Regulatory Open Forum

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.

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Ames Gross
President
Pacific Bridge Medical
Bethesda, MD
www.pacificbridgemedical.com
contact@pacificbridgemedical.com
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This is good new and I am glad the Indian government has decided to do something about these issues. 

I wish politics doesn't mess up with healthcare. The fact is that there are very good drugs and products manufactured in China and it will be a loss to patients not to have access to them. 

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Olga Peycheva
Regulatory and Study Start Up Specialist (Clinical trials)
Solutions OP Ltd
https://solutionsop.co.uk/
United Kingdom
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Original Message:
Sent: 20-Mar-2024 21:01
From: Ames Gross
Subject: Indian Drug Industry Trying to Right the Ship

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.

------------------------------
Ames Gross
President
Pacific Bridge Medical
Bethesda, MD
www.pacificbridgemedical.com
contact@pacificbridgemedical.com
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