Do we know whose prime concern is it to have a reasonable shelf life, moderate storage conditions and long expiration periods of the drug products? None other than the manufacturers, and in turn, the people who develop the products.
I may use the shelf life and expiration date synonymously in the later part, but conceptually for me, these two terms are slightly different. Mostly for export, a pre-shipment sample is required and a minimum of 80 per cent of shelf life is also requested by the customers. Imagine for a product with 18 months life if three months are lost before the shipment then the product will hardly have 12 months for usage. You may recall during the recent COVID 19 pandemic a series of extraordinary steps were taken by DCGI (CDSCO) to regulate the import and clearance of goods from the ports and materials with lesser available shelf life were allowed to be cleared. The availability of drugs and raw materials for manufacturing is very important. Even within the country, logistics are very difficult due to geographical and climatic problems to retain the utility of the product in good condition. Environment-controlled transportation is still a difficult proposition in India (both due to cost and availability). The consumers come in the picture much later and only when they are faced with short expiry products and when they are compelled to purchase more than required units due to the packaging or available commercial pack.
By rule of the thumb, most of my pharma marketing friends will agree, if one cannot have a product life of at least 18 to 24 months, better to not market such products. And if somebody demands 60 months expiry then also it is not worth marketing, indirectly it implies that the product is going to be on chemist shelf for such a long time. Such products are not in demand or are obsolete. It is sometimes suggested to have smaller batch sizes of slow-moving and highly specialised products. This will apply to specific or outdated molecules, drugs for some rare type of diseases in a particular place or additional strengths of the same molecule where all the strengths are not equally prescribed.
Unlike food, which is normally prepared for immediate consumption or to be used within a short duration, drugs have to be manufactured much in advance. They have to undergo critical tests and examination and they will be purchased and used only when the need arises, so equating food with drugs will not be prudent. The element of taste, appearance and smell is most important in foodstuff so its treatment in the context of shelf life and expiration has to be dealt with separately. However, its relevance with drug expiration will be at times quoted since both are meant for good health and life.
The question that needs to be answered is: What happens to near expiry or expired products which are returned by the retailers as non-saleable goods? Normally huge stocks are dumped to wholesalers and retailers towards the end of the financial year (FY) which helps to show a lot of green in the annual balance sheets. A situation like this is a common phenomenon and is not aimed to show any company or individual’s approach. It is also important to view a situation if the product could not be shipped due to a shortfall in the 80 per cent shelf life demanded by the customer. Such batches are repacked and diverted to other customers or markets. Ambitious and well-defined SOPs for the handling of returned or expired goods and raw materials (which are within the company only) are written by professionals, it is important to know and evaluate how seriously these SOPs are implemented.
It is not uncommon to find a lot of expired raw materials available in the manufacturing premises during internal audits. The companies having international business with highly regulated markets compulsorily follow their SOPs, my concern is for companies manufacturing for the domestic market only.
Few questions that must be answered by the regulators, industry and stability experts are as follows. These are not my views but possibilities that have been talked about, practised and requested to be considered by regulators:
Is it advisable to give a new lease of life to the existing material or batch of the expired product if it is found to be compliant with the specification?
How to evaluate that the ...
Read More
(All Rights Reserved)