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Steadily growing client roster and 100% retention rate. When looking for a regulatory partner, market stature and size are the first check-points, and CliniExperts wins this round hands-on. Ethics, integrity, and excellence. We are a responsible and respectable name that is also pragmatic, and possesses resources to deal with the regulatory dynamics and ground realities. Talent and commitment. CliniExperts teams across functions are led by the industry’s front-benchers, with an unquestionable commitment to quality. Always-up-to-date. We pride in our cutting-edge knowledge and information pool, which helps us file perfectly compliant applications complete in every respect. The sum of these features often awards us the “most favoured service provider” status.

ABOUT CLASS A, B, C and D In-vitro Diagnostics

As per the New Medical Rules, 2017, all IVD’s have been classified into four distinct classes. According to the MDR, the categories are Class A, Class B and Class C, and Class D. This the range of medical devices governed by CDSCO: Class A IVD devices are considered to have low risk and are usually exempt from regulatory control. Examples of Class A IVD devices include reagents and solutions used for laboratory testing. Class B IVD devices are considered to have moderate risk and may require limited regulation. Examples of Class B IVD devices include pregnancy test kits, blood glucose test strips, and urine analysis test strips. Class C IVD devices are considered to have high risk and require more extensive regulation. Examples of Class C IVD devices include HIV testing kits, hepatitis testing kits, and cancer diagnostic kits. Class D IVD devices are considered to have the highest risk and require the most extensive regulation. Examples of Class D IVD devices include genetic testing kits, companion diagnostics, and certain laboratory-developed tests.

CDSCO

DRUG IMPORTERS

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Authorized Agent Support

Marketing Authorization

Import license

Registration Certificate

Re-Registration Certificate

New Drug Approval API Registration

Test License for Importer

In India, it is mandatory for overseas finished drugs and API suppliers to operate through an Indian authorized agent.Considering this dependency, suppliers need a reputed, efficient, and resourceful inland agent to facilitate fast and smooth business operations. In short, companies need an all-rounder and an all-weather entity that they can depend upon, for anything and everything in drugs regulatory matters. Since over a decade, CliniEpxerts has played the role of a facilitator, trouble-shooter, and go-to team by offering best-in-class services to drug suppliers wanting India entry.

Know all about the Indian regulatory process for drug imports, and Cliniexperts services.

Service listing in service overview section

How It is Regulated?

In India, drug importers must obtain import licenses and registration certificates to distribute their products in the market. The Drugs and Cosmetics Act of 1940 and the Drugs and Cosmetics Rules of 1945 regulate drug imports, and the Central Drugs Standard Control Authority (CDSCO) enforces these regulations. Import licenses must be obtained under Form 10 for general and OTC drugs not listed in Schedule X, and Form 10-A for prescription drugs listed in Schedule X. These licenses must be renewed every three years. A registration certificate must be obtained under Form 40 to confirm that the imported drugs meet regulatory standards. Once these processes are complete, imported drugs can be sold through approved sales and distribution channels.

OTHER CONTRIBUTING FACTORS

Role of Authorized Agent

The authorized agent is an individual or entity appointed by the manufacturer or exporter to act as their representative in India. In drug import, an authorized agent plays a crucial role in facilitating 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 are responsible for the manufacturer's business activities in India, ensuring compliance with the Drugs & Cosmetic Act, 1940 & Drugs and Cosmetics Rules, 1945.
The authorized agent is responsible for testing the sponsor drug at the central government laboratory.
They must submit a Form-40 application to the Central Licensing Authority (CLA) through an online portal of the Ministry of Health and Family Welfare in the Central Government, to obtain a registration certificate (RC) in Form 41 for the drug.

The authorized agent is legally responsible for notifying CDSCO of any post-approval change in the approved site or drug in the registration certificate.
They must assist with adverse event reporting and product recalls when necessary.

New Drugs:

"New Drug" is defined as:

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 New drug

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.

CliniExperts 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:

Authorised agent or registered holder support
Marketing authorization
Registration certification
Import license
Test license

Post- marketing support

These are our service areas:

Rule 37 permissions (this is the rule governing patenting and packaging of proprietary medicines imported in bulk for retail sales). For more, click here.
Re-registration and import license renewal
Shelf life extension procedures for imported drugs

Import License for Drugs

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.

How to Apply

To apply for a drug import license in India:

Obtain a wholesale license from the State Drugs Licensing Authority or CDSCO.
Submit Form 8 or 8-A application to CDSCO along with required documents and fees.
Obtain import license under Form 10 or 10-A, which must be renewed every three years.
Obtain registration certificate under Form 40 from CDSCO.
Comply with regulations including labeling and storage requirements.
Notify CDSCO of any post-approval changes.
Assist with adverse event reporting and product recalls when necessary.

Authorized Agent Support

Form Names: N/A

Authorized Agent Support

Looking to enter the Indian pharmaceutical market? Our authorized agent support service provides end-to-end support to navigate complex regulations and obtain the necessary licenses and registrations. Contact us to learn more about how we can help you succeed in India's growing market.

