Recently a lot of noise is created on this topic in India related to the shelf life of the vaccines given to the children. As pharma professionals, we would like to share factual information with our readers. In this article views expressed by the authors are personal and does not represent any pharma company.
In the new drug development process “the shelf life extension” is a standard procedure and almost all the regulatory agencies approve the shelf life extensions of the pharmaceutical products.
When any drug product (tablet, capsule, syrup, vaccine) is developed in the Research and Development facility of any pharma company, there are multiple batches of the same formula by varying concentration of the drug and excipient (other than the active drug materials used in the pharmaceutical product) are developed. After checking lots of permutations and combinations one formula is finalized and the batch is prepared with that formula and named as an “Optimized batch”. Later this formula is given to the manufacturing to make the commercial batches of the same. In technical terms, these commercial batches are called “Validation batches”.
After the production of the commercial batch, AKA “validation batch” a minimum of one lakh samples either tablets, capsules or vaccines or any pharmaceutical product from this validation batch is separated and kept for stability as per the regulatory agency mandate. The stability is checked periodically 3, 6, 9, 12, 15, 18, 24 months. When any pharma company submit the documents for the marketing approval of any pharmaceutical product they have to submit compulsory the stability data of that product.
Generally, there are two types of stability data are required for the submission of one is normal room temperature stability and another one is accelerated stability (To assess the stability of a formulated product it is usual to expose it to “high stress”,i.e. condition of temperature, humidity and light intensity that causes break down). Every pharmaceutical company has to submit the room temperature stability data and accelerated stability data to the regulatory agency for getting the marketing permission. The accelerated stability data for a minimum of 6 months is mandatory.
Based on the stability data provided by the pharma company the “shelf life” is given by the regulatory agency. If the stability data (room temperature) 6 months and accelerated stability data of 6 months are provided by the company then they will get 12 months’ shelf life. If the company provide stability data of 9 months they get 18 months shelf life and after submitting 12 months’ data, they get shelf life for 24 months. This shelf life is also mentioned in every manufacturing and marketing permission given to the pharmaceutical company. Also, on every pharmaceutical product “manufacturing date” and “Expiry date” is mentioned which is nothing but the shelf life.
Now coming to the “Shelf life extension” consider the regulatory agency has given a shelf life of 12 months (based on the 6 months’ stability data) a “XXX” product of “XYXYXY Pharma company” and later the company provides the 12 months’ stability data of “XXX” product, then the regulator gives 24 months’ shelf life to the same product. This shelf life is also valid to the “XXX” product is already in the market with 12 months of the shelf life is printed on the box or vial or strip. But the caveat here is the company cannot able to tress all the samples present in the market and recall them and relabel them so they just provide the “Shelf life extension certificate” provided by the regulator. Maybe some companies relabel it with the updated “Shelf-Life” which is also valid, but if one can notice the relabel please consider it as normal but ask for the “Shelf-Life extension certificate”.
The shelf life extension income into the light in the Covid-19 era because most of the new drugs and vaccines are marketed by various pharma companies. Due to the Covid-19 emergency, most pharmaceutical companies are marketing and manufacturing the products in an accelerated manner.
With this article we only want to inform the people about the “Shelf Life Extension” and it is not any fraud or deception by the pharma companies to the customers if they provide you with the “Shelf Life Extension Certificate”.