Pharmaceutical Regulatory Aff airs are intended to protect public health by evaluating the processes of drug discovery, production and promotion of pharmaceutical products.

   Pharmacy Council of India has recently introduced this subject as an elective paper [BP 804ET] at fi nal year B.Pharm. The course has been designed to impart the fundamental knowledge on the regulatory requirements for approval of new drugs, and drug products in regulated markets in India and abroad. It is expected to prepare the students to learn in detail the regulatory requirements, documentation requirements, and registration procedures for marketing the drug products in the regulated markets.

   The reader shall be able to—(i) know about the process of drug discovery and development, (ii) know the regulatory authorities and agencies governing the manufacture and sale of pharmaceuticals, and (iii) know the regulatory approval process and their registration in Indian and international markets.

  Exercises have also been suggested.

 

1. New Drug Discovery and Development

2. Regulatory Approval Processes

3. Registration of Indian Drug Product in Overseas Market

4. Clinical Trials

5. Regulatory Concepts


     Revision Questions