Regulatory Body Requirement

The regulatory requirements for authorized agents for drug imports in India include obtaining a wholesale license to sell and distribute pharmaceutical drugs, responsibility for compliance with the Drugs & Cosmetics Act and Rules, testing the sponsor drug at the central government laboratory, and submitting the Form-40 application to the Central Licensing Authority for registration. The authorized agent is also responsible for issuing Form-9 to importers for drug import and notifying CDSCO of any post-approval changes in the registration certificate. They should also assist with adverse event reporting and product recalls when necessary.

Who can apply Any foreign company who want to capture the Indian market but does not have its business operations or partner in India.

Who can Apply

Obtain a wholesale license to sell and distribute pharmaceutical drugs in India
Ensure compliance with the Drugs & Cosmetics Act and Rules
Test the sponsor drug at the central government laboratory
Submit a Form-40 application to the Central Licensing Authority for registration using the identified online portal of the Ministry of Health and Family Welfare in the Central Government by paying the required registration fees
Once the registration certificate (RC) is obtained in Form 41, issue Form-9 to importers for drug import
Notify CDSCO of any post-approval changes in the registration certificate
Assist with adverse event reporting and product recalls when necessary.

Whole sale License

Form Names: 20B, 21B

Whole sale License

CliniExperts offer strategic planning services during product registration in addition to finding distributors and acting as an authorized agent in India. Our hand in glove approach ensures that at no point you find yourself battling with any process by yourself.

Regulatory Body Requirement

As per the provisions of the Drugs and Cosmetics Rules, the State Licensing Authority can grant a license for the sale or distribution of drugs in India. The license can be issued under Drugs and Cosmetics Rules to sell, stock, exhibit, or offer for sale or distribute drugs in India. The license can be issued for several products like drugs, biologicals, medical devices, and in-vitro diagnostics.

State Licensing Authority (SLA) is the regulatory authority associated with this service. To obtain this license, an individual is required to apply to the State Licensing Authority. The Competent Authority would then carry out an inspection and then grant a license.

Who can Apply

The applicant who wishes to store, distribute and sale the drugs in wholesale cn apply for wholesale License. The person should be a Registered pharmacist (RP) who have a degree or diploma in pharmacy from a recognized university or competent person (CP). Further, arrange one person with same competency for it.

How to Apply

Step 1: Creation of login ID on the respective State Licensing Authority website/portal
Step 2: Filing of online data on the portal
Step 3: Uploading of documents as per the checklist
Step 4: Payment of government fee on the portal
Step 5: Submission of application on the portal as well as hard copy in the respective State Licensing Authority

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

The Registration Certificate is a mandatory requirement for any company that wishes to import drugs into India. It is valid for a period of 3 years and must be renewed before it expires. The certificate ensures that the drugs you import meet India`s safety, efficacy, and quality standards, and that your business complies with all the relevant regulations.

In addition to the RC, you also need to obtain a No-Objection Certificate from the CDSCO for each drug you wish to import. This certificate confirms that the drug is not prohibited for import and that the CDSCO has no objections to its importation. This step is essential to ensure that your importation is legal and that you can avoid any regulatory issues.

Application Submission in Form 9

To obtain a drug import license in India, you must submit an application with all the required documents, including your Registration Certificate, No-Objection Certificate, and Import-Export Code, to the Central Drugs Standard Control Organization (CDSCO). The CDSCO will review your application and issue your license if it meets all the necessary requirements. With our expert guidance, you can navigate the process with ease and confidence, and get the necessary approvals to start importing drugs into India.

Approval in Form 10

After submitting application for a drug import license to the CDSCO, you will need to wait for their review and approval. During this process, the CDSCO may request additional information or documentation to ensure that you meet all the necessary requirements Once the CDSCO is satisfied that you meet all the requirements, they will issue your drug import license. With our expert guidance, you can navigate this process smoothly and get the approvals you need to start importing drugs into India.

Testimonials

The Brand That Promises To Turn, Your Business Around!

Atomy India Pvt ltd

We have been associated with CliniExperts for about a year now for our food products related services for FSSAI compliances and licenses from CliniExperts and are completely satisfied with their performance. Quick turnaround time in responding to queries, meticulous planning in completing the task, alongside the extensive knowledge of the regulations of the entire team is highly appreciable and marks the professionalism and quality driven ethics of the organization. We highly recommend their services as we believe it is best in the industry so far.

Rajeev Rattava

Finance Manager

Morepen Laboratories Ltd.

The team at CliniExperts is proficient in the subject matter and provide prompt services . We are satisfied with our engagement and would recommend their services.

Anubhav Suri

Business Head

Proficon Medisol Pvt. Ltd.

We have been professionally associated with Cliniexperts for more than 5 years now. They have smoothly sailed us all these years in different projects & this has been possible because of the knowledge & dedication cliniexpert team has in their portfolio. All the best Cliniexpert. Keep going.

Ajitesh Trehan

Director

Unity Enterprises

We appointed Cliniexperts for our Cosmetic registration project for one of our critical products for which we received the registration certificate much before the timelines committed by the company. The entire project was handled efficiently with sheer professionalism and in our comfort zone . We are very happy with the overall working experience with CliniExperts and will highly recommend their services to everyone.

Faiyaz

Founder, Unity Enterprises

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?

Yes

Whether copy of new drug permission required for import license application?

Yes if drug comes under the definition of new drug.

Contact us

Please feel free to talk to us if you have any questions. We endeavour to answer within 24 hours.