M.Pharm Drug Regulatory Affairs Course - Admission, Eligibility, Fees, Duration, Syllabus, Job & Salary 2024

M.Pharm Drug Regulatory Affairs Course:

 M.Pharm Drug Regulatory Affairs Course is also known as the Master of Pharmacy in Drug Regulatory Affairs Course. It is a 2-year full-time postgraduation course which is of 4th semesters in total. This course is designed to provide comprehensive knowledge and education regarding the entire Regulatory and quality compliance aspects of the pharmaceutical industry. Students are taught to nurture their knowledge of regulation and compliance and also to build their careers in the same. The ever-changing laws and regulatory affairs have raised the demand of the professionals that can help pharmaceutical companies to launch the product in the market.

M.Pharm Drug Regulatory Affairs Course Suitability:

1. This course is helpful to produce competent professionals in the pharmaceutical regulatory affairs industry.
2. This course will provide you quality inputs to the pharmaceutical regulatory affairs industry and build research writing and documentation expertise in the pharmaceutical regulatory affairs industry.

M.Pharm Drug Regulatory Affairs Course:

This course is beneficial as it deals with the knowledge and the skills of collection, analysis, and communication regarding the risk and benefits of health care products the regulatory agencies and people all over the world.

M.Pharm Drug Regulatory Affairs Course Brief:

Some of the major highlights of the course are enlisted as follows:

Level of the course	Postgraduate Level
Duration of the course	2 years divided into 4 semesters
Type of examination	Semester examination system
Eligibility Criteria	Graduation in the Pharmaceutical stream or preferably science stream, completed from a recognized institute or university, with a minimum aggregate score of 50% or as stated and required by the university.
Process of admission	Merit-based or Based on the performance in the entrance exam
Fees of the course	INR 80,000 to 5,50,000
Approx Starting Salary	INR 3lac to 8 lacs per annum
Top Recruiters or Companies	GlaxoSmith Pharmaceuticals, Cipla, Sun Pharma, Himalaya, Glenmark, Biocon, etc.
Top Recruiting Domains	Pharmaceutical Laboratories, Pharmaceutical companies, overseas firms, clinical research institutes, colleges, universities, etc.
Top Job Designation	Food Safety Scientist, Medical Information Associate, Regulatory Affairs Specialist, Drug Safety Specialist, Regulatory Affairs Associate, Drug Inspector, Quality control Associate, Regulatory Affairs Consultant, among others.

M.Pharma Drug Regulatory Affairs Course Admissions:

Most of the institutes in India offer this course to admit students based on their performance in a relevant entrance test. Some institutes also admit the students based on their obtained marks in the merit at the level of graduation, while some colleges or the universities conduct their own entrance tests for offering admission. The admission process usually varies across colleges as each college has its own admission criteria.

Some of the institutes in the country that conduct entrance tests for admission to the course are:

• College of Medicine & Health Sciences also known as SRM Medical Entrance Exam
• Indukaka Ipcowala College of Pharmacy
• Lovely Professional University
• Bharati Vidyapeeth

M.Pharma Drug Regulatory Affairs Course Fees:

The course fees for the Master of Pharmacy or M.Pharm Drug Regulatory Affairs Course Fees range from INR 80000 to 5.5 Lakh per annum. The fees may vary across the colleges based on the infrastructure and the facilities provided by the college/university.

M.Pharma Drug Regulatory Affairs Course Duration:

• M.Pharma Drug Regulatory Affairs Course Duration is of 2 years and this course is divided into 4 semesters of 6 months each duration. One academic year of the course consists of 2 semesters each.

M.Pharma Drug Regulatory Affairs Course Scope:

The M.Pharma Drug Regulatory Affairs Course Scope is really wide as it produces the trained professionals who can skilfully deliver in job roles such as:

• Regulatory Affairs Expert
• Assistant Project In-Charge
• Assistant Scientist
• Bio-tech expert
• Change Control expert
• Tech Engineer
• Stability Expert
• Medical Affairs Expert
• Research Assistant
• Quality System Engineer
• Quality Assurance Assistant

Professionals involved in Drug Regulatory Affairs constantly interact with other teams in the organization to get documents such as:

• batch records, 
• production equipment information,
• packaging specifications, and 
• technical reports

M.Pharma postgraduates can also traverse teaching as a career option upon the qualification of examinations such as NET, GPAT, & SLET. Karnataka, Andhra Pradesh, Haryana, Gujarat, Madhya Pradesh, Tamil Nadu, Maharashtra, Punjab, Rajasthan, Uttar Pradesh, and Kerala are the States in India to have pharmacy colleges.

