Mumbai: The Drug Controller General of India (DCGI) Rajeev Raghuvanshi on Thursday revealed that the Central Drugs Standard Control Organization (CDSCO) has conducted risk-based inspections of over 400 pharmaceutical manufacturing units over the past year and a half, resulting in the closure of 36% of these facilities.

“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,” Raghuvanshi said at an Indian Pharmaceutical Alliance (IPA) event. “These MSMEs had to shut down as they realised that they cannot meet the expectations of the regulators.”

As the quality assurance of drugs manufactured in the country continues to be a cause of concern, CDSCO is about to start four key projects that will help the Indian pharmaceutical industry to continue improving and maintaining the quality of the drugs coming out of India, the ‘pharmacy capital of the world’.

One of the four projects, the regulatory body CDSCO will be coming out with is a digital platform—Digital Drug Regulatory System, he said.

“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,” said Raghuvanshi.

The organisation plans to structure the platform in a way that brings aboard all the stakeholders involved in the industry from regulatory bodies to manufacturers and retailers.

“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,” he added.

Raghuvanshi then disclosed the second project the organisation is working on – the regulatory rationalisation initiative, under which CDSCO has hired two internationally renowned consultancy organisations. One of the two consultancy firms is tasked to look at CDSCOs’ internal process, while the second one will take a look at The Drugs and Cosmetics Act, 1940 and rules to rationalise while removing the redundancies and simplifying the whole regulation.

Quality Upgrades

The first one he disclosed will start its working from 1 July while the second one will begin its work in a couple of weeks time.

“Third being, increasing the internal scientific cadre at CDSCO. Unfortunately today there is not a single scientific cadre to do an internal review of the files, which the stakeholders are not comfortable with. So we are initiating a process to get the internal scientific cadre at CDSCO so that more than 50-60% of the activities of the final review can happen internally,” he continued.

Finally the fourth project, Raghuvanshi added, is not part of the CDSCO but for the Indian Pharmacopoeia Commission (IPC) to set up the Digital IP. IPC is an autonomous institution of the Ministry of Health and Family Welfare committed to ensuring quality and safety of drugs.

“The product is in its final stages and will be in use by the next month as it is under final testing,” he added. Raghuvanshi is also the secretary-cum-scientific director of IPC.

Furthermore, he revealed that the revised Schedule M part of the Drugs and Cosmetic Act, 1940 will begin its audit process from 1 July.

Schedule M deals with ‘Good Manufacturing Practices’ to be followed by pharmaceutical manufacturing units in the country.

Dr Arunish Chawla, secretary, department of pharmaceutical, said that quality is the paramount focus, standing on three essential pillars—market, patient, and neighbour. “Market quality commands a premium and builds reputation, which is our best defence against malpractices. Patient quality is driven by robust regulatory systems, and India is progressing rapidly on this front. Our mission going forward is to make quality the centre of policy framework,” he said. 

India has upgraded Schedule M of the Drug and Cosmetic Rules, surpassing WHO GMP standards in some areas. With the audits starting in July 2024, the country aims to produce world-class products, as emphasized by the Prime Minister’s vision of ‘Zero defect and Zero effect’, Chawla said. “Quality requires investment, and we support medium and small plants through reform initiatives. The integrity of the Indian industry relies on every player’s adherence to the highest standards. When one fails, it affects the entire industry. Therefore, we must collectively uphold quality to protect our reputation and ensure excellence in every aspect,” he added.