Why shelf-life rules for imported drugs might be relaxed
What's the story
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.
Rule implications
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.
Inventory management
Improving pharmaceutical inventory utilization
The health and family welfare ministry has said that the proposed amendment is also likely to improve the utilization of pharmaceutical inventories across the supply chain. This would be done by reducing avoidable wastage of medicines caused by restrictive residual shelf-life requirements. The government has invited comments on a draft notification proposing this amendment, published on June 22.
Selective application
Proposed relaxation won't be applicable to all medicines
It's important to note that the proposed relaxation won't be applicable to all medicines. Biological products and radiopharmaceuticals will continue to be governed by the existing requirement of a shelf life of more than 60%. This is due to their specialized nature and public health considerations involved in their use. The amendment only pertains to the residual shelf-life requirement at the point of import, leaving other regulatory standards unchanged.