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.
There are around 26 colleges that offer the course in India. Some of the top MPharm Drug Regulatory Affair colleges are Manipal College of Pharmaceutical Sciences, Chandigarh University, Delhi Pharmaceutical Sciences and Research University, Apex University, Vivekananda Group of Institutions, etc
2.1 Why Study M.Pharm Drug Regulatory Affairs
2.2 Who Should Pursue M.Pharm Drug Regulatory Affairs course
3.2 Admission 2022
4.1 Reference Books
8.1 Top Recruiters
M.Pharm in Drug Regulatory Affairs Quick Facts
The following are some of the top facts regarding the M.Pharm Drug Regulatory Affair course
- The Duration of the MPharm in Drug Regulatory Affair course is for a period of 2 years and is offered in full time mode.
- The entire MPharm in Drug Regulatory Affair syllabus is divided into 4 semesters.
- In the two year course, students study about various subjects such as Pharmaceutical Regulatory Affairs, National Regulatory Affairs, Regulatory Aspects of Controlled Drug Delivery System Lab, GLP GMP, Quality Assurance and Validation, etc
- The eligibility criteria to apply for the M.Pharm in Drug Regulatory Affairs is graduation in the Science stream (preferably B.Pharm) from a recognized university/institution with a minimum of 45%.
- The admission to the MPharm in Drug Regulatory Affair is done through merit basis on entrance examinations such as MET, GPAT, etc.
- Every year over 2.6 lakh students aspirses for the M.Pharm or related course.
- The average fees range from INR 72,000 to INR 5,20,000. The fee for this course at Amity Institute of Pharmacy- Noida is INR 1,02,000.
- After completing M.Pharm in Drug Regulatory Affairs students can become Drug Specialists, Medical Representatives, Drug inspectors, Medical Information Associates, etc.
- The top recruiters for the MPharm Drug Regulatory Affair are Sun Pharma, Glenmark, Biocon, GlaxoSmith Pharmaceuticals, and so on.
- After completing the course, students make an average salary of INR 3,60,000 to INR 8,00,000.
All About M.Pharm Drug Regulatory Affairs Course
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.
Why Study M.Pharm Drug Regulatory Affairs?
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.
Who Should Pursue M.Pharm in Drug Regulatory Affairs Course?
If the aspirants have the following objectives then they should take up the MPharm in Drug Regulatory Affair Course
- Candidates who want to make their career in the Pharmaceutical industry must pursue M.Pharm in Drug Regulatory Affairs.
- Students who want to work in the healthcare sector such as nursing homes, hospitals, etc can do this course.
- Those who want to make their future in clinical research and scientific writing can do this course.
- Candidates who wish to pursue a Career as a Pharmacist can take up the course.
- Similarly Candidates who wish to pursue a career as a Medical representative can take up the MPharm in Drug Regulatory Affair Course.
- The candidates who want to work as drug regulatory Officers and Pharmacovigilance acn take up the course
M.Pharm Drug Regulatory Affairs Admissions
For pursuing M.Pharm in Drug Regulatory Affairs students have to give the entrance exams and in some colleges, admission is also given based on the merit of the candidate. The admission process to the drug regulatory affair courses has been delayed due to the covid 19 pandemic. However, with a waning second wave, the admission processes to the different countries is expected to begin soon.
Let us see the various details about the admission process.
M.Pharm in Drug Regulatory Affairs Eligibility Criteria
Students who want to pursue M.Pharm in Drug Regulatory Affairs will have to fulfill the eligibility criteria.
- The candidate must be a graduate (preferably B.Pharm) from a recognized University.
- Candidates must score 50% at the graduation level. A relaxation of 5% is provided to the SC/ST/OBC candidates.
- Candidates who are in the final year of their graduation can also apply for the course. If selected they are provided provincial admission, which is confirmed when they produce the graduation passing certificate.
M.Pharm Drug Regulatory Affairs: Admission 2022
The admission process for the M.Pharm Drug Regulatory Affairs course is given below
- Admission to M.Pharm in Drug regulatory Affairs is done either on the basis of merit list or entrance examination. Candidates are required to visit the various websites of the colleges where they want to take admission and check the entry mode.
- The candidates are required to register themselves with the entrance examination authorities and fill up their application form with the personal details.
