Ikris Pharma highlights need for technologies like blockchain to pin down sources of medicine contamination

Nandita Vijay, BengaluruWednesday, November 23, 2022, 08:00 Hrs  [IST]

Close on the heels of the Gambian cough syrup tragedy, and the enforcement of QR code on 300 formulations, Ikris Pharma Network highlights the need for supply of foolproof quality medicines as a non-negotiable priority for any drug regulatory authority.

According to Praveen Sikri, CEO, Ikris Pharma Network, blockchain technologies could be considered for the entire drug manufacturing, distribution and sale network thereby keeping fake and substandard drugs from entering the supply chain.

Noting that track & trace technologies can improve the quality of medicines in India, Sikri said this could play an impactful role in tracking and monitoring the supply and quality of medicines and related products and therefore improve the overall quality landscape of the pharma industry.

India has around 3,000 drug companies and nearly 10,500 manufacturing units with lakhs of associated smaller suppliers, entities and businesses. The drug manufacturing, distribution and sale supply chain is long and complex. To keep a track of every change in a medicinal product that would have occurred at every node of the value chain from sourcing active pharmaceutical ingredients to processing and manufacturing of a drug to packaging and marketing and dispatching them to wholesalers, distributors, retailers and final users, he added.

Union government had always mandated some form of surveillance in the pharma supply chain. Back in 2015, the government had put in place a comprehensive traceability system called Drug Authentication & Verification Application (DAVA) for both export and domestic markets. More specifically, while labeling at primary level was exempted, there were compliance requirements for secondary and tertiary packaging.

The advent of Integrated Validation of Exports of Drugs and Its Authentication of a portal known as iVEDA was a simplified and user-friendly system, facilitating uploading of the tertiary and secondary level barcoding data for authentication of drug packages exported from India. Some of the advantages that this platform offers include easy registration, quick verification/approvals, option of aggregation/non-aggregation, allows bulk uploading of XML files etc, said Sikri.

But with the persisting problem of fake and counterfeit medicines and the recent Gambia episode are not isolated incidents. It was reported that fake drugs were responsible for the fatalities of 2,50,000 children every year globally. According to a USTR report, nearly 20% of all pharmaceutical goods sold in the Indian market are counterfeit, underlining the problem that exists within the country, he said.

Therefore it is mandatory to deploy track and trace technologies more effectively. There is need for serialization or giving a unique identity to the smallest saleable unit of a pharma product. Serialization must be paired with track and trace technologies. Not all countries with serialization requirements have mandated track and trace technologies.

The QR codes for top 300 brands of drug products are a step in the right direction. In addition, there should be more intense scrutiny and monitoring at the manufacturing stage itself. All factories and outlets must be identified and marked. GPS and RFID technologies could be employed, said Sikri.

Given the implementation challenges cited by sections of the pharma industry, the government could help financially through loans and subsidies for them to upgrade their manufacturing and infrastructure and systems in order to align with trace and track technologies. Essentially, the government needs to accelerate the pace of the ongoing adoption of trace and track technologies across the pharma industry, said Sikri.