M.Pharm in Drug Regulatory Affairs (DRA) is a 2-year PG program that provides a higher level of education and training in navigating the environment of the pharmaceutical industry. The course focuses on compliance and drug approvals. Candidates with a Bachelor’s degree in Pharmacy can apply for the MPharma course. Along with it, candidates must have a valid score in exams like CUET PG, GPAT, etc.
Some of the top institutions are JSS College of Pharmacy, SVKM`s Narsee Monjee Institute of Management Studies, S.R.M. Institute of Science and Technology, Maharshi Dayanand University, Amity University, etc. After an M.Pharm in Drug Regulatory Affairs, the graduates can work as Regulatory Affairs Specialist, Regulatory Affairs Executive, Regulatory Affairs Officer, etc. The average salary ranges between INR 4-15 LPA, depending on job roles and experience level.
- M.Pharm Drug Regulatory Affairs Course Highlights
- Why study M.Pharm Drug Regulatory Affairs?
- M.Pharm Drug Regulatory Affairs Eligibility Criteria
- M.Pharm Drug Regulatory Affairs Admission Process 2025
- M.Pharm Drug Regulatory Affairs Entrance Exams
- Top Colleges in India for M.Pharm Drug Regulatory Affairs
- M.Pharm Drug Regulatory Affairs Syllabus
- M.Pharm Drug Regulatory Affairs Jobs and Salary
- M.Pharm Drug Regulatory Affairs FAQs
M.Pharm Drug Regulatory Affairs Course Highlights
The table below highlights the M.Pharma Drug Regulatory Course details:
Category | Details |
Course Name | Master of Pharmacy in Drug Regulatory Affairs
(M Pharm DRA) |
Level of Study | Post-Graduate/Master’s |
Duration | 2 years |
Eligibility Criteria | Bachelor's degree in Pharmacy with 50-55% from a PCI recognised institution |
Entrance Exams | GPAT, CUET-PG, AP PGECET, TS PGECET, MET |
Admission Process | Entrance-Based |
Course Fee | INR 50,000 - INR 5,00,000 |
Average Salary | INR 4-15 LPA |
Job Roles | Regulatory Affairs Specialist, Regulatory Affairs Executive, Regulatory Affairs Manager, R&D Head- Pharmaceuticals |
Why study M.Pharm Drug Regulatory Affairs?
A few reasons to pursue an M Pharmacy in Drug Regulatory Affairs are listed below:
- Career Opportunities throughout the World - Knowledge of the international regulatory systems- FDA, EMA, and CDSCO, will allow job opportunities in many countries.
- Diverse Career Pathways - Graduates can be employed in regulatory affairs, quality assurance, clinical research, pharmacovigilance, or intellectual property.
- Patient Safety and Compliance - Proper understanding of regulations is a prerequisite to ensuring the safety and efficacy of medicines that are of good quality.
- Pharmaceutical Sector Growth - The demand keeps increasing for more regulatory professionals with growing drug developments coupled with stringent regulations.
- Interaction with Multiple Departments - Regulatory affairs professionals work closely with R&D, manufacturing, legal, and marketing, thereby resulting in a vibrant career.
- After completing M.Pharm Drug Regulatory Affairs, one can pursue higher education in PhD in Pharmaceutics.
M.Pharm Drug Regulatory Affairs Eligibility Criteria
The eligibility criteria for taking admission in the M.Pharm Drug Regulatory Affairs course are as follows:
- Passed Bachelor’s Degree in Pharmacy (B.Pharm.) with 50-55% marks from a Pharmacy Council of India (PCI) approved institution.
- Qualification in the applicable entrance examination.
M.Pharm Drug Regulatory Affairs Admission Process 2025
The admission process for the M.Pharm Drug Regulatory Affairs course at SVKM`s NMIMS (Mumbai) is as follows:
- Candidates must register and fill out the application form along with the application fee of INR 2500 for the M.Pharm in DRA course available on the college website.
- Candidates who have registered successfully will receive a call letter for a personal interview.
- Candidates must download the call letter and upload the specified documents mentioned in the application form. Failing to do so will result in the cancellation of the application.
- Candidates must carry any one requisite original ID proof (Aadhar Card/Voter ID/PAN Card/DL/Passport/College ID) for appearing for the personal interview.
- The college will release a merit list of shortlisted candidates after the personal interview.
- Candidates who have given and qualified for the GPAT exam will be given additional weightage of 10 marks. So it is better to register for the GPAT exam and appear as scheduled.
- Selected candidates will be called for admission counselling as per the merit list. On the day of counselling, the eligible candidates will be admitted as per merit and availability of seats.
- Candidates who have been granted a seat will then have to pay the 1st year program fee to confirm their admission in the M.Pharm DRA course.
- After this, they can join the course when the new session begins.
Candidates interested in the technical side of the pharma industry can consider the M.Tech in Pharmaceutical Technology program as an alternative path.