- After filling up the application form the candidates are required to upload the various documents in the required formats and size.
- Candidates will then need to pay the application fees.
- After applying for the entrance examination candidates will have to wait for the admit card which will be released by the conducting body.
- After the admit card is out candidates will have to sit in the entrance examination.
- The list of qualified candidates will be released by the conducting body and candidates will be able to choose the institution of their choice based on their marks.
In the case of merit based admission
- The candidates are required to follow the first 4 steps of the admission process through entrance examination.
- The selection is done based on scores obtained in the relevant course such as B.Pharm, B.Sc Pharmacology, Pharmacy, Life Sciences, and Biotechnology, etc.
- The college will release a list of the qualified candidates. If qualified then the candidates will have to confirm their seats by paying the admission fee.
M.Pharm Drug Regulatory Affair Entrance Examination
Some of the entrance exams conducted for admission to M.Pharm Drug Regulatory Affairs have been given below.
MET
- The MET Entrance Examination is conducted by the Manipal University, Bangalore, for admission to its various UG and PG programs.
- The entrance examination is held in online computer based mode.
- The application fee for the MET is INR 600 and the entrance examination fee is INR 1400.
- Most of the questions in the entrance examination are entrance based.
GPAT
- The GPAT is an entrance examination that is conducted by the National Testing Agency for admission to the M.Pharma or Integrated PhD courses.
- The entrance examination is Computer based online mode.
- The Duration of the entrance examination is 3 hours and consists of 125 questions.
- The Fees of the entrance examination is INR 2000 for Male and INR 1000 for Female, SC, ST and PwD candidates
| Entrance Exams | Conducting Body | Application Dates | Examination Dates | Result Date |
|---|---|---|---|---|
| MET | Manipal College of Pharmaceutical Sciences [MCOPS], Manipal | April 11-June 5, 2021 | June 11 - June 14, 2021 | To be Announced |
| GPAT | National Testing Agency (NTA) | December, 2021-January 2022 | Last week of February, 2022 | First week of March, 2022 |
| CET Bharati Vidyapeeth | Bharati Vidyapeeth, Pune | Till June 14, 202 | July 18 and August 2, 2021 | June 11 - June 14, 2021 |
How To Prepare for M.Pharm Drug Regulatory Affair?
Some of the tips to prepare for the entrance exams of M.Pharm Drug Regulatory Affair has been listed below
- Learn about the syllabus of the entrance examination and check out the important topics. Understand what is the weightage of the various sections .
- Start preparing notes so that it is easy for you to revise the syllabus. Check the previous year's question papers so that you get an idea of the important topics.
- Prepare a time table and divide time slots to each of the courses. Add more time slots to the tougher subjects.
- Complete the whole syllabus. Take help from the internet and books to prepare for the examination.
- Solve mock tests and previous year's question papers. This will help you in time management at the time of examination.
- In the entrance examination, try to answer the easier questions and keep the tougher questions for the last. This will give you more options to score heavily.
Important Links
M.Pharm Drug Regulatory Affairs Syllabus
The syllabus for the M.Pharm Drug Regulatory Affairs is given below.
