Working with the Central Drugs Standard Control Organisation (CDSCO) is part of almost every drug-related regulatory pathway in India. The rules are well defined, but in reality, the process can still feel a bit scattered when you’re dealing with applications, approvals, and timelines.
Drug regulation in India is shared between the Central and State/UT authorities. Therefore, understanding which activities fall under CDSCO and which are primarily handled by State licensing authorities is important for companies planning to manufacture, import, market or distribute drugs in India.
This blog goes over how CDSCO pharmaceutical regulations in India actually work, especially from a registration point of view, and what companies should be prepared for during the process.
Drug Classification and Regulatory Categories in India
Indian drug regulation does not rely on one single classification system for all regulatory purposes. Different classifications and regulatory categories apply. It just depends on the nature and regulatory status of the product.
CDSCO distinguishes between new drugs, investigational new drugs, subsequent new drugs and other drugs regulated under the Drugs and Cosmetics Act and Rules.
New Drugs
The New Drugs and Clinical Trials Rules, 2019 (NDCT Rules), provide the regulatory framework for new drugs and clinical trials. The New Drug Division handles these responsibilities.
Investigational New Drugs
CDSCO also has a separate Investigational New Drug (IND) Division. Under the NDCT Rules, an investigational new drug includes a new chemical or biological entity or substance that has not been approved for marketing as a drug in any country. The IND Division processes applications relating to clinical trials and the import or manufacture of investigational new drugs through the SUGAM portal.
Subsequent New Drugs
It also identifies Subsequent New Drugs (SNDs) as a regulatory category. This can include an already approved drug proposed for a new indication, new dosage form, new route of administration, modified-release dosage form or additional strength, among other specified situations.
Also Read: Phytopharmaceuticals Regulations In India
Regulatory Authorities for Drugs in India
CDSCO is India’s central drug regulatory authority. It performs important regulatory functions under the Drugs and Cosmetics Act, 1940, and the rules made under it.
The manufacture, sale and distribution of drugs are primarily the responsibility of State authorities, while CDSCO performs specified central functions.
Looking for Pharma Regulatory Affairs Services in India? Our team can guide you through every step.
Functions/Responsibilities of CDSCO for Pharmaceutical Drugs
The following are the functions of CDSCO:
- Approval of new drugs
- Processing applications for clinical trials
- Regulation of drug imports
- Laying down standards for drugs
- Control over the quality of imported drugs
- Coordination with State Drug Control Organisations
- Approval of specified categories of drug licences
- Regulatory oversight of relevant post-approval activities
Drug Licensing Authorities & Licenses in India
Drug licensing responsibilities in India are divided between Central and State/UT authorities. The state authorities may take care of retail, wholesale, and manufacturing licensing. CDSCO handles import licences.
Pharmaceutical Product Registration & Approval Process In India
There is no single registration process applicable to every pharmaceutical product in India. The regulatory pathway depends on regulatory category classification.
Many of the CDSCO applications discussed below are submitted through the SUGAM portal, so it is useful to understand the platform before looking at the individual approval pathways.
CDSCO SUGAM Portal
SUGAM is CDSCO’s online platform for submitting applications for various regulatory processes. It is for a range of regulatory activities, including applications relating to new drugs, clinical trials, import and registration and other regulated products and activities.
For example, CDSCO’s Investigational New Drug Division states that applications under Forms CT-04, CT-05, CT-18 and CT-21 are processed through the online SUGAM portal in accordance with the NDCT Rules, 2019. Similarly, CDSCO has directed that applications for certain new-drug, fixed-dose combination and subsequent-new-drug matters be filed through SUGAM.
Understand the CDSCO SUGAM Portal For Regulatory Submissions in detail.
New Drug Approval Process
Products falling within the definition of a new drug under the New Drugs and Clinical Trials Rules, 2019 (NDCT Rules), can follow the generic steps mentioned below:
Step 1: Decide the regulatory category – new drug, investigational new drugs, etc.
Step 2: Prepare the application and attach documents.
Step 3: Submit the application through SUGAM or other prescribed online systems
Step 4: Regulatory review and clarifications may be requested
Step 5: Expert review may be conducted.
Step 6: Regulatory decision and licence issuance if approved
The principal CT forms include CT-04, which is for permission to conduct a clinical trial of a new drug or investigational new drug. CT-18 is permission to import a new drug for sale or distribution, and CT-21 is permission to manufacture a new drug for sale or distribution.