M.Pharm Drug Regulatory Affairs Entrance Exams
The entrance exams for enrolling on the M Pharmacy Drug Regulatory Affairs courses are given below:
Entrance Exams | Registration Date | Exam Date | Application Fee |
GPAT 2025 | Apr 1 to 21, 2025 | May 25, 2025 | INR 3500 (Gen/OBC/EWS)
INR 2500 (SC/ST/Pwd/TG) |
AP PGECET 2025 | April 30, 2025 | June 6 to 8, 2025 | INR 1200 (UR)
INR 900 (BC/EWS)
INR 700 (SC/ST) |
TS PGECET 2025 | May 19, 2025 | June 16 to 19, 2025 | INR 1100 (Gen)
INR 600 (SC/ST/PwD) |
MET 2025 | April 20, 2025 (Phase 2) | May 12, 2025 (Phase 2)
[tentative] | INR 600 (All Courses)
INR 1400 (Selected Courses) |
CUET PG 2026 | February 2026 | March 2026 | INR 1400 (Gen)
INR 1200 (OBC/EWS)
INR 1100 (SC/ST/TG)
INR 1000 (PwD) |
Top Colleges in India for M.Pharm Drug Regulatory Affairs
Some of the top M.Pharm Drug Regulatory Affairs Colleges in India are listed below:
NIRF 2024 (Pharmacy) | Institutes | Total Course Fee |
4 | JSS College of Pharmacy, Ooty | INR 3,06,150 |
6 | JSS College of Pharmacy, Mysore | INR 3,06,150 |
10 | SVKM`s Narsee Monjee Institute of Management Studies (NMIMS), Mumbai | INR 3,02,000 |
11 | S.R.M. Institute of Science and Technology, Chennai | INR 4,00,000 |
16 | Delhi Pharmaceutical Sciences and Research University, Delhi | INR 2,40,000 |
22 | Amity University, Gautam Buddha Nagar | INR 2,70,000 |
38 | Maharshi Dayanand University, Rohtak | INR 62,000 |
47 | Parul University, Vadodara | INR 2,55,780 |
67 | Krishna Vishwa Vidyapeeth, Karad | INR 3,20,000 |
68 | M.S. Ramaiah University of Applied Science, Bengaluru | INR 5,00,000 |
70 | Gujarat Technological University, Ahmedabad | INR 50,000 |
74 | Guru Nanak Institute of Pharmaceutical Science and Technology, Kolkata | INR 3,30,700 |
88 | Kakatiya University, Warangal | INR 80,000 |
M.Pharm Drug Regulatory Affairs Syllabus
The MPharm in Drug Regulatory Affairs syllabus at Maharshi Dayanand University is given below:
Semester 1 | Semester 2 |
Good Pharmaceutical Practices | Documentation and Regulatory Writing |
Pharmaceutical Regulations in India | Biologicals Regulations |
International Pharmaceutical Regulations I | International Pharmaceutical Regulations II |
Clinical Research Regulations | Medical Device Regulations |
Pharmaceutical Regulatory Affairs Practical I | Pharmaceutical Regulatory Affairs Practical II |
Seminar /Assignment | Seminar /Assignment |
Semester 3 | Semester 4 |
Research Methodology and Biostatistics | Journal Club |
Journal Club | Discussion / Presentation
(Proposal Presentation) |
Discussion / Presentation
(Proposal Presentation) | Research work and Colloquium |
Research work | - |
M.Pharm Drug Regulatory Affairs Jobs and Salary
Some of the jobs available for M.Pharm in Drug Regulatory Affairs graduates have been mentioned below, along with the average salary:
Job Title | Recruiters | Average Salary |
Regulatory Affairs Specialist | Maerck Group/Medtronic/Coral Drugs/Symbiotech Pharmalab | INR 4-5 LPA |
Regulatory Affairs Manager | Lilly/Bayer/Medyur Pharma Ltd./Abbott Laboratories | INR 8-10 LPA |
R&D Head-Pharmaceuticals | Ideal Crew Technology/Agios Pharmaceuticals/Teva Pharmaceuticals | INR 12-15 LPA |
M.Pharm Drug Regulatory Affairs FAQs
What does Drug Regulatory Affairs do for the pharmaceutical sector?
Drug Regulatory Affairs ensures that pharmaceutical products are assessed for safety, efficacy, and quality according to both national and international standards before market authorisation. It also regulates the documentation, labelling, and clinical data. This group of professionals serves as a link between the pharmaceutical companies and the regulatory authorities.
How does Drug Regulatory Affairs influence drug development?
The Drug Regulatory Affairs assists companies in sifting through the legal and regulatory obligations such that the overall approval process is smooth, the timelines are reduced, and standards are adhered to internationally in case of pharmaceutical requirements. Regulatory strategy is integrated from development to commercialisation. This will facilitate market entry while mitigating the risk of non-compliance.
What will the career opportunities be after completing M-Pharma in Drug Regulatory Affairs?
The graduates can work as Regulators, as Quality Assurance Managers, or also Drug Safety Associates, among others. These would include the pharmaceutical companies, CROs, and regulatory bodies, where one finds excellent career growth both in the country and abroad.
Is M.Pharm in Drug Regulatory Affairs ideal for fresh pharmacy graduates?
Yes, it is well suited for pharmacy graduates who are interested in compliance, regulations, and drug approval processes. The curriculum imparts knowledge of comprehensive regulatory affairs along with an overview of world laws in the pharmaceutical space and regulatory framework, thus leading to a cherished career in the regulations and compliance domain.
