M.Pharm (Drug Regulatory Affairs)
Pursue the M.Pharm in Drug Regulatory Affairs at Indira University and become the link between pharmaceutical innovation and global compliance, to safeguard public health.
Study Mode
Full Time
Duration
2 Years
Commencement Month
July, 2026
Assessment
Continuous Internal Assessment (CIA) + End-Semester University Examination
Location
Indira University, Tathawade , Pune
Overview
The M. Pharm in Drug Regulatory Affairs is a two-year postgraduate program designed to prepare students for careers in the domestic and global pharmaceutical regulatory ecosystem. The curriculum provides in-depth knowledge of drug regulatory affairs, including drug development, regulatory documentation, dossier preparation, compliance systems, clinical research regulations, regulations in India, and global approval pathways in the USA, Europe, Australia, Japan, and emerging markets.
The program integrates scientific understanding with regulatory policy, ethics, and quality systems to ensure that graduates can successfully navigate product registration, regulatory submissions, audits, and post-marketing surveillance. With a strong focus on practical learning, students engage in professional regulatory case studies, documentation exercises, and industry-driven projects, shaping them to contribute effectively to pharmaceutical innovation, safety, and compliance.
Why pursue M.Pharm (Drug Regulatory Affairs) program with Indira University?
Overview
M. Pharm in Drug Regulatory Affairs program blends classroom learning with practical exposure to regulatory documentation, dossier preparation, case analysis, and compliance systems. Students gain experience through workshops, mock audits, hands-on CTD/eCTD compilation, and training in GMP, GCP, and pharmacovigilance. Exposure visits to pharma industries, regulatory departments, and quality assurance units help students understand real-world regulatory challenges. Interactive teaching, seminars, and industry interactions ensure holistic learning and professional readiness. The curriculum also emphasizes problem-solving and ethical decision-making to prepare students for leadership roles in the pharmaceutical domain.
Pedagogy
Teaching methodology in the drug regulatory affairs course includes interactive lectures, demonstrations, and structured workshops on dossier preparation, regulatory writing, and global regulatory pathways. Students undergo hands-on training in CTD/eCTD structure, validation documentation, GMP audits, and clinical trial regulatory submissions. Problem-based learning, regulatory case studies, and simulation exercises help develop analytical and decision-making skills. Coursework is supported by assignments, presentations, viva voce, and continuous internal assessments. Research methodology and dissertation work further strengthen scientific inquiry, documentation skills, and professional communication expected in regulatory agencies and the pharmaceutical industry.
Key Points:
- Interactive lectures and demonstrations
- Structured workshops and practical training
- Problem-based learning
- Real-world regulatory case discussions
- Simulation activities
- Continuous internal assessment
- Research methodology and dissertation-based learning
Industry Immersion
Pharm in Drug Regulatory Affairs in the School of Pharmacy bridges academic learning with real-world experience, offering students exposure to professional environments. It cultivates practical skills, builds industry networks, and enhances job readiness by involving participants in live projects, mentoring, and daily operations within their chosen field. This year, internships in the regulatory or quality assurance departments of partnered pharmaceutical companies are planned with hands-on tasks including dossier support, compliance documentation, and regulatory submissions.
Mprex Healthcare Pvt Ltd
Mprex Healthcare Pvt Ltd engages with students through knowledge-sharing initiatives. The focus lies on exposing students to the pharmaceutical industry’s operational, regulatory, and marketing frameworks. Experts provide insights into drug development, compliance, and innovation, enriching academic learning with applied industry perspectives.
Clinovi Research Pvt Ltd
Clinovi Research offers structured training and internship programs focused on clinical research and regulatory affairs. These initiatives help students grasp research protocols, ethics, and industry operations. The organization also supports placement efforts, equipping students with professional experience and connections crucial for a successful career start.
Intellectual Property Intellectual Services
This firm emphasizes research, training, and tech-enabled services in the field of intellectual property. Students explore areas like patent analysis, regulatory documentation, and tech integration. The collaboration enhances their understanding of innovation protection, legal frameworks, and strategic development within the pharmaceutical and healthcare industries.
Exposure Trips
As part of their experiential learning, students participated in trips, gaining firsthand insights into media innovations, industry trends, and emerging technologies, bridging academic knowledge with real-world experience in the dynamic field of media. This year, there are planned visits to manufacturing units so that the students can observe GMP operations, quality systems, and regulatory documentation processes.
IIPC (Industry Institute Partnership Cell)
At the School of Pharmacy, we organize regular visits to industrial manufacturing plants to provide students with firsthand insights into Good Manufacturing Practices (GMP). We offer opportunities for collaborative research projects and internships, ensuring hands-on exposure to real-world industry practices. To foster skill development beyond textbooks, our curriculum includes value-added programs and certification courses. Additionally, we have signed MOUs with various industries to ensure students receive the mentorship and guidance essential for their professional growth.
EDC (Entrepreneurship Development Cell)
We provide extensive entrepreneurial exposure through awareness camps, development programs, and skill-building sessions. Guest lectures focused on the pharma business, along with face-to-face interactions with successful entrepreneurs, enrich students’ perspectives. Through workshops, webinars, industrial visits, and personalized mentorship, we foster strong industry-institute collaboration and guide students toward innovative, industry-ready mindsets and entrepreneurial success.
Overview
Graduates can pursue careers in regulatory affairs, clinical research, pharmacovigilance, drug safety, quality assurance, quality control, documentation, and global product submissions. With the increasing demand for compliant manufacturing and regulatory oversight, the program opens opportunities in pharmaceutical companies, biotech firms, CROs, regulatory consultancies, and government agencies. Skills gained in the M.Pharm in Drug Regulatory Affairs program include dossier writing, regulatory strategy, audit readiness, and lifecycle management, preparing graduates to support product approvals, compliance, and post-market surveillance.
