Drug Registration in India: CDSCO Approval Process, Requirements & Regulatory Strategy

This guide maps every route for a pharmaceutical launch in India: new drug approval, clinical trials, import registration, manufacturing licensing, dossiers and post-approval obligations.

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

India has no single drug registration certificate that covers every medicine entering the market. The permissions a company needs depend on what the product is, whether the Central Drugs Standard Control Organization (CDSCO) treats it as a new drug, and whether it will be imported or manufactured in India. A finished-formulation import, a domestic generic, a biosimilar, a fixed-dose combination and a new indication for an approved product each follow a different route, use different forms and are reviewed against different evidence expectations.

This guide walks through those routes in the order a company meets them: classifying the product, deciding whether an Indian clinical trial is needed, registering an overseas manufacturing site, licensing import or manufacture, assembling the dossier, and managing the product after approval. It is written for pharmaceutical and biotech companies planning an Indian launch, and for the regulatory, medical and quality teams who will prepare the submission.

1. Which situation applies to your product

The table gives a starting point. The applicable route is fixed only after the product's composition, approval history and proposed Indian use are assessed against the current rules.

2. What "drug registration" covers in India

"Drug registration" is an umbrella term. In practice it can involve any of the following permissions, and a single product often needs several of them:

• Permission to conduct a clinical trial (Form CT-06)
• Permission to import a new drug for sale (Form CT-19 for an active pharmaceutical ingredient, Form CT-20 for a formulation)
• Permission to manufacture a new drug for sale (Form CT-22 for an API, Form CT-23 for a formulation)
• Registration certificate for an overseas manufacturing site and its products (Form 41)
• Import license (Form 10)
• State manufacturing license (Form 25 or Form 28)
• Fixed-dose combination approval
• Biological and biosimilar approval
• Post-approval changes and subsequent new drug approvals
• Pharmacovigilance and periodic safety reporting after approval

The governing law is the Drugs and Cosmetics Act 1940 and the Drugs and Cosmetics Rules 1945. New drugs, investigational new drugs, clinical trials and bioavailability or bioequivalence studies are governed by the New Drugs and Clinical Trials Rules 2019, which replaced the earlier Schedule Y framework for these activities. CDSCO publishes the NDCT Rules and their amendments on cdsco.gov.in. Medical devices and in vitro diagnostics follow the Medical Devices Rules 2017 and are covered in our CDSCO medical device regulatory guide.

Each permission has its own applicant, its own form, its own evidence expectation and its own review clock, and the sections below take them in the order they are usually applied for.

3. Who issues which permission: CDSCO and State Licensing Authorities

CDSCO is the central drug regulator under the Directorate General of Health Services, Ministry of Health and Family Welfare. The Drugs Controller General of India (DCGI) heads it and acts as the Central Licensing Authority (CLA) under the NDCT Rules. CDSCO's divisions cover new drugs, investigational new drugs, clinical trials, import and registration, biologicals, vaccines, fixed-dose combinations and medical devices.

State and Union Territory Licensing Authorities (SLAs) issue manufacturing licenses and sale licenses. The two levels work in sequence for many products.

For a new drug that will be manufactured in India, Rule 83 of the NDCT Rules requires the CDSCO permission in Form CT-23 (or CT-22 for an API) before the SLA can grant the manufacturing license for that product. For a new drug that will be imported, the CDSCO permission in Form CT-20 sits alongside the registration certificate and import license issued under the Drugs and Cosmetics Rules. Applications to CDSCO are filed through the SUGAM online portal by the manufacturer, its authorized Indian agent or its Indian subsidiary.

