TAILORED SOLUTIONS FOR PHASES II-IV: ACCELERATING LIFE-CHANGING THERAPIES WITH EFFICIENCY
CDSCO
DRUG IMPORTERS
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Shen Clinical Services– Your Obvious Choice For A Regulatory Partner
Authorized Agent Support
Marketing Authorization
Import license
Registration Certificate
Re-Registration Certificate
New Drug Approval API Registration
In India, it’s mandatory for overseas suppliers of finished drugs and APIs to work through an Indian authorized agent. Given this regulatory requirement, suppliers need a trusted, capable, and resourceful local agent to streamline their business operations efficiently. Shen Clinical Services LLP provides a comprehensive range of support for drug regulatory matters, serving as a reliable, all-encompassing partner for suppliers entering the Indian market. For over a decade, we have been a dependable facilitator and problem-solver, offering top-tier services to drug suppliers navigating the Indian regulatory landscape. Discover our full range of services in the service overview section.
How It is Regulated?
In India, drug importers are required to secure import licenses and registration certificates to legally distribute products in the market. Regulated by the Drugs and Cosmetics Act of 1940 and the Drugs and Cosmetics Rules of 1945, drug imports are overseen by the Central Drugs Standard Control Authority (CDSCO). Import licenses are issued under Form 10 for general and OTC drugs (not covered under Schedule X) and under Form 10-A for prescription drugs listed in Schedule X, with renewals mandated every three years. Additionally, a registration certificate under Form 40 is essential to verify that imported drugs comply with Indian regulatory standards. Once these requirements are met, imported drugs can be distributed through authorized sales channels. Shen Clinical Services LLP provides expert guidance and support for securing these essential licenses, ensuring a seamless and compliant entry into the Indian drug market.
OTHER CONTRIBUTING FACTORS
How It is Regulated?
An authorized agent is a person or entity designated by a manufacturer or exporter to serve as their representative in India. In drug imports, the authorized agent is vital in handling the import process on behalf of a foreign drug manufacturer or exporter.
- The authorized agent must hold a wholesale license to sell and distribute pharmaceutical drugs in India.
- They oversee the manufacturer’s business operations, ensuring compliance with the Drugs & Cosmetic Act, 1940, and the Drugs and Cosmetics Rules, 1945.
- The agent is responsible for testing the sponsor drug at a central government laboratory.
- A Form-40 application must be submitted by the agent to the Central Licensing Authority (CLA) via the Ministry of Health’s online portal to obtain a Form-41 registration certificate.
- The authorized agent is legally responsible for notifying CDSCO of any post-approval changes to the approved site or drug in the registration certificate.
- They must assist with adverse event reporting and product recalls as necessary.
New Drugs:
- A drug that has not been previously used in the country; or
- A drug that has not been previously approved for marketing in India; or
- A drug that contains a new chemical entity; or
- A drug that contains a new combination of previously approved active pharmaceutical ingredients or their salts or isomers or esters or ethers.
Investigational
- An Investigational New Drug (IND) is a pharmaceutical product that is under investigation and is not yet approved for marketing by the CDSCO.
- It is also known as a “clinical trial drug.”
- INDs are typically used in clinical trials to study their safety and efficacy in humans.
- The IND application should include information about the drug`s formulation, pre-clinical data, proposed clinical trial design, and a risk-benefit analysis.
- INDs are subject to regulatory oversight and monitoring by the CDSCO throughout the clinical trial process.
Fixed DOSE Combinations
- Fixed Dose Combinations (FDC) refer to two or more active pharmaceutical ingredients (APIs) combined in a fixed ratio into a single dosage form.
- FDCs are intended to simplify dosing and improve patient compliance.
- The CDSCO defines FDCs as “two or more drugs combined in a fixed ratio of doses, and available in a single dosage form.”
- FDCs can only be approved for use in India if they meet certain criteria, including safety, efficacy, and therapeutic justification.
- The CDSCO has issued guidelines for the evaluation and approval of FDCs, which include criteria such as the availability of individual drugs, the rationality of the combination, and the safety and efficacy of the combination.
- The CDSCO may also require additional clinical data to be submitted in support of an FDC application.
Phytopharamceutical drugs
- Phytopharmaceutical drugs are medicinal products that are derived from plants or plant materials.
- These drugs are developed using various parts of plants, such as roots, leaves, flowers, or seeds, and are used to treat or prevent diseases.
