The Regulatory Affairs Division (RAD) of the Indian Pharmaceutical Association (IPA) wants Regulatory Affairs Science as an academic discipline and a research topic as part of higher education in pharmacy.

In respect of this field of study, RAD is conceiving ideas from experienced drug regulatory officers, expert leaders of industry and prominent academicians, said Dr Subhash Mandal, chairman of RAD of IPA.

He said PG and research programmes in Regulatory Affairs Sciences have developed in some western countries and several universities offer higher level academic programmes in the subject. In India, discussions are going on among experts to justify its status as an independent academic discipline in the pharmacy education. RAD will apprise the Union government and the office of the Drugs Controller General of India (DCGI) of the necessity of introducing Regulatory Affairs as an academic discipline.

He pointed out that in today’s world when crores of rupees worth drugs are consumed everyday by people in the country and the industry manufactures millions of rupees worth drugs for domestic and international sale, regulatory professionals of the central and state agencies need to learn and acquire specialized knowledge and practical skill about regulatory aspects of pharmaceuticals, neutraceuticals, cosmetics, biotechnology, medical devices, food, herbal drugs and other life-science industries. Pharmaceutical Regulatory Affairs professionals are responsible for developing, compiling and filing documentation required to support the licensing and approval of pharmaceutical products.

Dr Mandal said that with an aim to bring up this science into the pharmacy academic domain, last year RAD had organised seminars and workshops on the concept and importance of regulatory affairs in various pharmacy colleges, and discussions held among academic groups, research groups and industries. The residuary work will be carried out this year. He said once the subject becomes an academic discipline, it will provide the students with the knowledge and skills required to fulfill vital roles in assuring adherence with the complex regulations necessary for the development, delivery and marketing of safe and effective health-care products.

For an international level progress of the subject, RAD will contact regulatory authorities in foreign countries such as USFDA (USA), MHRA (UK), TGA (Australia), Health Canada (Canada), MCC (South Africa), ANVISA (Brazil), EMEA (European Union), SFDA (China), NAFDAC (Nigeria), MEDSAFE (New Zealand), MHLW (Japan), MCAZ (Zimbabwe), SWISSMEDIC (Switzerland), KFDA (Korea), MoH (Sri Lanka), etc.

Regulatory Science is the science of developing new tools, standards, and approaches to assess the safety, efficacy, quality, and performance of all regulated products. The course on the subject will have several disciplines like operational regulatory affairs, strategic regulatory affairs, clinical research regulatory affairs, international regulatory affairs, regulatory compliance, and general regulatory affairs, said Dr Subhash Mandal.