We have a young professional team working on regulatory submissions for pharmaceutical products and other client-specific projects. We pride ourselves in having first-hand knowledge of drug regulatory rules etc. and keep ourselves updated all the time.

3. To enhance the communication aspects, CDSCO should ensure that the industry representatives, and other stakeholders have easy and open access to all the relevant regulatory information and are educated about the drug regulatory requirements, process involved in new drug development. 4. Similarly, CDSCO meetings including Pre-submission/ Post–submission/SEC meetings should be held as per the lai ...

BACKGROUND 1. Import or manufacture for sale of drugs are regulated under Drugs and Cosmetics Act, 1940 and Drugs Rules, 1945 and New Drugs and Clinical Trials Rules, 2019. 2. Detailed requirements and guidelines for conduct of nonclinical and clinical studies and approval of new drug are specified in SECOND SCHEDULE of New Drugs and Clinical Trials Rules, 2019.

Such discussion to help the reviewers becomes acquainted with the information to be included in the NDA. 4. In case the sponsor intends to seek exemption of local clinical trial, clear request for the same should be made in the NDA alongwith rationale and justification and the relevant regulatory provision, under which the exemption is sought. 5. Similarly, in case the sponsor intends to seek app ...