Job Designation	Description of the job	Approx.Annual Pay in INR
Drug Safety Expert	Drug Safety Experts are necessary to the pharmaco-vigilance department in performing its daily activities. Basically, Drug Safety Associates supervise drug-related events to be identified & reported. Drug Safety Associates liaise with healthcare aid providers for safety & efficiency aspects. They are accountable for ensuring that most safety reports received from the investigational sites or from post-marketing sectors are recognized and reported in accordance with ICH-GCP standards as also with the standard operational methods.	7.5 lacs
Regulatory  Affairs Assistant	The job title ‘Regulatory Affairs Assistant’ is used most frequently for entry-level, mid-level, &senior professionals functioning within the health care products industry. They are accountable for observing federal, state, & local government regulations, legislation, & laws that affect their employers' products. They basically assist other operators in steering new products through government-authorized permitted processes and watch their organization’s internal systems to ensure that they adhere to government directives. Regulatory Affairs Assistants are usually employed by pharmaceutical or medical device companies, for assisting in attaining government approval for drugs, medical devices, veterinary products, cosmetics, & food products. Regulatory Affairs Assistant occupies one career within the larger regulatory affairs profession, which exists in many industries.	5 lacs
Drug Inspectors	Drug Inspectors known as Quality Control Inspectors, work to guarantee that medical products are safe for human consumption. Their focal job is to examine food or pharmaceuticals at different stages of the manufacturing method in order to ensure that the requisite quality standards meeting. These experts have also held senior positions as consumer safety officers, responsible for implementing safety procedures and designing drug inspection technologies. They require- excellent oral & written communication skills, -problem-solving & decision-making skills, strong operation-monitoring & analytical abilities, & -familiarity with digital imaging, data analysis, &  tolerance analysis software In addition, they must be smart when using the weights, balances, & sorting or grading machines.	8 lacs
Medical Information Assistant	They are also known as Health Information Technicians, these professionals design & maintain health data in electronic & paper systems within several healthcare settings. They are accountable for- reviewing patient records organizing databases tracking patient outcomes and protecting patients' health information Such experts work in hospitals, physicians' offices, residential care facilities, & government agencies. They must hold good clinical knowledge & experience of working in a hospital environment, & research-based roles, besides that therapy-related knowledge that can turn well in the medical information industry.	4.5 lacs

M.Pharm Drug Regulatory Affairs Course Colleges:

M.Pharma Drug Regulatory Affairs Course Colleges are listed below. Some of the top institutes in India that offer this course are as follows:

Name of College	Place	Approx fees
College of Medicine & Health Sciences	Chennai	INR 1,80,000
Nitti  Gulabi Shetty Institute of Pharmaceutical Sciences	Mangalore	INR 1,20,000
Indukaka Ipcowala College	Gujarat	INR 91,000
AKS University	Satna	INR 1,50,000
Vijaya College	Hyderabad	INR 1,20,000
Maharishi Dayanand University	Rohtak	INR 80,000
Ch. Bansilal University	Bhiwani	INR 78,000
Bharati Vidyapeeth	Pune	INR 2,40,000
Amity University	Noida	INR 3,50,000
Manipal University	Manipal	INR 5,50,000
Lovely Professional University	Jalandhar	INR 3,50,000

M.Pharma Drug Regulatory Affairs Course Syllabus:

M.Pharma Drug Regulatory Affairs Course Syllabus is spread over 4 semesters, & essentially proposes to offer to eligible candidates advanced lessons in:

• Regulatory & Quality Compliance in the pharmaceutical industry
• Pharmaceutical Regulatory Affairs
• National & International Drug Approvals and Bio-ethics
• Modern Analytical Procedures
• Research Methodology and Pharmacological Screening
• International Regulatory Systems
• Clinical Trials and Healthcare Policies
• National Regulatory Affairs
• Emerging Concepts in Regulatory Affairs
• Quality Assurance GLP
• GMP and Validation
• Drug Regulatory Affairs
• Intellectual Property Rights and Bioethics
• Pharmaceutical Biostatistics and Computer Applications
• Current regulations &  their practical applications in the development & commercialization of drugs, biologics, & also, related medical devices
• Bringing a medical commodity to market around the globe, from discovery to commercialization.

