The process for new drug registration and approval in India relies heavily on the New Drug Approval regulations set forth by the Central Drugs Standard Control Organisation (CDSCO), a division of the Ministry of Health and Family Welfare. To demonstrate the quality, safety and efficacy of a new drug, it is critical to understand the role of different divisions within the CDSCO.
The CDSCO grants permission for new drugs and clinical trials, regulates the quality of drugs imported to India, and facilitates the functioning of the State Drug Control Organisations. At the Central level, the Drugs Controller General of India (DGCI) oversees the Central Licensing Authority, while the State Licensing Authorities are responsible for the issuance of licenses for drug manufacturing and sale.
Below is a summary of major legal provisions and their purposes:
Regulatory Legal Framework for New Drug Registration in India
The following key regulatory frameworks govern New drug registration and approval in India:
Regulation | Purpose |
Drugs and Cosmetics Act, 1940 | Provides the principal legal framework for regulating drugs in India. |
Drugs Rules, 1945 | Covers manufacturing, import, labelling, testing, sale and licensing requirements. |
New Drugs and Clinical Trials Rules, 2019 | Regulates new drugs, investigational drugs, clinical trials, BA/BE studies and Ethics Committees. |
The NDCTR was notified on 19 March 2019 through G.S.R. 227(E) and has since been amended through subsequent notifications.
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Explore India Regulatory Services →What Is Considered a New Drug Under CDSCO Regulations?
A drug can be classified as new if it is:
- A new chemical or biological entity
- A drug that has never been approved in India
- A new indication, route, strength, or dosage form
- A modified-release or delayed-release formulation
- A new fixed-dose combination
- A vaccine, recombinant DNA product, or monoclonal antibody
- A gene, cell, or stem-cell therapy product
- A phytopharmaceutical product
As of February 24, 2025, CDSCO has clarified that gastro-resistant and delayed-release capsules and tablets can be considered a new drug in India under Rule 2(1)(w) of the NDCTR. Classification is important as it defines the application type, government tariff, required clinical evidence, and review pathway.
Complete Process of New Drug Registration and Approval Process in India
Ensuring the safety, efficacy, and quality of a new drug requires navigating a detailed regulatory framework. The key steps include:
Step-by-Step New Drug Registration Process in India
- Pre-Submission Planning
- Prepare the application dossier in Common Technical Document (CTD) format for new drug applications (NDAs) or Abbreviated New Drug Applications (ANDAs) for generics.
- Arrange all necessary documents per CDSCO guidelines.
- Conduct preclinical (animal) studies to evaluate pharmacology and toxicity.
- Compile Chemistry Manufacturing and Control (CMC) data.
- Develop the clinical trial plan, especially for drugs being introduced in India for the first time.
- Determine if clinical trial data is required or if a waiver may be applicable.
- Review by CDSCO and Subject Expert Committee (SEC)
- CDSCO screens applications for completeness and compliance.
- Technical evaluation includes quality, safety, and efficacy data.
- Inspections of manufacturing facilities may be conducted to verify Good Manufacturing Practices (GMP) compliance.
- Clinical Trial Application
- Submit documentation via the SUGAM portal.
- Apply using Form CT-04 for clinical trials.
- Register the study with the Indian Clinical Trials Registry (CTRI).
- Conduct trials in accordance with:
- NDCTR 2019
- Good Clinical Practices (GCP)
- ICMR Ethical Guidelines
- Conduct Clinical Trials (Phase I–III)
- Ensure clinical trials follow GMP and GCP standards.
- Obtain approval from the Institutional Ethics Committee for every trial.
- Collect data according to Schedule Y requirements.
- Report adverse events promptly to CDSCO.
- Submission for Market Authorization (NDA)
- Submit Clinical Study Reports (CSRs) and all supporting documents through the SUGAM portal in CTD format.
- Submit Form CT-21 for market authorization (import or manufacture).
- Sample testing may be required by Indian Pharmacopoeia Commission (IPC) labs.
