The author of this article is Mr. Praveen Sikri, CEO of Ikris Pharma Network
Supply of foolproof quality medicine for patient population and other end users must remain a non-negotiable priority for any drug regulatory authority. The responsibility becomes that much more exacting if the regulator happens to belong to and serve a country that is not only the world’s largest manufacturer and exporter of generic medicines and vaccines, but also suffers from an extraordinarily high disease burden. In that backdrop, just as track and trace technologies have been employed by transportation, logistics and distribution companies with good effect for years, the same can also 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.
In what ways can track and trace technologies really boost the quality of medicines in the country?
Long and complex drug manufacturing, distribution and sale supply chain
Firstly, there can be no dispute that manufacturing of medicines and their distribution and sales thereafter involves a rather long and complex supply chain which also brings in the role of a large number of other players including manufacturers, contract manufacturers, suppliers, vendors, marketers, wholesalers, distributors, stockists, retailers, transport and logistics players, hospitals and healthcare facilities etc. To keep a track of every change in a medicinal product that would have occurred at every node of the value chain – from sourcing of raw material including APIs to processing and manufacturing of a drug to packaging and marketing to dispatching them to wholesalers, distributors, retailers and final users – would be a stupendous task. For a country that hosts around 3,000 drug companies and nearly 10,500 manufacturing units with lakhs of associated smaller suppliers, entities and businesses, this would become even more challenging. We must remember that more than 8,000 pharma units are either small or medium in nature.
Forms of tracking and tracing already present in India
Importantly, instituting tracking and tracing-related systems is not new for Indian pharma manufacturers and exporters. 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. Typically primary packaging has been defined as one wherein the package is in direct physical contact with the drug and secondary packaging refers to multiple primary packs and a tertiary packaging implies a shipper containing multiple secondary packs.
The advent of Integrated Validation of Exports of Drugs and Its Authentication or iVEDA
Drawing on its experience of the DAVA platform where there were issues related to uploading of data, the government has set up a new portal called iVEDA. A more simplified and user-friendly system, it facilitates 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.
Persisting problem of fake and counterfeit medicines
Despite such measures, there have been periodic incidents related to selling and usage of fake medicines reported internationally and within the country exposing the persistence of this problem. Only last month, the WHO issued an alert highlighting how four cough and cold syrups made by an Indian manufacturer had been linked with the deaths of 66 children in the West African country of The Gambia. And this has not been an isolated incident. Some years back, it was reported that fake drugs were responsible for the deaths of a whopping 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.
So, how can the government employ track and trace technologies more effectively in order to rule out a repeat of the above-mentioned incidents and to ensure that patients within India and outside only get drugs of unimpeachable quality and origin?
First, serialization or giving a unique identity to the smallest saleable unit of a pharma product is very important. It enables the finding out of current and past locations of the product through the entire supply chain. And serialization must be paired with track and trace technologies. Not all countries with serialization requirements have mandated track and trace technologies.
Second, the Drugs Technical Advisory Board’s (DTAB) recommendation that barcodes or QR codes should be introduced in the top 300 brands of drug products available in the Indian market must be implemented immediately. In fact, these codes must become a necessary compliance requirement for all brands and products across the industry without any exception. The barcode data must include all basic details such as unique product identification code, the name of the API, the brand name, the name and address of the manufacturer, the batch number, the batch size, the date of manufacturing, the date of expiry or retesting, the serial shipping container code, the manufacturing license number or the import license number, and any special storage conditions that might be required.
Third, even 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.
Fourth, there should also be a 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.
Fifth, given the implementation challenges as 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.