Department of Pharmaceutical Management & Regulatory Affairs
M. Pharm in Pharmaceutical Management & Regulatory Affairs (PMRA) was started in the year of 2011 having intake of 18 students. Two batches already passed out with hundred percent placements. This program cover the following special subjects related to program.
  1. Indian pharmaceutical regulations & guidelines.
  2. Management concepts up to 3 semesters.
  3. Business communication skills.
  4. Good manufacturing practices.
  5. Good laboratory practices.
  6. Pharmaceutical validations.
  7. Drugs discovery & development process outlines.
  8. Good clinical practices.
  9. Preclinical safety & efficacy studies.
  10. Regulatory submission national & international.
  11. Regulatory aspects of cosmeceuticals, neutraceuticals, biologicals & medical devices.
  12. Practical & seminar related to above subjects.
  13. In Sem-VI-dissertation work & viva-voce.
Importance of program
India is having more than 10000 (ten thousand) pharmaceutical industries and Gujarat itself is having more than 1500 from that. As per report, total turnover of drugs in 2011 was Rs. 1,04,540 crores in which export was Rs. 45,745 crores that is estimated to be Rs. 2,48,000 crores by 2019. Our export of drugs is increasing very fast every year. Even SSI and medium scale industries are also exporting drugs to other countries. So, the regulatory work and number of manpower required is more and will increase with years to come.
Looking at the increasing of export and increase in number of people required in regulatory affairs, we have started above mentioned M. Pharm program to provide well qualified peoples to industries. Looking at the structure of program, it provides all types of knowledge and skill for procedure for obtaining product approval in India and other regulated, semi-regulated and unregulated markets. The program also covers pharmaceutical management topics that provide all types of knowledge and skill for management of industries. We have separate a/c class rooms having internet & PowerPoint presentation facilities for PMRA students. We have best faculties for teaching from various departments and the department is headed by Mr. K. M. Patel, retired joint commissioner of food & drugs control office, with more than 31 years regulatory experience.
Sr. No. Name Designation More details
1 Mr. Karsanbhai Patel Associate Professor More Details …
2 Dr. Shrikalp Deshpande Professor More Details …
3 Dr. Maitreyi Zaveri Professor More Details …