By the end of this year, pharmaceutical companies must comply with new manufacturing standards, according to a notification from the Indian government. This action is a reaction to several deaths overseas that have been connected to medications made in India since 2022. The goal of the government’s increased manufacturing facility inspections is to improve the $50 billion pharmaceutical industry’s reputation.
Small pharmaceutical companies, on the other hand, have asked for a postponement, pointing to their current debt load. The government has expressed a commitment to enhancing the quality and safety of medications made in India by implementing the new standards in spite of these worries. The government’s proactive approach to addressing global concerns and ensuring that the pharmaceutical sector adheres to global best practices is highlighted by this regulatory push.
The December 28 notification underscores the need for pharmaceutical manufacturers to accept responsibility for the caliber of their goods. It emphasizes that the manufacturer bears the responsibility of making sure that pharmaceuticals are safe, effective, and meet all licensing requirements in addition to being appropriate for the intended use and not posing any risks to patients. The statement emphasizes how crucial it is for manufacturers to maintain strict standards in order to protect patient safety and stay in compliance with legal requirements.
It states that businesses must hold onto a sufficient number of samples of intermediate and final products to enable repeated testing or batch verification, and they must only market a finished product after receiving “satisfactory results” from tests of the ingredients.
The health ministry reported in August 2022 that “absence of testing of incoming raw materials” was discovered during inspections of 162 drug factories conducted since December 2022. The World Health Organization’s (WHO) international drug manufacturing standards were reportedly not met by more than 25% of India’s 8,500 small drug factories.
Small manufacturers have a year to address issues, whereas large drugmakers have six months. Small businesses requested an extension, pointing out that they would have to close almost half of them owing to high debt levels and the expenditures required to meet the requirements.
