The School of Health and Pharmacy, Acharya Aryabhata University, Hyderabad is planning to offer two-year Masters programme in Pharmaceutical Technology, and Enforcement and Regulatory Affairs to meet the growing needs of pharma industry and regulatory departments in these areas. Both the courses form part of its industry co-operative education initiative and will be offered from early January 2005.
The programmes are intended to bridge the gap between the existing academics and the industry needs. The curriculum is designed to strengthen the working technical knowledge of the candidates and enabling them to meet the legal and regulatory requirements both at national and international level. Though initially the programmes will be offered at University's Hyderabad campus, the management is seriously thinking to offer the programmes in various other locations of the country soon, TVPC Sastry, executive director of the University told Pharmabiz.
The co-operative education component helps the student to learn and obtain higher academic qualification without any hindrance to his work in the industry and this in turn assures the employer a well-qualified and sustained employee enriched with latest knowledge of his field helping him in discharging his duties more efficiently, he added.
The MS programme in Pharmaceutical Technology will be a four-semester (two year) course which will include subjects such as formulations and formulation development; industrial pharmacy and production of synthetic drugs; novel drug delivery systems and its quality control; pharmacokinetics and bio-pharmaceutics; quality control and pre-clinical GLP; calibrations and qualifications; validations; national, international drugs enactments and regulatory affairs; good manufacturing practices; GMP audits (internal and external); quality assurance and good documentation practice; personality development. The fourth semester will have a six months project work. The first batch, to be started from January 2005, will have about 30 seats.
Sastry said, the applicants for the programme must have a graduation in pharmacy from any recognized university with a minimum two years experience and presently working in pharmaceutical, biotechnology, medical devices, blood or blood products industry. The pharmaceutical associations including BDMA, OPM and state chapters of IPA and IPGA have found the programme useful to the industry.
The MS programme in Enforcement and Regulatory Affairs, designed to help the drugs control departments and regulatory departments in pharma companies, is to focus on key laws and acts such as CRPC, evidence act, IPC, essential commodities act, patents, WTO, trade and merchandise act, limitation act, drugs and cosmetics act, price control orders, drugs and magic remedies act, NDPSS act and rules, consumer protection act etc besides quality control and pre-clinical GLP; calibrations and qualifications; validations; national, international drugs enactments and regulatory affairs; good manufacturing practices; GMP audits (internal and external); quality assurance and good documentation practice. The fourth semester will have a six months project work. The first batch to start from January 2005 will have about 15-20 seats. The applicants should be pharmacy graduates having work experience in drugs control departments as enforcement officers and regulatory personnel in pharmaceuticals industry.
The University, established under the Private Universities Act of Chhattisgarh, is a unit of St Xavier Aryabhata Educational Society managed by the Vignan Group of Educational Institutions of Andhra Pradesh and is founded by Dr L Rathaiah. The University has also firmed up plans to offer full time programmes in ayurveda and international business in near future.