Bharati Vidyapeeth University has become the first institution in Maharashtra to start M Pharm in Drug Regulatory Affairs (DRA), a two-year post graduate degree course in pharma regulatory affairs from this year onwards.

The course comes as a welcome change as there is a need to equip leading Indian pharma companies on maximising compliances 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. M Pharm in Drug Regulatory Affairs (DRA) introduced by the University for the first time in Maharashtra is aimed at addressing the evolving and challenging nature of regulations globally in the pharma industry and profession.

Says Dr. Atmaram Pawar, dean, Pharmaceutical Sciences, Bharati Vidyapeeth University, Pune, "Though India is one of the largest exporters of generic drugs to the US, India has the potential to expand in countries that have regulatory markets. Formal education of drug regulations is one of the most relevant steps to promote India's drug business in the global regulatory landscape. M Pharm in DRA covers all such formal and case based education material in drug regulations."

He further adds,"The course has been designed on the premise that not only drug formulations but needs of patient and doctors are also changing with each passing day."

Four years of graduate pharmacy education followed by training on current regulatory issues would be able to equip community pharmacists as well. The course will also address the need of professionals running drug stores as the quantum of knowledge in terms of regulations is absent in the formal qualification offered by institutes in India. Secondly, there is no mandatory provision of Continuing Educational Programmes (CEPs) in such educational pattern. Maharashtra State Pharmacy Council (MSPC) has been conducting CEPs but it is completely voluntary in nature and not mandatory. Since there is no regulatory compulsion to conduct CEPs, the concept of CEP has not been able to garner nationwide response. Pharmacy Council of India (PCI) should implement it on a priority basis, rue experts.

Post Graduate M Pharm in Drug Regulatory Affairs (DRA) can be very 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 knowhow on relevant subjects like clinical trials, pharmaco-vigilance, dossier of drug products in regulated countries, exports and patents among other details related to it.  

Birla Institute of Technology, Ranchi, JSS College of Pharmacy-Mysore, JSS College of Pharmacy-Ooty, Manipal University, Manipal, Karnataka, Lachoo Memorial College of Science and Technology (Pharmacy), Jodhpur, Maharshi Dayanand University, Haryana, Alliance Institute of Advanced Pharmaceutical and Health sciences, Hyderabad, Brown's College of Pharmacy, Khammam, Andhra Pradesh, Sree Dattha Institute of Pharmacy, Andhra Pradesh are some of the institutes conducting Post Graduate courses in Regulatory Affairs in India.