DCGI directs state drug controllers to ensure pharma cos do stability testing for all drugs
|
Shardul Nautiyal, Mumbai
January 23 , 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.
|
|
|
|
|
TOPICS
|
That foods might provide therapeutic benefits is clearly not a new concept. ...
|
|
|
|