The capitalization of export opportunities in regulated and semi-regulated markets was the way forward for the Indian pharmaceutical sector. The government's ease of driving policy should benefit several Indian drug manufacturers.
This is being done to bring ease in the drug regulatory practices in India related to export of drugs, medical devices and cosmetics. All the stakeholders are, however, required to comply with the regulatory requirements of the importing countries as per their specific need.
To ease of doing business, CDSCO propose to make service online through SUGAM portal w.e.f. Ist March, 2017.(i) seeking written confirmation issued by CDSCO for export of API to European Union (350Nos) and (ii) Certificate of Pharmaceutical products (COPP) issued jointly by State and CDSCO (1550 Nos. approximately).
Through SUGAM portal Applicant can apply for permission under Import & Registration , Medical Devices & Diagnostics, Test License ,Cosmetics , Ethics Committee , BA/BE Division of CDSCO. Applicant can also Track the status of submitted application. And also Applicant can Answer Back to the Raised Queries. Applicant can also upload essential documents for Registration Certificate, Import Licence and other related activities.
In addition, risk-based inspection will be carried out by the Center and the State with specific tools, as reflected in the risk-based documents prepared by CDSCO. However, the applicant will be required to submit the details of the observations made during the self-inspection and follow any other overseas regulatory body or as decided by the Regulatory Center or State from time to time.
Whenever extra inspections are required, the reason for doing the same will have to be stated to the satisfaction of higher ups of the concerned Center and State Regulators.