Step-by-Step CDSCO Drug Approval Process
Steps | Main requirement |
1. Classify the product | Determine whether it is a new chemical entity, subsequent new drug, FDC, biologic, biosimilar, imported product or new claim for an approved drug. |
2. Develop a regulatory strategy | Assess whether Indian clinical trials, BA/BE studies, bridging data or a local clinical-trial waiver may be required. |
3. Prepare the quality dossier | Compile drug substance, formulation, manufacturing-process, specification, analytical-method, validation, impurity, stability and packaging data. |
4. Complete non-clinical studies | Conduct applicable pharmacology, pharmacokinetic and toxicology studies before human exposure. |
5. Apply for clinical trial permission | Submit Form CT-04 with the protocol, investigator’s brochure, informed-consent documents, CMC data and supporting safety evidence. |
6. Obtain Ethics Committee approval | Each clinical-trial site must be covered by an Ethics Committee registered with CDSCO. |
7. Register the study with CTRI | The study must be registered with the Clinical Trials Registry–India before enrolling the first participant. |
8. Conduct clinical development | Complete applicable Phase I, II and III studies according to NDCTR and Good Clinical Practice requirements. |
9. Prepare the marketing dossier | Organise the administrative, quality, non-clinical and clinical evidence in Common Technical Document format. |
10. Submit through SUGAM | File the correct application, pay the applicable fee and respond to CDSCO or Subject Expert Committee queries. |
11. Obtain central and state permissions | Secure CDSCO permission followed by the required manufacturing or import licence. |
12. Complete post-approval obligations | Maintain stability, pharmacovigilance solutions, labelling, Phase IV and post-approval change compliance. |
For clinical trials, CDSCO permission, site-level Ethics Committee approval, and registration with CTRI should be completed prior to screening. Ethics Committee approval should be reported to CDSCO within 15 days from the date of the approval.
CDSCO SUGAM Portal: Application Forms and Approval Pathways
Regulatory purpose | Application form | Permission issued |
Clinical trial | CT-04 | CT-06 |
BA/BE study | CT-05 | CT-07 |
Import of a new drug | CT-18 | CT-19 for API or CT-20 for formulation |
Manufacture of a new drug | CT-21 | CT-22 for API or CT-23 for formulation |
Manufacture for trial, testing or analysis | CT-10 | CT-11 or prior-intimation acknowledgement where eligible |
Import for trial or testing | CT-16 | CT-17 |
Form CT-21 is used for manufacture, not import. Applications to import new drugs are submitted in Form CT-18.
The Form 44 and Form 46 pathway for new-drug approvals should not be depicted as the new pathway for drug approvals in india. These were previously used under the old framework of the Drugs Rules and have now been replaced with the CT forms per NDCTR.
CDSCO and Subject Expert Committee (SEC) Review Process
Upon application submission, CDSCO assesses application completeness and considers the following:
- Quality of the product and manufacture controls
- Non-clinical safety information
- Clinical safety and efficacy
- Indication and dosage
- Risk and safety evaluation
- Labeling and prescribing information
- Pharmacovigilance
The application may be submitted for review by a Subject Expert Committee. Upon application submission, CDSCO may request additional studies, documents, samples of the product, or perform an inspection of the manufacturing site.
Pre-submission meetings may be requested for novel and complex molecules, biologics, advanced therapy medicinal products, or applications with unconventional developmental strategies.
