The Centre has decided not to take any immediate action against small-scale manufacturers of pharmaceuticals who have not fully implemented the track-and-trace bar-coding requirements for exports by the stipulated deadline of March 31, 2017.

Instead, the Commerce and Pharmaceuticals Departments are discussing ways to help the small manufacturers finance the machinery and infrastructure needed to implement the “parent-child relation’’ system for exports, a government official has said.

“There are some very small pharmaceutical companies who are finding it hard to come up with the resources to install the required machinery, including scanners. They have sought help from the government in the form of subsidies. We are examining in what form we could give them the required financial support,” the official said.

The Centre had put in place procedures relating to tracking and tracing of export consignment of pharmaceuticals and drugs using bar code technology in 2014 to prevent substandard or fake medicines manufactured illegally in other countries (including China) entering international markets with a ‘made in India’ tag. While most large and medium exporters have the system in place, the small manufacturers are lagging.

The Commerce Department has asked to the Pharmaceuticals Department to examine if there is any way of including subsidies for bar-coding infrastructure for the SSI sector under any of their existing schemes on quality upgradation.

“Once the new pharmaceutical policy, under deliberation, comes through, some provisions could be made on this. Till then, the Centre is not likely to take any action against small drug producers who haven’t the required bar-coding systems in place,” the official added.

The track and trace systems is unique with identifying printed code on each product in various stage of packaging and it allows traceability throughout the supply chain and helps in facilitating the manufactures’ identifications.

While bar code labelling at primary level (the material that first envelops the product) is voluntary, it is mandatory on secondary level packaging (boxes, cartons etc) and tertiary level (bulk handling & shipping in barrels etc).

The government also mandated implementation of parent-child aggregation at the secondary and tertiary levels of packaging for exports which basically means maintaining data (based on a unique ID) on which secondary packages went in which tertiary shipper.

The deadline for the SSI manufacturers to implement it was extended to March 31 2017, which has now lapsed.

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