The central government has empanelled National Institute of Pharmaceutical Education and Research (NIPER), Mohali, to conduct training programmes on regulatory aspects in pharmaceutical sciences for international delegations. The institute is expecting a major delegation from developing countries to attend a one-month training programme at NIPER soon.

The institute will impart hands-on training to these regulatory officials, mostly from African, Latin American and CIS countries, on cGMP/GLP validation procedures in pharmaceutical industry. Standardisation of herbal products, macro and micro-propagation of medicinal plants, separation techniques, modern analytical techniques for quality assurance, impurity profiles of bulk pharmaceutical chemicals and their formulations, degradation chemistry and stability testing of drugs and pharmaceuticals, bioavailability and bioequivalence of pharmaceutical dosage forms are all to be covered under the training programme.

Documentation in pharmaceutical research, development and manufacturing, recombinant DNA technology for drugs, secretory proteins and biomass production through fermentation, primary drug screenings, regulatory toxicology, synthesis and technology of chiral drugs, scale up techniques in pharmaceutical industry, development of eco-friendly processes, generation of combinatorial libraries of small molecules, computer aided drug design and pharmaceutical project management also comes under the module of training and continuing education programmes planned by the institute.

According to Dr CL Kaul, director, NIPER, the one-month course gives much insight into the dossier preparation by Indian pharmaceutical companies. "By familiarising foreign drug regulatory authorities on the systems adopted by Indian companies in preparing their dossiers, we are facilitating drug exports as these are the officials who clear import applications from Indian companies to their countries," Dr Kaul said.

Interestingly, NIPER has been imparting training for international regulatory agencies in a smaller way since last several years. During the last five years drug regulatory officials from about 35 countries have visited NIPER, Dr Kaul informed.