India Government Orders New Drug Making Standards
The Union Health Ministry issued a notification last Saturday, January 6, mandating Indian pharmaceutical companies to adhere to new manufacturing standards this year. While smaller companies have requested a postponement, they're citing their heavy debt as the reason.
Under the revised Schedule M guidelines, pharmaceutical companies will have to inform the licensing authority about recalling a drug and also report product defects, deterioration, or faulty production. Previously, there wasn't a system in place to notify the licensing authority regarding drug recalls.
To improve the reputation of the $50 billion pharmaceutical industry, Prime Minister Narendra Modi's administration has increased scrutiny of pharmaceutical factories in response to a string of overseas deaths associated with Indian-made drugs since 2022.
The latest guidelines, released on December 28, specify that manufacturers are accountable for ensuring product quality. This responsibility involves ensuring that the products are suitable for their intended use, meet licensing standards, and don't pose risks to patients due to insufficient safety, quality, or effectiveness.
Companies are required to ensure that a finished product is only marketed once it has undergone tests to ensure the ingredients meet satisfactory standards. Additionally, they must retain enough samples of both intermediate and final products to facilitate repeated testing or batch verification.
The Health Ministry highlighted in August that among 162 drug factories inspected since December 2022, there was a noted deficiency in the testing of incoming raw materials. Furthermore, it was revealed that less than a quarter of India's 8,500 small drug factories complied with the international manufacturing standards established by the World Health Organization (WHO).
The World Health Organization (WHO) and other health authorities have associated Indian cough syrups with the unfortunate deaths of at least 141 children across Gambia, Uzbekistan, and Cameroon.
To ensure a seamless transition from the current Schedule M to the revised one, a grace period of six months is granted for large manufacturers (with turnover over Rs 250 crore) and 12 months for Micro, Small, and Medium Enterprises (MSMEs) with a turnover of less than Rs 250 crore.
