Drug Regulatory Affairs Course Eligibility, Admission, Career

M. Pharm. in Drug Regulatory Affairs is a 2-year full-time postgraduate course that focuses on Drug regulations, Drug Safety, and Food Safety. Drug Regulatory Affairs refers to all aspects of the pharmaceutical development process and how they are subject to various degrees of regulation. M. pharma in Drug Regulatory Affairs focuses on the pharmaceutical law frame, guidelines covering Quality, Safety, and Efficacy as well as Health Authorities' attitudes and requirements, etc. This course enables the students to have a great influence on the drug development process and the success of it. Regulatory affairs professionals deal with these aspects. This course focuses on providing knowledge of different drug regulatory affairs, regulatory and quality compliance of different pharmaceutical companies, international and national regulatory affairs. The course also includes substantial project work including patents, thesis, publications, and dissertations, needed to be completed by enrolled students

 

Top Colleges

1. College of Medicine and Health Sciences

2. Nitti Gulabi Shetty Memorial Institute of Pharmaceutical Sciences

3. Indukaka Ipcowala College of Pharmacy

4. AKS University

5. Vijaya College of Pharmacy

6. Maharishi Dayanand University

7. Bharati Vidyapeeth

8. Amity University

9. Manipal University

10. Lovely Professional University

 

Highlights

Course Post Graduate
Duration  2 Years
Examination type Semester type
Eligibility Graduation in any stream, completed from a recognized university, with a minimum aggregate score of 45%
Admission Process Merit-based/ Based on the performance in the entrance exam
Course Fee INR 72,000 to 5,20,000
Average Starting Salary INR 3.5 to 7 lacs per annum
Top Recruiting Companies Sun Pharma, Glanmark, Biocon, GlaxoSmith Pharmaceuticals, and such.

 

Eligibility

Course Duration Eligibility Entrances
M.Pharma in Drug Regulatory Affairs 2 years Graduation in any stream, completed from a recognized university, with a minimum aggregate score of 45% GATE,  MET, BITS HD, PHARMA PG, AU AIMEE, NIPER

 

Top Recruiters

1. Sun Pharmaceutical Industries Limited 

2. Aurobindo Pharma Limited 

3. Lupin Limited 

4. Cipla Limited 

5. Dr. Reddy’s Laboratories 

6. Cadila Healthcare Limited 

7. Intas Pharmaceuticals Limited 

8. Glenmark Pharma Limited 

9. Torrent Pharmaceuticals Limited 

10. ManKind Pharma Limited 

11. Biocon Limited 

12. Piramal Enterprises Limited 

13. Wockhardt Limited 

14. Divis Laboratories Limited 

15. Abbott India Limited 

Admission Process

Admission to the program of M Pharma. in Drug Regulatory Affairs is conducted on the basis of the eligibility criteria as deemed by respective universities. This includes qualifying B.Sc. in Chemistry or equivalent examination with a minimum aggregate of 55% marks and above from a recognized university. However, the admission criteria are subject to vary for different colleges and institutes. Admission to the course is done on a merit basis, however, certain reputed colleges and universities may conduct their own entrance examination in the process of candidate selection. The overall marks obtained in the qualifying examination and entrance tests are thereby calculated to obtain the merit which is subject to differ for various universities.

Candidates can apply for the course both online as well as offline. All information regarding admission dates, counseling and selection of candidates will be notified through email or listed on the official website of the college.

 

Syllabus

Semester 1  Semester 2
Cosmetic Technology Clinical Trials and Healthcare Policies
Natural Products and Herbal Medicines Emerging Concept in Regulatory Affairs
Modern Analytical Technique National Regulatory Affairs
Research Methodology and Pharmacological Screening International Regulatory Systems
Pharmaceutical Regulatory Affairs National and International Drug Approvals and Bioethics
Semester 3 Semester 4
Fundamentals of Medical and Scientific Writing  Quality Assurance GLP GMP and Validation
Pharmaceutical Production and Management  Pharmaceutical Biostatics and Computer Applications
Natural Products and Herbal Medicines Professional Communication Skills
Nutraceuticals  Professional Competencies and Career Development 
  Synopsis

