Pharma MSMEs oppose compulsory QR code on all APIs

New Delhi, Dec 8 (KNN) Micro, Small and Medium Enterprises (MSMEs) in the pharmaceutical sector have opposed the mandatory requirement of Quick Response (QR) code or barcode on the label of all active pharmaceutical ingredients (APIs).

The ministry inserted a sub-rule (5) after the existing sub-rule (4) under the Rule 96 of the Drugs and Cosmetics Rules, 1945 through the amendment. The amendment Rule is scheduled to come into force from January 1, 2023.

The amendment provides boost to identification, capturing and sharing of important information on medicine packs, however MSMEs are worried that this move will further add to the cost of bulk drug manufacturing in the country.

Having a smaller share of exports as compared to big companies MSMEs will face the burden of mandating of QR code.

The MSMEs have now appealed to the government to suitably amend it to make QR code mandatory only for imported APIs to prevent the menace of spurious or substandard APIs in the country.

According to the new sub-rule, every active pharmaceutical ingredient (bulk drug) manufactured or imported in India shall bear Quick Response code on its label at each level packaging that store-data or information readable with software application to facilitate tracking and tracing.

The stored data or information shall include the minimum particulars including unique product identification code, name of the API, brand name (if any), name and address of the manufacturer, batch number, 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).  (KNN Bureau)