India to make barcoding mandatory on all drugs

India is to make barcoding mandatory on all medicines sold within the country after a recent report by the Office of the US Trade Representative (USTR) identified the country as the largest producer of counterfeit pharmaceuticals in the world.

Earlier this year, the government’s Drug and Technical Advisory Board ( DTAB), the country’s regulatory body for pharmaceuticals and medical devices, recommended that Indian law should be amended so that all medicines should be labeled with a  barcode.

This would allow pharmacists, customers and the government to trace medicines across the supply chain and identify where a drug was manufactured.

The news comes after the  USTR’s “ 2019 Special 301 Report”, published in April, said that “up to 20 percent of drugs sold in the Indian market are counterfeit and could represent a serious threat to patient health and safety”.

While barcoding is already compulsory in the country for medical devices and exported medicines, for drugs sold domestically it is currently voluntary.

Raja Selvam, a managing attorney at  Selvam & Selvam in Chennai said the change to the law is a “welcome move”.

Selvam added: “Making barcoding mandatory would help to avoid the infiltration of counterfeit drugs into the supply chain and ensure the safety of patients.”

DTAB said another widespread problem in India is false labelling. It said mandatory barcoding will help offset this as it will allow the government to quickly identify the manufacturer of a falsely-labelled product.

Vikrant Rana, a managing partner at  SS Rana & Co in New Delhi, said the change was timely, but there are certain challenges the law will have to overcome.

“Firstly, India being a largely agricultural society, in villages, where there is hardly any Internet connectivity or electricity, scanning will not be possible. “

He added that there may also be problems of costs related to the implementation of barcodes for companies which produce drugs.

Rana said the government needs to consider who is responsible for the cost of barcodes, as “adding the burden of costs related to the QR code will be too much for some companies to bear”.

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