CDSCO New Drug Approval in India: Process, Requirements, Documents and Timeline

The deep dive on India's new drug pathway: the Rule 2(1)(w) definition, Form CT-18 and CT-21 applications, SEC review, the Rule 101 waiver and timelines.

Last reviewed: September 2026
Regulatory scope: New Drugs and Clinical Trials Rules 2019 (NDCT Rules), Drugs and Cosmetics Act 1940 and Rules 1945, and CDSCO notices issued up to the review date

Whether a product is a new drug under the NDCT Rules is the first decision in any Indian marketing application. It fixes which forms are filed, which evidence the Central Drugs Standard Control Organization (CDSCO) expects, whether a Subject Expert Committee (SEC) reviews the file, whether an Indian clinical trial is needed, and which obligations continue after approval.

This guide covers that decision and the approval process that follows it: the legal definition of a new drug, the Investigational New Drug (IND) and Subsequent New Drug (SND) categories, the Form CT-18 and CT-21 applications, SEC review, the local clinical trial question, documents, timelines and the mistakes that cost applicants the most time. It is the deep dive companion to our drug registration in India guide, which maps the wider landscape: import registration, import licensing, State manufacturing licenses, fixed-dose combinations and biologicals.

1. The new drug definition under the NDCT Rules

"New drug" is a defined legal category, and a product can be decades old abroad and still fall inside it. Rule 2(1)(w) of the NDCT Rules brings five kinds of product into the category:

1. An unapproved substance. A drug, including an active pharmaceutical ingredient (API) or a phytopharmaceutical drug, that has not been used in India to any significant extent and has not been approved by the Central Licensing Authority (CLA) as safe and efficacious for the proposed claims. This covers a molecule entering India for the first time, whether or not it is approved abroad.
2. An approved drug with a new claim. A drug already approved by the CLA that is now proposed for a new indication, a new route of administration, a new dosage form, a new strength or a new patient population. The approval attaches to the claim, so the new claim is regulated even though the molecule is established.
3. A fixed-dose combination (FDC). Two or more individually approved drugs combined for the first time in a fixed ratio, or an approved combination in which the ratio or the ingredients change. Component approvals do not carry over to the combination; the FDC specifics are covered in the registration pillar.
4. A modified-release form or novel delivery system. An extended-release, sustained-release, delayed-release or otherwise modified-release form of an approved drug, or a novel drug delivery system. An immediate-release tablet reformulated as a once-daily extended-release tablet is a new drug even though the API has been sold in India for years.
5. Listed biological categories. Vaccines, recombinant DNA products, living modified organisms, monoclonal antibodies, stem cell derived products, gene therapeutic products and xenografts are new drugs by definition.

The explanation to the rule adds the four-year clause: a new drug remains a new drug for four years from the date of its first approval in India. Within that window, every applicant for the same molecule files under the NDCT Rules as a subsequent applicant. After four years the molecule is an established drug, the CDSCO new drug permission falls away, and licensing runs through the import or State manufacturing routes alone.

A product approved by the US Food and Drug Administration (FDA), the European Medicines Agency (EMA) or any other authority is still a new drug in India if it meets any limb, and a company's own long-marketed product re-enters the framework when a new strength, form, route, population or indication is proposed.

2. New drug, IND and SND compared

CDSCO runs separate divisions for New Drugs, Investigational New Drugs and Subsequent New Drugs, and the category decides the application content.

The three categories file on the same forms with different evidence packages. An IND completing global development files the full non-clinical and clinical package. A New Drug applicant with a reference-country approval files the global package plus the Indian position on local data. An SND applicant leans on the originator's approval and typically adds bioequivalence data for its own formulation with a complete chemistry, manufacturing and controls (CMC) module; the bioavailability and bioequivalence side has its own forms (CT-05 application, CT-07 permission) and, since the January 2026 NDCT amendment, an intimation route for specified study categories.

3. The approval process from classification to permission

The process for a new drug seeking marketing permission runs in this order:

1. Product definition: API, strength, dosage form, release characteristics, route, indication, population, dose and duration.
2. Classification against Rule 2(1)(w), including the four-year check on the molecule's first Indian approval.
3. Regulatory status review: approvals held in India and abroad, first-approval dates, approved indications and any restrictions or conditions attached.
4. Evidence inventory: CMC, non-clinical, clinical, pharmacokinetic and post-marketing data, mapped against what the pathway requires.
5. Gap assessment (section 11 of the pillar covers the method): what the Indian pathway requires that the current package lacks, and how each gap will be closed.
6. Local trial position: Rule 101 waiver category, bridging study or full Indian Phase III (section 7).
7. Dossier preparation in Common Technical Document (CTD) format against the NDCT Second Schedule.
8. Filing of Form CT-18 or CT-21 through the SUGAM portal, with the Sixth Schedule fee.
9. CDSCO screening, then SEC review with an applicant presentation.
10. Query response, sometimes across more than one SEC sitting.
11. Permission in Form CT-19 or CT-20 (import) or CT-22 or CT-23 (manufacture), with conditions.
12. Post-approval obligations: periodic safety update reports (PSURs), any Phase IV commitment, and the import or manufacturing licenses that sit downstream of the permission.

