Last Updated on September 11, 2022 by The Health Master
Manufacturers of pharmaceuticals have urged the Union Ministry of Health and Family Welfare to set up a central portal to store batch-by-batch the Quick Response (QR) codes printed on the labels of the top 300 brands of medications.
By doing this, duplication of QR codes will be avoided, reducing the availability of fake or spurious pharmaceuticals.
The health ministry published a draft Rule amending the 1945 Drugs Rules to require QR codes on the packaging of 300 life-saving medications beginning on May 1, 2023, in an effort to stop the sale of counterfeit drugs. This prompted the drug manufacturers to file an appeal.
The draft Rule issued by the ministry on June 16, 2022, mandated manufacturers to print or affix barcode or QR code on their primary packaging label or, in the case of inadequate space in the primary package label, on the secondary package label that stores data or information legible with a software application to facilitate authentication.
The store data or information shall include along with the manufacturing license number:
- The particulars include a unique product identification code,
- Proper and generic name of the drug,
- Brand name, name and address of the manufacturers,
- Batch number,
- Date of manufacturing,
- Date of expiry.
“Countries like Russia, the UK, Germany, Denmark, Sweden, Poland, and the US have maintained repositories.”
“The data of the codes or Unique Identification Numbers (UIN) in a batch are sent to the importer who loads the codes in the repository maintained by the government of that country.”
“These governments have software to identify if there is any duplication of the UIN.”
“Such a system is essential if authentication measures are to be truly effective,” said the Indian Drug Manufacturers Association (IDMA) in a representation to the health ministry.
The industry body recommended that the government set up a central portal where manufacturers could upload the printed codes in batches so that, in the event of counterfeit drug problems, they would not be required to verify that the fake medication was not produced by them.
Besides this, awareness programs should be initiated by the government so that the authentication measures are known and utilized, it added.
Drug companies that have implemented authentication measures like serialization said that the response is very low.
The awareness programs will increase the implementation of authentication measures, it stated.
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