India likely to join group of good drug manufacturing practice countries

India is planning to join a group of 41 countries having good manufacturing practice (GMP) standards for drugs in order to help domestic pharmaceutical exporters, to meet frequent inspection and manufacturing requirements being put in place by importing countries. The Pharmaceutical Export Promotion Council of India (Pharmexcil) is of the view that problems in terms of meeting different GMP and inspection procedures in different countries will be sorted out if India joins the Pharmaceutical Inspection Cooperation Scheme (PICS). The PICS, which include members like Australia, Canada, European and African countries and the US, is an informal co-operative arrangement between regulatory authorities in the field of GMP of medicinal products.  The Pharmexcil added that in case India does not join the group, domestic exporters should make sure that they follow the practices and regulations specified by the group. Meanwhile, India has invited regulators from 25 countries to participate in the global pharma exhibition to build familiarity between domestic drug regulators and their counterparts in other countries. At present, market size of Indian pharma industry stands at around Rs 1,30,000 crore of which about 50% of revenue comes from industry’s exports. The US is major importer of Indian pharma products followed by Russia, Germany and Austria. The growth in pharmaceuticals exports remained low at 1.2% to $14.84 billion in FY14, as some big Indian pharmaceuticals companies such as Ranbaxy and Wockhardt were facing exports ban in the US due to quality issues raised by the US Food and Drug Administration (USFDA). Further, domestic exporters are also facing restrictions in countries such as Brazil and Russia which recently placed their own plant audits for exporters.