Need for mandatory serial number, barcode and systems driven traceability for critical drugs and vaccines: online community platform
Jul 18, 2020
New Delhi [India], July 18 : A community engagement and social media platform has written to the Union Health Ministry suggesting that the government should make it mandatory for pharmaceutical manufacturers to implement serial numbers, bar codes and systems-driven end to end traceability and tracking for critical drugs and vaccines.
Sachin Taparia, CEO of Local Circles has addressed the letter to Dr VG Somani, Drugs Controller General of India (DCGI), Chairman of National Pharmaceutical Pricing Authority (NPPA), and Secretary to the department of pharmaceuticals.
"In the recent past, we gave a tip-off to the government about the black marketing of Remdesivir drugs used in COVID-19 treatment as an investigational therapy and the government took cognizance of this. But in a country like India, it is difficult to keep a close watch on black marketing of drugs through enforcement by the drug inspector network. Hence, we have suggested the government make it mandatory for pharmaceutical manufacturers to implement serial number, bar code and systems driven end to end traceability and tracking for critical drugs and vaccines," Taparia told ANI adding that the government is evaluating the input given by him.
"To illustrate a bit more, a unique serial number must be mandatorily put on every vial by the manufacturer along with a bar code and the barcode must be scanned at every step of the supply chain i.e. shipping from the manufacturer, receipt at the distributor, to receipt at the stockist/retailer and finally when the stock is issued by the retailer to the hospital/patient," read the letter.
The final issuance should be such that it requires the Aadhaar number of the actual patient and finally a digital signature by the doctor administering the drug or the vaccine, it said.
In such a system, since all the scanning devices are connected to the same central system, one would know where every vial is in the supply chain. And such a system must not only be there for delivering the drugs and vaccines but also tracking unused quantities and directing them back to the stockist for issuance to another patient, stated the letter.
"With a low cost of technology, the cost would be well under a rupee per vial. The government should define this end-to-end traceability process and then standardise it, so before a licence is granted for manufacturing or importing a critical drug or vaccine prone to shortages, the pharmaceutical manufacturer or importer must demonstrate that such an end-to-end traceability process exists and will be implemented with the supply," noted the letter.