4. Is your product a "new drug" under the NDCT Rules

Rule 2(1)(w) of the NDCT Rules defines a new drug to include:

1. A drug, including an active pharmaceutical ingredient or a phytopharmaceutical drug, that has not been used in India to any significant extent and has not been approved by the CLA as safe and efficacious for the proposed claims.
2. A drug already approved by the CLA for certain claims 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.
3. A fixed-dose combination of two or more drugs that are individually approved but are being combined for the first time in a fixed ratio, or an approved combination in which the ratio or the ingredients are changed.
4. A modified-release or sustained-release form, or a novel drug delivery system, of an approved drug.
5. Vaccines, recombinant DNA products, living modified organisms, monoclonal antibodies, stem cell derived products, gene therapeutic products and xenografts.

The explanation to the rule adds the four-year clause: a new drug continues to be treated as a new drug for four years from the date of its first approval in India. An applicant who wants to import or manufacture a molecule that CDSCO approved for another company two years ago therefore still files under the NDCT Rules, as a subsequent applicant, with a lighter evidence package. After the four years the molecule is treated as an established drug and the CDSCO new drug permission is no longer required, although the registration certificate, import license and manufacturing license requirements continue to apply.

An approval by the US Food and Drug Administration (FDA) or the European Medicines Agency (EMA) does not remove new drug status in India. The product remains a new drug in India if it meets any limb of the definition. A change to an approved product can also create a new drug without any change to the molecule: a new strength or an extended-release form of a product sold in India for ten years is filed under the NDCT Rules as a new drug.

The pre-classification questions below settle the position:

• Active ingredient, dosage form, strength and route
• Proposed indication and patient population
• Whether the product is approved anywhere, and where
• Whether the product, or the same molecule from another applicant, is approved in India, and when
• Whether it will be imported or manufactured in India
• Whether it is a chemical entity, a biological, a vaccine or a phytopharmaceutical
• Whether it is a fixed-dose combination
• Whether a new indication, dosage form, strength or route is proposed

5. The regulatory sequence from product to post-approval

The order below is the one we recommend for planning, and it is the order this guide follows.

1. Product definition (composition, form, strength, route, indication)
2. Regulatory classification (new drug or established drug; chemical, biological, FDC)
3. Approval status (India, reference countries, date of first Indian approval)
4. Import or manufacturing model (overseas site, Indian site, contract manufacturer)
5. Evidence inventory (clinical, non-clinical, chemistry manufacturing and controls (CMC))
6. Gap assessment against the chosen pathway
7. Submission strategy (which forms, which authority, in which order)
8. CDSCO review, including Subject Expert Committee (SEC) review where applicable
9. Permissions and licenses
10. Post-approval lifecycle (pharmacovigilance, periodic safety update reports (PSURs), variations)

Dossier writing starts after the gap assessment, once the pathway, the forms and the evidence needed for each module are fixed.

6. New drug approval for marketing

CDSCO's New Drugs Division processes applications to import or manufacture new drugs for sale, including drugs already approved in other countries and drugs proposed for new claims, indications, dosage forms or routes. Applications are filed in Form CT-18 (import) or Form CT-21 (manufacture) through SUGAM, with the documents listed in the Second Schedule of the NDCT Rules and the fee in the Sixth Schedule.

The application, the SEC review and the Rule 101 waiver decision are covered step by step in our CDSCO new drug approval guide.

The review has three components:

1. Technical screening by CDSCO for completeness and classification.
2. Subject Expert Committee (SEC) review. SECs are therapeutic-area committees of external clinicians and scientists. The applicant presents the product and answers questions. The SEC records recommendations, which may include approval, additional data, a local trial, a Phase IV commitment or a restricted indication. The DCGI acts on the recommendation.
3. Grant of permission in Form CT-20 (imported formulation) or Form CT-23 (domestically manufactured formulation), with any conditions attached.

The evidence expected at this stage depends on the product's development history:

• For a molecule not approved anywhere, the full non-clinical and clinical development package, including Indian Phase III data unless a waiver applies.
• For a molecule approved in a reference country, the global clinical package, the reference approval history, and either Indian clinical data or a justification for waiving it (section 8).
• For a subsequent applicant within the four-year window, a package that relies on the originator's approval, usually with bioequivalence data for the applicant's own formulation and complete CMC data.

