India Top 300 Pharma Brand Products QR code serialization requirements for 2023

Starting August 1, 2023, “The manufacturers of drug formulation products as specified in Schedule H2 shall print or affix Bar Code or Quick Response Code on its primary packaging label or, in case of inadequate space in primary package label, on the secondary package label that store data or information legible with software application to facilitate authentication”. The government suggest this will help in fighting falsified drugs circulation.

This mandate introduces Batch and product Traceability on Locally manufacturing or consumed product and this applies to all manufacturers who manufacture or export products to India as per SCHEDULE H2 list. The QR code needs to capture essential data which would enable traceability. This is the culmination of a process that began in 2021, when the Drugs Technical Advisory Board (DTAB) approved a proposal mandating QR codes and restrict counterfeit.

In the near future, QR codes will also link to a national database with pricing data from the?National Pharmaceutical Pricing Authority.

Companies are required to get a?GS1 Company Prefix, a unique number that identifies a company as the owner of a barcode and the product to which it’s affixed, and a?GS1 Global Location Number. GS1 Global Trade Item Numbers will serve as the “unique identification code.”

From tracking the origin of medicine, to the manufacturing, packaging and transportation of distribution, the pharmaceutical supply chain needs to be secured to guarantee that the products are authentic and safe for the patient. To protect consumers, regulators have responded to the counterfeit-drug problem by enforcing higher standards of transparency and traceability throughout the pharmaceutical supply chain.

We Kevision, have already deployed our Domestic Product Traceability Solution at multiple location in India for Multiple MAH. KevSecure Pharma Cloud for DPS has facility to cater to web-link encoded in QR Code as per GS1 digital link. Customer has full control over product authentication and with minimal changes in present operation and process KevSecure Pharma Cloud can fulfil the API Traceability.

We offer Solutions for various packing levels

i)?Carton

ii)?Blister

iii) Strip

iv) Label

Kevision offers end to end solutions, starting from Line Level Equipment to the Cloud, including appropriate infrastructure. The Kevision Pharma Cloud offers 24 X 7 up time for product verification. Our application is compatible for all major configurations, involving Main Domain, Sub-Domains as well as Plant Servers and in addition to this, both in premise and cloud server application hosting options are available. KevSecure Pharma Cloud offers flexibility to use our solution starting from L1to L4 or 3rd Party L4.

Kevision Systems, part of the Kevin group, is a leading provider of complete solutions and services to protect your products and supply chain. We are also a leading Solutions Provider for Vision-Based Inspection Systems for products, especially in the Healthcare, Food & Beverage as well as Automobile Industries. With Global Trade becoming seamless, the need for increased security & traceability of products is imperative for product authenticity. Kevision partners with clients to provide a robust & secure solution to meet product & client safety as well as regulatory compliance.

Our stack of technologies includes powerful?Vision Systems, turnkey?Serialization?and?Aggregation?hardware and Software solutions, and the?KevSecure Suite, that supports all Cloud & On Premise Applications.