JAWAHARLAL NEHRU TECHNOLOGICAL UNIVERSITY HYDERABAD

Course Objectives

The topics which are present in the Drug regulatory affairs are very much useful

which increases the knowledge regarding the regulatory aspects in the pharmaceutical industries.

Course Outcomes:

• Students will come to know the different competent regulatory authorities globally.
• Students be aware of technical aspects pertaining to the marketing authoritization application (MAA)
• The regulatory guidelines and directions framed by the regulatory authorities will be helpful to place the drug products in market for marketing approvals.

UNIT - I

Drug Regulatory Aspects (India)

• 1. Indian drug regulatory authorities, Central and State regulatory bodies (FDA)
• 2. Drugs and Cosmmetics Act and Rules with latest Amendments (Selective)
• 3. Special emphasis – Schedule M and Y
• 4. New drugs – Importation, Registration, development, Clinical Trials, BE NOC & BE studies
• 5. Various Licences – Test Lic., Import lic., for testing of drugs and API’s, Manufacturing Contract and Loan licence manufacturing.

UNIT - II

Good Manufacturing Practices (GMP)

• 1. Indian GMP certification, WHO GMP certification.
• 2. ICH guidelines for stability testing and other relevant ones (Q1-Q10)
• 3. Export permissions and manufacturing for semi-regulated countries
• 4. Understanding of the plant layouts with special emphasis on the environment &safety.(HVAC, Water Systems, Stores Managemant, Effluent etc.)
• 5. Quality Assurance and Qulaity Control – Basic understanding for in-built quality.

UNIT - III

A detailed study of regulatory aspects that affect drug product design, manufacture and distribution in a developed country such as USA and in a developing country such as Brazil, Hatch Waxmann Act; Bolar Provisions and other FDA Regulations. Regulatory aspects of pharmaceutical and bulk drug manufacture, regulatory drug analysis.

UNIT - IV

Documentation related to manufacturing, cleaning methods, retention samples and records, quality control, batch release documents, distribution records, complaints and recalls. Quality, safety and legislation for cosmetic products and herbal products.

UNIT - V

Governing Regulatory Bodies across the globe. Country Authority Submission

• a. U.S Food & Drug Administration USDMF
• b. Canada Therapeutic Product Directorate DMF
• c. Europe
• 1) European Medicines Agency (EMEA/ National Authorities) EDMF R19 M.PHARM INDUSTRIAL PHARMACY
• 2) European Directorate for Quality of Medicines CEP/COS & Health Care Products.
• 3) MHRA – Medicines and Health Care Products Regulatory Agency
• d. Product Filing
• e. Responding Regulatory Deficiencies
• f. Final Approval Procedure Preparation, review and submission of Drug Master Files to Regulatory Authorities as per their specific requirements. TEXT AND REFERENCE BOOKS
• 1. Original laws published by Govt. of India.
• 2. Text Book of Forensic Pharmacy by Mithal B. M.; Vallabh Prakashan, New Delhi.
• 3. Laws of Drugs in India by Hussain.
• 4. Text Book of Forensic Pharmacy by Jain N. K.; Vallabh Prakashan, New Delhi.
• 5. Pharmaceutical Regulatory Affairs - Selected Topics, CVS Subramanyam and J Thimmasetty, Vallabh Prakashan Delhi - 2013 R19 M.PHARM INDUSTRIAL PHARMACY M.Pharm I Year I Sem (Industrial Pharmacy)