Efforts to constantly upgrade drug manufacturing facilities have been the focus of the drug regulatory authorities in India ever since starting of generic exports from the country on a big scale in the nineties. And the manufacturing facilities of all the top Indian pharma companies used to get inspected by the US FDA and the European regulatory authorities since then. Although there has been a steady growth of pharmaceutical exports from India to a number of developed countries over the years, there has been an increase in import bans and letters warning Indian companies supplying drugs to the US and European markets. The US FDA feels that the proliferation of India’s drug manufacturing has led to a gradual decline in standards and quality of products. In several cases the US FDA and European authorities had found inadequacies in Indian facilities in complying with global drug manufacturing norms and have taken actions in the past. This is despite the fact that India has 1,400 manufacturing WHO-GMP certified units, and over 800 are UK MHRA approved units. Apart from this, India continues to have the highest number of US FDA approved manufacturing facilities outside the US. Despite all this, global regulatory actions are continuing against Indian drug companies. In fact, this has resulted in a drop in the export of pharmaceutical products from India in the recent years. There is a dire need to avoid such repeated actions against the country’s pharmaceutical exporters to maintain the global position of India in this vital sector.
Towards this goal, the Union health ministry has been taking a series of measures to upgrade the drug manufacturing facilities and practices. The ministry last month decided to frame and release a draft guideline towards constant upgradation of good manufacturing practices (GMP) to align India-specific standards with global regulations. This process according to ministry sources will take three months. One of the biggest challenges towards harmonization with global regulations is the high cost of filing clinical documentation. Manufacturers of a new drug have to spend several million dollars for the cost of trials of any new product. A regulatory inspection study conducted by the Indian Institute of Science points out that most medium and small pharmaceutical units in India already meet global environmental regulations. This is a great consolation for the sector as these companies form a significant portion of India’s drug manufacturers. The Drug Controller General of India, meanwhile, has submitted a proposal to the health ministry to mandate upgradation of Schedule M units across the country to WHO-GMP level. DCGI also has a plan to bring about uniformity in inspections of Schedule M units across the country as a part of its programme to upgrade Schedule M units to WHO-GMP standards. Another move by the health ministry is to join Pharmaceutical Inspection Co-operation Scheme (PIC/S) as suggested by Indian Pharmaceutical Alliance to enhance recognition of the country as provider of quality drugs to global markets.