Government Demands 1 year Residual Shell Life for Imported Drugs

The Union Ministry has announced the revised rule on shell life for imported drugs, as part of facilitating patients with medicines of the best usable shell life.

The proposal states that the medicine must have a shell life of 12 months from the date of import, instead of the existing rule of 60 percent of total shell life. This improves the maximum utilization of pharmaceutical inventions.

What led to New Rule?

The need to optimize the pharmaceutical supply chain and reduce unnecessary wastage of medicine led to this new rule on expanding the shell life to 12 months.

The major reasons for wastage are;

• Due to strict import rules.
• Pharmacies and hospital stores medicine beyond the requirement.
• Improper storage methods that lead to medicine wastage.

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In the old rule of 60 percent, it was found to be over-restrictive, as many medicines reportedly get blocked in strict port rules. That very often leads to the expiry of medicine before dispatch.

Therefore, companies often end up in discarding those medicines, which cost huge operational fees and supply chain costs as well, leading to significant financial loss for companies.

Another way of wastage that is seen is when certain hospitals or pharmacies store medicine beyond the requirements, which often leads to crossing the date of expiry, and the medicine is simply of no use.

Same applies to the improper methods of storage of essential medicines. There are various parameters of hot and cool applied to medicines, often neglected or not met with.

Mass Relief for Companies

The present rule of 12 months ensures sufficient and realistic time for essential medicines to be properly dispatched and used, thereby allowing them to be consumed before expiration.

This plan ultimately eases out the supply management costs and improves the effective inventory and utilization throughout the entire pharmaceutical network.

By replacing the rule, the government is helping to cut down the operational costs and other logistical hurdles for the industry.

All the existing shipping disruptions and port clearances will no longer be a financial loss for the respective companies on board.

Pharma companies can now manage the inventories much more flexibly. Thereby ensuring better stock utilization and less capital loss in blocked medicine. This in turn will boost the ease of doing business for companies.

Whereas the strict quality, safety and efficiency standards under the Drug and Cosmetic Act, 1940, continue to apply.

The specialized drugs like biological and radiopharmaceuticals are exempted from the new rule and will continue to meet the old law of 60 percent residual shell life requirement.