NMRA, Drug control body of Sri Lanka released a draft notification which state, Starting from August 1, 2024, “The board of national medicine authority (Sri Lanka) has decided to implement products authentication changes in order to enhance the protection against falsified medicine circulation in the market.
This notification introduces product labelling and product specific QR coding on product getting into the market and this applies to all manufacturers who manufacture or export products. The QR code needs to capture essential data which would enable traceability.
The QR codes must contain :
- Proper name of the drugs
- Generic Name and strength of the drugs
- Batch number
- Date of manufacturing
- Date of expiry
- Price of the product
- Name of the manufacturer and site address
Whereas additional sticker to be placed on each commercial pack indicating the compliance as per below.
- “NMRA approved” in legible font
- Retail price: Rs . XXX.00
- REG no. MXXXXXFR (NMRA registration certification number)
Being draft notification, presently the directive is under discussion between all the MAH, importer, local manufacturer and 3PL. it is expected that 3-6 month transition/grace period will be allocated after approval of the final notification release for compliance.
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.” To meet the local regulation and also align with various global regulation requirement.
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 300i Traceability Solution at multiple location in India for Multiple MAH and we have updated solution in line with new Sri-Lanka regulation. KevSecure Pharma Cloud for 300i 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
- Carton
- Blister
- Strip
- 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.
