Earlier this year, the Indian government issued a notification upgrading its drug manufacturing requirements. This notification said that large Indian drug manufacturers had 6 months to upgrade their game, smaller Indian drug makers had 12 months. The notification said Indian drug makers had to take more responsibility over the quality of their products. Drug makers could only sell their products after significant testing was done to assure patient safety. In addition, drug makers needed to keep more products and ingredients in-house after sales to continue on-going testing and verification. This notification follows an earlier directive that state drug authorities increase their oversight of drug manufacturing sites and exported and imported drugs.
Drug problems in India became more apparent in the middle of last year. According to the US FDA’s report on the state of pharmaceutical quality, the US FDA had over 900 recalls in India as a result of GMP violations. Besides this report, the US congress has also stepped up its oversight and concern of drugs coming from India and China. In an effort to improve the quality of drugs coming from India, the US FDA plans to dramatically increase the number of Indian drug inspections. Going forward, the West wants to increase its dependence on Indian drug makers as they slowly shy away from China.
Written by: Ames Gross – President and Founder, Pacific Bridge Medical (PBM)
Mr. Gross founded PBM in 1988 and has helped hundreds of medical companies with regulatory and business development issues in Asia. He is recognized nationally and internationally as a leader in the Asian medical markets. Mr. Gross has a BA degree, Phi Beta Kappa, from the University of Pennsylvania and an MBA from Columbia University.
Source used in the article: https://www.reuters.com/business/healthcare-pharmaceuticals/us-fda-boost-inspections-drug-manufacturing-units-india-2024-02-27/