DCGI Directs State Drug Controllers to Make ‘Stability Testing’

With a specific end goal to ensure that drugs don’t lose their potency till the expiry dates printed on the package based on the test outcomes, the Central Drugs Standard Control Organization (CDSCO) has guided all the state drug regulator to ensure that manufacturers do stability testing for all drugs before it is marketed as mandated in the law.

This is done for all drugs towards making stability tests compulsory, including active pharmaceutical ingredients (APIs).

Dr. G N Singh Drug Controller General of India (DCGI) said, “An advisory letter has already sent to the state drug controllers on the same and we are waiting for the desired result for patient safety”.

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 outcomes, Dr. Singh concluded.

The stability behind stability testing is to give evidence on how the quality of a drug substance or drug product differs with time affected by a variety of environmental factors, for example, temperature, humidity, and light, and to build up 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 stated, ” Stability testing will enable us to take an edge over poor quality APIs like Povidone Iodine (PVP-I) supplied from different countries. PVP-I, otherwise called iodopovidone, is an antiseptic used for skin disinfection when surgery. Since it is an essential drug used regularly in clinics, poor quality PVP-I accompanies short expiry dates and becomes powerless after the expiry date which is detrimental to patient safety.”

It has been noticed in developing economies certain foreign markets supply high-quality material to regulated markets and low-quality material to cut down cost.

This drive by the drug controller will also prove to be a game changer for the domestic industry which is presently embracing global regulatory standards towards drug quality, he included.

Ashland is a US Headquartered global specialty chemicals conglomerate and is the main 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 best and safe pharmaceutical required in a health set up.


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