India’s drug regulator, the Drugs Controller General of India (DCGI), will meet with cosmetics industry representatives on Tuesday, November 19 to discuss regulatory issues.
DCGI to address concerns surrounding Schedule M
The meeting aims to address concerns surrounding the government’s newly notified Schedule M.
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“The industry has been facing various issues,” said an industry expert, according to ET. “Earlier it had raised concerns regarding the government’s newly notified schedule M that proposed blanket ban on manufacture of any other article or product apart from drugs in the units licensed for drug manufacture. This requirement would mean setting up a new plant exclusively for cosmetic manufacturing.”
Licence before Dec 11, 2001 to manufacture
Further, he mentioned that units licensed before December 11, 2001, were allowed to manufacture related items like nutraceuticals and ayurvedic medicines in the same plant, as an exception to the rule that no manufacturing activity should take place there.
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“We have asked for permitting the manufacture of cosmetics in the area dedicated for manufacture of topical products,” the expert added. “We will discuss this issue during the meeting.”
