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Pharma Majors Face Regulatory Hurdles

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September 24: Apart from Ranbaxy, many other major players in the pharma space have also been under the regulator’s scanner. India-based manufacturing facilities have seen 7 violations of good manufacturing practices in the last three months and this is when only 7% of facilities out of US are audited every year. In this segment, we discuss the implications of surprise USFDA checks, difficulties in the approval process and the need for self-discipline in Indian companies.