Pharmacy Services

Last Updated on May 12, 2022

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

Guidance on Clinical Trials Applications-For Applicants
English ( 750 KB – PDF)

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)