 

Skills

1. Patience

2. Determination

3. Attention to detail and accuracy

4. Analytical skills

5. Scientific skills

6. Ability to work in a team

7. Observation skills

8. Problem-solving skills

Top Entrances

Some colleges and universities have their entrance examination for the course of M. Pharm. in Drug Regulatory Affairs, but even accept the score of national level entrance examinations. Most of the colleges and universities associated with this course prefer the merit basis of selection for the admission process. Some of the top accepted scorecards of the national level entrance exam are as follows:

1. GATE

2. MET

3. BITS HD

4. PHARM PG

5. AU AIMEE

6. NIPER

7. RPET Pharmacy

Career

Job Profiles Description Salary
Drug Safety Specialist Drug Safety Specialists are vital to the pharmaco-vigilance department in operating its daily activities. Essentially, Drug Safety Associates oversee drug-related events to be identified and reported. They are responsible for ensuring that most safety reports received from the investigational sites or from post-marketing sectors are identified and reported in accordance with ICH-GCP standards as also with the standard operational procedures. 6 lacs
Regulatory Affairs Associate The job title ‘Regulatory Affairs Associate’ is used most frequently for entry-level, mid-level, and senior professionals working within the health care products industry. They are responsible for monitoring federal, state, and local government regulations, legislation, and laws that affect their employers' products. They typically assist other employees in steering new products through government-authorized approval processes and watch their organization’s internal procedures to ensure that they conform to government directives. 4 lacs
Drug Inspector Drug Inspectors, also known as Quality Control Inspectors, work to ensure that products are safe for human consumption. Their main responsibility is to examine food or pharmaceuticals at various stages of the manufacturing process in order to ensure that the requisite quality standards are being met 7 lacs
Medical Information Associate Health Information Technicians, these professionals organize and maintain health data in electronic and paper systems within various healthcare settings. They are responsible for reviewing patient records, organizing databases, tracking patient outcomes and protecting patients' health information 3.5 lacs

 

FAQ's

Q: What is the main principle of this course?

A: The main principle of this course is to impart education regarding various  Drug regulations, Drug Safety, and Food Safety. Drug Regulatory Affairs,  pharmaceutical law frame, guidelines covering Quality, Safety, and Efficacy as well as Health Authorities' attitudes and requirements, etc

 

Q: Who are the top recruiters in this field?

A: The top recruiters in this field are:

1. Sun Pharmaceutical Industries Limited 

2. Aurobindo Pharma Limited 

3. Lupin Limited 

4. Cipla Limited 

5. Dr. Reddy’s Laboratories 

6. Cadila Healthcare Limited 

 

Q: What is the duration of this course? 

A: The duration of this course is 2 years.

 

Q: What are the top entrances in this filed?

A: The top entrances in this field are as follows:

1. BITS HD

2. PHARM PG

3. AU AIMEE

4. NIPER

 

Q:  What is the examination type in M. Pharma. Drug Regulatory Affairs?

A: The examination type is a semester-based examination.

 

Q: What are the top colleges for M.Pharma in Drug Regulatory Affairs?

A:  Some of the top colleges are as follows:

1. College of Medicine and Health Sciences

2. Nitti Gulabi Shetty Memorial Institute of Pharmaceutical Sciences

3. Indukaka Ipcowala College of Pharmacy

4. AKS University

5. Vijaya College of Pharmacy

 

Q: What the important skills required in this course?

A: Some of the important skills in this course are as follows:

1. Patience

2. Determination

3. Attention to detail and accuracy

4. Analytical skills

5. Scientific skills

6. Ability to work in a team

7. Observation skills

8. Research skills

10. Problem-solving skills

 

Q: Do we have any specified entrance tests for this course?

A: No, there is no specified entrance exam for this course. Rather many colleges have a merit-based selection process. Some universities and colleges do accept the scorecard of various national level examination.

 

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