Steps 1 to 6 are completed before dossier writing starts. A pre-submission meeting with CDSCO, available under the NDCT Rules on payment of a fee, is worth taking for products where the classification, the waiver position or the evidence sufficiency is genuinely arguable.

4. The application: Form CT-18 and Form CT-21

Permission to import a new drug for sale is applied for in Form CT-18; permission to manufacture is applied for in Form CT-21. The permission comes back in Form CT-19 (imported API), CT-20 (imported formulation), CT-22 (manufactured API) or CT-23 (manufactured formulation). Both applications are filed on SUGAM, CDSCO's online portal, by the manufacturer, its authorized Indian agent or its Indian subsidiary.

Further licenses sit alongside the permission. An imported new drug also needs the manufacturing site and product registered (Form 40 to Form 41) and an import license (Form 8 to Form 10), and a domestically manufactured new drug needs the State manufacturing license, which under Rule 83 of the NDCT Rules can be granted only after the CT-23 or CT-22 permission exists. Both sequences, with the applicant requirements and validity periods, are set out in the registration pillar.

For clinical development before the marketing application, the parallel forms are CT-04 (application) and CT-06 (permission) for a clinical trial, and CT-10 and CT-11 for manufacturing the new drug for trial, test and analysis. Every trial is registered prospectively on the Clinical Trials Registry India (CTRI), and each site needs the approval of a registered ethics committee.

5. Documents in a new drug application

The NDCT Second Schedule lists the data required with a CT-18 or CT-21 application, and CDSCO accepts the dossier organized in CTD format. The content scales with the product's history.

Administrative. The application form and fee receipt, a power of attorney where an agent files, applicant and manufacturer details, the wholesale or manufacturing license of the Indian applicant, reference-country approvals and free sale certificates, Good Manufacturing Practice (GMP) certificates, undertakings, and the proposed package insert and labels drafted to Indian labeling rules.

Quality (CMC). Drug substance: manufacturer, synthesis or manufacturing process, characterization, impurity profile, specifications, analytical method validation and stability. Drug product: composition, pharmaceutical development, manufacturing process and validation, excipients, finished product specifications, container closure, batch data, and stability generated under Indian Zone IVb conditions (30 °C / 75% relative humidity) for the proposed shelf life.

Non-clinical. Pharmacology, pharmacokinetics, toxicology, safety pharmacology, genotoxicity and reproductive toxicity reports where the pathway requires them. For a molecule with a reference-country approval and post-marketing history, the NDCT Rules let the CLA abbreviate or omit parts of this module; the abbreviation is claimed and justified in the dossier.

Clinical. Clinical study reports with protocols and statistical analysis plans, integrated efficacy and safety summaries, pharmacokinetic and bioequivalence data, published literature, and the post-marketing experience from countries where the product is sold. What a reviewable clinical study report contains, and how it is granulated for submission, is covered separately. For trial-stage applications the Investigator's Brochure and informed consent documents carry the same weight.

Before filing, the package is checked for cross-module consistency: the indication claimed in the overview matches the indication studied, the specification in the quality module matches the one on the stability report, the label matches the evidence, and the classification in the cover letter matches what the data support. Each mismatch found by the reviewer becomes a query.

6. Subject Expert Committee review

New drug applications are reviewed with the help of Subject Expert Committees: therapeutic-area panels of external clinicians, pharmacologists and scientists convened by CDSCO. The applicant is called to present the product and answer questions in person. The SEC records its recommendations in minutes that CDSCO publishes on its website, and the Drugs Controller General of India (DCGI) acts on them.

An SEC recommendation can approve the proposal as filed, approve it with a restricted indication or population, require additional data, require a local clinical trial or a Phase IV commitment, or decline it. The published minutes for the same molecule or therapeutic area are worth reading before filing: they show what the committee asked earlier applicants, and the same questions recur.

Preparation for the SEC sitting needs clinical input, because the recurring question types are the local relevance of the pivotal trial population, the comparator choice against Indian standard of care, dose justification for the Indian population, the ethnic sensitivity of the molecule's pharmacokinetics, and the benefit-risk balance in the proposed indication. Each needs an answer prepared from the study data by people who can defend it in the room.

7. The Indian clinical trial question and the Rule 101 waiver

Whether a new drug needs an Indian clinical trial is decided product by product. The NDCT Rules give the CLA the power to relax, abbreviate, omit or defer clinical and non-clinical data requirements, and Rule 101 names the countries whose approvals can support that decision: the United States, the United Kingdom, Japan, Australia, Canada and the European Union.

