DCGI to discuss regulatory issues with cosmetics companies next week
India's drug regulator, the DCGI, is set to meet with cosmetics industry representatives to address regulatory concerns. The industry seeks clarification on Schedule M, which proposes a ban on manufacturing non-drug items in drug manufacturing uni...
The Drugs Controller General of India (DCGI) regulates the import and quality of cosmetics in India.
The meeting will be attended by the manufacturers, importers and industry associations.
"The industry has been facing various issues. 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," said an industry expert, adding that the requirement was not financially viable.
"We have asked for permitting the manufacture of cosmetics in the area dedicated for manufacture of topical products i.e. external preparations such as creams, lotions etc. We will discuss this issue during the meeting," he further said.
He said that an exception was provided from the requirement that no manufacturing activity shall be undertaken therein except in respect of units licensed prior to 11.12.2001. In view of the aforesaid exception, units licensed prior to 11.12.2001 were allowed to manufacture allied items such as nutraceuticals, ayurvedic medicines etc. in the same plant.
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