Blue stripe rule sparks pharma worry

New Delhi: The Centre had directed drugmakers last month to add a blue line on the antibiotic packaging strips, seeking to curb the rampant use of these medicines. But pharma companies believe this step will instead hamper operations and cause financial disruptions.In January this year, the government had issued a notification, announcing, "all antimicrobial drugs and their preparations shall bear a conspicuous blue vertical strip on the left side running throughout the body of the label without disturbing the other conditions printed on the label".However, pharma associations have expressed their concern over the move, with many associations writing to the government urging it to withdraw the notification.The Himachal Drug Manufacturers' Association (HDMA) has written to the ministry of health, citing that the proposed packaging measure lacks scientific substantiation, global regulatory alignment, and proportional public-health justification, while imposing significant operational and economic disruption.According to the HDMA, the proposal lacks evidence-based rationale."There is no publicly available data or regulatory assessment which demonstrates that a colour marking on packaging influences prescribing behaviour, restricts misuse, or contributes meaningfully to antimicrobial resistance (AMR) control. AMR is primarily driven by prescribing and dispensing practices, not by secondary packaging design," the letter dated February 17 said.Antimicrobials are already regulated through Schedule H/H1 warnings, cautionary labelling, traceability systems, QR/barcodes, and pharmacovigilance mechanisms, hence the new proposal is duplication and no major international regulator mandated colour based identifier, it further said. Various associations including the RSS affiliate-Laghu Udhyog Bharati has urged the Centre to withdraw the proposed blue line requirement.

from Economic Times https://ift.tt/Z4BpY7s