ARC advises tech upgrades for Indian drugmakers

Pharma companies in India need to step up by leveraging enabling technologies for improving productivity and manufacturing quality, and for enhancing regulatory compliance. Such technology enhancements will have "a force multiplier effect" on their productivity growth, says ARC Advisory Services.

Of course, Indian drugmakers also need to protect brand image. Doing so will require technology adoptions to satisfy regulatory authorities for standards compliance, good manufacturing practices and electronic recordkeeping.

Some Indian drugmakers have recently run afoul of the U.S. FDA, says ARC, with the regulator finding significant deviations from good manufacturing practices during facility inspections. In some cases, the regulator worked with customs officials to prohibit products from entering the U.S. 

ARC analysts note that the India pharma industry can help itself by working to improve in three areas: increasing process understanding, mitigating risks and achieving continuous improvements through PAT deployment; securing the supply chain to minimize drug counterfeits; and following such sustainability trends as use of disposables technology in pharma manufacturing operations.

- see the ARC article


Using AI and RWD to Uncover Rare Disease Insights, Accelerate Commercialization and Improve Patient Outcomes

Wednesday, March 24 | 2pm ET / 11am PT

Learn how transformed real world data into real world insights to assist Audentes in their development of AT132 for the treatment of XLMTM. The session reviews how IPM.ia and Audentes collaborated to uncover the XLMTM patient population.