Imported Drug Registration Process
Before importing drugs into India, the foreign manufacturer’s drug and manufacturing premises must be registered under the applicable Drugs and Cosmetics Rules requirements. The process is broadly given below:
First Step: Submit Form 40 through the CDSCO/SUGAM system.
Second Step: Provide the prescribed information and supporting documents. It includes information concerning the manufacturer, manufacturing premises and the drug proposed for registration
Third Step: CDSCO scrutinises the application and may raise deficiencies.
Fourth Step: Registration Certificate Form 41 is issued on fulfilment of the requirements.
Import Licence Process
For drugs other than those specified in Schedule X, the Drugs Rules provide for an import licence in Form 10; for Schedule X drugs, the licence is Form 10A. The application is made in Form 8 or Form 8A, respectively. The application must be accompanied by the Registration Certificate in Form 41.
The process is therefore as follows:
- Submit Form 8/Form 8A for the Import Licence.
- Provide the required Registration Certificate and supporting documents.
- CDSCO scrutinises the application.
- Form 10/Form 10A is issued when the requirements are fulfilled.
CDSCO separately publishes a Process Flow of Registration Certificate and a Process Flow of Import Licence, confirming that these are distinct regulatory processes.
Manufacturing Permission for a New Drug
For a new drug intended to be manufactured in India for sale or distribution, the NDCT framework provides Form CT-21 for the application for permission to manufacture.
The process can be summarised as follows:
First: Determine whether the product is a new drug.
Second: Prepare the required technical and supporting data.
Third: Submit Form CT-21 through the prescribed online system.
Fourth: CDSCO evaluates the application and may raise queries.
Fifth: Once the requirements are satisfied, permission to manufacture the new drug for sale or distribution is granted.
CDSCO’s current Citizen Charter specifically lists CT-21 for permission to manufacture new drugs, while CDSCO’s New Drugs Division identifies manufacture and import of new drugs as functions processed under the NDCT Rules, 2019.
Clinical Trial Permission Process
For a clinical trial of a new drug or investigational new drug, CDSCO identifies Form CT-04 as the application for permission to conduct the trial. The process is briefly provided below:
- Prepare the clinical-trial application and supporting documents.
- Submit Form CT-04 through the prescribed online system.
- CDSCO reviews the application and may seek additional information.
- Where required, the proposal undergoes expert/Subject Expert Committee consideration.
- Regulatory and Ethics Committee requirements must be satisfied before the trial begins.
Recognition of Approvals from the US, EU and Other Countries
Prior approval of a drug in another country can form part of the regulatory information relevant to an Indian application. However, an overseas approval does not automatically constitute permission to market the drug in India.
CDSCO’s New Drugs Division specifically deals with applications for drugs already approved in other countries for specified claims, indications, dosage, dosage form and route of administration.
The Indian regulatory authority evaluates the application under the applicable Indian requirements. Therefore, applicants should provide the relevant information and supporting documentation required under the applicable Indian pathway rather than assuming that approval by the US FDA, EMA or another foreign authority will automatically result in approval in India.
Clinical Trial Requirements in India
NDCT Rules apply to clinical trials of a new drug or investigational new drug in India. Form CT-04 is the application to conduct a clinical trial and is submitted to the Central Licensing Authority. It is accompanied by the information, documents and prescribed fee specified under the Rules. If permission is granted, it is issued in Form CT-06.
The key requirements are given below:
- Regulatory permission: Submit Form CT-04 with the information needed and documents.
- Ethics Committee approval: The clinical trial must have approval from a registered Ethics Committee before beginning.
- Informed consent: It must be obtained from trial participants according to the NDCT Rules.
- Safety and compensation: The Rules provide requirements for reporting serious adverse events and compensation in specified cases of trial-related injury or death.
- Clinical trial registration: Registration with the Clinical Trials Registry–India (CTRI) is mandatory before the first participant enrols. CDSCO’s current FAQ expressly confirms this requirement.
- GCP compliance: Clinical trials must comply with the applicable Good Clinical Practice requirements.
The permission to conduct the clinical trial is granted in Form CT-06. Where the automatic/deemed approval provisions apply, the prescribed information is submitted in Form CT-4A, and the permission/automatic approval remains valid for two years, unless extended by the Central Licensing Authority.
CDSCO Fees for Drug Applications in India
The fees are not the same every time. It depends on the application type. The NDCT Rules, 2019, provide fees for applications relating to new drugs and clinical trials in the Sixth Schedule. The Drugs Rules prescribe fees for drug import and other licensing activities.