The NDCT Rules also provide for accelerated approval. Where a drug for a serious or life-threatening condition shows a meaningful benefit in Phase II data, the CLA may grant approval on that data with a condition to complete a Phase IV study confirming clinical benefit. Surrogate endpoints can be accepted for this purpose.

7. Investigational new drugs and clinical trial permission

An investigational new drug (IND) is a new chemical or biological entity or substance that has not been approved for marketing in any country. The IND Division processes clinical trial applications for these products, and applications to import or manufacture them for trial use, through SUGAM.

An IND program should be planned with the eventual marketing application in view. The Phase I to Phase III program generates the clinical module of the future Form CT-18 or CT-21 dossier, so the endpoints, comparators and populations chosen for the trials decide what can be claimed at approval.

Clinical trial permission

An application to conduct a clinical trial of a new drug or an investigational new drug is filed in Form CT-04. Permission is granted in Form CT-06. The application carries:

• The trial protocol
• The Investigator's Brochure
• The informed consent documents and patient information sheet
• Available non-clinical data (pharmacology, pharmacokinetics, toxicology)
• Available clinical data from earlier phases or other countries
• CMC information and the investigational product specification
• Investigator and site details, with each site's ethics committee registration
• The sponsor's undertakings, insurance and compensation arrangements under Chapter VI of the NDCT Rules

The CLA decides within 90 working days. For a drug discovered in India, or whose research and development is being done in India and which will be manufactured and marketed in India, Rule 23 shortens the period to 30 working days, after which permission is deemed granted if the applicant receives no communication. Every trial must be registered on the Clinical Trials Registry India (CTRI) before the first subject is enrolled. Ethics committee approval is needed from each participating site.

Bioavailability and bioequivalence (BA/BE) studies of new drugs follow the parallel forms CT-05 and CT-07. The New Drugs and Clinical Trials (Amendment) Rules 2026, notified as G.S.R. 46(E) on 20 January 2026, introduced an intimation route for specified categories of BA/BE studies in place of prior permission, with a 45 working day window and stated exclusions. Our pharmacokinetics and pharmacodynamics guide covers the BA/BE study design side, and our CSR submission Q&A covers the clinical study report that follows.

EvySaif prepares the Investigator's Brochure and informed consent documents that go into a CT-04 application.

8. When an Indian clinical trial can be waived

Whether an Indian trial is needed is decided product by product. The NDCT Rules give the CLA the power to relax, abbreviate, omit or defer non-clinical and clinical data requirements, including local clinical trial data, in defined situations. Rule 101 lists the countries whose approvals can support a waiver: the United States, the United Kingdom, Japan, Australia, Canada and the European Union.

In August 2024 CDSCO issued an order under Rule 101 waiving the local clinical trial requirement for new drugs already approved in those countries when the drug falls into one of five categories:

1. Orphan drugs for rare diseases
2. Gene therapy and cell therapy products
3. New drugs used in a pandemic situation
4. New drugs used for special defense purposes
5. New drugs with a significant therapeutic advance over the current standard of care

The waiver carries two conditions. The applicant must show that there is no evidence of a difference in the drug's metabolism or response in the Indian population, and must commit to a Phase IV post-marketing study in India. Outside these five categories, the SEC decides case by case whether the global data are sufficient, whether a bridging study is needed, or whether a full Indian Phase III trial is required.

Because the waiver depends on the reference approval, the category and the ethnic sensitivity argument, the evidence for each of these points should be assembled before the CT-18 or CT-21 application is filed.

9. Importing a drug: registration certificate and import license

Imported drugs, both bulk drugs and finished formulations, are regulated under Part IV and Part VI of the Drugs and Cosmetics Rules. The overseas manufacturing site and each drug made there must be registered before an import license can be issued. The two permissions are separate and are applied for in sequence.