| 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 | - |
M.Pharm in Drug Regulatory Affairs Reference Books
Reference books with their authors while pursuing M.pharm in Drug Regulatory Affairs are :
| Books | Author |
|---|---|
| Drug Regulatory Affairs | Papiya Bigoniya |
| An introduction to Drug Regulatory Affairs | Poonam Kushwaha |
| New Drug Approval Process, | R.A Guarino |
| Drug discovery and development | Mukul S.Chorghade |
| Good Manufacturing Practices for Pharmaceuticals | S H Willing |
Learning Outcomes of M.pharm in Drug Regulatory Affairs Program are :-
- Pharmaceutical Knowledge and Understanding
- Research literacy and proficiency in Pharmaceutical Sciences
- Information & Digital Literacy
- Problem Solving & Decision Making
- Teamwork Leadership and Behavioral Skills
- Promoting achievement of improved health outcomes in India and at Global level
- Professional and ethical Conduct
- Employability Entrepreneurship Skill
- Communication Skills
M.Pharm Drug regulatory Affairs: Course Comparison
The comparison between M.Pharm in Drug regulatory Affairs vs PG Diploma in Drug Regulatory Affairs are mentioned below according to full form, Course duration, overview, objective, average fees and salary
| Parameter | M.Pharm | PG Diploma in Drug Regulatory Affairs |
|---|---|---|
| Full form | Masters of Pharmacy in Drug Regulatory Affairs | Post Graduate Diploma i n Drug Regulatory Affairs |
| Course Duration | 2 Years | 1-2 Year |
| Overview | Course is for Graduates (Preferably B.Pharm Graduates) | The course is for all Graduates and Post Graduates, employed and yet to be employed keen on taking Regulatory affairs as their career choice. The course helps to provide a comprehensive education in the important aspects of Regulatory and Quality Compliance in the pharmaceutical industry. |
| Admission Criteria | Applicants should have Completed Graduation from any Recognized University. | Any Graduate can Apply for a Diploma level program. |
| Average Fee | INR 72,000-5,00,000 | INR 1,30,000 |
| Average Salary | INR 3,60,000- INR 8,00,000 | INR 3,00,000- INR 5,00,000 |
M.Pharm Drug Regulatory Affairs Colleges In India
The table for the top Indian Colleges for M.Pharm Drug Regulatory Affairs is given below.
M.Pharm Drug Regulatory Affairs College Comparison
Here the comparison is given between the 3 best M.pharm in Drug Regulatory Affairs College. This will help you decide which college you can choose for yourself. The comparison has been given between Amity Institute of Pharmacy, Manipal College of Pharmaceutical Sciences, and Poona College of Pharmacy.
| Parameters | Amity Institute of Pharmacy | Manipal College of Pharmaceutical Sciences- [MCOPS] Manipal | Poona College of Pharmacy |
|---|---|---|---|
| Overview | Approved by the Pharmacy Council of India, Amity Institute of Pharmacy is a well-known institution of Amity University. It offers a four-semester regular course for M.Pharm in Drug Regulatory Affairs. | MCOPS is the first college in Karnataka that introduced the M.Pharm course in 1970. It has ranked first among private pharmacy institutions in the Country. It is currently one of the premier institutions of the Manipal Academy of Higher Education. | Considered as one of the best pharmacy colleges established in the country. The college has been approved by AICTE. Poona College of Pharmacy was established in 1981. |
| NIRF Ranking | - | 7 | 22 |
| Affiliation | PCI | Manipal Academy of Higher Education | AICTE |
| Location | Noida | Manipal | Pune |
| Average Annual Fees | INR 1,02,000 | INR 4,17,000 | INR 1,25,000 |
| Average Placement Package | INR 3,60,000 | INR 4,00,000 | - |
Study M.Pharm Drug Regulatory Affairs Abroad
Candidates have the opportunities to study the M.Pharm Drug Regulatory Affairs courses in the abroad colleges. Candidates often prefer to study in the abroad colleges as they provide better infrastructure, research facilities and better placement options . However the candidate are required to keep the following things in mind before they apply to the foreign colleges
Eligibility criteria
The following are the list of some of the eligibility criteria that the candidates must keep in mind.
- Candidates are required to have a 3-4 year undergraduate or equivalent in with a minimum aggregate score of 65% or higher. In some cases the candidates are required to have a GPA of 3.0 out of 4.0 (83-88%)
- The candidates are required to have science in their 12th or equivalent examination with an aggregate score of 75-80%. Candidates are required to have physics , chemistry and Biology as their compulsory subjects in their 12th
- Candidates are required to pass entrance examinations such as GRE or SAT.
- All the international students will have to give English proficiency tests (IELTS, TOEFL, PTE, etc) for studying abroad
- Documents such as CV mentioning the previous work experience, letters of recommendation, Statement of Purpose, bank statements , etc have to be submitted.
