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Manufacturing License for Biologicals in India - 27/27A & 28/28A


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    CliniExpert-usp test license

    With over a decade of regulatory compliance experience, CliniExperts provides complete regulatory solutions. Our team is well-versed in the latest industry practices. We have extensive connections to speed up the acquisition of licenses and approvals for your biologicals.

    Manufacturing License for Biologicals – Overview

    CDSCO and SLA have notified biological manufacturers (except schedule X) to obtain manufacturing license. In order to apply for a manufacturing license, manufacturers must use form 27/27A. The SLA may issue the license on form 28/28A following the joint inspection of the premises. Typically, if there is no query or rejection, it takes 60 days for the license to be issued after the application is submitted.
    Form 27_27A 28_28A

    Who Can Apply?

    The application is open to any new Indian entity that wishes to manufacture biological goods in India.

    Manufacturing License for Biologicals in India – 2727A & 2828A

    How To Apply?

    The Applicant must follow the following process:

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      Establish login credentials for the state-specific website, if relevant.
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      Assemble the documentation needed.
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      Fill out the application.
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      Pay the government charge as outlined in the Drugs and Cosmetic Act.
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      Submit the application.
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    Validity

    The license validity for manufacturing biological products is 5 years.

     
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    Fee Involved

    There is a government fee of Rs. 7500 for the application process.

    Important Documents

    Important Documents
    During the documentation process, the following documents should be present:
    • List of SOPs
    • List of machinery & Equipment
    • Application Form
    • Site master file
    • Plant layout
    • List of technical persons with qualification and experience

    Timeline to get 28/28Afrom Central Drugs Standard Control Organisation

    60

    Days

    Essential Tips

    The primary considerations that need to be made while preparing and submitting this application are:
    • The documents submitted must follow the authority's provided checklist.
    • The manufacturers should acquire an NOC from the pollution Control Board and fire department.
    • The facility should comply with the Schedule M1 requirement.
    • The obstacles or issues that are most likely to arise when filling out or applying for the manufacturing license are:
    • Failure to acquire the NOC from the fire department and pollution control.
    • The layout and site master file not provided in the specified order.
    • Non-acceptance of the chemists.
    Expert Advise

    Facility should comply the Schedule M1 requirement.

    NOC from the pollution Control Board & fire department is must.

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    Frequently Asked Questions

    What is the primary requirement for the license application?

    The manufacturing company must have an authorized formulation, analytical, and microbiology chemist employed by the company.

    List down the documents required for the application process.

    During the documentation process, the following documents should be present:

    • List of SOPs
    • List of machinery & Equipment
    • Application Form
    • Site master file
    • Plant layout
    • List of technical persons with qualification and experience

    How much fee the government charge from the manufacturers for the application process?

    There is a government fee of Rs. 7500 for the application process.

    What is the government timeline to obtain License?

    Normally, it takes 60 days for the license to be issued after the application is submitted.

    Can a manufacturer formulate a biological product after getting License?

    No, the manufacturers must obtain product permissions and may also seek GMP certification.