The Director General of Foreign Trade in the Department of Commerce has issued a Public Notice No. 21 (RE-2011)/2009-2014 dated January 10, 2011 mandating that all exports of pharmaceuticals and drugs from India would be made under a trace and track surveillance system. This would be done at primary, secondary and tertiary levels of packaging labels following GS-1 global standards. The system would be made effective from July 1, 2011. It may be recalled that last year some consignments of pharmaceuticals and drugs exported to Africa from China were seized by African regulatory authorities on the grounds of their being sub-standard or spurious. These consignments though had originated in China had labels of ‘Made in India’ pasted on them. This had created some adverse publicity for Indian generic pharmaceuticals and India had to specifically take this up with the African drug regulatory authorities and the Chinese Government. The Chinese Government had informed the Government of India that these consignments had been sent from China and the relevant exporters had been criminally prosecuted and cases against them in Courts were pending.

India is a major generic pharmaceutical producer and exporter and has acquired the role of pharmacy for the developing world. Indian drugs and pharmaceuticals are sold at affordable price and have been found to be safe, efficacious and of good quality. Therefore, the action taken by DGFT is in order to re-assert India’s claim as a credible generic pharma supplier and at the same time to mandate an internal discipline upon the exporting community. India exports medicine worth more than US $ 9 billion annually. Large parts of its medicines are exported to the USA, European Union and Africa. The trace and track system would offer the consumer an opportunity to track the movement of products upto their manufacturer and thereby establishing their originality. Thus, it will be a deterrent against mischief likely to be done by exporters from other countries as well as unscrupulous exporters within the country. Since the decision would be implemented within six months, the Government expects industry to prepare itself to comply strictly by the stipulated date.

Trace and track surveillance for pharmaceutical exports required; exporters must adopt GS1 packaging standards and enable product traceability. The Director General of Foreign Trade mandated a trace and track surveillance system for all pharmaceutical and drug exports, requiring GS1-compliant labelling at primary, secondary and tertiary packaging levels to enable traceability to the manufacturer; exporters must adopt these packaging and tracking obligations and comply by the notified implementation date.