An Issue of Quality
2015 has been a difficult year for Indian pharma companies – and ASSOCHAM is calling for the country to get its “house in order”.
Stephanie Sutton |
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.”
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