Recent CDSCO and NDCTR Updates (2025–2026)
Date | Regulatory update | Practical impact |
27 March 2025 | CDSCO exempted eligible orphan drugs from sampling and testing at port offices. | This can simplify import clearance for qualifying orphan products. |
6 May 2025 | Revised Similar Biologics Guidelines, 2025 were published for comments. | The draft promotes analytical comparability and a risk-based approach to animal and comparative clinical studies. It remains a draft, not a final binding guideline. |
9 July 2025 | Online CT-04 applications for cell and gene therapy products were introduced. | Relevant clinical-trial applications can be submitted through SUGAM. |
29 October 2025 | Online post-approval changes for Form CT-06 cell and gene therapy permissions were introduced. | Applicable clinical-trial changes can now be filed electronically. |
20 January 2026 | G.S.R. 46(E) introduced prior intimation for eligible manufacture of drugs for analytical and non-clinical testing. | The CT-10, CT-12 and CT-13 process was operationalised on 6 March 2026. |
21 January 2026 | G.S.R. 50(E) introduced prior intimation for certain BA/BE studies conducted for export. | The Form CT-05 route became operational on 21 April 2026 and does not apply to ordinary India-market BA/BE studies. |
9–10 March 2026 | Online post-approval and Forms 28-D/28-DA functions were introduced for r-DNA products. | More recombinant-product licensing activities moved online. |
21 April 2026 | CDSCO introduced deferred PSUR filing through SUGAM when product marketing is delayed. | PSUR safety data may begin from the date of actual marketing. |
11 May 2026 | Parallel CDSCO and Ethics Committee review was formally advised. | Sponsors may submit to both at the same time, although the study cannot start without the required approvals. |
3 June 2026 | CDSCO directed licence holders to maintain an effective pharmacovigilance system under Schedule M. | Pharmacovigilance systems may be examined during regulatory inspections. |
22 June 2026 | Draft G.S.R. 504(E) proposed annual PSUR filing until the product is marketed. | This is a draft proposal and should not yet be treated as an effective rule. |
24 June 2026 | SUGAM filing was introduced for post-approval changes to vaccine and anti-sera import licences and registration certificates. | Relevant post-approval import changes can now be filed online. |
2 July 2026 | Navi Mumbai International Airport was notified as an authorised airport for drug imports. | Approved pharmaceutical imports may use this additional authorised entry point. |
ICH Harmonization in India: Impact on New Drug Registration
India has been harmonizing its pharmaceutical regulations with ICH practices.
ICH-aligned area | Importance for Indian drug applications |
Common Technical Document | Quality, non-clinical and clinical evidence should be organised in a structured CTD format to support efficient regulatory review. |
Stability studies | Stability programmes should support the proposed shelf life, packaging and storage conditions of the product. |
Good Clinical Practice | Clinical trials must protect participants and generate reliable, traceable and ethically acceptable clinical evidence. |
Quality risk management | Manufacturers should identify, evaluate and control risks affecting product quality throughout development and commercial production. |
Pharmaceutical development | Applicants should demonstrate an understanding of the formulation, manufacturing process and critical quality attributes. |
Clinical safety reporting | Adverse events, serious adverse events and emerging safety risks must be documented and reported within applicable timelines. |
Pharmacovigilance | Marketing authorisation holders must maintain systems for signal detection, periodic safety reporting and continuing benefit-risk evaluation. |
Biological products | ICH principles support product characterisation, manufacturing consistency, viral safety, immunogenicity assessment and comparability studies. |
India's Alignment with ICH Guidelines for New Drug Registration
For pharmaceutical companies, alignment with ICH standards facilitates the preparation of global development and regulatory programs for the Indian market. However, even with alignment, a global regulatory dossier cannot be submitted without localization.
India-Specific Regulatory Requirements Beyond ICH Harmonization
- CDSCO applications or forms
- Fee payment and declarations
- Product labeling and inserts
- Justifications for clinical trials and waivers
- Documentation for manufacturing and importing
- Ethics committee and CTRI documentation
- Pharmacovigilance commitment(s)
- Responses to CDSCO and Subject Expert Committee queries
Therefore, ICH harmonization is supportive of the India Pharmaceutical Regulatory Approval process; however, it does not substitute the stipulations of the Drugs and Cosmetics Act and Rules as well as the New Drugs and Clinical Trials Rules.
2026 CDSCO Prior-Intimation Routes: Eligibility and Restrictions
The analytical and non-clinical prior-intimation routes do not apply to several classes of products including, but not limited to, certain cytotoxic products (including some sex hormones), beta-lactam products, narcotics and psychotropic drugs, as well as biologics containing live microorganisms. No products manufactured through these routes may be sold.
The export BA/BE prior-intimation route is restricted to the specified oral single dose crossover studies in healthy adults, while all other studies, including the India market studies and high-risk products, will proceed through the regular approval route.
CDSCO Local Clinical Trial Waivers in India
Do not assume that Foreign Regulatory Approval will lead to India Pharmaceutical Regulatory Approval.
