Drug, Cosmetic Mfrs asked to complete data uploading by Apr 30
Irfan Tramboo
SRINAGAR, Mar 27: While the Online National Drug Licensing System (ONOLS) now has several new features which will add to making the licensing system seamless and robust, the J&K Drugs & Food Control Organization (DFCO) has promptly directed for compliance from the concerned in this regard by the end of April this year.
As per details, in the first phase, online application submissions related to sales licensing, fresh manufacturing licensing for drugs/ cosmetics and product endorsement were released over the portal while additional online features were developed and provided over the portal from time to time in a staggered manner for use by stakeholders.
As of date, the DFCO said, that the online services features which include uploading of data by existing manufacturers of drugs/ cosmetics and submission of data for review at the official end, review and approval/ rejection of submitted data of existing manufacturers at the official end, submission of retention applications, additional product endorsement and the change in technical staff are available.
Notably, J&K is the first State/UT in the country to adopt PAN India ONDLS for disposal of various regulatory clearances while the portal has now completed one year of its operation and has attained stability.
With the addition of the new features, the DFCO has stated that it is in constant touch with National Drug Regulatory Authority and Centre for Development of Advanced Computing (CDAC), Noida in making the ONDLS portal robust, industry-compatible and user friendly.
Keeping in view the new additions, the details suggest that all the existing manufacturers of drugs / cosmetics (own licensee/loan licensee) have been directed show compliance and ensure, first, registration of Corporate Office (firm site address) over the portal, second, registration of technical staff (individual basis) as per licenses; hiring and mapping with licenses thereof, third, after successful registration, uploading of existing license and product approvals data through license management tab, fourth, submission of uploaded, fifth, after review of uploaded data at the official end, online application submission for below regulatory clearances which include: retention of licenses product approvals if due for retention, additional product endorsement and change in technical staff.
It has been directed that the process of registration and existing data uploading followed by submission of data shall be completed by or before April 30, 2023, by all the manufacturers of drugs and cosmetics while the data submitted shall be reviewed and approved/ rejected at the official end instantly on first come first serve basis and is expected to be completed by May 30, 2023.
Further, DFCO has also stated that no offline application for available online services will be entertained beyond the cut-off date which has been noted as June 1, 2023.
It has been also stated that the loan licensee will be able to register/upload data over the portal only after principal manufacturer has completed registration / data uploading, while it has been underlined that the existing Cosmetic Manufacturers who have not obtained licenses as per new licensing regime, Cosmetic Rules, 2020 shall not upload data “but shall apply afresh as per Cosmetics Rules, 2020.”
Lastly, DFCO said that the CDAC has informed that 5 types of certifications are likely to be released over the portal in a short time and that the information regarding the same shall be disseminated accordingly.
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