CDSCO's August 2024 order under Rule 101 waives the local clinical trial requirement for new drugs already approved in those jurisdictions when the product falls into one of five categories: orphan drugs for rare diseases, gene and cell therapy products, new drugs used in a pandemic situation, new drugs used for special defense purposes, and new drugs with a significant therapeutic advance over the current standard of care. The waiver carries two conditions: no evidence of a relevant difference in the drug's metabolism or response in the Indian population, and a committed Phase IV study in India.

Outside the five categories, the SEC decides case by case: the global data may be accepted as sufficient, a pharmacokinetic or clinical bridging study in Indian subjects may be asked for, or a full Indian Phase III trial may be required. Indian participation in the global pivotal trial strengthens the case for acceptance and is planned into multinational programs at the design stage. The waiver position, with the evidence behind it, belongs in the dossier at filing; a local trial requirement that surfaces for the first time in the SEC minutes restarts the clinical clock.

8. Accelerated approval

The NDCT Rules provide an accelerated route for drugs addressing serious or life-threatening conditions or diseases of special relevance to India. Where Phase II data show a meaningful benefit, the CLA may grant marketing permission on that data, with surrogate endpoints accepted and a binding condition to complete a post-approval Phase IV study confirming clinical benefit. The same logic supports conditional access programs for unmet needs.

The permission carries the Phase IV protocol as a condition, and a sponsor that cannot resource the confirmatory study in India should price that into the pathway choice at the start.

9. Products already approved in India: the SND pathway

An SND application is a full new drug application scoped to what changed. The company holding an immediate-release approval that files for an extended-release form submits the new formulation's pharmaceutical development, its bioequivalence or pharmacokinetic bridge to the reference form, and stability on the new product; the molecule's original safety and efficacy package is cited by reference. A new indication is filed with the clinical evidence for that indication and an updated package insert, and goes to the SEC like any other new claim.

Classification decides which of two routes the change follows. A pack size change or a process change within the approved specification is a post-approval variation under the licensing rules. A new strength, form, route, population or indication is an SND. The route is established before development money is spent, since the two routes need different evidence and different applications.

10. Timelines

CDSCO publishes review targets; the clock runs on a complete accepted application and stops while a query is open.

The project timeline is longer than the review target because the stages run in sequence: pathway and gap assessment, any bridging or local study, dossier writing, the review with one or two query rounds, an SEC sitting that may carry to a second meeting, and the downstream import or manufacturing license. The plan is built stage by stage, with the local trial question resolved first because it is the largest variable.

11. Seven mistakes that delay approval

1. Classifying by intuition. A product filed outside the new drug framework that CDSCO places inside it (a modified-release form, a new strength, an FDC ratio change) is returned for refiling, with the review time spent to date lost.
2. Filing before the waiver position is built. An application silent on the local trial question leaves the SEC to answer it, and the committee's usual answer is to ask for a study.
3. Treating the reference approval as the evidence. The FDA or EMA approval is history and support; the dossier still has to carry the data, mapped to the Indian claim.
4. Inconsistent modules. An indication, specification or label that differs between modules converts into query letters; the consistency check in section 5 is run before filing.
5. Under-preparing for the SEC. The committee asks clinical questions in person; a team without clinical expertise in the room turns a one-sitting review into two.
6. Working from an old rulebook. The NDCT framework has been amended repeatedly, including in January 2026, and the requirements that apply are the current notices on cdsco.gov.in as of the filing date.
7. Stopping the plan at the permission. The CT-20 or CT-23 permission is followed by the registration certificate, import license or State manufacturing license, plus PSUR and Phase IV obligations; the registration pillar maps that remainder.

12. New drug approval checklist

Download the CDSCO new drug pathway checklist (PDF)

13. How EvySaif supports CDSCO new drug projects

EvySaif Research & Medical Affairs Solutions is a clinician-led regulatory and medical writing consultancy in Pune, India, serving pharmaceutical and biotech companies in India, the Middle East and Europe.

On new drug projects we take the pathway work and the evidence work together: classification under Rule 2(1)(w) with the four-year check, the Rule 101 waiver assessment, the gap assessment against the Second Schedule, and regulatory strategy through the pre-submission meeting. Our regulatory writing team prepares the CTD dossier for the CT-18 or CT-21 filing and the responses to CDSCO and SEC queries, and our clinicians prepare the SEC presentation and the clinical answers from the study data. After the permission, we handle the PSUR cycle and the documentation for the downstream licenses, with the CDSCO India service page describing the full submission service.

No consultant controls an approval decision. We commit to a defensible classification, a consistent dossier and SEC answers prepared to the standard the committee applies.

If a new drug filing is on your roadmap, contact EvySaif with the product, its approval history and the evidence you hold, and we will return the classification, the pathway and the gap list before any document is drafted.

14. Frequently asked questions

Last reviewed: September 2026. This article is general regulatory information, not legal or product-specific regulatory advice. Verify requirements against the legislation and CDSCO, State or Union Territory requirements in force on the date of any application.