In a significant move to enhance drug safety and combat counterfeit medicines, the Ministry of Health and Family Welfare, Government of India, has amended Rule 96 of the Drugs Rules, 1945. The amendment, detailed in G.S.R. 823(E) dated November 17, 2022, mandates the inclusion of Bar Codes or Quick Response (QR) Codes on the packaging of specified drug formulations. This regulation, enforced by the Central Drugs Standard Control Organization (CDSCO), aims to improve the traceability and authentication of drugs, ensuring that consumers receive genuine and safe pharmaceutical products. The new requirements came into force on August 1, 2023. These changes are part of the broader India drug barcode regulations designed to ensure drug integrity and public health safety.
Key Labeling Requirements as Per the Amendment
Mandate for Barcodes or QR Codes:
- Applicability: The regulation requires manufacturers of certain drug formulations, listed in Schedule H2 of the notification, to print or affix Barcodes or QR Codes on the primary packaging label. If the primary packaging does not have enough space, the codes can be placed on the secondary packaging label instead. Schedule H2 includes a comprehensive list of drug formulations that must comply with these new labeling requirements, as detailed in the notification by CDSCO.
- Data Requirements: The codes must store specific information, readable by software applications, to facilitate drug authentication. This information includes:
- Unique product identification code
- Proper and generic name of the drug
- Brand name
- Name and address of the manufacturer
- Batch number
- Date of manufacturing
- Date of expiry
- Manufacturing license number
Additional Information
Unique Product Identification Code:
- This code is to be determined by the manufacturer according to their Standard Operating Procedures (SOPs) to ensure proper identification of the product.
Scope of Applicability:
- The regulation is mandatory for the 300 brands of drug formulations listed in the notification. Manufacturers may voluntarily apply these codes to other brands.
Applicability to Domestic and Foreign Manufacturers:
- Both domestic and foreign manufacturers producing these drug formulations for the Indian market must comply with the new labeling requirements.
Batch-Specific Requirements:
- Any batch of the specified drug formulations manufactured on or after August 1, 2023, must include the Barcode or QR Code on its label.
Handling Inadequate Space on Labels:
- If the primary packaging label does not have enough space, the code can be affixed or printed on the secondary package label.
Provisions for Imported Products:
- Ideally, imported products should come with the required codes. However, they may be affixed after customs clearance with permission from the Licensing Authority under the Drugs Rules, 1945.
Conclusion
The amendment to Rule 96 of the Drugs Rules, 1945, mandating Barcodes or QR Codes on drug formulations, marks a significant step towards enhancing drug safety and traceability in India. By ensuring that detailed and accurate information is easily accessible, this regulation helps protect consumers from counterfeit drugs and supports the overall integrity of the pharmaceutical supply chain.For manufacturers and importers, understanding and implementing these new requirements is crucial. Partnering with regulatory companies like Morulaa can provide the necessary guidance and support to navigate these changes effectively, ensuring compliance with the Medical Device 14 (MD-14) standards and maintaining market readiness through the SUGAM portal for drug registration. CDSCO plays a critical role in this regulatory framework.
Morulaa: Your Regulatory Partner
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