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With intensified focus on digitisation of filing and approval procedures related to drug regulatory system, the Central Drugs Standard Control Organisation (CDSCO) has instructed its divisions to restrict shifting or reallocation of IT equipment without prior intimation and approval of the administration and the IT cell in its headquarters.
The Organisation has said that it has observed that IT-related equipment such as desktop computers, laptops, printers, scanners, UPS systems, networking devices, and other associated peripherals are being shifted or reallocated from one office, or section, or room, to another without prior information to the administration and IT Cell of CDSCO(HQ).
"Such unauthorized movement creates difficulties in inventory management, asset tracking, network configuration, and maintenance of IT infrastructure," said the administration.
In order to maintain proper inventory records, network security, asset tracking and smooth functioning of IT infrastructure, it has taken various decisions, which the divisions should follow, it added.
"No IT-related equipment shall be moved, shifted, exchanged, or reallocated from one place/section/room to another without prior intimation and approval of the Administration and IT Cell of CDSCO(HQ)," said the Administration in a circular.
Any requirement for shifting or replacement of IT equipment must be submitted in writing through the Administration office and the IT Cell shall verify and update the inventory and technical configurations before any such movement is carried out.
Non-compliance with these instructions may lead to administrative action and responsibility for any loss, damage, or disruption arising thereof shall rest with the concerned Official or Section, it added.
The CDSCO has been shifting various application forms to online mode in the recent past, as part of its efforts to digitise and streamline the regulatory submission procedure. It has switched various application and approval processes related to drugs and medical devices to Sugam portal in the recent years.
It has also been promoting Online National Drugs Licensing System (ONDLS) portal, designed as a single window platform for online processing of various applications submitted by the stakeholders for issuance of manufacturing and sales licenses including Blood Banks, and other certificates like COPP, GMP, WHO-GMP, Market Standing certificate etc., and post approval changes.
The system is expected to help in establishment of uniformity with regard to the requirement of submission of documents for different type of applications as well as issuance of licenses/permissions throughout India and support uniform administration of the provisions of the Act and Rules by utilising the latest technologies tools including e-governance through the online portal for State/UT Drug Control Authorities.
Besides, the Central drug regulator also has also been developing a unified Digital Drugs Regulatory System (DDRS) to act as a single portal for all regulatory activities.
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