DCGI Inspections Trigger Closure of 36% Pharma Plants, Pave Way For Digital Revolution

Rajeev Raghuvanshi, the Drug Controller General of India (DCGI), announced that the Central Drugs Standard Control Organization (CDSCO) has undertaken risk-based inspections of more than 400 pharmaceutical manufacturing units in the last eighteen months. These inspections have led to the shutdown of 36% of these facilities.

Raghuvanshi stated at an IPA (Indian Pharmaceutical Alliance) event, “We have been successfully doing risk-based inspections and inspected about 400 manufacturing units and I am not very happy to say that more than 36% of them had to be closed because there was a reason to close them. These MSMEs had to shut down as they realised that they cannot meet the expectations of the regulators.”

With ongoing concerns about the quality assurance of domestically manufactured drugs, CDSCO is set to launch four pivotal projects. These initiatives aim to bolster the Indian pharmaceutical sector, often hailed as the global hub of pharmacy, by enhancing and upholding the standards of drug quality.

Among the quartet of initiatives being introduced by the regulatory authority CDSCO, one notable project is the Digital Drug Regulatory System—a pioneering digital platform set to streamline regulatory processes in the pharmaceutical sector. The organization aims to design the platform to integrate all stakeholders in the industry, including regulatory bodies, manufacturers, and retailers, ensuring comprehensive participation and collaboration.

Raghuvanshi further added, “So four big-ticket projects are in the pipeline and one of them we are coming out with is our digital platform, which would cover the complete regulatory value chain in this country. Each and every stakeholder, government, private, semi-government, whoever has any stake in the regulatory value chain would be brought onto that platform. And so, you have solutions to all kinds of quality issues. We are waiting on the final approval from the government but to design this we have already floated the RFP and the final tender is yet to be done.”