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

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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.

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:

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

Validity

The license validity for manufacturing biological products is 5 years.

Fee Involved

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

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 28/28A from Central Drugs Standard Control Organisation

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.

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

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