Master of Pharmacy in Drug Regulatory Affairs is a two years post-graduation course. The M.pharm Drug Regulatory Affairs course educates the students about the important aspects of  Regulatory and Quality Compliance in the pharma industry. 

The M.pharm Drug Regulatory Affairs course can be a good career perspective in the future because the Pharmaceutical Industry in India is expected to grow from USD 42 Billion in 2021 to USD 120-130 Billion by 2030. Also the Pharmaceutical and healthcare sector is expected to see 20% higher hiring in the coming years. 

Students who have graduated in B. Pharm from a recognised  University with a minimum of 50% are eligible to apply for M.Pharm in Drug Regulatory Affairs Course. The admission is done either on the basis merit list or entrance examination. The course fee for M.Pharm in Drug Regulatory Affairs ranges from INR 72,000 to INR 5,20,000.

M.Pharm in Drug Regulatory Affairs impart knowledge about different areas of pharmaceutical industry such as drug discovery, validation, drug development procedure, medical devices, analytical methods, water, sterile and non-sterile facility, Non-Clinical drug development and clinical trials, Generic Drug Development Process, Process validation of APIs and finished products, drug laws, GLP, CGP, etc.

MPharm Drug Regulatory Affair offers the candidates a niche career option. The course enables the candidates to work in the Healthcare and Pharmaceutical industry. The following are the list of top benefits that the candidates can get after the completion of the course.

  • Good Compensation : MPharm in Drug Regulatory Affair earns an average salary of INR 5,21,000 per annum in India. Apart from the salary the candidates are offered  various perks and benefits such as retirement benefits, provident funds, DA and Travelling allowance.
  • Increased Employment Opportunities: Candidates after passing the course are absorbed in the pharmaceutical or healthcare industries, both of them are expected to grow at a rate of 20% in the coming years. According to the India Skills Report 2016, more than 1,34,000 jobs would be generated per year in the  pharmaceutical and  healthcare industry, thus the MPharm Drug Regulatory candidates will have a lot of employment opportunities. 
  • Job security: Candidates who work as a pharmacist or drug regulatory officer have a fairly secure job. For an Industry that is expected to generate over 58,000 new jobs every year, Job security is the last thing that the candidates need to worry about.
  • Students in this course learn about the uses of Pharmacological Screening methods. This enables them to regulate the harmful contents in the drugs and create  safer and efficient drugs for the Population.
  • After understanding the relationship between Pharmaceutical Sciences and the global environment students can make better decisions across the functional areas of the pharma industry.
  • Students can develop and sustain effective individual and organizational performance by leveraging Research skills, Information and Technological competencies in the given Pharmaceutical framework
  • Students can develop positive perspectives and skills that create productive domain leaders and improve health outcomes globally.


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 -


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