The time taken for CDSCO approval can vary depending on the complexity of the drug and the completeness of the application. It typically takes several months to a year or more for the entire approval process, including review, evaluation, and possible queries or clarifications from CDSCO.
EVTL India is a trusted certification consultant that offers valuable assistance in the CDSCO (Central Drugs Standard Control Organization) registration process. Their expertise and services can help pharmaceutical companies navigate the complexities of CDSCO regulations and ensure a smooth and successful registration. With their support, you can streamline the registration process and meet the necessary requirements effectively. EVTL India provides regulatory guidance, assists with document preparation and submission, liaises with CDSCO officials, ensures compliance with regulations, offers testing and analysis services, and provides post-registration support. Their comprehensive assistance simplifies the CDSCO registration process, saving you time and effort while ensuring compliance with regulatory standards.
ID Proof Document.
Undertaking issued by a Government Authority.
Address Proof Document.
Copy of BA/BE Site Registration as approved by CDSCO in case of BA/BE Approved sites Registration.
CDSCO stands for the Central Drugs Standard Control Organization. It is the regulatory body for pharmaceuticals and medical devices in India. CDSCO is responsible for approving, regulating, and controlling drugs and ensuring their safety, efficacy, and quality.
CDSCO approval is essential for pharmaceutical companies to market and sell their drugs in India legally. It signifies that the drug has undergone rigorous testing and meets the required quality, safety, and efficacy standards set by CDSCO.
You can verify the CDSCO approval status of a drug by checking its product packaging or label for the CDSCO license number. You can also search the CDSCO website or use their online portals to access the approved drug list or inquire about specific approvals.
CDSCO grants various types of approvals for drugs, including new drug approvals, clinical trial permissions, import licenses, manufacturing licenses, and marketing authorizations. The specific approval type depends on the drug development stage and the intended purpose.
Obtaining CDSCO approval involves submitting a comprehensive application with detailed information about the drug, its formulation, manufacturing process, clinical trial data (if applicable), and supporting documentation. CDSCO experts review the application, and if it meets the requirements, approval is granted.