Biological Registration Certificate in India – Form 40 & 41


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    Make the Biological Registration Process streamlined with CliniExperts. Let our experts help you with the Biological Registration Certificate to Import Biological products in India by Filing Form 40 and getting the License in Form 41.

    Biological Registration Form 40 & 41– Overview


    If the overseas manufacturer wants to register their manufacturing premises and import and market biologicals product in India, they need to obtain a Registration Certificate from the regulatory authority. Central Drugs Standard Control Organization (CDSCO) is the regulatory authority of India that grants the registration certificate. To obtain the registration certificate, the applicant must register on the SUGAM portal. This application should be made in Form 40, uploading all the required documents, and by paying the government fees. The applicants must also fill the undertakings specified in Schedule D-I and D-II and provide documents as per the Drugs and Cosmetics Act and Rules.

    What is Form 40 and 41

    Form Names

    40

    Application Form 40 is filled and submitted to the regulatory body to obtain a biological license to import Biological products in India.

    41

    The Biological Registration Certificate is granted by the CDSCO in Form 41.

    Who Can Apply?


    Indian Applicant on behalf of Foreign Manufacturer


    How To Apply?

    Selection of Indian Agent
    Generation of SUGAM credentials
    Applying for Registration Certificate in Form 40 by filling online form, uploading documents in pdf formats and submission of Govt. fee
    Submission of Application

    Fee Involved

    The fees for Biological Registration Certificate is USD 10,000 for each manufacturing site and USD 5,000 for each drug to register the manufacturing premises and import biologicals in India.

    Validity

    The registration certificate will be valid for three years.

    Important Documents

    The following documents are required while taking the permission for registration of manufacturing premises and the product meant for import and market in India:
    Wholesale license and/or manufacturing license. Drug master file Site master file Free sale certificate/Certificate of Pharmaceutical Product Good Manufacturing Practice Certificate Power of attorney

    Timeline to get Form 41 from CDSCO

    The Government Timeline is 9 months.

    Essential Tips

    The applicant looking for a registration certificate to register their manufacturing premises and import and use biologicals in India must ensure these essentials are followed

    Stability data of at least six months is available at the time of application.


    Must have new drug approval from the regulatory authority india.


    The documents submitted while making an application must be notarized or apostilled.


    The indication/strength/dosage form/ route of administration of the approved product should not be changed.


    Documents submitted by the applicant or manufacturer must have correct details of name and address.

    Expert Advise

    The manufacturer must ensure that any previous registration certificate is not granted to the manufacturing site they have currently applied to.

    The manufacturer must see that all the regulatory documents are within the validity period.

    The product samples sent for testing at the government laboratory must be well within the shelf life and in sufficient quantity.

    Frequently Asked Questions

    Should an individual get a registration certificate for biologicals that will not be sold or distributed in India but will be transited from India to other countries?

    No, registration certificate is not needed in such cases of only transit.

    When is the manufacturer required to obtain a fresh registration certificate?

    The manufacturer must obtain a fresh registration certificate in the following conditions. These conditions are laid down by the Drugs and Cosmetics Act, 1940.

    • The address of the Indian agent in the certificate or registered manufacturer in the certificate has changed.
    • The name of the foreign manufacturer or Indian manufacturer mentioned in the registration certificate has changed.
    • The Indian agent or the constitution of the manufacturer mentioned in the registration certificate has changed.

    In a case where the firm's constitution and the manufacturing site's address operating under form 41 has changed, how long will the registration certificate remain valid?

    The registration certificate will remain valid for three months from the date of the change. Necessary new registration certificate must be applied for with the new address.

    Who is the Licensing Authority for Wholesale license?

    State Licensing Authorities.

    Will the applicant be required to pay any fees in case of post-approval changes?

    The manufacturer will be required to pay additional fees if the post-approval changes will affect the following:

    • Registration certificate.
    • The manufacturing process of the product.
    • Packaging or labelling of the product.
    • Testing or documentation of the product.

    When will the manufacturer with a registration certificate not require paying any fees?

    The manufacturer should not pay any additional fees in minor cases like the following:

    • change in the batch size
    • change in the source of API or excipients
    • tightening of test limits to existing tests
    • inclusion of warnings in package inserts
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