PharmD Info

A forum for Indian Pharmacy Professionals

New to forum? Learn how to post your questions/topics --- Click Here
Pharmacy Education is an online discussion forum is a group open to any pharmacy students and graduates to update and share their knowledge related to their specializations.Eg: Study materials, Exam Questions, Case & Problem Based Learning Discussions.
Forum rules: Dear User, Kindly read our forum rules before you proceed with our PharmD Info, Your first 5 posts/topics requires moderator approval and this website is purely meant for educational and knowledge sharing purpose only so you should not make any topics/replies/messages which criticize, threaten or abuse any member, pharmacy governing bodies and organizations. Your post will be deleted automatically by our BB Pruning System if your topic is not viewed by members for more than 5 days. So, make sure that your topics and its related contents are unique and valuable. We expect you to be an active member of our forum to continue with your free membership.Kindly note that if a member received more than five warnings from moderator/members they will be blocked automatically by our Bulletin Board system.
  • User avatar
Bharati Vidyapeeth University has commenced its two-year post graduate degree course - M Pharm in Drug Regulatory Affairs (DRA). Four students have already enrolled for the course.

The two-year full time AICTE recognised PG degree course is expected to help students learn the basic tools necessary for smooth regulatory filings. The course offers insights into the regulatory framework of all major regulatory bodies across the world such as USA, Europe, Australia, South Africa, South East Asia, Japan over a period of one year.

The necessary skill oriented subjects for this course such as analytical chemistry, research methodology and pharmaceutical administration form an important part of the curriculum.

Explains Dr. Atmaram Pawar, dean, pharmaceutical sciences, Bharati Vidyapeeth University, "The regulatory bodies in the world are diverse due to the geographical, socioeconomic and cultural reasons. India is expanding its pharma business world over. Therefore, the knowledge of the regulatory norms of specific countries is essential. USFDA is the most advanced regulatory body in the world. Significant regulatory knowledge is already available in India, however, the regulatory norms are ever changing and ever expanding. Therefore, keeping updated on the current regulatory scenario and learning the regulatory norms of rest of the countries including Europe and Asia is becoming the need of the hour."

M Pharm in DRA can be prospective and purposeful for budding pharmacists as it covers laws related to drug manufacturing, testing and registration in India, developing countries and developed countries. US and European regulations are majorly covered in the syllabus which also includes know-how on relevant subjects like clinical trials, pharmaco-vigilance, dossier of drug products in regulated countries, exports and patents among other details related to it.

Recognizing the need for new area of expertise, Dr Pawar further informed that second year of the course is dedicated to full time research work where students acquire practical skills in using regulatory knowledge and to contribute to the existing knowledge base through innovation. The efforts of the course are directed towards producing well trained regulatory professionals from the college.

The course comes as a welcome change as there is a need to equip leading Indian pharma companies on maximizing compliance's related to consent decree, Form 483, data integrity and quality management systems. This would also entail maintenance of electronic records for inspection readiness of Indian pharma companies.

"Most pharmaceutical companies in India are now spreading their businesses globally and therefore the need for regulatory professionals with expertise in regulatory requirements of most countries is required. We also anticipate growing role of the regulatory professionals even in Indian regulatory bodies like Central Drug Standard Control Organisation (CDSCO) and State Food and Drug Administration (FDA)," he concluded.
Similar Topics
Topics Statistics Last post
0 Replies 
by Admin
31 Jul 2017, 17:00
Hiring for Regulatory Affairs Specialist
by Admin  - 13 May 2017, 08:23  - In: M Pharm Jobs
0 Replies 
by Admin
13 May 2017, 08:23
0 Replies 
by Admin
17 May 2017, 10:30
0 Replies 
by Admin
15 Jun 2017, 15:04
0 Replies 
by Prajith
11 Aug 2016, 15:16


Drug Safety Alerts from PvPI

The preliminary analysis of SUSARs from the PvPI d[…]

Pharm D Pathophysiology Notes - PharmD II Year Ba[…]

Pharm D Pathophysiology Notes - PharmD II Year An[…]

Alcoholic Liver Disease

Pharm D Pathophysiology Notes - PharmD II Year To[…]