DRA PHARMACEUTICAL REGULATIONS IN INDIA M.Pharmacy 1st Semester 2023 (2022-2023) Previous Year's Question Papers/Notes Download - HK Technical PGIMS

This M.Pharm 1st Semester exam paper on Drug Regulatory Affairs (DRA102T) provides a comprehensive overview of India’s pharmaceutical regulatory framework, covering:

Key Topics Included:

1. Regulatory Bodies & Guidelines:

   • CDSCO, DCGI, DTAB, CPCSEA: Roles in drug approval and clinical trials.

   • ICH & ICMR Guidelines: Photo-stability testing, stem cell research, and bioequivalence studies.

2. Drug Approval & Compliance:

   • Clinical Trial Phases: From Trial Batch to Bioequivalence (BCS Classification).

   • Patents & IPR: What inventions cannot be patented (Section 3 of Indian Patent Act).

3. Manufacturing & Quality Control:

   • Biologicals & Narcotics: Regulations for precursors and psychotropic drugs.

   • ISO Certification: Application process for pharmaceutical units.

4. Latest Amendments:

   • DPCO (Drug Price Control Order): Impact on Indian drug pricing and market.