Regulatory Focus™ > News Articles > Indian Pharmacist Group Calls for Stricter Regulations on Storage Temperature Instructions

Indian Pharmacist Group Calls for Stricter Regulations on Storage Temperature Instructions

Posted 20 April 2015 | By Michael Mezher 

Indian Pharmacist Group Calls for Stricter Regulations on Storage Temperature Instructions

A group representing pharmacists in India is calling for regulators to amend the country's Drugs and Cosmetics Act to more strictly control how manufacturers specify temperature storage instructions for their products.

Background

The environment drugs and other healthcare products are stored in plays a critical role in ensuring their safety and efficacy. Manufacturers are required to control for a number of environmental factors, including temperature, humidity, ventilation and exposure to sunlight, based on their product's sensitivity to those factors.

Because the risks posed by improper storage do not vanish after a product leaves the manufacturer, companies must also consider how their products are distributed, warehoused, stored at pharmacies and ultimately how they are handled by consumers.

The requirements for controlling environmental factors are often found in good manufacturing practice (GMP) and good distribution practice (GDP) guidelines. In 2013, India released a draft of its Guidelines on Good Distribution Practices for Pharmaceutical Products, which has yet to be put into effect. However, neither the draft guidelines nor the Drugs and Cosmetic Act establish specific requirements on how storage temperature instructions must be written.

Shortcomings in Temperature Instructions

In a letter addressed to the Central Drugs Standard Control Organization (CDSCO), the Indian Pharmaceutical Association (IPA) calls out shortcomings with the current state of temperature labeling in the country. The group alleges that "there is complete non-uniformity in the storage temperature instructions on labels," and points to inconsistencies in labeling standards as the culprit.

In preparing its claims, IPA says it surveyed the Indian pharmaceuticals market to determine the extent of the shortcomings of storage temperature instructions. Some of the products IPA observed are said to have no storage temperature instructions at all, while others had such strikingly vague instructions as "store at room temperature." IPA points out that room temperature varies greatly throughout the year in India, and calls for requirements to list the specific temperature range in which a product should be stored.

IPA also calls for more specificity in storage temperature instructions for where a product should or should not be kept, such as "Do not keep in the freezer," or "Keep out of sunlight."

In light of the deficiencies found in temperature storage instructions, IPA is urging regulators to adopt specific guidelines to help make medicines safer for consumers.

IPA Letter


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