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.
Application Form 40 is filled and submitted to the regulatory body to obtain a biological license to import Biological products in India.
The Biological Registration Certificate is granted by the CDSCO in Form 41.
Indian Applicant on behalf of Foreign Manufacturer
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Selection of Indian Agent |
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Generation of SUGAM credentials |
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Applying for Registration Certificate in Form 40 by filling online form, uploading documents in pdf formats and submission of Govt. fee |
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Submission of Application |
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.
The registration certificate will be valid for three years.
The Government Timeline is 9 months.
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.
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.
No, registration certificate is not needed in such cases of only transit.
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 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.
State Licensing Authorities.
The manufacturer will be required to pay additional fees if the post-approval changes will affect the following:
The manufacturer should not pay any additional fees in minor cases like the following:
