Business Standard: Validation Check Imposed on Medicine Exports in India

The August 5th edition of the Business Standard reports on Drug Controller General of India (DCGI) requiring all pharmaceutical contracted manufacturing exports will be required to furnish validation certificates of authenticity for importing firms overseas.

• The move, initiated by the office of the Drugs Controller General of India (DCGI), is expected to boost India’s image as a supplier of quality, low cost medicines.


• According to the official directive, all contract manufacturers exporting medicines using neutral code (which do not mention the name of the manufacturing or marketing firm) will have to present certificates from the regulators of the importing country to prove the genuine nature of the importing firm. In other words, the foreign regulator will have to endorse the product name and marketing registration these companies have obtained from the regulator.


• The drug exporters hailed the intention of the DCGI, but expressed concern over the sudden implementation of the circular. “There are hundreds of medicine products that are being exported to all parts of world”, they said adding: “ If DCGI wants the credentials of all the foreign sourcing companies from respected drug regulators, the consignments will not be cleared for the next three months. It will affect our credentials and credit worthiness.”


• The exporters wanted the directive to be confined to less regulated markets, where there is scope for mischief. Indian drug exports had recently come under regulatory scrutiny in several countries due to alleged complaints of spurious and counterfeit medicines.

XStream System applauds the move by DCGI and encourages screening and validation within all points of the supply chain as an important solution to counterfeit, substandard and adulterated pharmaceuticals.

XStream’s XT250 system can be easily deployed within the supply chain to screen, validate and authenticate pharmaceuticals within their sealed, unit-of-sale container without opening, destroying and degrading the product.

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