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US FDA, India Office, which opened a ‘Centre of Excellence in Regulatory Sciences’ at JSS College of Pharmacy, Mysuru is envisaged to spur potential partnerships which could enable knowledge management and create a pool of required pharmacy professionals. This is the first of its kind Centre of Excellence in Regulatory Sciences.
Dr. Sarah McMullen, Country Director, US FDA India Office (INO) inaugurated the ‘Centre of Excellence in Regulatory Sciences’ at the JSS College of Pharmacy, Mysuru.
As per the latest data, India has 865 plants with US FDA approval. US is the largest purchaser of India’s generic drugs.
According to Dr TM Promod Kumar, principal, and Dean, JSS College of Pharmacy, Mysuru, India has the highest number of US FDA approved plants outside the US. Regulatory sciences is pivotal in obtaining marketing authorization from regulatory agencies like US FDA.
The key objective of the Centre is to make available a pool of competent professionals in regulatory affairs with fundamental knowledge on various good regulatory practices. The intent is also to provide a focal point for knowledge management, with the ability to capture new knowledge and practices from the healthcare sector, he added.
To this end, our vision was to establish a core program support and management plan. This is an effort to enhance skill sets in regulatory science and utilize the resources to propel the regulatory profession forward, Dr Kumar told Pharmabiz.
We commenced the Pharmaceutical Regulatory Affairs (PRA) course in 2010 in the Department of Pharmaceutics. The PRA is a comparatively new & specialized discipline, which has developed to protect public health, by controlling the safety and efficacy of products which includes pharmaceuticals, veterinary medicines, medical devices, pesticides, agrochemicals, cosmetics, and complementary medicines, he stated.
PRA department in a pharmaceutical company is a vital unit that drives the R&D efforts of the company to the market successfully. The regulatory department works with a focus to get products to the market with a commercially viable label, in the quickest possible time. Now this is also one of the emerging disciplines of pharmacy profession. It deals with the approvals and lifecycle management of products and devices across globe. It brings R&D efforts and as India is working to be a key players in drug development, there is need for approval, primary interpreters of the laws and regulations, advisers on the legal and scientific compulsions and requirements besides provide suggestions in new policy implementation & research, noted Dr Kumar.
Dr. McMullen briefed about US FDA and the significance of India globally. FDA regulates US imports from India and OGPS (Office of Global Policy and Strategy) mission, FDA registered pharmaceutical firms and pharmaceutical inspections in India.
She also provided an overview on India Office (INO) focus areas like Advanced Manufacturing Technologies, Biopharmaceuticals, Real World Evidence/Data, Nitrosamine Impurities and Innovations.
Present at the inaugural were Gregory Smith, International Relations Specialist, – Drugs; Dr. Sudheendra Kulkarni, medical product safety coordinator, BIMO, Devices; and Dhruv Shah medical product safety coordinator- Drugs, Dr. C G Betsurmath, executive secretary, JSS Mahavidyapeetha, Dr. Prashant Vishwanath Dean (Research), JSS AHER, Mysuru, Dr. M. P. Venkatesh, associate professor, and Dr. Balamuralidhara V, HoD, Dept. of Pharmaceutics and Dr Bangarurajan, professor, JSS College of Pharmacy, Mysuru (JSSCPM) .
Dr. Surinder Singh, Vice Chancellor, JSS Academy of Higher Education and Research (JSS AHER), Mysuru, said that it was the pharma industry personnel designing the curriculum for better outcome.
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