The career opportunities for M. Pharm in Drug Regulatory Affairs graduates include:
Regulatory Affairs Associate
Regulatory Affairs Manager
Drug Safety Specialist
Pharmacovigilance Associate
Quality Assurance Executive
Quality Control Officer
Clinical Research Associate
Medical Writing Executive
Documentation Executive
Dossier Specialist
Validation Officer
Product Registration Executive
Compliance Officer
Intellectual Property Analyst
Regulatory Consultant
Overview
The application process at Indira University is designed to be straightforward and transparent. Each stage, from filling out the application form to final submission, is clearly outlined, providing applicants with a seamless and hassle-free experience as they apply to various programs.
Candidate should have passed a B.Pharm degree examination of an Indian university establish by law in India from an institution approved by Pharmacy council of India and has scored not less than 55% of maximum marks (Aggregate of Four year of B. Pharm)
Provided that –
- There shall be reservation of seats for the students belonging to the Scheduled Castes, Scheduled Tribes and Other Backward Classes in accordance with the instructions issued by the Central Government/State Government/Union Territory Administration, as the case may be, from time to time.
- For SC/ST candidates the prescribed percentage of marks will be 50% of the maximum marks (aggregate of four years of B. Pharm).
- Every student, selected for admission to postgraduate pharmacy course in any of the pharmacy institution in the country should have obtained Registration with the State Pharmacy Council or should obtain the same within one month from the date of his admission, failing which the admission of the candidate shall be cancelled.
- Students must have B Pharmacy degree from an institution approved by the Pharmacy Council of India under section 12 of the Pharmacy Act.
And
Obtained Non zero score in Graduates Pharmacy Aptitude Test (GPAT)/ Indira CET (PG)
Our Scholarships
At Indira University, we believe that quality education should be accessible to all. To support students from economically challenged backgrounds, we offer a variety of scholarships. These scholarships help reduce financial burdens, allowing deserving students to focus completely on their learning and personal growth. By providing this support, we enable students to build a solid foundation for a successful future, ensuring that financial constraints never come in the way of their education and aspirations.
M.Pharm in Drug Regulatory Affairs focuses on drug approval processes, regulatory documentation, compliance with national and international drug laws, and pharmaceutical regulatory submissions.
Candidate should have passed 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 maximum marks (Aggregate of Four years of B. Pharm) AND Obtained a non-zero score in Graduates Pharmacy Aptitude Test (GPAT)/ Indira CET (PG)
Subjects include Drug Regulatory Guidelines, GMP, GLP, GCP, Regulatory Documentation, Intellectual Property Rights, and global regulatory frameworks.
The field offers strong global career opportunities due to increasing regulatory compliance requirements in pharmaceutical exports and international drug markets.
Salaries are competitive, especially in multinational pharmaceutical companies, with higher growth potential as regulatory expertise and experience increase.
Yes, regulatory professionals are in demand globally, particularly in the USFDA, EMA, and international compliance-focused pharmaceutical organizations.
Regulatory Affairs Executive, Compliance Manager, Drug Safety Associate, Regulatory Consultant, and Documentation Specialist.
Fees Structure SOP for the Academic Year 2026-2027
| FEES STRUCTURE SOP FOR THE ACADEMIC YEAR 2026-2027 | ||||||||
|---|---|---|---|---|---|---|---|---|
| Sr. No. | Name of the Program | Level | Specialization Options | Duration (Years) | Intake | Tuition Fees (₹) | Development Fees (₹) | Total Fees Per Year (₹) |
| 1 | B. Pharmacy | UG | Pharmaceutical Sciences | 4 Years | 60 | 1,71,000.00 | 19,000.00 | 1,90,000.00 |
| 2 | B. Pharm. Pharm. Tech. MBA | UG | Pharmaceutical Sciences | 1 & 2 Year | 40 | 2,16,000.00 | 24,000.00 | 2,40,000.00 |
| Pharmaceutical Sciences | 3 & 4 Year | 2,34,000.00 | 26,000.00 | 2,60,000.00 | ||||
| PG | Pharma MBA | 5 Years | 4,50,000.00 | 50,000.00 | 5,00,000.00 | |||
| 3 | M. Pharmacy | PG | Pharmaceutics | 2 Years | 15 | 1,80,000.00 | 20,000.00 | 2,00,000.00 |
| Pharmaceutical Quality Assurance | 2 Years | 15 | 1,80,000.00 | 20,000.00 | ||||
| Pharmacology | 2 Years | 15 | 1,80,000.00 | 20,000.00 | ||||
| Regulatory Affairs | 2 Years | 9 | 1,80,000.00 | 20,000.00 | ||||
| Phyto-Pharmacy and Phyto-medicine | 2 Years | 6 | 1,80,000.00 | 20,000.00 | ||||
| 4 | Pharm. D. (Doctor of Pharmacy) | UG + PG | Pharm. D. | 6 Years | 30 | 2,02,500.00 | 22,500.00 | 2,25,000.00 |
| 5 | Master of Business Administration – Pharma | PG | MBA – Pharmaceutical and Healthcare Management | 2 Years | 60 | 4,50,000.00 | 50,000.00 | 5,00,000.00 |
| 6 | Ph.D. – Doctor of Philosophy | Doctoral | Pharmaceutical Sciences | – | – | – | – | 1,00,000.00 |