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Barcode essential for medicine trade to US, EAN moots common system for exporters
Joe C Mathew, New Delhi | Friday, June 25, 2004, 08:00 Hrs  [IST]

Following the US Food and Drug Administration (US FDA)'s recent mandate on barcoding of human drugs and biological products, EAN India has announced its plans to work very closely with Indian pharmaceutical majors to facilitate adoption of a common barcode system for all export supplies in compliance with global best practice and US FDA requirements.

At present, more than 400 Indian pharma and medical supplies exporters have already adopted barcoding using EAN.UCC standards. According to Ravi Mathur, CEO, EAN India, since US is a major buyer of medicines and medical product, Indian exporters would need to quickly incorporate barcodes on their export supplies to meet the US FDA directive.

He added that a number of pharma exporters to CIS countries etc have already been using EAN barcodes based on country/buyer requirements.

The global EAN system offers a set of standards for data identification, data capture, and data communication. It acts as a common language for supply chain players to efficiently communicate essential business information and streamline supply chain process thereby facilitating high quality patient care.

Recently the FDA announced that it would demand bar codes on all medicines for hospital use, in such a way that the hospitals can use readers to ensure that the patients correctly receive their medicine, thus ensuring safety. In addition, the rule also requires the use of machine-readable information on container labels of blood and blood components intended for transfusion.

In the notification, HHS Secretary G Thompson said, "Bar codes can help doctors, nurses and hospital to make sure that they give their patients the right drugs at the appropriate dosage. By giving health-care providers a way to check medications and dosages quickly, we create an opportunity to reduce the risks of medication errors that can seriously harm patients."

FDA estimates that the bar code rule, once implemented, will result in more than 500,000 fewer adverse events over the next 20 years and would save, all concerned, huge money. FDA estimates a 50 per cent reduction in medication errors that would otherwise occur when drugs are dispensed or administered, even though some hospitals that currently have bar code systems in place report a higher error reduction from bar code usage.

The EAN.UCC system is recommended by many international and national medical device, medical and pharma associations like the European Confederation of Medical Devices (EUCOMED), the Health Industry Distributors (HIDA) in the USA, the National Wholesale Druggists Association (NWDA) in the USA and other key industry groups.

EAN India is a not-for-profit organisation set up by various industry bodies and the Ministry of Commerce, Govt of India to promote global supply chain standards. EAN India administers and promotes the use of EAN.UCC standards in the Indian industry. It is an affiliate of EAN International, Brussels, which overseas the operations of 100 EAN organisations across the world.

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