QR codes now mandatory for vaccines, cancer drugs

• The Ministry of Health and Family Welfare notified amendments to the Drugs Rules, 1945 to expand the ambit of Schedule H2 and bring additional categories of drugs under the QR code-based track and trace framework.

• It is a major step towards strengthening the quality, safety and integrity of India’s pharmaceutical supply chain.

• Schedule H2 provides for the affixation of a bar code or quick response (QR) code on the packaging of specified drug products to facilitate their authentication and traceability across the supply chain.

• The requirement for QR code-based identification was earlier applicable to the top 300 pharmaceutical brands in the country. 

• Under the amended provisions, all vaccines, antimicrobials, narcotic and psychotropic drugs covered under the Narcotic Drugs and Psychotropic Substances (NDPS) Act, 1985, and all anti-cancer drugs have been included under Schedule H2 of the Drugs Rules, 1945. 

• The present amendment significantly expands its coverage, thereby broadening the scope of traceability and strengthening safeguards against the circulation of counterfeit and substandard medicines.

• The enhanced traceability mechanism will facilitate authentication of medicines at various stages of the supply chain and enable improved tracking and verification of drug products.

• The QR code shall carry nine key data elements for each drug product, namely the unique product identification code, proper and generic name of the drug, brand name, name and address of the manufacturer, batch number, date of manufacture, date of expiry, manufacturing licence number, and details of excipients. 

• The availability of these details through digital authentication tools will facilitate seamless verification and tracking of medicines across the supply chain.

• Manufacturers will be required to print or affix a bar code or QR code on the primary packaging label of the product or, where there is inadequate space, on the secondary packaging label. 

• The QR code shall store information that can be accessed through software applications to facilitate authentication and verification of the product throughout the supply chain.

• The measure is expected to strengthen regulatory oversight and support efforts to curb the distribution of spurious medicines in the market.