SPS
Post Graduate
2 Years
Programme Overview
Masters of Pharmacy in Drug Regulatory Affairs (DRA) is a two-year postgraduate course in the field of Pharmacy. Drug Regulatory Affairs is one of the specializations of the M. Pharmacy course. M Pharm in Drug Regulatory Affairs is is a field in the pharmaceutical industry that combines scientific and legal aspects of drug development. DRA is a vital unit in a pharmaceutical company because it ensures the safety and efficacy of products while also protecting public health. DRA professionals
Programme Objectives
- To ensure that drugs comply with regulations throughout their life cycle. This includes developing regulatory strategies, securing approval for drug submissions, and ensuring regulatory compliance. Ensuring safety and efficacy: Ensuring that drugs and medical devices are safe and effective for their intended use
- Ensuring that drugs and medical devices meet quality and purity requirements
- Ensuring that the appropriate clinical trials are conducted
- Ensuring that drug labels are accurate and up-to-date
- To Develop strategies to ensure regulatory compliance
- Securing approval of drug submissions
- Preparing submissions for regulatory agencies
- Coordinating team activities
- Participating in discussions related to drug regulatory affairs
Programme Outcomes
Students after completion of the course
- Will understand regulatory concepts, write and review regulatory documents.
- Will optimize and maintain regulatory procedures,
- Will develop documentation / research writing expertise,
- Will update knowledge with new legislation in a constantly changing environment,
- Will know the regulatory process in drug development, formulations, novel drug delivery systems and devices.
- Will understand the system for the submission of DMF, e-CTD, Dossier, etc.
- Will understand the marketing authorization, regulatory compliance systems of different countries
- Will do the preparation for audits and inspections,
- Will promote to higher level in RA career ladder and.
Career Path
The topmost career opportunities after M. Pharmacy in Regulatory Affairs include the following:
Pharmacy Benefit Analyst: For a business to go a long way, the client base has to be taken care of. So, the Pharmacy Benefit Analysts conduct regular research to retain the existing clients and work on strategies to rope in the new ones.
They also have the responsibility of updating new benefit plans after communicating with the clients and analyzing the claim processing requests from the clients.
Production and Manufacturing: A student can work in Production department after M.Pharm, where he will be involved with actual manufacturing of different herbal dosage forms
- Registration and Regulatory Affairs Head: As mentioned earlier, the pharmaceutical industry is among those which need to be regulated by the government or other agencies. This makes it mandatory for a company to have a registration and regulatory affairs head. The major responsibilities under this designation include filling up the regulatory agencies with the product information and issues. Another role they play here is to coordinate the manufacturing process in such a way that it works within the specified rules and regulations of the legal department staff.
- Pharmacists: There are various degrees that help a candidate become a pharmacist and M. Pharm in Pharmaceutical and Regulatory Affairs is one of them.
- Senior Quality Executive: This job post is one of the senior positions in a pharmacy company. The Senior Quality Executive has to keep a continuous check on the working standards of the company. They have to make sure that with efficient working, the quality is not being compromised. When it comes to a pharmaceutical company, the emphasis on quality and safety gets doubled.
- Drug Inspector: In the government sector, this is one of the most coveted positions for Pharmacy graduates. If you have completed a degree in any of the streams under Pharmacy, you become qualified for taking the pertinent exam. There is a specific test for drug inspectors and after qualifying that, candidates can take up this position. The best part about this job is that one gets a handsome salary as well as other perks attached to it.
- Food Safety Scientist: In the present times, the foods, as well as eating habits, have changed significantly. A lot of chemicals are being used in the food items and it somehow makes them harmful for human consumption. The responsibility of food safety scientists is to make sure that the food we eat is safe and has no adverse effect on the health whatsoever.
- This is again, one of the most reputed and well-paying career opportunities after M. Pharm in Pharmaceutical Management and Regulatory Affairs.
- Medical Information Associate: The key role of a Medical Information associate includes giving out medical information and addressing the inquiries associated with the same. He or She also has to respond to the queries of the external agencies, government bodies, clients as well as other healthcare practitioners if or when required.
Eligibility Criteria
Minimum percentage and others criteria for admission will be as per UGC/ Concerned Regulatory Bodies.
Provided below are the criteria that need to be met for the given course.
For National Students
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 4 years 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.
- It is mandatory to submit a migration certificate obtained from the respective university where the candidate had passed his/her qualifying degree (B. Pharm.)
For International Students
- Rule framed by University Grants Commission (UGC) and notified in its website www.ugc.ac.in will be followed for deciding the eligibility and admission of International students to various courses offered in Om Sterling Global University, Hisar.
Programme Syllabus
The program of study for Masters of Pharmacy in Drug Regulatory Affairs extends over a period of four semesters (two academic years). The curricula and syllabi for the program prescribed from time to time by Pharmacy Council of India, New Delhi is followed.
Semester I
| S.No. | Subject |
|---|---|
| 01. | Good Regulatory Practices |
| 02. | Documentation and Regulatory Writing |
| 03. | Clinical Research Regulations |
| 04. | Regulations and Legislation for Drugs & Cosmetics, Medical Devices, Biologicals & Herbals, and Food & Nutraceuticals In India and Intellectual Property Rights |
| 05. | Regulatory Affairs Practical I |
| 06. | Seminar/Assignment |
Semester II
| S.No. | Subject |
|---|---|
| 01. | Regulatory Aspects of Drugs & Cosmetics |
| 02. | Regulatory Aspects of Herbal & Biologicals |
| 03. | Regulatory Aspects of Medical Devices |
| 04. | Regulatory Aspects of Food & Nutraceuticals |
| 05. | Regulatory Affairs Practical II |
| 06. | Seminar/Assignment |
Semester III
| S.No. | Subject |
|---|---|
| 01. | Research Methodology and Biostatistics* |
| 02. | Journal club |
| 03. | Discussion / Presentation (Proposal Presentation) |
| 04. | Research Work |
Semester IV
| S.No. | Subject |
|---|---|
| 01. | Journal Club |
| 02. | Research Work |
| 03. | Discussion/Final Presentation |
How to Apply
Any queries you have about the admissions and related matters, you can fill out the Admission Enquiry form; if you are unable to make a decision on deciding the program, book a free tele-counseling session with us; If you are sure about a program you are enrolling for, you can go ahead fill out the online application.
