Indian pharmaceutical companies are facing new manufacturing standards set by the central government, following a series of overseas deaths linked to Indian-made drugs since 2022. The government’s move comes as a response to the need to improve the image of the $50 billion industry, which has been under scrutiny due to quality and safety concerns.
According to a notification dated December 28, manufacturers are mandated to take responsibility for the quality of pharmaceutical products, ensuring they are safe for use, and comply with licensing requirements. The notification also requires companies to conduct satisfactory tests on ingredients before marketing finished products, and to retain samples for repeated testing.
The health ministry reported in August that inspections of 162 drug factories found an “absence of testing of incoming raw materials,” and that fewer than a quarter of India’s 8,500 small drug factories met international drug manufacturing standards set by the World Health Organization (WHO).
Large drugmakers are given a six-month timeline to address these concerns, while small manufacturers have a 12-month deadline. However, small companies have requested an extension, citing the heavy debt burden they already carry and warning that meeting the new standards could lead to shutdowns for nearly half of them.
The WHO and other health authorities have linked Indian cough syrups to the deaths of at least 141 children in Gambia, Uzbekistan, and Cameroon. This has raised serious concerns and prompted the government to take swift action to address the reputation and safety issues facing the pharmaceutical industry.
The new manufacturing standards are a response to the need to improve the quality and safety of pharmaceutical products in India, following a series of overseas deaths and concerns about regulatory compliance. With the government’s mandate, pharmaceutical companies are required to ensure the safety and efficacy of their products, meeting the newly established standards to maintain public trust and the industry’s reputation. On Jan 6, 2024, the central government issued the notification in response to the series of overseas deaths linked to Indian-made drugs, and the subsequent scrutiny of pharmaceutical factories.