Registration certificate (Form 40 to Form 41)

The registration certificate confirms that CDSCO has accepted the overseas manufacturing site and the listed drugs. The application is filed in Form 40 by the manufacturer, or by its authorized agent in India, or by its Indian subsidiary. The applicant in India must hold a valid wholesale license (Form 20B and Form 21B). The application carries:

• A power of attorney from the manufacturer to the Indian agent, apostilled or legalized
• Schedule D(I) information about the manufacturer: site details, manufacturing license from the country of origin, Good Manufacturing Practice (GMP) certificate, inspection history, and an undertaking to allow CDSCO inspection
• Schedule D(II) information about each drug: composition, specifications, analytical methods, stability data, batch records, labels, and the free sale certificate or marketing authorization from the country of origin
• Product literature and labels compliant with Indian labeling rules
• Evidence that the site complies with Schedule M or an equivalent GMP standard

The registration certificate in Form 41 is valid for three years from the date of issue. Adding a new drug from an already registered site is done by endorsement of the existing certificate.

Import license (Form 8 to Form 10)

Once the registration certificate is issued, the importer applies in Form 8 for the import license in Form 10. The importer must be the holder of the wholesale license, and the license lists each drug covered. Form 8A and Form 10A serve the parallel route for import of small quantities for examination, test and analysis. The import license is valid for the period stated on it, which tracks the validity of the registration certificate.

New drugs

If the imported product is a new drug, the CDSCO permission in Form CT-20 is a third permission in the set. The typical order is registration certificate, then new drug permission, then import license, although CDSCO accepts parallel processing in practice for some applications. Confirm the sequencing for the specific product in a pre-submission meeting, which the NDCT Rules provide for on payment of a fee.

Simplified import sequence

1. Overseas manufacturer appoints an Indian agent or subsidiary holding a wholesale license
2. Site and product documentation assembled to Schedule D(I) and D(II)
3. Form 40 application filed on SUGAM
4. CDSCO review, queries, and site inspection where required
5. Registration certificate in Form 41
6. Form CT-18 application and Form CT-20 permission if the product is a new drug
7. Form 8 application and import license in Form 10
8. Commercial import, port clearance and market release
9. Post-approval compliance and renewal before expiry

Our CDSCO India regulatory page describes the site registration and import licensing service.

10. Manufacturing a drug in India

Domestic manufacturing is licensed by the State Licensing Authority of the state in which the site is located. Drugs outside Schedule C and C(1) are licensed on Form 25, applied for on Form 24. Schedule C and C(1) drugs, which include biologicals, sera, vaccines, injectables and other listed categories, are licensed on Form 28, applied for on Form 27. The license is site-specific and product-specific: each additional product is added by endorsement.

For a new drug, Rule 83 of the NDCT Rules requires the CDSCO permission in Form CT-23 (formulation) or Form CT-22 (API) before the state application for that product can be granted. In loan license and contract manufacturing arrangements the CT-23 permission and the product endorsement are held by the party that will sell the product.

A manufacturing license application covers:

• Site layout, premises and equipment
• Qualified technical staff and their qualifications
• Manufacturing process and in-process controls
• Product composition and specifications
• Analytical methods and quality control arrangements
• Stability data supporting the proposed shelf life
• Packaging and labels
• Schedule M compliance (revised Schedule M requirements, aligned with World Health Organization GMP, apply to all manufacturers, with an extended compliance deadline notified for smaller manufacturers)

Dossier-based licensing (2026)

In February 2026 CDSCO issued guidance on dossier-based licensing of drugs for uniform product licensing across states. The guidance sets out an administrative section and a technical section, and the checklist has been incorporated into the Online National Drugs Licensing System (ONDLS) used for manufacturing license applications. CDSCO has asked State and Union Territory authorities to adopt it. The state application is now reviewed against a technical dossier with the same headings as the CDSCO checklist, so the quality, stability and validation sections have to be prepared for the state filing in the same way as for a CDSCO filing.