For example, Form CT-04 for permission to conduct a clinical trial carries the fee prescribed under the Sixth Schedule. The fee is not payable where the clinical trial is conducted by a person or institution/organisation funded or owned wholly or partially by the Central or State Government, as provided under the NDCT Rules.
Because CDSCO fees are activity-specific and can be amended, the applicable fee should be verified against the current Rules and CDSCO fee information before submitting an application.
CDSCO Drug Approval Timelines
CDSCO timelines vary according to the type of application. Its 2025 Citizen Charter provides the following targeted internal processing timelines:
- IND application requiring SEC consultation: 30 working days
- New Drug / Clinical Trial / Global Clinical Trial / New Claim application requiring SEC consultation: 90 working days
- Subsequent New Drug requiring SEC consultation: 90 working days
- Fixed-Dose Combination requiring SEC consultation: 90 working days
- Import Registration of Drugs & Biologicals: 270 working days
- Import Licence for Drugs & Biologicals: 45 working days
- Major import post-approval change: 180 working days
- Minor import post-approval change: 90 working days
These are targeted internal processing timelines, not guaranteed market-authorisation dates. The actual time may depend on deficiencies, queries, expert review and the completeness of the application.
CDSCO Labelling Requirements For Drugs In India
The labelling requirements must be as per the Drugs and Cosmetics Rules 1945. Part IX specifies the requirements to be followed in detail. The manner of labelling is as follows:
- Name of the drug
- An accurate statement about the net content in terms of weight, volume, measure, number of units of content, number of units of activity (as the case may be) and the weight, measure and volume can be expressed in the metric system.
- Content of active ingredients
- Manufacturer’s name and the address of the premises where the drug has been manufactured.
- A distinctive batch number, that is to say, the number of the particular batch from which the substance in the container is taken, is recorded and is available for inspection. The figure representing the batch number must precede the words ”B. No.” or ”Batch No.” or ”Batch” or ”Lot” or ”Lot No. ”
- The label must also carry the date of manufacture and date of expiry, where prescribed under the applicable provisions.
- Drugs falling under specific schedules or categories may have additional cautionary statements, statutory warnings or labelling particulars prescribed by the Rules.
Additional labelling requirements apply to specific categories. It covers Schedule X drugs and drugs intended for export, as provided under the Drugs and Cosmetics Rules, 1945.
Post-Approval Drug Safety and Pharmacovigilance
Getting drug approval from CDSCO isn’t really the final step. Once pharma products are out in the market, that’s when post-approval tracking actually starts. In India, this comes under pharmacovigilance, where side effects or unexpected reactions get noticed during regular treatment and reported over time. Pharmacovigilance involves detecting, assessing, understanding, and preventing adverse effects or other drug-related problems.
Post-approval safety monitoring and reporting requirements may apply under the New Drugs and Clinical Trials Rules, 2019, to new drugs and the conditions of the regulatory permission. CDSCO also processes specified post-approval changes to imported drugs, including major and minor changes, through its regulatory framework.
Companies should therefore maintain appropriate safety information and comply with the applicable adverse-event reporting and post-approval requirements.
Conclusion
At Artixio, our team of experts try to understand every aspect of the novel or generic products in the context of the Indian market and provide high quality end-to-end regulatory solutions for CDSCO registration process and post approval maintenance of pharmaceutical products.
Stay tuned to Artixio for more insights into pharmaceutical regulations and market trends, and reach out to us at info@artixio.com.
FAQs
1. What is the difference between drug registration and an Import Licence in India?
They are separate regulatory requirements. CDSCO issues the Registration Certificate in Form 41 for registered bulk drugs and finished formulations, while the Import Licence is issued in Form 10 or Form 10A, as applicable. CDSCO separately publishes process flows for Registration Certificates and Import Licences.
2. What form is required to conduct a clinical trial of a new drug in India?
An application for permission to conduct a clinical trial of a new drug or investigational new drug is made in Form CT-04. If permission is granted, the Central Licensing Authority issues it in Form CT-06. The NDCT Rules prescribe the information, documents and fee requirements for the application.
3. Does approval by the US FDA or EMA automatically approve a drug in India?
No. Foreign approval can form part of the information considered by CDSCO, and CDSCO specifically handles applications involving drugs already approved in other countries. However, the product must still satisfy the applicable Indian regulatory requirements; overseas approval does not itself constitute Indian marketing authorisation.
