Govt proposes immediate licence suspension for substandard drug makers
New Delhi, Nov. 4 -- India has proposed the immediate suspension of manufacturing licences for medicines that fail critical quality tests, the Union health and family welfare ministry said on Wednesday.
The government has proposed amendments to the Drugs Rules, 1945, through a draft gazette notification.
Under the draft rules, manufacturing licences will be suspended at once when a government analyst declares a drug "Not of Standard Quality" (NSQ) on parameters including assay, dissolution, related substances, impurities, or sterility.
The proposal is significant for India's $60-billion pharmaceutical industry, which supplies generic medicines globally. It comes amid recurrent domestic crackdowns on substandard drugs and international ...
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