M.Pharm in Drug Regulatory Affairs (DRA) is a 2-year postgraduate degree that provides a higher level of education and training in navigating the complex regulatory environment of the pharmaceutical industry, especially focusing on compliance and drug approvals.
The eligibility criteria for enrolling on the M.Pharm Drug Regulatory Affairs course is to pass Bachelor’s Degree in Pharmacy (B.Pharm.) with 50-55% marks from Pharmacy Council of India (PCI) approved institution. Along with it, candidates may need to qualify an applicable entrance examination.
The average course fee for studying M.Pharm in Drug Regulatory Affairs in India ranges between INR 50,000-5,00,000. 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, Delhi Pharmaceutical Sciences and Research University, Maharshi Dayanand University, Amity University, and M.S. Ramaiah University of Applied Science.
M.Pharm in Drug Regulatory Affairs graduates can work at various positions in the Pharma sector. Some of the common job roles are Regulatory Affair Specialist, Regulatory Affair Executive, Regulatory Affairs Manager, Regulatory Affairs Officer, R&D Head-Pharmaceuticals. They can earn an average salary of INR 4-15 LPA depending on job roles and experience level.
M.Pharm Drug Regulatory Affairs: Course Highlights
| 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 PCI recognised institutionQualify entrance examination |
| Entrance Exams | GPAT, CUET-PG, AP PGECET, TS PGECET, MET |
| Admission Process | Entrance-Based |
| Course Fee | INR 50,000 - INR 5,00,000 |
| Colleges | JSS College of Pharmacy, SVKM`s Narsee Monjee Institute of Management Studies, S.R.M. Institute of Science and Technology, Delhi Pharmaceutical Sciences and Research University, Maharshi Dayanand University, Amity University, M.S. Ramaiah University of Applied Science, Gujarat Technological University, Krishna Vishwa Vidyapeeth |
| Average Salary | INR 4-15 |
| Job Roles | Regulatory Affair Specialist, Regulatory Affair Executive, Regulatory Affairs Manager, Regulatory Affairs Officer, R&D Head-Pharmaceuticals |
Why study M.Pharm Drug Regulatory Affairs?
Pursuing an M.Pharm in Drug Regulatory Affairs (DRA) presents numerous advantages, here are several key reasons for choosing this specialization:
- High Industry Demand – The necessity for regulatory compliance is paramount in the pharmaceutical field, leading to a strong demand for DRA professionals globally.
- Global Career Opportunities – Familiarity with international regulatory systems (FDA, EMA, CDSCO, etc.) creates job opportunities across various countries.
- Diverse Career Paths – Graduates can pursue careers in regulatory affairs, quality assurance, clinical research, pharmacovigilance, and intellectual property rights.
- Ensuring Patient Safety & Compliance – A solid grasp of regulations is essential for guaranteeing that medications are safe, effective, and of superior quality.
- Growing Pharmaceutical Sector – With the rise in drug development and more stringent regulations, the demand for regulatory professionals continues to grow.
- Interaction with Multiple Departments – Experts in regulatory affairs work closely with R&D, manufacturing, legal, and marketing teams, resulting in a vibrant career.
- Competitive Salary & Career Growth – Careers in drug regulatory affairs often come with attractive salaries and opportunities for swift career progression.
M.Pharm Drug Regulatory Affairs: Eligibility Criteria
The eligibility criteria for taking admission in M.Pharm Drug Regulatory Affairs course are as follows:
- Passed Bachelor’s Degree in Pharmacy (B.Pharm.) with 50-55% marks from Pharmacy Council of India (PCI) approved institution.
- Qualification in applicable entrance examination.
