Health ministry is planning to implement track and trace system for drugs circulating in the domestic market, to check the menace of counterfeit and spurious drugs within the country. It is understood that DTAB in its meeting yesterday had actively deliberated on acting upon the recommendation submitted by the task force set up by the health ministry.
If things go as planned, the Centre plans to amend the Drugs & Cosmetics Act and rules to modify it as per the submitted recommendations in the coming months. Task Force, which was chaired by Dr H G Koshia, commissioner of Gujarat FDCA, had submitted its recommendation on the requirement for adopting an effective track and trace system in 2012. As per the recommendation, all the domestic manufacturers will soon have to incorporate bar coding and Unique Identification Number (UIN) in every pack of medicine, so that it will enable effective tracking of the products right from its inception stage to the delivery point.
Dr Koshia informed that other important factor to the track and trace mechanism is the 2D bar coding on the central portal having links to the entire manufacturer’s database. Whenever tracking is done from any point in the distribution chain, the query will be sent to the central portal from where it will be directed to the manufacturer’s database.
He further said that the bar code on the label on every pack of medicine will have all the essential details of the product including its batch number and date of manufacturing. During labeling of products by the manufacturers, this unique bar code will be affixed on the label, while at the same time computer will generate a set of unique numbers for each bar code for a batch. Each time the product is invoiced or transferred to the subsequent whole seller or retailer, the data would be updated in the manufacturer’s portal.
Dr Koshia pointed out that the beauty of this software is that it is very difficult to copy this randomly selected unique ID, which even if tampered can be easily tracked right at the point through an impressive tracing system. "We had conducted a thorough nation wide study before recommending these inputs, taking suggestions from all the stakeholders for an efficient result. Any citizen can easily take a picture of the unique ID-bar code and send it to the central portal for verification. The details on the product will be counter checked on the spot, which if found fake would be immediately sent to consumer warning him of the product. Simultaneously, a report will also be sent to the concerned drug controllers of the state where the product was manufactured and later sold,” he added.
When implemented, over 8000 plus drug manufacturers in country will have to comply and work in accordance with it. Interestingly, track and trace system for the domestic pharma products will be applicable for all the three levels of packaging i.e. primary, secondary as well as tertiary.
"The decision to implement track and trace system for domestic manufacturers is done with a view to safeguard the interest of the general public and to empower them with the right to identify a genuine product from that of fake. This will also boost the confidence of the genuine manufacturers and further strengthen the regulatory apparatus," informed a highly placed source from the DTAB.
The source said that manufacturers will be given enough time to adopt the software and other technological needs before implementing it. It is understood that in next two three years the track and trace system will be in place.