New Cosmetic Rules will boost manufacturing industry: Dr. Lalit Kumar Goel

Chennai, February 24, 2023 :

The Cosmetics Rules 2020 will boost the cosmetic manufacturing industry as they are clear and fair for the cosmetic manufacturing companies which are engaged in substantial quantities of production.
 
As per the rules, the manufacturers of the cosmetics need to obtain GMP certificates from the licensing authorities, but this provision was not included in the old rules. It is hoped that this provision will enable the manufacturers to increase their exports in large quantities, comments Dr. Lalit Kumar Goel, the resource person for continuous training programmes (CTP) for drug inspectors deputed by DCO India, the association of regulatory officers.
 
While speaking in a seminar on New Cosmetic Rules 2020 in Sonipet in Haryana, he said obtaining a good manufacturing practices certificate from the authorities is one of the major changes included in old and the new rules. Another important aspect in the new rules is that no substantial change has been included in the penal section. Similarly, the fee for cosmetic manufacturing has been increased to Rs. 10,000 from the existing Rs. 3,500. Additional product fee has been raised from Rs. 100 to Rs. 500.
 
Dr. Goel, who is the state deputy drugs controller in Haryana, has opined that the manufacturers and all other stakeholders must understand one important fact that the cosmetics are meant for human beings only, and not for animals like those of medicines. The Rules help the entrepreneurs to invest in cosmetic manufacturing and it does not become a hurdle in rigid nature. As per the new rules no pre-approval inspection at the manufacturing facility is required to ensure that the manufacturing process and facility meet the appropriate requirements. This is a major advantage for the manufacturers, he said.
 
Highlighting a valid point in the rules, he said the new rules do not mandate for any clinical trial for the products, but there is only one condition that the cosmetics should conform to the BIS standards. A manufacturer of pharmaceuticals is free to manufacture cosmetics in the same premises, but it should be in separate facilities. Likewise, there is no requirement of sale licenses for sale of cosmetics in India as it has been exempted under Schedule K of the Drugs and Cosmetics Act, 1940. However, for import of cosmetics, registration and licenses are required from the CDSCO office.
 
He said the rule also allows the ayurvedic drug manufacturers to manufacture Ayurveda cosmetics.
 
Later, while talking to Pharmabiz, Dr. Goel said previously the cosmetics were defined under Section 3 (aaa) of the Drugs and Cosmetics Act, 1940. As per the new Cosmetics Rules, 2020, manufacturing license is issued on Form COS-8 based on several conditions of infrastructure facilities at the manufacturing site. This is for maintaining conformity to the norms of GMP standards. ExpressPharma