| College Name | QS Ranking 2021 | Average Fees |
|---|---|---|
| Stanford University, Stanford, USA | 2 | INR 25,09,000 |
| The University of Oxford, Oxford, UK | 5 | INR 25,03,000 |
| University of Michigan, USA | 21 | INR 36,57,335 |
| University of Toronto, Toronto Canada | 25 | INR 41,09,000 |
| University of Manchester, UK | 27 | INR 24, 65,928 |
| University of Waterloo, Canada | 166 | INR 48,07, 610 |
| The University of Arizona, Tucson, Arizona | 273 | INR 33,42,348 |
| University of South Florida, USA | 581-590 | INR 23,67,099 |
| University of Greenwich, London, UK | 701-750 | INR 22,05,000 |
| University of East London, London, UK | 801-1000 | INR 21,09,000 |
| The University of British Columbia, Vancouver, Canada | - | INR 12, 09,000 |
| The University of Texas at Austin, Austin, USA | - | INR 33,04,000 |
| The Free University of Berlin, Berlin, Germany | - | INR 1,04,000 |
| University of Toyama, Toyama, Japan | - | INR 3,59,129 |
| Osaka University, Suits, Japan | - | INR 3,73,160 |
M.Pharm Drug Regulatory Affairs: Jobs And Salary
M.Pharm Drug Regulatory Affairs is an evergreen course and offers good job opportunities to candidates in the pharma sector. Candidates can check the job opportunities and salaries below. The salary ranges from INR 25,000 to INR 50,000 per month.
| Job Profile | Job Description | Salary |
|---|---|---|
| Medical Information Associate | Responsible for handling the medical information queries of the patients. He/she is also responsible to maintain the data of the patients and help them with new systems. | INR 3,50,000 |
| Drug Safety Specialist | The main responsibilities include medical supervision, clinical trials, checks whether the drug regulations have been followed or not, coordinates with the chief medical directors, etc. | INR 6,93,555 |
| Regulatory Affairs Associate | Responsible for taking approvals for the new pharma products. He monitors whether the company policies are being implemented along with the government regulation. | INR 4,00,000 |
| Drug Inspector | Check on all the safety measures, supervise the quality of the product, and utility performance. He/she is responsible to see whether the medicine is safe for human beings or not. Examination of pharmaceuticals at different stages at the time of research is also the duty of a drug inspector. | INR 7,00,000 |
M.Pharm Drug Regulatory Affairs: Top Recruiters
The Following are the list of top Recruiters for the MPharm in Drug Regulatory Affair Course candidates
| Pfizer | GlaxoSmithKline | Johnson & Johnson |
| Novartis | AstraZeneca | Dr. Reddy’s Laboratories |
| Piramal | Biocon | Cipla Inc. |
| GVK Bio | Zydus Cadila | Amgen |
| Glenmark Pharma | Syngene | Merck |
M.Pharm Drug Regulatory Affairs Future Scope
M.Pharm Drug Regulatory Affairs course offers a lot of job opportunities in various fields such as hospitals, Pharmaceutical market research companies, Pharma Consultancy, clinical trials or patents, drug research, drug regulatory affairs, etc. The salary ranges from INR 3,00,000 per annum to INR 6,00,000 per annum. However, the salary increases as the experience in the field increases. Candidates experience good career growth after studying this course.
Candidates can become Medical Information Associates, Quality Assurance, Drug Inspector or Drug Controller, Regulatory Administrator, Regulatory Food Safety Scientists, Medical Information Associates, Regulatory Compliance Manager, Medical Coder, Dispensary Manager, Pharmaceutical Validation Analyst, Clinical Data Manager, Medicines Safety Manager, Regulatory Affairs Director, Regulatory Affairs Consultant or Drug Safety Specialist.
However, apart from the jobs the candidates will also have the option of Higher Education. Candidates can opt for PhD or MBA after the completion of the course.
MBA in Pharmaceutical Management: MBA in Pharmaceutical Management is a 2-year postgraduate degree course that teaches the candidates about the various managerial and administrative aspects of Drug Manufacturing, Production Management, Pharmaceutical Marketing, Brand Management. The admission to the MBA in Pharmaceutical Management course is done on the basis of entrance tests such as CAT, SNAP, MAT, etc.
PhD Pharmacy: PhD Pharmacy, or Doctor of Philosophy in Pharmacy, is a doctoral degree course which can be pursued after post-graduation. The minimum duration of the course is 3 years and it can be extended to a period of 5 years. The top entrance exams for admission to the PhD Pharmacy course are NET , UGC NET and various RETs conducted by various institutes.
M.Pharm Drug Regulatory Affair FAQs
Ques. Is it a good idea to do an M.Pharm in drug regulatory affairs?
