Why shelf-life rules for imported drugs might be relaxed

Why shelf-life rules for imported drugs might be relaxed

The Indian government has proposed a major change in the shelf-life requirement for imported medicines.

The new rule, if implemented, would replace the current norm of more than 60% shelf life with a minimum residual shelf life of 12 months at the time of import.

The move is aimed at easing business operations in the pharmaceutical sector while ensuring patients receive medicines with sufficient usable shelf life remaining.

Addressing concerns of stringency in existing rule

The existing percentage-based rule has been criticized for being too stringent, especially for medicines with longer shelf lives.

For example, a drug that is valid for five years would need over three years of shelf life remaining at the time of import under the current norm. This has led to avoidable wastage in the industry.

The proposed amendment aims to address these concerns by providing a fixed 12-month period for distribution and consumption without such restrictions.