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New technological advancements, Health and medicine

  • Published
    17th Nov, 2023
Context:

As per the latest update, the Central Drugs Standard Control Organization has been working to launch an Integrated IT platform to bring in transparency and uniformity in all its processes to create confidence in domestic and international markets.

About the New IT Portal:

  • The portal will create provisions to capture information from various stakeholders routinely “similar to ITR returns and GST filing”.
  • Objective:
    • To track products right from the stage of procuring raw material, to supply chain, and finally patterns of consumption categorised by quantity, area, and season.
  • Key features:
    • The portal will enable manufacturers, distributors and retailers to upload their invoices on the portal for this end-to-end tracking to become possible.
    • To share information about spurious and not of standard quality medicines with state regulators to tackle the problem of the movement of these drugs across state boundaries.
    • Investigations and prosecution launches will also be done through the portal in such cases. It will also help track all types of court cases for prosecution and convictions.
    • It will bring online activities that are still done physically like periodic safety updates, show cause notices, adverse event reporting and post approval changes.
    • Improve inspections by assigning inspectors at random to various sites in a masked manner, randomised allocation of work such as processing applications for licenses and approvals.
    • Assigning QR codes to samples collected and reports to allow verification at every stage of the process and automatically generate officials’ performance reports.
  • Requirements:
    • The online platform will need to be compatible with other government portals such as the Government e-Marketplace, Bureau of Indian Standards and Clinical Trial Registry.
    • It will also also have a provision to sign documents using authentication mechanisms like OTP, Aadhaar, PAN card, and DigiLocker.

What was the immediate trigger point?

  • To improve the regulatory framework after a series of incidents came to light where Indian manufactured syrups were found to be contaminated and were even linked to deaths of children in the Gambia and Uzbekistan.
  • To make the global standard for good manufacturing practices will be made mandatory for all Indian companies.

Central Drugs Standard Control Organization:

  • It is the National Regulatory Authority (NRA) of India for the medical devices industry under the provisions of the Drugs & Cosmetics Rules.
  • It works under the Ministry of Health & Family Welfare.
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