Small firms seek exemption from India's drug traceability law

The Confederation of Indian Pharmaceutical Industry (CIPI) wants small drugmakers exempted from India's traceability requirements for exported medicines.

A report on India's Pharmabiz website suggests the CIPI plans to take up the issue shortly with the Ministry of Commerce and the Pharmaceuticals Export Promotion Council (Pharmexcil).

Earlier this year, India's Directorate General of Foreign Trade (DGFT) gave small scale industry (SSI) companies a one-year extension on the requirements, but the CIPI wants it to go further and remove the need to comply entirely.

From March 31, 2017, SSIs making pharmaceuticals for export must add unique serial numbers to medicine packs, record the relationship between primary, secondary and tertiary packaging (aggregation) and report data to India's Drug Authentication and Verification Application (DAVA) portal.

The CIPI's executive secretary Sudesh Lumar argues that many SSIs make medicines for export to low-income markets which lack the infrastructure to scan bar codes on packaging and implement track-and-trace, and certainly do not require the burdensome aggregation element of the scheme.