In response to a surge in overseas deaths associated with drugs manufactured in India since 2022, the Indian government issued a notification on Saturday, requiring pharmaceutical companies to adhere to new manufacturing standards by the end of this year.
The move comes as part of Prime Minister Narendra Modi's initiative to enhance scrutiny of pharmaceutical factories and improve the reputation of the $50 billion industry.
The notification, dated December 28, emphasises the manufacturer's responsibility for ensuring the quality of pharmaceutical products, ensuring they are suitable for their intended use, and complying with licencing requirements to avoid jeopardising patient safety.
The directive also stipulates that companies can only market finished products after obtaining satisfactory results from ingredient tests and must retain sufficient quantities of intermediate and final product samples for batch verification.
A health ministry report in August highlighted a lack of testing of incoming raw materials in 162 drug factories inspected since December 2022. It revealed that fewer than a quarter of India's 8,500 small drug factories met the international manufacturing standards set by the World Health Organisation (WHO).
The notification sets a deadline of six months for large drugmakers and 12 months for small manufacturers to address these concerns. Small companies, burdened by heavy debt loads, have requested an extension, arguing that meeting the standards would lead to the closure of nearly half of them due to financial constraints.
The World Health Organisation and other health authorities have previously linked Indian cough syrups to at least 141 child deaths in Gambia, Uzbekistan, and Cameroon.