- The CDSCO defines phytopharmaceutical drugs as “drugs that are developed using active ingredients derived from plants, either in their raw or processed form.”
- These guidelines also cover aspects such as the identification and characterization of active ingredients, stability testing, and clinical evaluation.
- Phytopharmaceutical drugs are considered as drugs under the Drugs and Cosmetics Act, 1940, and are subject to the same regulatory requirements as other drugs.
Shen Clinical Services service basket
With a 360-degree service offering, we cover all aspects of drug import licensing and regulatory support.
Pre-marketing support
We include the following areas:
- Authorized agent or registered holder support
- Marketing authorization
- Registration certification
- Import license
- Test license
Post- marketing support
We include the following areas:
- Authorized agent or registered holder support
- Marketing authorization
- Registration certification
- Import license
- Test license
Authorized Agent Support
Form Names: Form 8, Form 9, Form 10
Import License for Drugs
Meet all your Regulatory Compliance needs. CliniExperts’ professionals help you plan and streamline regulatory approval processes for Drug Import License
Regulatory Body Requirement
- Obtaining a wholesale license from the State Drugs Licensing Authority or CDSCO.
- Compliance with the Drugs & Cosmetics Act, 1940 and Drugs and Cosmetics Rules, 1945.
- Submission of Form 8 or 8-A application to CDSCO along with required documents and fees.
- Obtaining import license under Form 10 or 10-A, which must be renewed every three years.
- Procuring a registration certificate under Form 40 from CDSCO.
- Compliance with labeling and storage requirements.
- Notification to CDSCO of any post-approval changes.
- Assistance with adverse event reporting and product recalls when necessary.
Who can Apply: Any person or company registered under the Companies Act, 1956 or 2013, or any other relevant law, can apply for a drug import license in India. The applicant must also have a premises suitable for storage and distribution of the imported drugs, and must comply with all the requirements under the Drugs and Cosmetics Act, 1940 and Drugs and Cosmetics Rules, 1945. The applicant must also appoint an authorized agent who holds a valid wholesale license to sell and distribute the imported drugs in India.
Regulatory Body Requirement
- Obtaining a wholesale license from the State Drugs Licensing Authority or CDSCO.
- Compliance with the Drugs & Cosmetics Act, 1940 and Drugs and Cosmetics Rules, 1945.
- Submission of Form 8 or 8-A application to CDSCO along with required documents and fees.
- Obtaining import license under Form 10 or 10-A, which must be renewed every three years.
- Procuring a registration certificate under Form 40 from CDSCO.
- Compliance with labeling and storage requirements.
- Notification to CDSCO of any post-approval changes.
- Assistance with adverse event reporting and product recalls when necessary.
Who can Apply: Any person or company registered under the Companies Act, 1956 or 2013, or any other relevant law, can apply for a drug import license in India. The applicant must also have a premises suitable for storage and distribution of the imported drugs, and must comply with all the requirements under the Drugs and Cosmetics Act, 1940 and Drugs and Cosmetics Rules, 1945. The applicant must also appoint an authorized agent who holds a valid wholesale license to sell and distribute the imported drugs in India.
Authorized Agent Support
Form Names: Form 8, Form 9, Form 10
Import License for Drugs
Meet all your Regulatory Compliance needs. CliniExperts’ professionals help you plan and streamline regulatory approval processes for Drug Import License
Regulatory Body Requirement
- Obtaining a wholesale license from the State Drugs Licensing Authority or CDSCO.
- Compliance with the Drugs & Cosmetics Act, 1940 and Drugs and Cosmetics Rules, 1945.
- Submission of Form 8 or 8-A application to CDSCO along with required documents and fees.
- Obtaining import license under Form 10 or 10-A, which must be renewed every three years.
- Procuring a registration certificate under Form 40 from CDSCO.
- Compliance with labeling and storage requirements.
- Notification to CDSCO of any post-approval changes.
- Assistance with adverse event reporting and product recalls when necessary.
Who can Apply: Any person or company registered under the Companies Act, 1956 or 2013, or any other relevant law, can apply for a drug import license in India. The applicant must also have a premises suitable for storage and distribution of the imported drugs, and must comply with all the requirements under the Drugs and Cosmetics Act, 1940 and Drugs and Cosmetics Rules, 1945. The applicant must also appoint an authorized agent who holds a valid wholesale license to sell and distribute the imported drugs in India.
Regulatory Body Requirement
- Obtaining a wholesale license from the State Drugs Licensing Authority or CDSCO.
