NEW DELHI, INDIA – Indian pharmaceutical companies are facing new manufacturing standards this year, as mandated by a central government notification released on Saturday. The move comes in the wake of a series of overseas deaths linked to Indian-made drugs since 2022, prompting the government to tighten its scrutiny of pharmaceutical factories and cleanse the image of the $50 billion industry.
The notification, dated December 28, emphasizes the importance of pharmaceutical products being fit for their intended use, complying with licensing requirements, and ensuring patient safety. It also requires companies to conduct satisfactory tests on ingredients and retain samples for verification. This comes after health ministry inspections found an “absence of testing of incoming raw materials” at many drug factories.
In light of these concerns, the notification sets a deadline for large drugmakers to address the issues within six months, while small manufacturers have 12 months. However, small companies have requested an extension, citing the heavy financial burden of meeting the new standards, which they fear could lead to the shutdown of nearly half of them due to existing debts.
International health authorities have connected Indian cough syrups to the deaths of at least 141 children in Gambia, Uzbekistan, and Cameroon, sparking further scrutiny of the Indian pharmaceutical industry.
The new standards are intended to address these issues and restore trust in Indian-made drugs. Published On: Jan 6, 2024