M.Pharma Drug Regulatory Affairs is a two-year course. The drug Regulatory Affairs postgraduate course will enable you to enter a niche career in the Healthcare or Pharmaceutical sector. This program prepares students for academic and managerial positions in the pharmaceutical industry. The curriculum emphasizes critical thinking and leadership in a healthcare environment.
This course deals with comprehensive knowledge of all the important aspects of Regulatory and Quality Compliance in the pharmaceutical industry. The course will also cover pharmaceutical regulatory affairs, national and international drug approvals, and more so that the students will be competent specialists in the field.
M.Pharma Drug Regulatory Affairs Highlights
Course Level |
Post Graduation |
Full-Form |
M.Pharma Drug Regulatory Affairs |
Duration |
2 Years |
Eligibility |
MBBS/ BDS/ BAMS/ BHMS/ BUMS/ B.Pharma/ BVSc/ BSc Life Sciences/ BSc Biology/ BSc Biochemistry/ BSc Nursing/ BMLT/ BPT/ BTech (Bio-Tech.) with minimum 55% marks |
Admission Process |
Merit or Entrance Based |
Average Salary |
INR 3 LPA - INR 5 LPA |
Job Profiles |
Researcher in the laboratory, Academician, Assistant Lab Technician, Immunologist, Neuroscientist, Endocrinologist etc |
Top Recruiters |
Clinical Laboratories, Medical Colleges or Universities, Hospitals, Medical Research Units, Biotechnological Companies, Pharmaceuticals Industry etc |
Eligibility Criteria for M.Pharma Drug Regulatory Affairs
1. The interested candidate must have an undergraduate degree that is a minimum of 3 years with at least 50 percent marks in aggregation, from a recognized educational institution.
2. The candidate must have studied any of the following subjects: Botany, Chemistry, Physics, Biology, Zoology, Biotechnology, Biochemistry, Pharmacy, Medical Sciences, Agriculture, Ayurveda, Applied Sciences, and B.Sc., Management, among others.
3. Work experience is preferred by a few institutions but is not compulsory.
Admission Process
1. Colleges publish admission notices on their website from June when most Indian universities would have finished degree exams.
2. Candidate to apply for each college, as each college considers each mark the cut-off mark.
3. Some private colleges and deemed universities perform their counselling process by conducting their university-level entrance exams.
4. Some colleges require a minimum of 50% aggregate in the qualifying examination.
5. Candidates who qualify for the test are called for an interview before the final seat allotment.
6. Paramedical Admission is done on the basis of both Entrance Exams as well as the basis of Merit. Various Entrance Exams such as UPSEE, GPAT, NEET etc are conducted to enrol students for Paramedical courses.
Career after M.Pharma Drug Regulatory Affairs
M.Pharm in Drug Regulatory Affairs impart knowledge about different areas of the pharmaceutical industry such as drug discovery, validation, drug development procedure, medical devices, analytical methods, water, sterile and non-sterile facilities, Non-Clinical drug development and clinical trials, Generic Drug Development Process, Process validation of APIs and finished products, drug laws, GLP, CGP, etc.
Candidates can work with international, national, and local stakeholders to improve the safety and effectiveness of pharmaceutical products. This master's degree program in drug regulatory affairs combines technical skills with business skills and is ideal for those seeking a non-clinical career in the pharmaceutical industry.
M.Pharma Drug Regulatory Affairs Syllabus
Semester 1 |
Semester 2 |
Pharmaceutical Regulatory Affairs |
International Regulatory Affairs |
National Regulatory Affairs |
Clinical Trials and Healthcare Policies |
Drug Approval and International Drug Regulations |
Modern Analytical Techniques |
Pharmaceutical Regulatory Affairs Lab |
International Regulatory Systems Lab |
Modern Analytical Techniques |
Controlled Drug Delivery System Lab and their regulatory aspects |
National Regulatory Affairs Lab |
Clinical Trials and Healthcare Policies Lab |
Drug Approval and International Drug Regulations Lab |
Behavioural Science |
Modern Analytical Techniques Lab |
Communication Skill |
Communication Skill |
- |
Semester 3 |
Semester 4 |
Biostatistics and Computer Applications |
Major Project Experimental and thesis |
GLP, GMP, Quality Assurance and Validation |
Major Project Thesis Presentation and Viva Voce |
Biostatistics and Computer Application |
Professional Competencies and Career Development |
Communication Skill |
- |
Behavioural Science |
- |
Major Project Protocols and Synopsis |
- |