper.
Frequently asked questions
What counts as a new drug in India?
A new drug is one not used in India to any significant extent and not yet approved by the Central Licencing Authority, under Rule 2(1)(w) of the NDCT Rules, 2019. It also includes an approved drug with a new claim, indication, dosage form or strength, a new fixed-dose combination and a modified-release version. If you are unsure, we check the product against the definition before any money is spent on a filing.
Which form do I file for importing a new drug?
An importer files Form CT-18 with the Central Licencing Authority at CDSCO. Permission is granted in Form CT-19 for an active pharmaceutical ingredient or Form CT-20 for a formulation. The applicant must already hold a valid wholesale licence under the Drugs and Cosmetics Rules, 1945. Once permission comes through, the import registration and licence follow, and we line those up in sequence so nothing waits.
Which form do I file to manufacture a new drug?
A manufacturer files Form CT-21, and permission is granted in Form CT-22 for an API or Form CT-23 for a formulation. The applicant must already hold a drug manufacturing licence. No fee is payable on CT-21 where the same applicant completed Phase I to Phase III trials in India and already paid the trial fees. After permission, the State Licensing Authority endorses the product on your licence.
How long does CDSCO take to decide?
The rules give the Central Licencing Authority 90 working days from receipt of the application to decide on CT-18 or CT-21. Queries and a Subject Expert Committee review can stretch the real time, since each query waits for your reply. A dossier that already answers the obvious questions keeps you close to that 90-day window.
Do I need to run a clinical trial in India?
Not always. Under Rule 101, a local trial can be waived if the drug is approved in the USA, UK, Japan, Australia, Canada or the EU. It must also be an orphan drug, a gene or cellular therapy, a pandemic or special defence drug, or a significant therapeutic advance. Data requirements can also be relaxed for life-threatening or rare diseases. We assess your case against these routes before you plan a trial.
How long does a drug stay a “new drug”?
Most new drugs stay new for four years from their first approval by the Central Licencing Authority. Vaccines, r-DNA products, living modified organisms, monoclonal antibodies, stem cell products, gene therapy products, xenografts and modified-release or novel delivery forms stay new drugs permanently. After four years, an ordinary molecule can be licensed by the State Licensing Authority without fresh CDSCO permission, which makes later launches simpler.
What does Taxhint actually do on a new drug approval?
We handle the regulatory paperwork: checking the pathway, building the file to the CDSCO checklist, SUGAM filing, fee payment, query replies and follow-up, and then the import or manufacturing licence. The scientific data, clinical trials and testing come from your technical team, the foreign manufacturer, contract research organisations and accredited labs. You deal with one point of contact throughout.
What happens after the permission is granted?
Permission is the start, not the finish. An importer needs the import registration and licence for the product, and a manufacturer needs the product endorsed on the state manufacturing licence. A Phase IV trial may be a condition, and periodic safety update reports are due under the Fifth Schedule. We keep a calendar of these so none slips.
What it costs
Our fee plus the government fee that applies to your case, quoted before you commit. Tell us the situation and we will price it exactly.
Government fees are set by the Sixth Schedule to the NDCT Rules, 2019 and paid through Bharatkosh. For reference, a pre-submission meeting is ₹5,00,000 and a post-submission meeting ₹50,000. Clinical trial applications are ₹3,00,000 for Phase I and ₹2,00,000 each for Phases II, III and IV.
Ready to begin?
Send us the product details and its approval status abroad; we will tell you the route, the form and the data CDSCO expects.