New Delhi: In an effort to streamline the online filing of applications related to registration and import of cosmetics and to help it stick to the stipulated timelines, the central drug regulator has decided to restrict the number of products in a single online application and allow multiple applications.
The Central Drugs Standard Control Organisation (CDSCO) has informed all stakeholders including cosmetics industry and trade associations that the restriction will be implemented with effect from August 16 and requested all stakeholders to note the change for submission of applications on the Sugam online portal.
“In order to further streamline the process, it has been decided to restrict the number of products to a maximum of fifty per single online application and multiple applications can be made. This has been evolved for processing the disposal of the applications within stipulated timeline as per the Cosmetics Rules, 2020,” said the drug regulator.
The move is in pursuance to the implementation of e-governance system in the CDSCO, and following the responses taken from the stakeholders related to the system through an effort in December, 2016.
The drug regulator, in 2016, sought the stakeholders to submit their responses on the extent of relief or facilities the system has actually generated and things that are required to improve the system, including on processing and approval of applications through Sugam, among others.
The CDSCO received various applications for registration and import of cosmetics including post approval change through Sugam online portal, following the e-governance implementation.
According to the Cosmetics Rules, 2020, once the application for import registration is submitted, the Central Licensing Authority should examin the documents furnished online and on being satisfied, grant import registration certificate or may reject such application for which reasons shall be recorded in writing within a period of six months from the date of application.
In the event of rejection, the applicant may appeal to the Central government within 45 days and the government shall pass orders within a period of 90 days from the date of appeal.
The Rule says that a single application may be made and a single registration certificate in Form COS-2 may be issued in respect of import of one or more cosmetics manufactured by the same manufacturer. This is provided that the cosmetics are manufactured at one factory or more than one factory functioning conjointly as a single manufacturing unit for cosmetic intended for registration.
It may be noted that earlier this year, the CDSCO has directed the registered importers of cosmetics in the country to provide an annual statement with details of imported cosmetics from the date of grant of registration as per the Cosmetics Rules, 2020.
The directive followed the regulator’s observation that the details of cosmetics imported annually by such importers are not being provided to its office, as per the requirement.
Under the Cosmetics Rules, 2020 notified on December 15, 2020 under the Drugs and Cosmetics Act, 1940, the Central Drugs Standard Control Office (CDSCO) grants Import Registration Number (IRN) under Form COS – 4A for cosmetics which are already registered for import and sale into India as per the relevant rules.
As per the requirements of conditions of IRN under the Form, the importer shall provide the statement of details of cosmetics imported annually to the Central Licensing Authority.
