The Drugs Controller General of India (DCGI) Dr Surinder Singh has asked all state drug controllers, port and zonal officers to initiate action against the exporters and merchant exporters who violate the labelling provisions and put only neutral code on the labels of their products in violation of the Drugs and Cosmetics Act.
In a directive to the state drug controllers and all port and zonal officers, the DCGI has said it has been brought to the notice of this Directorate that some of the exporters/ manufacturers/ merchant exporters are trying to export the drug formulations manufactured under neutral code of actual manufacturer mentioning their name as 'manufacturer' or 'manufactured by' or 'the manufacturer'.
“This Directorate may like to inform you that such type of labelling amounts to contravention of provisions of the Drugs & Cosmetics Rules and would be covered under the definition of Spurious Drugs',” he said. The DCGI has asked the state drug controllers and port and zonal officers to ensure that all the exporters/merchant exporters should mention their name and address with their status as 'Manufacturer', 'Manufactured by' and 'The Manufacturer'- manufactured under neutral code of actual manufacturer on the label of export of drug formulations.
As per Rule 94 of the Drugs & Cosmetics Rules the exemption is given to the manufacturer to mention neutral code issued by state licensing authority in place of name and address of the manufacturer of the label to meet the requirement of exporting country.
The DCGI's action in this regard comes in the wake of complaints against several exporting companies. Some of the companies against whom complaints have been received by the DCGI office included M/s. Promed Exports Pvt Ltd, New Delhi, M/s. Protech Biosystems Pvt Ltd, Haryana, Ms/. Hindustan Syringes & Medical Devices Ltd, Haryana and M/s. Harsoria Healthcare Pvt Ltd, Haryana.