11. The dossier: what it contains

The dossier is the structured evidence package behind a regulatory application. The NDCT Second Schedule lists the required content for new drug applications, and CDSCO accepts submissions organized in the Common Technical Document (CTD) format. Mapping the Indian requirements onto the five CTD modules keeps a global dossier reusable.

Before filing, each document is checked against the regulatory position the application takes. The checks that most often fail are: the indication in the clinical overview is broader than the indication studied; the drug product specification in Module 3 differs from the one in the stability report; the label lists a strength not covered by the clinical data; and the classification in the cover letter does not match the evidence in Module 5.

EvySaif prepares CTD and eCTD regulatory dossiers for CDSCO, for the GCC and SFDA drug registration routes, and for other markets.

12. Fixed-dose combinations

A fixed-dose combination (FDC) is a new drug under the NDCT definition when the components are combined for the first time in India, or when the ratio or the ingredients of an approved combination change. Individual approval of each component does not carry over to the combination.

The assessment centers on the therapeutic rationale: why the components should be co-administered in a fixed ratio, whether the dosing of each component in the combination matches its approved dosing, whether there is a pharmacokinetic or pharmacodynamic interaction, and what clinical evidence supports the combination in the proposed indication. CDSCO's FDC division categorizes applications by whether the components are new molecules, approved molecules combined for the first time, approved combinations with changed ratios, or combinations already approved in India, and the evidence expectation rises with the novelty.

CDSCO's 2026 Gazette notifications include a prohibition of 16 FDCs under Section 26A of the Act, and earlier years saw larger lists. The current prohibition notifications should be checked before an FDC program starts, including for combinations that other companies have marketed in India.

13. Biologicals, biosimilars and vaccines

Vaccines, recombinant DNA products, monoclonal antibodies, cell and gene therapy products and similar biologics are new drugs by definition under limb (v) of Rule 2(1)(w). Their regulation involves CDSCO's biologicals and vaccine functions, the Review Committee on Genetic Manipulation (RCGM) for recombinant products, and the Guidelines on Similar Biologics (2016) for biosimilars.

A biological dossier carries requirements that a small-molecule checklist does not cover:

• Full characterization of the molecule (structure, post-translational modifications, impurity profile) using orthogonal analytical methods
• Cell bank history and characterization
• Manufacturing process description with process validation, including viral clearance where applicable
• Potency assays and their validation
• Batch consistency data across multiple batches
• Stability under the proposed storage conditions, including in-use stability
• Immunogenicity assessment in the clinical program
• A pharmacovigilance plan and risk management plan
• For biosimilars, a comparative quality, non-clinical and clinical program against a reference biologic, with the reference product sourced from an acceptable jurisdiction

For imported biologicals, the manufacturing site registration and the RCGM and CDSCO permissions run in parallel with the NDCT application. Site inspection by CDSCO is common for biological sites.

14. Subsequent new drugs and post-approval changes

A subsequent new drug (SND) application covers two situations. The first is an applicant seeking to import or manufacture a molecule that another company has had approved in India within the last four years. The second is the holder of an approval seeking a new indication, a new dosage form, a new strength, a new route or a new patient population for an approved product. Both are filed in Form CT-18 or CT-21 and reviewed by the New Drugs Division, with SEC review for new claims.

Changes that do not create a new drug are handled as post-approval variations under the Drugs and Cosmetics Rules and the relevant license: a change of manufacturing site, a process change within the approved specification, a change in pack size, or a label change that does not alter the approved claims. The route for each change is established before the change is implemented.

Our regulatory strategy consulting service starts with this classification question for lifecycle changes.

15. Published CDSCO timelines

CDSCO publishes targeted processing timelines in its Citizen Charter and in the NDCT Rules. They are review targets for the authority once a complete application is accepted, and the clock stops while a query is outstanding.

