An Issue of Quality

Any pharma company in any country can fall afoul of regulators, but 2015 has seen a number of warning letters and export bans targeting Indian facilities, leading the Associated Chambers of Commerce & Industry of India (ASSOCHAM) to admit that the country is feeling the strain, particularly when it comes to conducting inspections. ASSOCHAM is now calling on India’s pharma industry to do more to ensure that it doesn’t fall behind. At the moment, India ranks fourth in the world in pharmaceutical production, but ASSOCHAM expects a significant amount of drug export revenue to take a setback during the fiscal year 2013-14 because of recent difficulties (1). “India has a meager number of 1,500 well equipped inspectors for more than 10,000 factories engaged in pharmaceutical products leading to the country’s products facing regulatory hurdles in the overseas markets,” explained an ASSOCHAM statement. “The mismatch between the domestic regulatory mechanism and the international regime is resulting in recall and rejection of drugs made by even some of the well known companies, leading to unrest and frustration.”

Some of the most high-profile incidents to have plagued India’s pharma industry recently include: the European Medicines Agency banning around 700 generic medicines tested by GVK BioSciences and an FDA warning letter for three Dr Reddy’s plants in November 2015. According to ASSOCHAM, India faces a number of challenges when it comes to exporting to heavily regulated markets like Europe and the US, particularly as there is no global harmonization of quality systems. There are also domestic challenges related to accessing finance; Indian companies can receive subsidies from the Indian government to help carry out quality checks – but only if they are located in certain areas within the country. ASSOCHAM says, “While at times, the FDA gets into minute details which have more to do with the cumbersome procedure rather than quality, we need to get our own house in order by way of continuous skilling of the regulators at the national and state levels in sync with the best global practices.”

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