India (Commonwealth Union)_ The Union Health Ministry has recently included schedule H2, mandating barcodes on the leading 300 pharmaceutical products such as analgesics, vitamins, diabetes and hypertension medicines, among others. However, according to reports, the pharmaceutical industry has requested 18 months from the date of the last notice to implement the move. The addition of schedule H2 following Schedule H1 will go into effect on August 1, 2023, with the intention of ensuring authenticity and traceability across the pharmaceutical manufacturing and supply chain.
Manufacturers of drug formulation items listed in Schedule H2 are required to print or place a barcode or a rapid response code on the package. According to the All India Organisation of Chemists and Druggists, the rule has been mandated to restrict the selling of fake drugs. According to Rajiv Singhal, the General Secretary of AIOCD, the pharma industry is appreciating the action taken by the Indian government, as these QR codes would prevent the duplication of medications.
According to the statement from the Ministry of Health and Family Welfare, the producers of pharmaceutical products and medications as mentioned in Schedule H2 are mandated to print or affix a barcode or Quick Response Code on the primary packaging label; or, if there is insufficient space on the primary packaging label, it can be printed on the secondary packaging label that contains data or information readable by the software to ensure authentication. The statement added that once ratified, the changes to the Drugs and Cosmetic Rules, 1945, will take effect in May of next year.
Alok Malik, executive vice president and business head of India Formulations, Glenmark Pharmaceuticals Ltd., said: “We welcome the government’s move to introduce QR codes in medicine packaging as they can greatly help in controlling the counterfeiting of drugs by tracking their journey from factory to patient. Counterfeit drugs are a threat to patient safety and this initiative will be another important move towards assuring the authenticity and traceability of the drugs.”
