The Pharmacy Council of India (PCI) has officially notified an amendment to the Master of Pharmacy (M.Pharm) Course Regulations, introducing Medical Devices as a new postgraduate specialisation across Indian universities starting from the 2027–28 academic year. Delivered in English under the Credit-Based Semester System (CBSS), the four-semester, two-year programme is designed to equip pharmacy graduates with specialized technical, manufacturing, and regulatory expertise to meet the rapidly expanding demands of the medtech sector.
The curriculum provides structured training across academic theory, practical laboratory work, and advanced research. The first semester covers core fundamentals, including medical device technology, regulatory affairs, manufacturing processes, biocompatibility, and toxicology, accompanied by practical laboratory sessions. The second semester broadens into emerging innovations, quality control, risk assessment, safety management, clinical evaluation, market access, intellectual property rights (IPR), and entrepreneurship, alongside seminars and advanced lab work. The final two semesters focus entirely on research methodology, biostatistics, journal clubs, and intensive dissertation projects.
To ensure high standards of practical training, the regulations permit students to conduct research either at approved on-campus facilities or through formal Memorandums of Understanding (MoUs) with recognized external partners. These eligible partner institutions include CDSCO-approved manufacturers, nationally recognized device testing laboratories, Institutes of National Importance, Indian Pharmacopoeia Commission materiovigilance centres, accredited Clinical Research Organisations (CROs), and specialized R&D facilities. This strategic regulatory addition establishes a vital academic bridge between traditional pharmacy training and the modern medical device industry.
Written by: Pragna Biswas
Graphics by: Pramit Hazra