M.Pharm Drug Regulatory Affairs: Entrance Exams
The entrance exams for enrolling into M.Pharm Drug Regulatory Affairs course are given below:
| Entrance Exams | Level | Registration Date | Exam Date | Application Fee |
|---|---|---|---|---|
| GPAT 2025 | National | 1-21 Apr 2025 | 25 May 2025 | INR 3500 (Gen/OBC/EWS)INR 2500 (SC/ST/Pwd/TG) |
| CUET-PG 2025 | National | 2 Jan-8 Feb 2025 | 13 Mar-1 Apr 2025 | INR 1400 (Gen)INR 1200 (OBC/EWS)INR 1100 (SC/ST/TG)INR 1000 (PwD) |
| AP PGECET 2025 | State | Mar-Apr 2025 | 5–7 Jun 2025 | INR 1200 (UR)INR 900 (BC/EWS)INR 700 (SC/ST) |
| TS PGECET 2025 | State | 17 Mar–19 May 2025 | 16–19 Jun 2025 | INR 1100 (Gen)INR 600 (SC/ST/PwD) |
| MET 2025 | University | 1 Feb-15 Mar 2025 (Phase 1)30 Mar-20 Apr 2025 (Phase 2) | 18,19 Apr 2025 (Phase 1)12 May 2025 (Phase 2)[tentative] | INR 600 (All Courses)INR 1400 (Selected Courses) |
M.Pharm Drug Regulatory Affairs: Colleges and Fees
Some of the top M.Pharm Drug Regulatory Affairs Colleges in India are listed below:
| Institutes | NIRF (Pharmacy) | Course Fee |
|---|---|---|
| JSS College of Pharmacy, Ooty | 4 | INR 3,06,150 |
| JSS College of Pharmacy, Mysore | 6 | INR 3,06,150 |
| SVKM`s Narsee Monjee Institute of Management Studies (NMIMS), Mumbai | 10 | INR 3,02,000 |
| S.R.M. Institute of Science and Technology, Chennai | 11 | INR 4,00,000 |
| Delhi Pharmaceutical Sciences and Research University, Delhi | 16 | INR 2,40,000 |
| Amity University, Gautam Buddha Nagar | 22 | INR 1,38,000 (ns)INR 2,70,000 (s) |
| Maharshi Dayanand University, Rohtak | 38 | INR 62,000 |
| Parul University, Vadodara | 47 | INR 2,55,780 |
| Krishna Vishwa Vidyapeeth, Karad | 67 | INR 3,20,000 |
| M.S. Ramaiah University of Applied Science, Bengaluru | 68 | INR 5,00,000 |
| Gujarat Technological University, Ahmedabad | 70 | INR 50,000 |
| Guru Nanak Institute of Pharmaceutical Science and Technology, Kolkata | 74 | INR 3,30,700 |
| Kakatiya University, Warangal | 88 | INR 80,000 |
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 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 cancellation of 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 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 counseling as per merit list. On the day of counseling the eligible candidates will be admitted as per merit, and availability of seats.
- Candidates who have got a seat, will then have to pay the 1st year program fee for confirming their admission in the M.Pharm DRA course.
- After this, they can join the course when the new session begins.
M.Pharm Drug Regulatory Affairs: Syllabus
The syllabus for M.Pharm Drug Regulatory Affairs at Maharshi Dayanand University, (Rohtak) 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 Affair 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 is the function of Drug Regulatory Affairs in the pharmaceutical sector?
Drug Regulatory Affairs guarantees that pharmaceutical products meet both national and international standards, ensuring their safety, effectiveness, and quality prior to market authorization.
In what way does Drug Regulatory Affairs influence drug development?
It assists companies in navigating legal and regulatory obligations, facilitating a smoother approval process, minimizing delays, and ensuring adherence to global pharmaceutical regulations.
Which international regulatory bodies hold significance in this area?
Major organizations include the FDA (USA), EMA (Europe), CDSCO (India), MHRA (UK), TGA (Australia), and WHO, each establishing specific criteria for drug approval.
How does Drug Regulatory Affairs enhance patient safety?
It imposes rigorous quality control measures, keeps track of adverse reactions, and guarantees that only safe and effective medications are accessible to patients.
What essential skills are necessary for a career in Drug Regulatory Affairs?
Critical thinking, meticulous attention to detail, familiarity with pharmaceutical regulations, proficiency in documentation, and a solid grasp of regulatory standards are vital.