The CDSCO may grant a local Clinical Trial Waiver for certain products that are already approved and are being marketed in certain countries, provided that the product demonstrates sufficient evidence of safety, efficacy, and the evidence of the population of India.
Products Eligible for Local Clinical Trial Waivers
- Drugs for Orphan Diseases
- Gene and Cell Therapies
- Drugs used in a Pandemic
- Products for specific purposes of defense
- Other products that provide a marked improvement in therapeutic use
A waiver of this type will be considered for the specific product and may require additional Phase IV studies, active safety surveillance and other safety monitoring and assessment conditions.
Biologics and Biosimilars Approval Requirements in India
Details necessary for all biologics include:
- Cell lines and cell banks
- Raw materials and controls
- Purification and viral safety
- Product structure, purity and potency
- Process validation
- Stability and cold-chain requirements
- Immunogenicity and risk management
A biosimilar is required to prove its similarity through analytical studies and through functional, pharmacokinetic and, when needed, clinical studies.
The draft Similar Biologics Guidelines of May 6, 2025, encourage a more scientific overall assessment approach. Decreased animal and/or comparative clinical studies will need to be justified scientifically and will need to be accepted by CDSCO. The draft cannot be viewed as law until formally notified.
Pharmacovigilance and Post-Marketing Surveillance Requirements in India
Authorization holders are required to have a system for post-marketing surveillance during which they remain responsible for collecting adverse event reports, assessing cases, and reporting to authorities along with risk minimization.
CDSCO Post-Marketing Surveillance Requirements
Obligation | Requirement |
PSURs | Every six months for the first two years and annually for the following two years, unless CDSCO specifies otherwise |
PSUR deadline | Within 30 calendar days after the end of the reporting period |
Delayed launch | PSUR safety data may begin from the actual date of marketing |
Safety reporting | Serious and unexpected adverse reactions must be reported within applicable statutory timelines |
Phase IV studies | May be imposed as a condition of approval |
Schedule M PV system | Must be documented, maintained and available for regulatory inspection |
Special Cases in New Drug Registration and Approval in India
- Drugs approved abroad: CDSCO may accept foreign clinical data under specific conditions.
- Fixed Dose Combinations (FDCs): Special rules apply; clinical trial permission may be required.
- Emergency use / public health urgency: Fast-track approval available for pandemic or rare disease drugs.
Documents Required for CDSCO New Drug Approval
- Form 44 with applicable fees
- Full CMC data
- Preclinical pharmacology and toxicology data
- Published literature (if available)
- Clinical trial protocol (if applicable)
- Regulatory status in other countries
- Submission in CTD/eCTD format recommended
Specific Timelines for CDSCO Drug Registration and Approval Process
Activity | Estimated Time |
Preclinical Studies | 6–12 months |
Clinical Trials (Phases I–III) | 1–3 years |
Review by CDSCO | 6–12 months |
Total Time for Approval | 2–5 years (on average) |
Fast-track approval is available for drugs of national importance or rare diseases.
Common Reasons for CDSCO Approval Delays
- Product misclassification
- Use of a wrong or outdated application form
- Missing CMC or stability data
- Discrepancies between the dossier, protocol and label
- Insufficient justification for local trial waiver
- Missing Ethics Committee approval and CTR registration
- Insufficient justification for selection of reference biosimilar
- Unanswered queries on SUGAM for extended periods
- Insufficient planning for pharmacovigilance
Conclusion
India’s regulatory environment for new drug approval is complex but well-defined. Adhering to CDSCO and NDCTR 2019 requirements ensures compliance, patient safety, and timely access to new treatments. With strategic planning, pharmaceutical companies can introduce innovative medicines efficiently.
How DDReg Can Help
DDReg supports pharmaceutical companies through every stage of the drug registration and approval process in India. From dossier preparation in CTD/eCTD format to managing clinical trial submissions, regulatory affairs services interactions, and post-marketing safety reporting, our team ensures complete compliance with CDSCO and NDCTR 2019 requirements. With expertise in handling both new drug applications and complex cases such as fixed-dose combinations, biologics, and priority reviews, DDReg helps companies achieve faster approvals and seamless market access.