The Pharmacy Council of India (PCI) should consider the increasing job opportunities for pharmacy graduates in the areas of quality assurance (QA) and regulatory affairs, and while revising the curriculum due importance should be given to these potential areas, said Dr Rao V S V Vadlamudi, president, Indian Pharmaceutical Association (IPA).
According to him, the graduates in pharmacy (B Pharm) can achieve plenty of chances in the manufacturing industry sector. If the industry-oriented course is modified by adding industry based syllabuses with industry-academia interaction, the graduates can utilize the opportunities arising in the industry sector. This will help the industry to absorb full-fledged human resources for their needs, and in turn, the fresh graduates can have a better understanding of the need of the industry.
The IPA president was delivering the inaugural address at the national workshop on ‘Ensuring quality through Good Laboratory Practice” organised by IPA West Bengal branch in Kolkata. Dr Vadlamudi wanted the industry associations to conduct workshops on GLP in all the states in association with pharmacy colleges. It will help the pharmaceutical industry immensely.
He spoke elaborately on GLP definition and scope, GLP purpose, historical perspective, elements of the practice, five basic elements, resources, key players, test facility and processes, materials and documents.
Dr Subhash C Mandal, chairman, regulatory affairs division of IPA said although Good Laboratory Practice (Schedule L1) has been implemented since November 2010, there are some grey areas which require to be clarified through interactions between regulatory officials and drug manufacturers. He said several regulatory issues from various states have been taken up with the concerned authorities during the last one year and some of them have been solved, but there are certain crucial issues remaining to be addressed.
Dr Jayanta K Chattopadhyay, former GM, Fresenius Kabi Oncology Ltd, spoke on the topic “maintenance, calibration, and validation of equipments”. He critically explained the requirements as per Schedule L1 and other regulations like US FDA requirements.
Sankar Gupta, former, deputy DC of CDSCO spoke on “documentation, storage and archival”.