New Delhi, India – Indian pharmaceutical companies are facing new manufacturing standards this year, as announced by the central government. The move comes after a series of deaths linked to Indian-made drugs in foreign countries caused concern and prompted increased scrutiny of the industry.
In response to the string of overseas deaths involving Indian-made drugs, the central government released a notification on Saturday, emphasizing the need for pharmaceutical companies to ensure the quality and safety of their products. The $50 billion industry has come under fire, prompting the government to take action to clean up its image.
According to the notification, manufacturers are now required to take responsibility for the quality of pharmaceutical products, ensuring they meet the necessary standards and pose no risk to patients. The implementation of these new standards aims to address concerns raised by health authorities regarding the safety and efficacy of Indian-made drugs.
The health ministry’s inspections of drug factories revealed an “absence of testing of incoming raw materials” in 162 drug factories since December 2022. Furthermore, less than a quarter of India’s 8,500 small drug factories met the international drug manufacturing standards set by the World Health Organization (WHO).
In response to the new standards, large drugmakers are given a six-month deadline, while small manufacturers have 12 months to comply with the requirements. However, small companies have raised concerns about the financial burden and have requested an extension, warning that meeting the standards could lead to the closure of nearly half of them due to existing heavy debts.
The announcement comes as the WHO and other health authorities have linked Indian cough syrups to the deaths of at least 141 children in Gambia, Uzbekistan, and Cameroon.
According to the notification, the new standards are aimed at improving the quality and safety of pharmaceutical products, addressing concerns raised by health authorities about the industry. The implementation of these standards will require pharmaceutical companies to make significant investments to meet the requirements, posing a challenge for small companies already facing heavy debt burdens.