M. Pharm in Regulatory affairs

The Department of Regulatory affairs, established in the academic year 2009-10, is dedicated to fostering excellence in academia, research, and the development of students into pharmaceutical professionals. Additionally, it is equipped with state-of-the-art laboratory and pilot plant facilities catering to both conventional and novel drug delivery systems. Recognized for its contributions to the field, the department has secured grants from various funding agencies to support its research endeavors. Emphasizing continuous learning and growth, the department provides regular training sessions for both students and faculty, focusing on advanced instruments and statistical tools. At the forefront of pharmaceutical research, the department’s activities are centered on formulation science and drug delivery. It excels in preformulation studies and the development and evaluation of diverse pharmaceutical dosage forms, including innovative nanotechnology-based delivery systems. The department’s scholarly output is impressive, with over 200 research articles published to date. Additionally, it has overseen the successful completion of 150 postgraduate projects and 07 doctoral projects, with 12 ongoing doctoral projects. In response to evolving industry demands and regulatory requirements, the department initiated an M. Pharm program in Regulatory Affairs in 2020. Furthermore, in 2022, department started certificate course titled “Quality Technolatory,” further enhancing its educational offerings and industry relevance.

A Pass in the following examinations

a) B. Pharm Degree examination of an Indian university established by law in India from an institution approved by Pharmacy Council of India and has scored not less than 55 % of the maximum marks (aggregate of 4years of B. Pharm.)

b) Every student, selected for admission to post graduate pharmacy program in any PCI approved institution should have obtained registration with the State Pharmacy Council or should obtain the same within one month from the date of his/her admission, failing which the admission of the candidate shall be cancelled.

Note: It is mandatory to submit a migration certificate obtained from the respective university where the candidate had passed his/her qualifying degree (B. Pharm.) Proficiency in the English language may be required for international applicants.

Graduates of the M. Pharm in Regulatory affairs have a wide range of career opportunities in the pharmaceutical industry, research institutions, regulatory agencies, and healthcare sectors. Some potential career paths and roles include:

• Formulation Scientist/Development Chemist: Designing and developing pharmaceutical formulations and drug delivery systems.
• Regulatory Affairs Specialist/Manager: Managing regulatory submissions, ensuring compliance with regulatory requirements, and navigating the regulatory approval process for pharmaceutical products.
• Quality Assurance/Quality Control Manager: Ensuring compliance with quality standards and implementing quality control measures in pharmaceutical manufacturing.
• Research Scientist: Conducting research on drug formulation, drug delivery systems, and regulatory aspects of pharmaceutical development.
• Pharmaceutical Consultant: Providing expertise and consultancy services on pharmaceutical formulation, regulatory affairs, and quality assurance to pharmaceutical companies and healthcare organizations.
• Academician/Researcher: Pursuing further studies or engaging in academic research and teaching in universities and research institutions.

Course of study

Semester I

Course Code	Course	Credit Hours	Credit Points	Hrs./w k	Marks
MPH101T	Modern Pharmaceutical Analytical Techniques	4	4	4	100
MPH102T	Drug Delivery System	4	4	4	100
MPH103T	Modern Pharmaceutics	4	4	4	100
MPH104T	Regulatory Affair	4	4	4	100
MPH105P	Pharmaceutics Practical I	12	6	12	150
	Seminar/Assignment	7	4	7	100
Total		35	26	35	650

Semester II

Course Code	Course	Credit Hours	Credit Points	Hrs./w k	Marks
MPH201T	Molecular Pharmaceutics (NanoTech and Targeted DDS)	4	4	4	100
MPH202T	Advanced Biopharmaceutics & Pharmacokinetics	4	4	4	100
MPH203T	Computer Aided Drug Delivery System	4	4	4	100
MPH204T	Cosmetic and Cosmeceuticals	4	4	4	100
MPH205P	Pharmaceutics Practical II	12	6	12	150
	Seminar/Assignment	7	4	7	100
Total		35	26	35	650