An end-to-end launch timeline for an imported new drug therefore runs from site registration through SEC review to the import license, and the phases overlap only where CDSCO accepts parallel filing. A realistic plan adds time for one or two query rounds at each stage and for a site inspection where the site has not been inspected by CDSCO before.

16. Common causes of delay

1. Wrong classification. A product filed as an established drug that CDSCO treats as a new drug (a new strength, a modified-release form, an FDC ratio change) is returned to be refiled under the NDCT Rules.
2. Documents prepared in isolation. Clinical, CMC and labeling documents prepared by different teams without a single regulatory position produce the inconsistencies listed in section 11.
3. Evidence gaps found after filing. A missing Indian stability dataset, an incomplete impurity qualification or an absent bridging study costs far more to address after a query than during the gap assessment.
4. SEC queries treated as administrative. SEC questions on ethnic sensitivity, comparator choice, dose justification or benefit-risk need a clinical and statistical answer prepared by the people who understand the data.
5. Outdated regulatory information. FDC notifications, PSUR requirements, Schedule M deadlines and NDCT amendments have all changed within the last two years. A dossier built to an old checklist misses current requirements.
6. Reliance on the reference approval alone. An FDA or EMA approval supplies evidence and history. It does not decide the Indian classification, the local trial question or the site registration requirement.
7. Unregistered site or missing wholesale license. The registration certificate cannot be issued without the Indian agent's wholesale license, and the import license cannot be issued without the registration certificate. Missing prerequisites hold the whole sequence.

17. Three worked scenarios

Scenario 1: an FDA-approved oral drug entering India by import

The product is approved in the US and the EU and has not been approved in India. Under Rule 2(1)(w)(i) it is a new drug in India. The applicant is the manufacturer's Indian subsidiary, which holds a wholesale license. The steps are:

1. Confirm whether the product falls within one of the five Rule 101 waiver categories. If it does, assemble the ethnic sensitivity argument and the Phase IV commitment. If it does not, plan for SEC review of the global data and a possible bridging study.
2. File Form 40 for site and product registration with Schedule D(I) and D(II) information.
3. File Form CT-18 with the global dossier in CTD format, the Indian regulatory position and the waiver justification.
4. Present to the SEC; respond to queries; receive Form CT-20.
5. File Form 8; receive Form 10.
6. Start PSUR submissions on the NDCT cadence from the date of the CT-20 permission.

Scenario 2: a new molecule developed by an Indian biotech company

The molecule has completed preclinical development in India and will be manufactured and marketed in India. It is an investigational new drug. The steps are:

1. Obtain a test license to manufacture the investigational product for trials (Form CT-10 to Form CT-11).
2. File Form CT-04 for the Phase I trial with the non-clinical package, the Investigator's Brochure and the protocol. Rule 23 gives a 30 working day decision window with deemed approval.
3. Register the trial on CTRI before enrollment; obtain ethics committee approval at each site.
4. Progress through Phase II and Phase III under successive CT-04 permissions, with the marketing claims in view when the Phase III endpoints and comparator are chosen.
5. File Form CT-21 with the full development package; SEC review; Form CT-23.
6. Apply to the State Licensing Authority for the manufacturing license on Form 24 or Form 27 with the CT-23 permission attached.

Scenario 3: an approved product with a new indication

The company markets an approved product in India and wants to add an indication. Under Rule 2(1)(w)(ii) the new indication makes the product a new drug for that claim. The steps are:

1. Confirm whether the new indication is approved in a Rule 101 reference country and what clinical data support it.
2. Assess whether the existing Indian safety database and the global efficacy data are sufficient, or whether the SEC will expect Indian data in the new population.
3. File Form CT-18 or CT-21 as a subsequent new drug application limited to the new claim, with an updated package insert.
4. After Form CT-20 or CT-23, update the label and the PSUR scope to cover the new indication.

