Publication:

Assessment of compliance of smoke-form and smokeless tobacco product packages with COTPA packaging and labelling amendment rules, 2024

Background Pictorial health warnings (PHWs) on tobacco packages are a proven tobacco control tool. India mandates that PHWs cover 85% of the principal display area under COTPA, as updated by the December 2024 amendment rules. Evidence on manufacturer-level compliance as assessed at the point of retail sale remains limited. We assessed compliance of smoke-form and smokeless tobacco product packages at retail outlets in Mumbai with the December 2024 COTPA amendment rules and compared compliance between categories.

Methods A cross-sectional observational study was conducted in Mumbai from September to November 2025. Packages were collected from diverse retail settings by purposive sampling with saturation. A validated structured checklist based on the December 2024 amendment rules was used. Descriptive statistics and Fisher’s exact test were applied.

Results 48 packages (30 smoke-form, 18 smokeless) were assessed. Only 27 (56.3%) displayed PHWs in accordance with December 2024 regulations, 15 (31.3%) carried outdated warnings, and 6 (12.5%) had no PHW. Among packages with current PHWs (n=27), smokeless products showed poorer compliance than smoke-form on warning size (0% versus 95.0%, p<0.001), ‘not for minors’ message (28.6% versus 95.0%, p=0.001), and pictorial quality (0% versus 100%, p<0.001). Misleading descriptors were more prevalent on smokeless products (57.1% versus 10.0%, p=0.024).

Conclusions Compliance with COTPA packaging and labelling regulations remains inadequate at the retail level, with smokeless tobacco sector showing the greatest deficiencies. Urgent enforcement action, regular retail-level monitoring, and sector-specific regulatory attention are essential to translate packaging mandates into effective tobacco control outcomes.