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CDSCO

DRUG IMPORTERS

Your Trusted Regulatory Ally with Delighted Clients, specializing in drug imports.

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Service About

As your dedicated regulatory partner, we take pride in our unwavering commitment to excellence and success in the complex realm of drug imports. With a rich history of serving the pharmaceutical industry, we have built a solid reputation as a reliable ally, ensuring compliance and seamless processes for our diverse clientele.

  • Managed Services and Products
  • Flexibility and Adaptability
  • Competitive Advantage

ZYPS – The Clear-Cut Selection for Your Regulatory Partner

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Authorized Agent Support

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Marketing Authorization

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Import license

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Registration Certificate

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Re-Registration Certificate

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New Drug Approval API Registration

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Test License for Importer

In India, it is a mandatory requirement for overseas suppliers of finished drugs and Active Pharmaceutical Ingredients (APIs) to operate through an authorized Indian agent. Given this essential reliance, suppliers seek a reputable, efficient, and resourceful inland agent to ensure swift and seamless business operations. In essence, companies require a versatile and dependable entity that can handle every aspect of drug regulatory matters. For more than a decade, ZYPS has assumed the roles of facilitator, problem-solver, and go-to team, providing top-notch services to drug suppliers seeking entry into the Indian market.

Explore comprehensive insights into the Indian regulatory process for drug imports and discover the array of services offered by ZYPS in the service overview section

How the Regulation is Enforced?

In India, importers of pharmaceuticals are required to secure import licenses and registration certificates for the distribution of their products in the market. The regulatory framework governing drug imports is established by the Drugs and Cosmetics Act of 1940 and the Drugs and Cosmetics Rules of 1945, with enforcement carried out by the Central Drugs Standard Control Authority (CDSCO). Import licenses, categorized under Form 10 for general and over-the-counter drugs not listed in Schedule X, and Form 10-A for prescription drugs listed in Schedule X, must be obtained. These licenses necessitate renewal every three years. Additionally, a registration certificate, obtained under Form 40, is required to verify that the imported drugs adhere to regulatory standards. Upon completion of these processes, the imported drugs are permitted for sale through approved sales and distribution channels.

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Additional Contributing Factors

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Responsibilities of Authorized Agent

The designated agent is a person or entity chosen by the manufacturer or exporter to serve as their representative in India. In the context of drug imports, the authorized agent plays a vital role in streamlining the import procedures on behalf of a foreign drug manufacturer or exporter.

  • The appointed agent is required to possess a wholesale license for the sale and distribution of pharmaceutical drugs in India.

  • They bear the responsibility for overseeing the business operations of the manufacturer in India, ensuring adherence to the Drugs & Cosmetic Act, 1940, and the Drugs and Cosmetics Rules, 1945.

  • The designated agent is tasked with conducting tests on the sponsor drug at the central government laboratory.

  • To secure a registration certificate (RC) for the drug, they are required to submit a Form-40 application to the Central Licensing Authority (CLA) via the Ministry of Health and Family Welfare's online portal in the Central Government. The RC is issued in Form 41.

  • The designated agent holds legal responsibility for informing CDSCO about any post-approval changes in the registered site or drug listed in the registration certificate. Additionally, they are obligated to support adverse event reporting and facilitate product recalls as needed.

Novel Pharmaceuticals

  • "Novel Pharmaceuticals or New Drug" is defined as:

  • A pharmaceutical substance that has not been
    previously utilized within the nation; or

  • A drug that has not been previously approved for
    marketing in India; or

  • A drug that contains a new chemical entity; or

  • A pharmaceutical formulation incorporating a novel
    combination of previously sanctioned active
    pharmaceutical ingredients or their salts, isomers, esters, or ethers.
Investigational New Drug (IND)

  • An Investigational New Drug (IND) is a pharmaceutical
    product undergoing investigation and has not yet
    received approval for marketing from the CDSCO.

  • It is alternatively referred to as a "clinical trial drug."

  • INDs are typically used in clinical trials to study their
    safety and efficacy in humans.

  • The IND application must encompass details regarding
    the drug's formulation, pre-clinical data, planned 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.

  • Fixed Dose Combinationss 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.
ZYPS service basket

With a comprehensive service portfolio, we address every facet of licensing for drug imports and provide 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).

  • 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

Fulfill your Regulatory Compliance requirements with ZYPS. Our experts assist you in strategizing and optimizing regulatory approval processes for obtaining a 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.

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Authorized Agent Support
Form Names: N/A

Authorized Agent Support

If you aim to penetrate the Indian pharmaceutical market, our authorized agent support service offers comprehensive assistance from start to finish. We guide you through intricate regulations, ensuring the acquisition of essential licenses and registrations. Reach out to us to discover how we can contribute to your success in India's expanding 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

  1. - Obtain a wholesale license to sell and distribute pharmaceutical drugs in India

  2. - Ensure compliance with the Drugs & Cosmetics Act and Rules

  3. - Test the sponsor drug at the central government laboratory

  4. - 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

  5. - Once the registration certificate (RC) is obtained in Form 41, issue Form-9 to importers for drug import

  6. - Notify CDSCO of any post-approval changes in the registration certificate

  7. - Assist with adverse event reporting and product recalls when necessary.

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Whole sale License
Form Names: 20B, 21B

Whole sale License

ZYPS provides strategic planning services for product registration, along with identifying distributors and serving as an authorized agent in India. Our collaborative approach ensures that you are supported at every step, eliminating the need for you to navigate any process on your own.

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
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Steps For Getting Import License

To secure the Drug Import license, it is necessary to acquire a drug license from either the State Drugs Controller or the Central Drugs Standard Control Organization (CDSCO), contingent on the type of drug intended for import. Additionally, obtaining an import-export code from the Directorate General of Foreign Trade (DGFT) is mandatory.

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.

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.

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.

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ZYPS team's in-depth knowledge and proactive approach played a pivotal role in ensuring our compliance needs were not just met , but exceeded expectations.

Choosing Complete Regulatory and Compliance Solutions for our business needs in India was a decision that significantly eased our regulatory challenges.

Testimonial

Serana Belluci

Medical goods Import agent

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ZYPS team's in-depth knowledge and proactive approach played a pivotal role in ensuring our compliance needs were not just met , but exceeded expectations.

Choosing Complete Regulatory and Compliance Solutions for our business needs in India was a decision that significantly eased our regulatory challenges.

Testimonial

Serana Belluci

Medical goods Import agent

Shape Icon

ZYPS team's in-depth knowledge and proactive approach played a pivotal role in ensuring our compliance needs were not just met , but exceeded expectations.

Choosing Complete Regulatory and Compliance Solutions for our business needs in India was a decision that significantly eased our regulatory challenges.

Testimonial

Serana Belluci

Medical goods Import agent

Frequently Asked Questions

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
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.
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.
Yes
Yes if drug comes under the definition of new drug.
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