According to a government notification issued on Saturday, Indian pharmaceutical companies are required to satisfy new manufacturing requirements this year. However, tiny businesses have requested a delay, citing their debt load.
Startled by a series of foreign fatalities connected to Indian-made medications since 2022, the administration of Prime Minister Narendra Modi has increased the inspection of pharmaceutical facilities in an effort to improve the $50 billion sector’s reputation.
“The manufacturer must assume responsibility for the quality of the pharmaceutical products to ensure that they are fit for their intended use, comply with the requirements of the licence and do not place patients at risk due to inadequate safety, quality or efficacy,” said the notification, dated Dec. 28.
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 said in August 2022 that “absence of testing of incoming raw materials” was discovered during inspections of 162 medication companies conducted since December 2022. The World Health Organization’s (WHO) international medication production criteria were reportedly not met by more than 25% of India’s 8,500 small drug companies.
Large pharmaceutical companies had six months to address those concerns, and minor producers had twelve months, according to the notification. Due to their already high levels of debt, small businesses had requested an extension of the deadline, citing the risk that the investments necessary to satisfy the standards would force nearly half of them out of business.