- Compliance with the Drugs & Cosmetics Act, 1940 and Drugs and Cosmetics Rules, 1945.
- Submission of Form 8 or 8-A application to CDSCO along with required documents and fees.
- Obtaining import license under Form 10 or 10-A, which must be renewed every three years.
- Procuring a registration certificate under Form 40 from CDSCO.
- Compliance with labeling and storage requirements.
- Notification to CDSCO of any post-approval changes.
- Assistance with adverse event reporting and product recalls when necessary.
Who can Apply: Any person or company registered under the Companies Act, 1956 or 2013, or any other relevant law, can apply for a drug import license in India. The applicant must also have a premises suitable for storage and distribution of the imported drugs, and must comply with all the requirements under the Drugs and Cosmetics Act, 1940 and Drugs and Cosmetics Rules, 1945. The applicant must also appoint an authorized agent who holds a valid wholesale license to sell and distribute the imported drugs in India.
Authorized Agent Support
Form Names: Form 8, Form 9, Form 10
Import License for Drugs
Meet all your Regulatory Compliance needs. CliniExperts’ professionals help you plan and streamline regulatory approval processes for Drug Import License
Regulatory Body Requirement
- Obtaining a wholesale license from the State Drugs Licensing Authority or CDSCO.
- Compliance with the Drugs & Cosmetics Act, 1940 and Drugs and Cosmetics Rules, 1945.
- Submission of Form 8 or 8-A application to CDSCO along with required documents and fees.
- Obtaining import license under Form 10 or 10-A, which must be renewed every three years.
- Procuring a registration certificate under Form 40 from CDSCO.
- Compliance with labeling and storage requirements.
- Notification to CDSCO of any post-approval changes.
- Assistance with adverse event reporting and product recalls when necessary.
Who can Apply: Any person or company registered under the Companies Act, 1956 or 2013, or any other relevant law, can apply for a drug import license in India. The applicant must also have a premises suitable for storage and distribution of the imported drugs, and must comply with all the requirements under the Drugs and Cosmetics Act, 1940 and Drugs and Cosmetics Rules, 1945. The applicant must also appoint an authorized agent who holds a valid wholesale license to sell and distribute the imported drugs in India.
Regulatory Body Requirement
- Obtaining a wholesale license from the State Drugs Licensing Authority or CDSCO.
- Compliance with the Drugs & Cosmetics Act, 1940 and Drugs and Cosmetics Rules, 1945.
- Submission of Form 8 or 8-A application to CDSCO along with required documents and fees.
- Obtaining import license under Form 10 or 10-A, which must be renewed every three years.
- Procuring a registration certificate under Form 40 from CDSCO.
- Compliance with labeling and storage requirements.
- Notification to CDSCO of any post-approval changes.
- Assistance with adverse event reporting and product recalls when necessary.
Who can Apply: Any person or company registered under the Companies Act, 1956 or 2013, or any other relevant law, can apply for a drug import license in India. The applicant must also have a premises suitable for storage and distribution of the imported drugs, and must comply with all the requirements under the Drugs and Cosmetics Act, 1940 and Drugs and Cosmetics Rules, 1945. The applicant must also appoint an authorized agent who holds a valid wholesale license to sell and distribute the imported drugs in India.
Steps For Getting Manufacturing License
To obtain the Drug Import license , it is required to obtain a drug license from the State Drugs Controller or the Central Drugs Standard Control Organization (CDSCO), depending on the type of drug we wish to import. Also, it is mandatory to have an import-export code from the Directorate General of Foreign Trade (DGFT).
Application for Registration Certificate
Application for Registration Certificate
Approval in Form 10
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Frequently Asked Questions
Who can apply for import license?
Any firm/company having wholesale license in Form 20B/21B/21C or manufacturer having manufacturing license in Form 25/28 can apply for import license
Who can provide form 9?
Form 9 can be provided either by Indian agent or by manufacturer however if manufacturer is providing form 9 then it should be apostle or attested from Indian Embassy in country of origin.
Can importer import the products without getting registration certificate (Form 9)?
No however if importer is other then registration certificate holder then undertaking in form 9 from Indian agent along with copy registration certificate would be required.
Is India specific label is mandatory requirement to get the Import license?
Is India specific label is mandatory requirement to get the Import license?
Yes
Whether copy of new drug permission required for import license application?
Whether copy of new drug permission required for import license application?
Yes if drug comes under the definition of new drug.
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