The young pharmacists who wish to get into regulatory affairs must have a strong background of pharmacy practices and regulatory understanding. The pharmacy profession in the country today needs a large number of such specialists, felt pharma experts and officials of enforcement bodies.
India's pharmacovigilance system is poor and the coming generation should increase their awareness about this area. The awareness on regulatory affairs and strong pharmacy background will help them to be absorbed into industry also. The students must be encouraged to get into industry projects in regulatory to gain better understanding.
Pharmaceutical and biotechnology products are regulated products and with globalization the demand of these products has increased which requires more regulatory staff. The medicine exported from one country needs to comply with the rules of other country. India exports an equal number of medicines produced and used for domestic use in the country. US FDA has set up its offices in New Delhi and Mumbai and US Pharmacopeia opened its office in Hyderabad. With the arrival of international agencies to our country, we can imagine that India will soon emerge as a global player.
Proper training should be imparted to the personal working in the patent offices and trainers from our country and US could be utilized for this purpose.The students of pharmacy must know about patent rules and their curriculum must be updated with new policies and rules.
India is becoming the destination of clinical trials, but personally he does not agree with the development as Indians are becoming guinea pigs for the trials. It is mandatory that the students of pharmacy to understand the basics of regulatory affairs from early stages. The course on regulatory affairs has bright future globally and the person indulging in regulatory affairs is acting as an ambassador between industry and enforcement bodies.
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