FDAnews
www.fdanews.com/articles/181377-india-proposes-electronic-monitoring-in-response-to-quality-concerns

India Proposes Electronic Monitoring in Response to Quality Concerns

April 14, 2017

In response to growing concerns over drug quality in India, the government is proposing to create an electronic platform to monitor its drug supply.

Under the proposal by the Ministry of Health and Family Welfare, drugmakers would be required to register with the portal and provide data on drug sales, including details of wholesalers, batch numbers, quantities supplied and batch expiration dates.

Once the platform is in place, only registered drugs would be allowed to sell in the country. Details for each step of the product supply chain will be required.

India requires bar codes for exported pharmaceuticals, but not for domestic sales. The ministry hopes the new portal for supply chain quality assurance will avoid the need for bar coding of domestic products.

Internal audits are critical element of your quality management system. Your approach must be both systematic and documented to remain compliant. Order the webinar CD/Transcript Conducting an Internal Audit for Pharmaceutical and Medical Device Companies today and learn how to perform an effective internal audit that ensures your company remains compliant.

View today's stories