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.