Laboratory sessions & research in the discipline include the following:

• International Regulatory Systems Lab
• Clinical Trials and Healthcare Policies Lab
• National Regulatory Affairs Lab
• Emerging Concept in regulatory Affairs Lab
• Pharmaceutical Regulatory Affairs Lab
• National and international Drug Approvals and Bio-ethics Lab

Drug Regulatory Affairs is an important constituent of the pharmaceutical industry, since:

• It promotes the Research and  Development initiatives of the company to the market.
• With increasing global competition among pharmaceutical companies, the key to success lies in getting timely marketing approval from the regulatory agencies of the region where the drug is to be sold.

The course also includes important project work including patents, thesis, publications, and dissertations, required to be completed by enrolled students.

A semester-wise bifurcation of the course’s syllabus is tabulated below.

1st Semester	2nd Semester
Cosmetic Technology	Clinical Trials & Healthcare Policies
Natural Products & Herbal Medicines	Emerging Notion in Regulatory Affairs
Modern Analytical Procedures	National Regulatory Affairs
Research Methodology & Pharmacological Screening	International Regulatory Systems
Pharmaceutical Regulatory Affairs	National & International Drug Approvals & Bioethics
3rd Semester	4th Semester
Basics of Medical & Scientific Writing	Quality Assurance GLP GMP & Validation
Pharmaceutical Production & Management	Pharmaceutical Biostatics & Computer Applications
Natural Products & Herbal Medicines	Professional Communication Skills
Nutraceuticals Theory	Professional Competencies & Career Development
-	Synopsis Viva-Voice

M.Pharm Drug Regulatory Affairs Course Jobs:

M.Pharma Drug Regulatory Affairs Course Jobs are enlisted below. M.Pharma Drug Regulatory Affairs postgraduates are hired in capacities such as:

• Regulatory Affairs Adviser
• Regulatory Affairs Expert
• Regulatory Affairs Assistant
• Drug Safety Expert
• Drug Inspector
• Quality control Assistant
• Food Safety Specialist
• Medical Information Assistant

Master of Pharmacy proposes various specializations with which one can choose his most liked field. Master of Pharmacy grants better display to practical skills. It enables one to study Ph.D. (Pharmacy) in:

• Pharmaceutics
• Pharmaceutical Chemistry
• Pharmacology
• Pharmaceutical Marketing & Management

Some of the job sectors which an M.Pharm Candidate can locate are:

• Health care Centres
• Hospitals and medical centers
• Pharmacy Shops
• Drug Control Department
• Pharmaceutical Companies
• Educational colleges and institutes
• Sales & Marketing Department
• Research centers
• Food & Drug Administration

M.Pharma Jobs for Freshers:

Some of the job opportunities for Freshers of M.Pharma course are enlisted below:

• Drug Examiner
• Pharmacy owner
• Research professional
• Lab Scientist
• Pathologist technician
• Research & Development Executive
• Medical Representatives
• Medical Coder

M.Pharma Government Sector Jobs:

The jobs which can be founded by an M.Pharma graduate in the public sector are enlisted below:

• Research Inquisitor
• Drug Control officer
• Pharmacy owner
• Pharmaceutical Research Assistant
• Medical Representative
• Medical Coder
• Professor/teacher
• Production Supervisor

M.Pharm Private Sector Jobs:

Various job possibilities are available for M.Pharma postgraduates in the private sector. The jobs which can be founded are enlisted below:

• Drug Therapist
• Pharmacist
• Medical Representative
• Drug Analyst 
• Research Scientist
• Medical Coder
• Drug Controller
• Production Manager

Salary Scale for M.Pharma Course Professionals:

The approx salary for a graduate of the M.Pharma Course is INR 2.5 to 4 LPA. This may be different based on the experience of the candidates. The salary & incentives would be increased based on the performance and experience of the candidate.

CONCLUSION:

Dear Aspirants, we have tried our best to share and bring out a clear picture of the M.Pharma Drug Regulatory Affairs Course keeping in front of you almost all the aspects of the course discussing each and every detail, so that you students can get all the information regarding the course under one roof. This is also to help in the calculative and most accurate decision-making process regarding the career & future shaping of the students.

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