Last Updated on May 11, 2023
Following guidelines are intended to help the industry and other applicants to meet the regulatory requirements related to Clinical trials or bio equivalence centers/ studies and Advertisement of therapeutic goods.
1. Conduct of Clinical Trials and Bio-equivalence/ Bioavailability
2. Advertisement of Therapeutic Goods

Guidelines for Advertisement of Therapeutic Goods
English ( 510 KB – PDF)

Monitoring Advertisement of Therapeutic Goods
English ( 510 KB – PDF)
3. Rational Use of Drugs

Guidelines for Responsible Use of Antimicrobials
English ( 335 KB – PDF)
4. Reliance Mechanism

Reliance Mechanism in Regulatory processes, A DRAP’s approach on Good Reliance Practices
English ( 454 KB – PDF)