What is Form 42?
Form 42 is an application form submitted to the CDSCO by a manufacturer or their authorized Indian agent for obtaining permission to import drugs or cosmetics into India for purposes like examination, testing, analysis, or clinical trials. It is used when the products are not meant for commercial sale but are instead imported for R&D or institutional review.
The applicant must be authorized to act on behalf of the foreign manufacturer and should furnish complete information about the product, its intended use, and supporting documentation to justify the import.
What is Form 43?
Form 43 is the official import license granted by the CDSCO once the Form 42 application has been reviewed and approved. It authorizes the applicant to import the mentioned drug or cosmetic under the specific conditions stated in the license. Importantly, Form 43 is only applicable for non-commercial imports and cannot be used for marketing or sales purposes.
The license is valid for a period of three years unless cancelled or suspended earlier by the licensing authority due to non-compliance or misuse.
Key Documents Required
When applying for an import license under Form 42, the following documents are typically required:
Cover letter stating the purpose of the application
Duly filled and signed Form 42
Power of Attorney or Authorization Letter from the foreign manufacturer
Copy of manufacturing license in the country of origin
Product details including composition and intended use
Free Sale Certificate (if applicable)
Copy of labels and packaging materials
Undertaking for non-commercial use of imported items
Payment receipt of applicable fees through Bharatkosh
Submitting complete and accurate documentation ensures timely processing of the application and helps avoid unnecessary delays or rejection.
Common Use Cases
Importers apply through Form 42 and receive Form 43 typically for:
Clinical trials and bioavailability studies
Quality testing by laboratories
Research and development purposes
Examination and evaluation by government institutions or hospitals
Final Thoughts
Understanding the correct procedure and documentation for Forms 42 and 43 is crucial for any organization involved in drug or cosmetic import for non-commercial purposes. Failure to comply with the regulatory requirements may lead to import rejections, fines, or legal complications. Therefore, it's essential to be precise and well-informed when approaching CDSCO for import permissions.
For those looking for expert guidance, Agile Regulatory provides professional assistance with documentation, application filing, and end-to-end support for obtaining drug and cosmetic import licenses under Form 42 and Form 43. With a deep understanding of CDSCO procedures, Agile Regulatory ensures a smooth and compliant approval process.
