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KPRDO’s proposal to remodel medicine strips with regulatory information not feasible: DCGI

Nandita Vijayasimha, Bengaluru
Friday, October 11, 2024, 08:00 Hrs  [IST]

The Drugs Controller General of India (DCGI) has communicated to the Karnataka Pharma Retailers & Distributors Organization (KPRDO) that its suggestion to remodel medicine strips is not feasible.

In August 2024, KPRDO in its letter to the regulatory authority had proposed that every single tablet or capsule with a batch number, expiry date, MRP and drug name along with any other regulatory information required as per law will be useful during drug dispensing. 

C Jayaram, president, KPRDO in his letter to the DCGI stated that if this information is introduced on the medicine strips, then the pharmacists need not hesitate to sell single tablets to patients.

In his reply to KPRDO, DCGI Dr. Rajeev Singh Raghuvanshi stated, “It is pertinent to mention that it may not be feasible to include the details like batch number, expiry date, MRP and drug name along with any other regulatory information on every single capsule and tablet. However the Union government had amended the Rule 96 vide GSR 823(E) dated November 17, 2022 with regards to capturing the requisite information in the form of QR (Quick Response) or barcodes for top 300 brands which is already enforced”.

According to pharma industry experts, using QR codes scanned by smartphones, allow patients and pharmacists to access detailed information to provide all necessary data on medication strips. It would offset the counterfeit drugs. This approach would streamline information sharing, reduce clutter on packaging, and ensure that up-to-date data is always available. It could also enhance patient education and adherence by making it easier to access important details quickly.

Implementing this could involve collaboration with manufacturers and regulatory bodies to standardize the information provided through the QR codes. Additionally, promoting awareness and education about how to use QR codes would be essential for patient engagement, they added.

Jayaram noted that the DCGI proposal to print QR/barcode for 300 molecules was after KPRDO members met the regulatory authority. “We received a letter stating that, soon all molecules will have QR/barcode to scan original products.”

Early this month, it is reported, “The Drugs Technical Advisory Board (DTAB), the body that advises the Central and state governments on technical matters related to drugs in the country, has recommended implementing track and trace mechanism on all oncology products through QR and bar code. This was to prevent fake drugs mixed with genuine stocks and sold to unsuspecting cancer patients, putting their life at risk.”

 




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