The Central Drugs Standard Control Organisation (CDSCO), India’s national regulatory body for pharmaceuticals, cosmetics, and medical devices, has mandated the inclusion of QR codes on Active Pharmaceutical Ingredients (APIs) manufactured or imported in India. This regulation, effective from January 1, 2023, aims to facilitate the tracking and tracing of products throughout the supply chain. Affordable QR code solutions for Pharma MSMEs are essential to ensure compliance with these new standards.
Regardless of their size or revenue, small and medium-sized pharmaceutical companies must comply with this QR code requirement. Currently, many MSMEs rely on basic desktop inkjet or laser printers to produce their labels. However, meeting the CDSCO’s QR code standards necessitates investing in specialized QR code generation software, barcode printers, and consumables.
For many smaller pharma companies, the cost of implementing these solutions is difficult to justify, given their business volumes. As a result, many have delayed compliance until enforcement actions compel them to adopt these measures.
Non-compliance poses significant risks. Companies may face penalties from state or central drug regulatory agencies during inspections or audits. In addition, API consignments could be delayed by customs during export, or by local authorities during transit, leading to financial losses due to product confiscation or rejection by customers who are wary of products stored under unknown conditions for extended periods.
This raises the critical question: can MSMEs comply with the regulations in a cost-effective way? YES
Risks of Using Free Online QR Code Generators for CDSCO Compliance in Pharma
One common approach is to use online QR code generators. While these tools are often free and easy to use, they come with significant risks. The product and batch data entered into these platforms may not be secure, and there is no guarantee of the tools’ authenticity. Furthermore, the QR codes generated may not meet CDSCO’s stringent requirements, which include:
- Unique product identification code
- Name of the API
- Brand name (if applicable)
- Manufacturer’s name and address
- Batch number
- Batch size
- Date of Manufacturing
- Expiry or retesting date
- Serial shipping container code
- Manufacturing or import license number
- Special storage conditions (if applicable)
Key elements like the Unique Product Identification Code and the Serial Shipping Container Code are often missing from generic online generators, leaving companies vulnerable to compliance issues.
Cost-Effective QR Code Solutions with Expert Guidance for CDSCO Compliance
An alternative solution is to work with industry experts who offer cost-effective, compliant software tailored to these regulatory requirements. This type of software can generate QR codes that adhere to CDSCO’s standards without unnecessary features that increase costs. Additionally, companies can opt for basic desktop barcode printers that are affordable and suitable for smaller print volumes.
To ensure your company remains compliant without overspending, consult with an expert today and explore the right tools for your needs.
Codentrix Technologies Private Limited is an expert in the field of AIDC technology specialising in Traceability solutions based on barcodes and QR codes. We are offering a QR code solution specifically suited for the MSME to meet the CDSCO QR code mandate. Our Team has Pharma background and close to two decades of Pharma regulatory experience. We will be able to provide you the software, barcode printer and labels and help you be compliant. Please contact us for a demo of the software.
