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.

They were speaking in a symposium on “Indo-American Pharmaceutical Regulatory Affairs” at the Sri Ramachandra University in Chennai. The programme was organized by the pharmacy college of the university in association with IPA, Tamil Nadu chapter, JSS University, Mysore and Annamalai University, Chidambaram.

Madhusoodana Rao, COO-Global Generics, Orchid Chemicals & Pharmaceuticals, Chennai said compared to US, 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. He opined that students must be encouraged to get into industry projects in regulatory to gain better understanding.

Dr B Suresh, Vice-Chancellor of JSS University said 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. He said, “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”, Dr Suresh said.

Dr S P Thyagarajan, Pro-Chancellor of Sri Ramachandra University while speaking on Intellectual Property Rights said 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. He said the students of pharmacy must know about patent rules and their curriculum must be updated with new policies and rules.

M Bhaskaran, the director of Tamil Nadu state drugs control department while delivering his presidential address, said 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. He exhorted the students of pharmacy to understand the basics of regulatory affairs from early stages. He further said the drugs used for domestic purpose and for exporting must have the same quality.

J Jayaseelan, secretary of IPA Tamil Nadu said 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.