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Following Central Drugs Standard Control Organisation (CDSCO)’s mandate for submission of real time stability study on a drug for its initial three batches, the Maharashtra Food and Drug Administration (FDA) this year has witnessed a surge in new product approvals after a lean phase of almost a year.
The purpose of stability testing is to provide evidence on how the quality of a drug varies with time under the influence of a variety of environmental factors such as temperature, humidity and light.
It was observed that pharmaceutical companies were showing reluctance to do stability studies ever since the government mandated stability studies for all drugs including active pharmaceutical ingredients (APIs) as per government notification dated May 02, 2017.
The issue of uniform implementation of submitting stability studies by the pharmaceutical companies for drug approval was taken up earlier this year by the Union health ministry.
CDSCO has mandated submission of one month of accelerated stability study and six months of real time stability study on a drug for its initial three batches to get the requisite drug approval for the company. Real time stability study is then supposed to be performed for 12 months, 18 months, 24 months and subsequently for 12 months or more based on the shelf life of the product.
Stability studies were earlier only restricted to patent or proprietary medicines before the government notification dated May 02, 2017.
While accelerated stability study stipulates that the drug has to be tested for its stability under the controlled 40 degree centigrade and relative humidity of 75, real time stability study stipulates that the drug has to be tested for its stability under the controlled 30 degree centigrade and relative humidity of 65.
CDSCO had earlier directed all the state drug controllers to ensure that manufacturers do stability testing on drugs before it is marketed as mandated in the law.
Stability testing will ensure that the label claims made by the manufacturer on the drug packaging are validated through scientific evidence and process based on test results.
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