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Drug cos seek prompt action against gamma irradiation plants in Konkan region for lack of cold storage facilities
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Shardul Nautiyal, Mumbai
November 30 , 2018
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Drug manufacturers have reported to the Maharashtra Food and Drug Administration (FDA) in writing that four gamma irradiation plants in the Konkan region have no cold storage facilities and have sought prompt action on the matter. Lack of cold storage facilities at these plants is in gross violation of the licensing conditions as stipulated in Drugs and Cosmetics (D&C) Act, 1940.
There are concerns that gamma irradiation facilities should have the storage facilities in place as it is an important stage in the supply chain to be able to deliver quality and efficacious drug in the market for patient and consumer safety.
Cold chain items, such as vaccines, insulin, biotech products and products derived from blood or plasma, can be classified as particularly high risk because they are at risk from freezing as well as elevated temperatures.
“We will be inspecting the facilities based on the complaints and will take necessary action if there is contravention of rules,” according to a senior FDA official.
Following manufacture, some medicinal products need to be stored and shipped at lower than ambient temperatures to assure their quality and efficacy. These are often referred to as “cold chain products”. Wholesalers, retailers and gamma irradiation plants which have Form 28 as per norms are expected to store and distribute them in strict accordance with the product labeling requirements.
Distribution chain for medicinal products can be complex, potentially involving a number of storage locations, wholesalers and modes of transport, before the delivery finally reaches the pharmacy.
The transportation arrangements from one location to another should be regarded as an extension of the storage activities and distributors are expected to treat each journey as unique with the length and complexity, as well as any seasonal variations, being considered when choosing the packing method and mode of distribution.
Cold chain products should be packed in such a way as to ensure that the required temperatures are maintained throughout the journey and the medicines are transported in accordance with their labeling requirements to prevent jeopardising their quality.
For small volumes of lower risk products, with short journey times of less than three hours, insulated containers are generally used. For extended journeys gel or ice packs are added to the packaging to maintain appropriate temperatures throughout.
The code of ethics states that pharmacists should ensure that “refrigerators used for pharmacy stock are capable of storing products between 2 degree centigrade and 8 degree centigrade. They must be equipped with a maximum or minimum thermometer, or other suitable alternative, which is checked on each day the pharmacy is open and the maximum and minimum temperatures recorded.
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