M.Pharm ( Pharmaceutical Regulatory Affairs)



About The Programme:

This course helps to provide a comprehensive education in the important aspects of Regulatory and Quality Compliance in the pharmaceutical industry. It is designed in such a way to provide industrial level education regarding the applicable rules and regulations. Students are encouraged to enhance their knowledge of regulatory and compliance issues and to explore careers in these exciting times. The ever-changing laws and regulations are driving demand for pharmaceutical regulatory affairs professionals, who can help companies effectively bring medical products to market. The course is beneficial as it offers many careers them after passing it successfully. The course also provides the knowledge of filling of information regarding new drug development, manufacture, control, stability studies, packaging, labelling etc. with regulatory agencies in a prescribed format. 

After completion of the course, participant is expected to have in-depth knowledge and up-to-date understanding of concept of generic drug and innovator, drug discovery and development, Regulatory strategy, approval process of all regulatory filings in various countries, filing process of IND, NDA and ANDA, IMPD, and Investigator Brochure (IB), DMF, US Hatch Waxman Act and code of federal regulations (CFR), US registration for foreign drugs, Europe IMPD, marketing authorization application (MAA), Centralized procedure, bioequivalence and drug product assessment-in vivo, Manufacturing and Controls (CMC) and their regulatory importance, Submission of global documents (CTD/eCTD), Filing process in India-IND, NDA, Clinical trials (Schedule Y) etc. It offers the combined knowledge of theoretical and practical knowledge in all areas that affects the drug quality. It also provides the working knowledge of various analytical instrumental techniques, method development, documentation, protocol and SOP writing etc.  


Intake: 15 seats


Tuition Fee: 12500/- per semester as proposed to the Fee Regulatory Committee.


Approval: The programme is duly recognized by both the Pharmacy Council of India (PCI) and All India Council for Technical Education (AICTE)


Duration of Programme: The duration of this Programme is 2 years after completion of B. Pharm course.


Admission Eligibility: For the purpose of admission, a candidate shall have passed the qualifying examination in the B. Pharm discipline with 55% marks (50% marks for SC/ST/SEBC candidates) and obtained the qualifying marks in GPAT/GSET for pharmacy (Please visit www.jacpcldce.ac.in for more details).

Note: I.S.E.A. = "Internal Assessment Sessional Exams" , E.S.E. = "End Semester Exams", * = "Non University Examination"

Subject codeSubject nameNo. of HoursCredits Marks (I.A.S.E.)Duration (I.A.S.E.)Marks(E.S.E.)Duration(E.S.E.)Total Marks
MRA101TGood Regulatory Practices44201 hr803 hr100
MRA102TDocumentation and Regulatory Writing44201 hr803 hr100
MRA103TClinical Research Regulations44201 hr803 hr100
MRA104TRegulations and Legislation for Drugs &Cosmetics, Medical Devices, Biologicals &Herbals, and Food & Nutraceuticals In Indiaand Intellectual Property Rights44201 hr803 hr100
MRA105PRegulatory Affairs Practical I126506 hr1006 hr150

Subject codeSubject nameNo. of HoursCredits Marks (I.A.S.E.)Duration(I.A.S.E.)Marks(E.S.E.)Duration(E.S.E.)Total Marks
MRA201TRegulatory Aspects of Drugs & Cosmetics44201 hr803 hr100
MRA202TRegulatory Aspects of Herbal & Biologicals44201 hr803 hr100
MRA203TRegulatory Aspects of Medical Devices44201 hr803 hr100
MRA204TRegulatory Aspects of Food & Nutraceuticals44201 hr803 hr100
MRA205PRegulatory Affairs Practical II126506 hr1006 hr150

Subject codeSubject nameNo. of HoursCredits Marks (I.A.S.E.)DurationMarks(E.S.E.)Duration(E.S.E.)Total Marks
MRM301TResearch Methodology and Biostatistics*44201 hr803 hr100
MJC302PJournal Club I1125025
MDP303PDiscussion/ Presentation (Proposal Presentation)225050
MRW304PResearch Work - Dissertation Phase I281450300350

Subject codeSubject nameNo. of HoursCredits Marks (I.A.S.E.)DurationMarks(E.S.E.)Duration(E.S.E.)Total Marks
MJC401PJournal Club II112525
MDP402PDiscussion/ Presentation (Proposal Presentation)337575
MRW404PResearch Work - Dissertation Phase I32160400400
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