Concerned over non compliance in storage temperature instructions on medicine labels, the Indian Pharmaceuticals Association (IPA) urged the Drug Controller General of India (DCGI) to immediately take cognizance on the matter and take appropriate steps.
Considering the huge health risk associated with this negligence, IPA has suggested the Centre to amend the drugs and cosmetics rules in lines with the DTABs recommendations and proposed good distribution practices (GDP), while considering the suggestions of the association as well.
IPA made these observations based on an extensive study done on the labels of thousands of medical products available across the Indian market. They found that there is complete non-uniformity in the storage instructions of the labels of the pharma products. In fact, such is the situation that some of the products do not even carry any storage temperature instruction on the label.
Experts cite that the only way to tackle this issue is by coming out with a clear-cut, unambiguous storage temperature instruction guidelines, with mandatory requirements of mentioning proper storage temperature on label. They strongly stressed that it should be made mandatory to mention minimum specific storage temperature or else the product should be termed misbranded.
Another disturbing trend they noticed is that many of the products carry storage temperature instruction like ‘store at room temperature’, ‘store in a cool place’, or ‘store between 2 degree C to 8’, or ‘do not store between 25 degree C’ etc. which is confusing and very difficult to comprehend for a lay man. Most importantly, IPA noted that having such ambiguous statements is highly risky as the room temperature across the country varies widely, so does the temperature as per the changing climate.
IPA in its representation to the DCGI urged that using such confusing statements in the labels should be completely stopped, instead replacing it with specific temperature requirements. Kaushik Desai, general secretary of the IPA stressed that it is essential to mention precise room temperature on the label, which includes upper as well as lower temperatures of storage range, while deleting all other unnecessary wording that may confuse people.
He further pointed that there is an urgent need to bring about stringent, and uniform scientifically sound guidelines for labeling of storage temperature requirements of drugs. “Keeping in view with such serious variation in the labeling, there is an urgent need to have very specific rules for mentioning the storage temperature specifications on medicines' label. As this will go a long way in assisting and guiding the stakeholders in the transport and storage chain as well as the public to properly decipher and understand at what temperature the medicines needs to be kept. Also steps should be taken by the CDSCO to immediately implement the proposed GDP,” he insisted.
The Central Drugs Standard Control Organization (CDSCO) in 2013 had published a draft GDP for pharmaceutical products. The aim behind this was to ensure consistent quality of pharma products throughout the distribution process where all parties in the supply chain contribute to maintaining the quality of products until they reach the patient.