DCGI Directs State Drug Controllers To Ensure Pharma Cos Do Stability Testing For All Drugs

DCGI Directs State Drug Controllers To Ensure Pharma Cos Do Stability Testing For All Drugs

Mumbai, 22 Jan 2018: In order to ensure that drugs do not lose their potency till the expiry dates printed on the package based on the test results, the Central Drugs Standard Control Organisation (CDSCO) has directed all the state drug controllers to ensure that manufacturers do stability testing on drugs before it is marketed as mandated in the law.


This is done towards making stability tests compulsory for all drugs, including active pharmaceutical ingredients (APIs). “An advisory letter has already been sent to the state drug controllers on the same and we are waiting for the desired outcome for the sake of patient safety”, Drug Controller General of India (DCGI) Dr G N Singh said.


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, Dr Singh concluded.


The purpose of stability testing is to provide evidence on how the quality of a drug substance or drug product varies with time under the influence of a variety of environmental factors, such as temperature, humidity, and light, and to establish a retest period for the drug substance or a shelf life for the drug. 


Hailing this as a positive development, Nelson Corda, Managing Director, India, Ashland said, “Stability testing will help us take an edge over poor quality APIs like Povidone Iodine (PVP-I) supplied from other countries. PVP-I, also known as iodopovidone, is an antiseptic used for skin disinfection before and after surgery. Since it is an essential drug used most often in hospitals, poor quality PVP-I comes with short expiry dates and becomes ineffective after the expiry date which is detrimental to patient safety.” 


It has been observed that certain foreign markets supply high quality material to regulated markets and low quality material to developing economies to cut down cost.  This initiative by the drug regulator will also prove to be a game changer for the domestic industry which is currently embracing global regulatory standards towards drug quality, he added. 


Ashland is a US Headquartered global specialty chemicals conglomerate and is a leading producer of cellulose ethers and a global leader in vinyl pyrrolidones.  PVP-I is in the World Health Organization's List of Essential Medicines, the most effective and safe medicine needed in a health set up. Pharmabiz