In a strict crackdown on quality control standards, the national drug regulator of India has ordered the closure of more than 100 pharmaceutical plants across the country. This action comes after cough syrup manufactured in India was linked to the deaths of several children.
India’s drug regulator, the Central Drugs Standard Control Organization (CDSCO), has been actively inspecting hundreds of pharmaceutical plants over the past year and a half. These inspections, known as “risk-based inspections,” were triggered by reports linking cough syrup produced in India and exported worldwide to the deaths of dozens of children.
During these inspections, conducted at more than 400 manufacturing units, the CDSCO identified significant lapses in quality control measures. As a result, over 36% of the inspected facilities, primarily micro, small and medium enterprises (MSMEs), were ordered to shut down. According to CDSCO chief Rajeev Raghuvanshi, these closures were due to the realization by the enterprises that they could not meet the required regulatory standards.
The Indian government, while acknowledging the importance of a strong domestic pharmaceutical industry, is prioritizing consumer safety. The CDSCO’s crackdown aims to eliminate substandard practices and ensure the quality and efficacy of medications produced in India. Raghuvanshi emphasized that the government is not generalizing the issue but taking firm action against identified defaulters. Additionally, he mentioned plans for implementing new projects to help the industry improve product quality.
This shutdown of over 100 plants is likely to disrupt the supply of medicines in India. The extent of the disruption and the measures being taken to ensure continued availability of essential medicines are yet to be fully understood. However, it is clear that the Indian government is prioritizing public health by ensuring stricter adherence to quality control standards within the pharmaceutical industry.
