What is Form 42?
Form 42 is the official application form used by a manufacturer or an authorized Indian agent to apply for an import license to bring drugs or cosmetics into India. It must be submitted to the licensing authority, typically the Drugs Controller General of India (DCGI), along with prescribed documents and fees.
This form is used for products that are not intended for commercial sale, such as those imported for testing, clinical trials, examination, or analysis. Hence, it’s commonly used by research institutions, pharmaceutical R&D teams, and testing labs.
What is Form 43?
Once the CDSCO reviews and approves the application submitted via Form 42, it issues the Import License in Form 43. This license permits the applicant to legally import the specified drugs or cosmetics into India for the mentioned purposes.
It is important to note that Form 43 does not authorize retail sale or marketing of the products. It is strictly limited to non-commercial activities like evaluation and research.
Documents Required with Form 42
When submitting Form 42 to obtain an import license, the following documents are generally required:
Cover letter with application purpose
Duly filled Form 42
Authorization letter or Power of Attorney
Product details (technical specifications, composition)
Manufacturing license copy from the exporting country
Free Sale Certificate (if applicable)
Labeling details
Undertaking for non-commercial use
Prescribed government fees (via Bharatkosh)
Validity and Conditions
The Form 43 import license remains valid for three years from the date of issuance unless suspended or cancelled earlier. The imported drugs or cosmetics must not be sold or distributed commercially and should only be used for the approved purpose.
Any misuse or deviation from declared use can lead to legal penalties, suspension of license, and even blacklisting of the importer.
How Agile Regulatory Can Help
Navigating CDSCO procedures, compiling documents, and ensuring compliance can be challenging—especially for first-time applicants or research organizations with limited regulatory knowledge.
That’s where Agile Regulatory steps in. Our team specializes in CDSCO licensing services, including Form 42 applications and securing Import Licenses under Form 43. From preparing documentation to timely submissions and follow-ups with CDSCO, we provide end-to-end support to ensure you get your license without unnecessary delays.
Conclusion
Form 42 and Form 43 play a crucial role in regulating the non-commercial import of drugs and cosmetics into India. Whether it’s for clinical research, testing, or analysis, securing this license is mandatory. For a smooth and compliant licensing process, consider expert assistance from a regulatory partner like Agile Regulatory, who can handle the complexities while you focus on your core objectives
