One Portal for Drug Control: Upcoming IT Platform to Track Medicines End-to-End

What’s in Today’s Article?

• Why in News?
• Drug Regulation in India
• Idea to Create One Portal for Drug Control
• About the Drug Portal and its Functions
• Significance of the Drug Portal

Why in News?

• The integrated IT platform that apex drug regulator (CDSCO) has been working on will be able to track products right from the stage of procuring raw material, to supply chain, and finally patterns of consumption.

Drug Regulation in India

• The Drugs and Cosmetics Act, 1940 and Rules 1945:These have entrusted various responsibilities to central and state regulators for regulation of drugs and cosmetics.
• Central Drugs Standard Control Organisation (CDSCO):The CDSCO under the Directorate General of Health Services, Ministry of Health & Family Welfare, is the National Regulatory Authority (NRA) of India.
  • Under the Drugs and Cosmetics Act, CDSCO is responsible for -
    • Approval of Drugs.
    • Conduct of Clinical Trials.
    • Laying down the standards for Drugs.
    • Control over the quality of imported Drugs in the country.
    • Coordination of the activities of State Drug Control Organizations.
    • Further CDSCO along with state regulators, is jointly responsible for grant of licences of certain specialised categories of critical Drugs such as vaccine and sera, etc.
  • The Indian government has announced plans to subject all medical devices, including implants and contraception, to CDSCO scrutiny.
• Drugs Controller General of India (DCGI):DCGI is the head of department of the CDSCO of the Government of India responsible for approval of licences of specified categories of drugs such as blood and blood products, IV fluids, vaccines and sera in India.
  • DCGI also sets standards for manufacturing, sales, import, and distribution of drugs in India.

Idea to Create One Portal for Drug Control

• The idea to create a unified portal was first proposed during a Chintan Shivir (brainstorming session) earlier this year (in February 2023).
  • The brainstorming session brought all stakeholders together to discuss ways to improve the regulatory framework after a series of incidents came to light.
  • For example, the Indian manufactured syrups were found to be contaminated and were even linked to deaths of children in the Gambia and Uzbekistan.
  • At the same meeting, it was decided that the global standard for good manufacturing practices will be made mandatory for all Indian companies.
  • The government has already asked around 8,000 smaller companies that do not comply with it to do so.
• Now, a team has been formed that is dedicated to working on developing the portal and getting it up and running.
• 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.

About the Drug Portal and its Functions

• The government has called for software service providers to develop the system.
• Apart from manufacturers, distributors and retailers will also need to upload their invoices on the portal for this end-to-end tracking to become possible.
• The portal will create provisions to capture information from various stakeholders routinely “similar to ITR returns and GST filing”.
• Once operational, all other portals used by drug regulators will be discontinued. Hence, the portal will become a single window for all drug regulatory activities.
• It will 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 have a provision to sign documents using authentication mechanisms like OTP, Aadhaar, PAN card, and DigiLocker.
• It will also help track all types of court cases for prosecution and convictions.
• The upcoming portal will have separate dashboards for separate stakeholders, allowing them access to custom reports on a need-to-know basis.

Significance of the Drug Portal

• The integrated IT platform will bring in transparency and uniformity in all the processes (of drug manufacture and distribution) and create confidence in domestic and international markets.
• The platform will bring online activities that are still done physically like periodic safety updates, show cause notices, adverse event reporting and post approval changes.
• The portal will help improve inspections by assigning inspectors at random to various sites in a masked manner, randomised allocation of work such as
  • Processing applications for licences and approvals, and
  • Assigning QR codes to samples collected and reports to allow verification at every stage of the process.
• It will also automatically generate officials’ performance reports.
• The portal will create searchable registries of manufacturers, marketeers, retailers, pharmacies, and even subject matter experts.

Q1) How is the online sale of medicines regulated in India?

The current statutory framework makes no provision for the online sale or distribution of medications in India. While the Drugs and Cosmetics Act and Rules do not validate the legal status of the e-pharmacies, they do not make their operation illegal either.

Q2) What is the DigiLocker?

DigiLocker is a digitisation service provided by the MeitY under its Digital India initiative. It allows access to digital versions of various documents and provides 1 GB storage space to each account to upload scanned copies of legacy documents.

Source: From procuring raw material to retail: Upcoming IT platform to track medicines end-to-end