Indian pharma: Obligatory dynamic QR code or barcode on 300 medicines from August 2023 

More than 300 medicines produced or retailed in India will have to carry a web-linked dynamic QR code or barcode, primarily on primary packaging, under India’s amended Drug Rules 2022, from 1 August 2023. The requirements have been introduced to protect the $60 billion industry where counterfeiting has become a major problem for the approximately 60% of Indian-produced pharmaceutical products sold domestically across the nation of 1.4 billion. The remaining 40% of medicines produced in India are exported and are already subject to providing authentication and traceability data.  

This change implies a significant shift towards anti-counterfeit measures and traceability for a gigantic section of the enormous Indian pharma industry and is a challenge too in terms of having to provide a relatively large amount of data in a very limited space such as a blister of tablets. Markem-Imaje is already working with leading Indian pharma companies to implement such levels of traceability on blister packs and labels and other primary or outer substrates to ensure 2D barcode and QR track and trace and thus protect a brand’s reputation, and, of course, consumers’ health.
 

Unique authentication code on all medicines 

The new rule is actually an amendment to the Drugs and Cosmetics Act 1940 and its subsequent Drugs Rules 1945, and demands eight sets of data be contained on the lowest sellable unit of each pharma product sold across India. The rule stipulates that either a barcode or Quick Response code contain the authentication information “on its primary packaging label or, in case of inadequate space in primary package label, on the secondary package label that stores data or information legible with software application to facilitate authentication.” 

The barcode or QR code on medicines must contain the following information: 

- Unique product identification code;

- Both proper and generic name of the drug;

- Brand name of the drug;

- Name and address of the manufacturer;

- Batch number;

- Date of manufacturing;

- Date of expiry;

- Manufacturing license number.

Indeed, the sheer amount of data required makes use of a standard barcode impossible for all but those most granular information like batch number, unless they are 2D dynamic barcodes.  The most commonly used examples of these are the Data Matrix or the QR code which may also be GS1 compliant and the ideal solution for the new Rules.
   

Markem-Imaje track and trace QR code solutions 

The challenge of the new regulation is to print high-quality, legible codes on potentially very small spaces, requiring from 80 to 100 characters, plus a scannable QR code or other 2D barcode to provide static longer information like the manufacturer address details, otherwise occupying up to 240 characters. “The problem here is that the size of the QR code becomes huge and the QR codes are difficult to read,” says Suddhachitta Ray, Vertical Marketing Manager. 

The other possible solution, requiring the printing of only 35-45 characters, is to provide a web linked QR code on medicines.  “This is the option we are seeing most pharma companies prefer because, as a result, the QR code is small, print quality can be assured and can be easily scanned.  Here, the printed code contains only the URL, with its related webpage containing the eight datapoints that Drugs Rules amendment requires,” he continues.   

Besides the code itself, the chosen printing technology is of the utmost importance because of the production speeds and volumes required to effectively operate and serve the medicinal needs of the now most populous nation on earth.  

Printing technologies for dynamic QR code on medicines  

High-quality QR codes can be effectively printed using all of MI’s primary packaging technologies with varying levels of scanability and speed, however, the marking quality for producing QR track and trace and other such 2D barcodes varies considerably when it comes to printing on different substrates.  

The most common substrates used in the packaging of retail pharma products are aluminum foil blisters and strips, mono carton or paperboard boxes, and glass or plastic bottles or vials with printed paper and plastic labels affixed to the container.  All of MI’s printing technologies can effectively mark QR/2D barcodes on labels, the latter the most commonly used on liquid medicines and injectables, though CO2 and fiber laser printers are some of the fastest and most cost-effective on this substrate. MI customers are able to print complex labels with a QR code and multiple rows of text at speeds of 160-180 labels per minute using one CO2 laser printer to produce the labels, with around 300 achieved using fiber lasers.   

When it comes to printing on carton, the main outer packaging for pharma goods, especially those made of porous paper, all MI printing technologies may be used. However, on this substrate, CO2 laser outperforms other technologies, for example achieving maximum speeds of 280 products per minute (PPM) with seven lines of code or 500 PPM with four lines of code.
 

Best printing tech for foil blisters   

By far the most ubiquitous primary substrate used in pharma are aluminum foil blisters that hold tablets, and which, according to the new Drugs Rules, should contain at least part of a unique identification code for medicine; this is because pharma retailers often sell sole blister packs without a box.   

For this application, until now, Indian pharma producers have most commonly-used a Stereo Printer or Contact Coder, which is extremely cost effective and supports the current packaging machine speed of around 50-60 strokes a minute. With the introduction of QR codes or 2D codes on the primary substrate, Stereo Printers have become instantly obsolete. This vacuum has been occupied with Thermal Inkjet (TIJ) as a preferred technology by the industry because of its consistent print quality, low maintenance and high-speed print capability at up to 240 PPM.

When it comes laser printing, the technology offers excellent print quality, especially using fiber lasers, and can easily mark the QR code on 200 PPM with a single CO2 laser head, and up to 480 PPM using multiple heads, with even higher speeds for fiber models. Although the initial investment for laser is high, with no consumables costs and higher coding speeds, in the medium to long term, laser has overall lower OPEX. Indeed, given the high volume of production of these medicines, the payback period can be as short as eight months. With ever increasing traceability and authentication regulations like the track and trace QR code, laser has a major role in future pharma printing needs.

The productivity of all of MI’s printing technologies can be even further enhanced using our Packaging Intelligence software suite CoLOS®, combined with cameras on the production lines to guarantee legibility of the 2D barcode, Data Matrix or dynamic QR code on medicines. This combination of hardware and software guarantees seamless and automated data exchange with the Cloud services of numerous devices on multiple production lines within the same factory, generating all the required reports. This ensures that the customers meet and even exceed all the requirements of the amended Drugs Rules. 

To find out more about how Markem-Imaje can help you to comply, please contact: bchidanand@markem-imaje.com.