Ans. M.Pharm in drug regulatory affairs opens up better job opportunities to the candidates. However, it is not necessary to do this course after B.Pharm as the job opportunities depend upon the experience and knowledge of regulations of each country. After doing B. Pharm also students can very easily find job opportunities in the pharmaceutical sector. However, the M.Pharm degree increases their knowledge and skills so the students with this degree are given preference over those who have simply done B.Pharm.
Ques. What are the benefits of doing M.Pharm in Drug Regulatory Affairs?
Ans. The benefits of doing M.Pharm in Drug Regulatory Affairs are given below
- Many companies are now recruiting Drug Regulatory Affairs professionals
- Good salary and schedule
- According to the US Bureau of Labor Statistics, the field may grow by 8% each year
- You can choose what kind of regulatory career you want to develop
Ques. What is the career growth in M.Pharm Drug Regulatory Affairs?
Ans. Good career growth is there for the candidates who have joined the pharma sector after doing M.Pharm Drug Regulatory Affairs. Candidates can go to the other relevant fields in the similar industry such as Quality Assurance, Marketing, Clinical Affairs, Project Management, etc.
Ques. Which are the top 5 companies to work for an M.Pharm in Drug Regulatory Affairs.?
Ans. Every candidate looks for top companies to join after doing M.Pharm in Drug Regulatory Affairs as they offer a good stable career. The top companies to join after doing the course are
- Astro IPR (Sister firm of Intas Pharma)
- Zydus Cadila
- Lupin
- Sun pharma
- Amneal
Ques. Which is a better career opportunity for an M.Pharm Drug Regulatory Affairs graduate, regulatory affairs or quality assurance?
Ans. Both the career opportunities have their benefits and both are considered as good. In regulatory affairs, the candidate acts as a link between the Government and the pharma lab where he/she works. The responsibility is to see whether the medicine going to enter the market is safe or not.
Quality assurance focuses on the stages of manufacturing a medicine. It is a more specialized job when we compare it to regulatory affairs. However, the regulatory affair is a new profession.
Ques. Which country is considered to be the best to study M.Pharm Drug Regulatory Affairs?
Ans. USA, UK, Japan, Canada, and India are considered to be the best countries to study M, Pharm Drug Regulatory Affairs. However, the fees of universities in countries other than India are higher. The degree of Pharmacy obtained from these countries is recognized all over the world therefore it is easy for the students to get a job anywhere.
Ques. Is it necessary to have work experience to take admission in M.Pharm in Drug Regulatory Affairs?
Ans. The admission to M.Pharm in Drug Regulatory Affairs is mostly based on the score of the candidate obtained in the entrance exams of different universities/institutions or based on merit in India. However, if we talk about foreign universities some of them ask for work experience. The work experience gained after graduation is beneficial for the students as they get the practical knowledge which increases their interest in further studies. Work experience will help them to get admission to a foreign university easily.
Ques. Are there scholarships available to study M.Pharm Drug Regulatory Affairs abroad?
Ans. Yes, students who desire to study this course abroad can avail scholarships from different universities. The scholarship details will have to be checked by the candidates on the official websites of different international universities. Some of the scholarships available to study M.Pharm Regulatory Affairs abroad are Griffith International Starter Scholarship, University of Alberta-India First-year excellence scholarship, Go clean scholarship, etc.
Ques. Is it beneficial to do M.Pharm Drug Regulatory Affairs abroad?
Ans. Yes, it is beneficial to do this course from abroad, however, the fees of this course in the international university are high but it will give you better outcomes when compared to doing M.Pharm Drug Regulatory Affairs in India.
This is because students learn about the development procedure of modern medicines, they will get better salary package when compared to those who have pursued this course in India also and they can also get an opportunity to work abroad as many students want to work abroad so it will be beneficial for them to join a good college abroad to study M.Pharm Drug Regulatory Affairs.
Ques. Which job profile is better, pharmacovigilance or regulatory affairs?
Ans. It is always upon your choice which job profile you like. If you like jobs like seating jobs or data entry then you should choose Pharmacovigilance but if you like document management sort of things then regulatory affairs is a better choice. It depends on your interest. If we talk about salary then the salaries offered to both are almost similar so you can choose any job option between them based on your interest.
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