Validation check imposed on medicine exports

Pharma industry lauds idea, but suggests looser rules on ground

Domestic drug companies engaged in contract manufacturing of medicines meant for export markets will have to furnish validation certificates to prove the authenticity of the importing firms. 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.

The DCGI directive, to take effect immediately, may cause a temporary delay in the export of medicines from the country, industry sources fear.

India gets outsourcing of about Rs 10,000 crore a year worth of medicine manufactures on a contract basis from foreign firms. Almost all major players, including leaders like Aurobindo and Ind-Swift, are known to be using their spare capacities to manufacture medicines for foreign companies. Indian pharma exports were Rs 38,433 crore in 2008-09.

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.

The DCGI was unavailable for comments.