18. Regulatory gap assessment

A gap assessment asks whether the available evidence and documentation support the regulatory position the application will take.

19. 2026 regulatory watch

Indian drug regulation changed in several places during 2026. Each of the items below should be read from the CDSCO notice itself before it is relied on.

• NDCT amendment, January 2026. The New Drugs and Clinical Trials (Amendment) Rules 2026 (G.S.R. 46(E), 20 January 2026) introduced the intimation route for specified BA/BE studies, with exclusions and a 45 working day window.
• Dossier-based licensing, February 2026. CDSCO's guidance on dossier-based licensing of drugs set a common administrative and technical checklist for state manufacturing licenses, incorporated into ONDLS.
• PSUR draft notification, June 2026. A draft notification proposed annual submission of periodic safety update reports for subsequent years until the drug is marketed, under the NDCT framework.
• Globally developed products, August 2026. CDSCO published a clarification on applications to import and market new drugs not approved anywhere in the world where a global Phase III trial with Indian participants is ongoing or completed.
• FDC prohibitions, 2026. Gazette notifications under Section 26A prohibited 16 fixed-dose combinations.
• Schedule M. The revised Schedule M GMP standard applies to all manufacturers. Check the current notified compliance deadline for smaller manufacturers.

A regulatory strategy prepared today should be checked against the notices and amendments in force on the filing date.

20. Post-approval obligations

• Periodic safety update reports. Under the NDCT Rules, PSURs for a new drug are submitted every six months for the first two years after approval and annually for the following two years. The June 2026 draft notification proposes extending annual submission beyond that period until marketing. EvySaif prepares PSURs, PBRERs and DSURs for CDSCO and other agencies.
• Adverse event reporting to CDSCO and the Pharmacovigilance Programme of India within the required timelines for serious adverse events.
• Phase IV commitments attached to a CT-20 or CT-23 permission, including any study accepted as a condition of a local trial waiver.
• Variations for site, process, specification, pack and label changes, classified under section 14.
• Renewals of the registration certificate and import license before expiry, and of the state manufacturing license on its cycle.
• Compliance with new notifications, including FDC prohibitions and labeling changes, that apply to marketed products.

21. Drug registration readiness checklist

Collect the following before the regulatory assessment starts. The same list, with a forms quick-reference table, is available below as a printable two-page PDF.

Download the drug registration readiness checklist (PDF)

22. How EvySaif supports pharmaceutical registration projects

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

Our support for drug registration covers:

Regulatory strategy. Classification under the NDCT definition, pathway selection, local trial waiver assessment, gap assessment, pre-submission meeting preparation, and regulatory intelligence on CDSCO notices. See regulatory strategy consulting.

Regulatory documentation. CTD and eCTD dossiers for Form CT-18 and CT-21 applications, Form 40 and Form 8 packages with Schedule D(I) and D(II) information, state manufacturing license dossiers to the 2026 dossier-based licensing checklist, and responses to CDSCO and SEC queries. See regulatory medical writing and CDSCO India registration.

Clinical documents. Protocols, Investigator's Brochures, informed consent documents, clinical study reports and integrated summaries written to the NDCT Second Schedule.

Safety and lifecycle. PSURs, PBRERs and DSURs, EU risk management plans, pharmacovigilance plans, and variation classification.

Medical affairs. Publication support, scientific communication and evidence strategy for products after launch. See medical affairs strategy.

Our team includes practicing clinicians and clinical pharmacologists, who prepare the clinical and statistical answers to SEC questions from the study data. No consultant can guarantee an approval decision. We commit to a correct classification, a complete and internally consistent dossier, and query responses prepared to the standard the SEC expects.

If you are planning to register, import, manufacture or extend a pharmaceutical product in India, contact EvySaif for a pathway assessment. A CDSCO drug regulatory consultant on our team will review the product, confirm the classification and set out the forms, evidence and sequence before any document is drafted.

23. 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.