Ph. Regulatory Affairs | Hindu College of Pharmacy

Vision

To make Department of Pharmaceutical Regulatory Affairs a center of excellence in the area of academics, research and to be a preferred place of destination to study Pharmaceutical Regulatory Affairs.

Mission

To impart knowledge, analytical thinking, professional ethics and training for students and faculty members in Pharmaceutical Regulatory Affairs. To develop, promote and nurture regulatory activities by way of collaboration and industry-academia interaction pursuing advances in pharmaceutical regulatory sciences.

Intake (M.Pharm) 15 Seats

Level of Study Post Graduate Degree

Mode of Program Credit Based Semester System (CBSS)

Duration 4 Semesters

Established 2010

Batches Completed 12+

About the Department

The Department of Pharmaceutical Regulatory Affairs was established in the year of 2010. It was started as a fifth Post Graduate course in Pharmacy at our college. This department consists of 1 Professor, 4 Assistant Professors as faculty members. After successful completion of the course, till now 12 batches of students have passed out.

Students after completion of M.Pharm (PRA) were placed in various departments of Pharmaceutical Industries such as Regulatory Affairs, Pharmacovigilance, Quality Assurance, Clinical Data Management, SAS programmers, Medical Coders etc. Passed out students from the Department of Pharmaceutical Regulatory Affairs (PRA) were successful in getting the placements in various prestigious companies such as Eli Lilly, Glaxo Smithkline, Hetero Drugs, CDSCO, TATA consultancy services (TCS), Infosys, Mylan Labs, etc., and as Faculty in various reputed Pharmacy Colleges.

Objectives

To prepare professionals for pharmaceutical regulatory affairs positions in the Industry, Academia & Research
To facilitate the students in advancing them in the aspects of Pharmaceutical regulatory affairs knowledge
To provide knowledge in the field of regulatory affairs, as per academic, research & pharmaceutical industrial requirement
To keep track of the ever-changing legislation in all the regions
To update students with thorough knowledge of global laws and regulations, applicable in the various stages of clinical trials, drug development, market authorization approvals across the globe
To facilitate students to work on live projects in pharmaceutical regulatory affairs departments at industries
To provide learning environment for preparing, compiling and submitting required documents as per industry and regulatory authority requirements for the registration of healthcare products

Course Structure

Semester I

MRA 101T — Good Regulatory Practices
MRA 102T — Documentation and Regulatory Writing
MRA 103T — Clinical Research Regulations
MRA 104T — Regulations and Legislation for Drugs & Cosmetics, Medical Devices, Biologicals & Herbals, and Food & Nutraceuticals In India and Intellectual Property Rights
MRA 105P — Regulatory Affairs Practical I

Semester II

MRA 201T — Regulatory Aspects of Drugs & Cosmetics
MRA 202T — Regulatory Aspects of Herbal & Biologicals
MRA 203T — Regulatory Aspects of Medical Devices
MRA 204T — Regulatory Aspects of Food & Nutraceuticals
MRA 205P — Regulatory Affairs Practical II
MPH 104T — Regulatory Affairs (Pharmaceutics I semester)

Eligibility

B.Pharm Degree examinations in an Indian University established by law in India from an institution approved by PCI and has scored not less than 55% of maximum marks (aggregate of 4 years B.Pharm). 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 admission, failing which the admission of the candidate shall be cancelled. Selection Criteria through Merit and written test / personal interview.

Fees

Indian Students: INR Rs. 75,000/- (I Year) and Rs. 75,000/- (II Year) | NRI Candidates: USD 10,820/-

Career Prospects

A graduate in science with a desire to make a difference will find the world of Regulatory Affairs (RA) very rewarding. Regulatory Affairs was introduced by government authorities to monitor and regulate the development, manufacture, testing and marketing of drugs, medical devices, food products, cosmetics and veterinary products. Globalization and the demand for safe medicines and food have spurred the demand for regulatory affairs professionals.

The main function of the regulatory affairs department is to ensure the safety and efficacy of all manufactured medicines, food, devices and cosmetics. A regulatory affairs professional acts as a link between its employer, its product and the regulatory bodies.

Ensuring company's products comply with regulations
Collecting, collating and evaluating scientific data
Preparing submissions for regulatory approval
Advising other departments on regulatory requirements
Providing strategic advice to management for the entire drug development cycle
Pharmaceutical, medical devices, cosmetics and biotechnology companies
Government agencies
Clinical and hospital settings
Clinical Research Organizations involved in new drug/medical device/technology development
Faculty in pharmacy institutions

Department Activities

29/10/2021 — Current USFDA Regulations for Pharmaceuticals and Career Opportunity
21/10/2021 — Quiz Programme and Blood Donation by Bajarang Foundation
12/07/2022 — Career Opportunities for Pharmacy Students in Canada
19/10/2022 — Clean India Programme
02/09/2022 — Behavioral Addiction
02/09/2022 — Career Guidance for Pharmacy Students by Dr KMN Murali Krishna
25/08/2022 — Career Opportunities in Pharmacy — How to Become a Pharma Entrepreneur by B. Praneeth, CEO, Times Pharma
23/07/2022 — Role of Youth, Teachers and Intellectuals in Nation Building
22/06/2022 — Seminar on Attitude for Success
10/11/2022 — Personality Development Programme on behalf of Rastra Sevika Samithi
31/01/2023 — SAS Awareness Programme
06/03/2023 — Celebration of Birth Anniversary of Prof. Mahadeva Lal Schroff
29/03/2023 — Career Opportunities in Ireland for Pharma Graduates
09/06/2023 — Online Workshop on Intellectual Property Rights and Patents and Design Filing
21/08/2023 — Significance of Clinical Writing in Regulatory Approval Process
25/09/2023 — Pharmacist Day Celebrations; Theme Pharmacists Strengthening Health Systems
10/10/2023 — Good Manufacturing Practices to Culture of Quality Moving to the Desired State
10/11/2023 — Career Progression Programme