Pharma MSMEs need hand-holding by govt to implement QR Code

While it is difficult to estimate the quantum of financial resources required to implement the QR code, it is evident that at this stage the pharma MSMEs will not be able to face an additional costing burden in the wake of capital crunch among other challenges encountered by the MSMEs

On January 18, 2022, the Union Health Ministry came out with the Drugs (Amendment) Rules, 2022 making it mandatory for all Active Pharmaceutical Ingredients (APIs) manufactured or imported in India to bear Quick Response (QR) code on its label at each level of packaging that stores data readable with software application to facilitate tracking and tracing of the ingredients used in all medicines. The stored data shall include unique product identification code, name of API, brand name, name and address of the manufacturer, batch no, batch size, date of manufacturing, date of expiry or retesting, serial shipping container code, manufacturing licence number or import licence number and special storage conditions required, if any.

The amendment Rule is scheduled to come into force in the country from January 1, 2023. Since APIs of good quality is core to the manufacturing of effective and safe medicines, the Union Health Ministry's implementation of QR code on API packs for tracing its origin and movement from manufacturers to formulators is a laudable decision. The QR code will help track and trace medicines during the entire supply chain and ensure its authenticity. The Health Ministry's initiative in this regard is a good step as the supply of spurious and substandard medicines in the pharmaceutical market has been a major issue plaguing the country for a long time. Though the Indian government has periodically been taking several measures to contain, if not completely eradicate, this menace, it seems to have failed in its attempts as there are reports of spurious and substandard medicines making its entry in the pharmaceutical supply chain in the country.

It is under this background, the Ministry has now made it mandatory for all APIs manufactured or imported in India to bear QR code on its label at each level of packaging. Of course, the new rule provides an impetus to the trace and track guidance which aids identification, capturing and sharing of important information on medicine packs. The QR code reiterates high quality and traceability of all APIs. In the wake of the ongoing pandemic, QR code is the way forward to ensure adherence of stringent timelines for the critical supplies of medicines in the country.

Quite expectedly, the Indian pharmaceutical industry by and large has welcomed the government's move in this regard as it is of the view that API of good quality is core to the manufacturing of effective and safe medicines. The supply chain with respect to its security and integrity in proper storage condition plays a very important role to enhance supply of good quality APIs. The industry has welcomed the move as a push towards transparency in supply chain management. However, the small and medium pharmaceutical industries in the country have voiced concern that mandatory requirement of QR code on the pack of APIs manufactured in the country will further add to the cost of bulk drug manufacturers, especially the pharma MSMEs. So, mandating of QR code is an unnecessary burden on MSMEs which have a miniscule share of exports. They are concerned that the pharma MSMEs are already reeling under steep rise in prices of imported Chinese APIs. They argue that QR code is hardly effective in addressing spurious or adulterated API menace. Hence it would be a futile exercise to put in place QR code to ensure API quality. Moreover, they argue that APIs are not sold to consumers directly. Drug makers do necessary quality check of APIs before using it for formulations as per the provisions of Drugs and Cosmetics Rules. If there is any spurious API, it will be checked at formulations' end immediately. Hence, there is no need to put in place QR code on API packs to ensure its quality. The pharma MSMEs also state that the new rule is a repetitive exercise by the government as it had implemented the trace and track regulation where the Drug Authentication and Verification Application (DAVA) is based on GS1 standards.

The QR code is unwarranted at this stage on the API packages as a mechanism already exists to verify the product details, including at which Indian manufacturing facility the pharmaceutical ingredient was produced. While it is difficult to estimate the quantum of financial resources required to implement the QR code, it is evident that at this stage the pharma MSMEs will not be able to face an additional costing burden in the wake of capital crunch among other challenges encountered by the MSMEs. Obviously, the mandating of QR code is an appreciative move which will go a long way in developing a robust and secure supply chain for APIs. But, all said and done, the MSMEs need hand-holding by the central government to implement QR Code as the pharma MSMEs do not have wherewithal at this stage to bear any additional financial burden.

(The author is freelance journalist with varied experience in different fields)