REGISTRATION CERTIFICATE | FORM 41
A Registration Certificate, also known as Form 41, is a certificate issued by the Central Drugs Standard Control Organisation (CDSCO) under Rule 27A for the registration of a manufacturer’s premises and drugs intended for import into and use in India.
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Any foreign manufacture intending to sell their products in India has to obtain a registration certificate in Form 41. The manufacturing facility must be registered for imports. In the event a single manufacturer operates two or more factories that are located in different locations and produce the same or different drugs, each manufacturing unit will need its own Registration Certificate.
The foreign manufacturer with a wholesale drug licence, or the foreign manufacturer’s local authorised agent with a manufacturing or wholesale drug licence, may submit the application for registration and import.
To obtain a Registration Certificate in Form 41 an application shall be made to the licensing authority (CDSCO) in Form 40. This application can be made by the foreign manufacturer himself having a valid wholesale drug license in India or by his authorised agent in India having a valid drug manufacturing license or a valid wholesale drug license. The Registration Certificate in Form 41 shall be valid for a period of three years from the date of its issue.
If the manufacturer fails to comply with any of the conditions, the licensing authority may suspend or cancel the Registration Certificate for whatever period it deems appropriate, either entirely or in relation to some of the substances to which it relates. No Registration Certificate is required for an inactive bulk substance to be used in a drug formulation, with or without pharmacopoeial conformity.
Procedure for Obtaining a Registration Certificate in Form 41 in India:
- Obtaining Login credentials: To obtain a Registration Certificate in Form 41, the applicant must first register in an online portal and create a Login ID and Password
- Documentation: The applicant must produce documents and upload them online accordingly. All documents must meet the rules of The Drugs And Cosmetic Act, 1940
- Fees: The applicant must pay the required fees online by the requirements as per The Drugs And Cosmetics Act, 1940, The Drugs And Cosmetics Rules, 1945.
- Inspection: Following the submission of documentation, the Drug Inspector visits the manufacturing premises to authenticate the location and verify the documents.
- Issue of Registration Certificate: Post Inspection by the Drug Inspector, the licensing authority verifies the documents and inspection report submitted by the Drug Inspector and will grant the registration certificate.
Pre - Requisites / Documents required for Registration Certificate in Form 41:
- Application Form 40: An application in Form 40 has to be made to the licensing authority by the manufacturer or by his authorised agent in India.
- Power of Attorney: A power of attorney is required in the name of authorised signatory ideally a Director authorised by the Board of Directors in the case of a company, or the proprietor in the case of a proprietorship firm.
- Address of manufacturing premises: The address of manufacturing unit has to be mentioned in the application Form 40. Incase the manufacturer has two different units manufacturing same or different drugs both manufacturing site address should be mentioned
- Drugs Imported: The form shall capture proper brand name, different pack size, different strength to be imported in India.
- Challan: The original and detail challan of the fees paid has to be uploaded
- Wholesale Drug License: The foreign manufacturer or his authorised agent has to have a valid wholesale drug license in India.
- Undertaking: An undertaking shall be submitted by the proprietor or by the board of directors in case of company is mandatory
- Plan Layout: A plan layout showing all the equipment, men and material flow layout, etc.
- Others: The manufacturer has to submit information and undertakings specified in schedule D-I and schedule D-II signed by or behalf of the manufacturer.
The company/firm applying for a Registration Certificate in Form 41 will remain liable to pay a registration fee of ten thousand US dollars (or its equivalent in Indian rupees). A fee of twenty five thousand US dollars shall be liable for any expenses that may be necessary for the licensing authority or any other persons to whom the licensing authority has delegated powers in this regard to inspect or visit the manufacturing premises or drugs.
Obtaining a registration certificate in Form 41 can be time-consuming and the licensing procedure consists of steps that require a clear and thoughtful method. Any blunder during the registration procedure may result in the applicant being denied the certificate. We reduce the likelihood of application rejection and ensure that registration certificates are issued quickly and without complications.
You can apply for a Fresh Registration Certificate in Form 41 / Renewal of Registration Certificate / Amendment in Registration Certificate / Change in Constitution / Surrender of Registration Certificate through M/s. The Permiso and obtain the application reference number within 2 days. If you have any issues or facing any difficulty with the application, you can call +91 8104691667 or email us at info@thepermiso.com
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REGISTRATION CERTIFICATE Registration Procedure
