The Union Ministry of Health in India made important amendments in the Drug Rules, 1945. It introduced the mandatory inclusion of Quick Response (QR) codes on the primary level and secondary level packaging labels for the top 300 brands and asked the Department of Pharmaceuticals to identify these 300 drug brands.
On June 14th, 2022, the Ministry of Health published the Notification for implementing the prints of QR codes or barcodes. The draft mentions that if there is no space in the medicine strip, the QR code should be printed on the packet. The data should be readable with software applications for the purpose of authentication. As per the draft notification issued, the QR code affixed or printed on the primary packaging level and secondary packaging level should store the following data or information as follows:
- 1. Unique product identification code: 2XX2XPY7G7X
- 2. Proper and generic name of the drug: SAMPLE 500 MG TABLET 5
- 3. Brand name: Kevision Systems
- 4. Name and address of the manufacturer: ST 101, One 42, B/H Ashok Vatika, Ahmedabad, India
- 5. Batch number: Test Batch
- 6. Date of manufacturing: 17/06/2022
- 7. Date of expiry: 31/12/2024
- 8. Manufacturing licence number: LIC-SAMPLE-DEMO-0013
Mentioned above is the sample data we have used to exhibit a sample QR code:
Any objections and suggestions for the amendment in the Drugs Rules, 1945 will be received and reviewed from any person within 30 days from the date of the issuance of the notification. According to the notification, the rule shall come into force on May 1st, 2023.
Regarding the API update, in the previous amendment, the Ministry made it mandatory to print QR codes on all the Active Pharmaceutical Ingredients (APIs) or bulk drugs manufactured or imported in India. The QR code should be affixed on all the levels of packaging. To know more about the details, read our article on: Recommendations by Indian associations on Drugs & Cosmetics (Amendment) Rules, 2022
The Indian government has already issued DGFT guidelines. In the last update, the Ministry has also made it mandatory to print serialized code on secondary packs and aggregate till the Tertiary level. The generated data has to be uploaded to the iVEDA portal. A new deadline has also been issued by the government. To know more about the details, read our article on: Regulatory Update by DGFT for Indian Pharmaceutical Track & Trace System.
Kevision Systems, part of the Kevin group, is a leading provider of complete solutions and services for Serialization & Track and Trace, enabling companies to protect their brands & products. 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.