4 min readNew DelhiNov 17, 2023 01:12 AM IST
First published on: Nov 16, 2023 at 10:27 PM IST
The integrated IT platform that apex drug regulator the Central Drugs Standard Control Organization has been working on to bring in transparency and uniformity in all its processes — and create confidence in domestic and international markets — will be able 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. 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.
According to a document detailing the requirements, the portal will create provisions to capture information from various stakeholders routinely “similar to ITR returns and GST filing”.
The government has called for software service providers to develop the system. Once operational, all other portals used by drug regulators will be discontinued. The portal will become a single window for all drug regulatory activities.
“The idea to create a unified portal was first proposed during a Chintan Shivir (brainstorming session) with stakeholders earlier this year. Now, a team has been formed that is dedicated to working on developing the portal and get it up and running,” a senior official in the know said.
The brainstorming session in February brought all stakeholders together to discuss ways 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. 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.
Another important function of the portal will be 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.
ExplainedOne portal for drug control
The upcoming portal will have separate dashboards for separate stakeholders, allowing them access to custom reports on a need to know basis. One of the portal's requirements is to have enough parameters to make the data searchable. Once operational, all other portals used by drug regulators will be discontinued.
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 licenses 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.
The portal will have separate dashboards for separate stakeholders, allowing them access to custom reports on a need to know basis. One of the portal’s requirements is to have enough parameters to make the data searchable.
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.
The portal will have separate dashboards for separate stakeholders, allowing them access to custom reports on a need to know basis. One of the portal's requirements is to have enough parameters to make the data searchable.
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