Indian Pharma Companies Face Stricter Manufacturing Standards Amid Global Scrutiny

In a move aimed at enhancing the credibility of the $50 billion pharmaceutical industry, the Indian government has mandated that pharmaceutical companies comply with new manufacturing standards this year. The decision comes in the wake of heightened scrutiny, prompted by a series of overseas deaths linked to drugs manufactured in India since 2022.

A government notification released on Saturday emphasizes the need for manufacturers to take responsibility for the quality of pharmaceutical products. It underscores the importance of ensuring that these products are suitable for their intended use, adhere to licensing requirements, and do not compromise patient safety due to inadequate safety, quality, or efficacy.

According to the notification dated December 28, companies are required to market finished products only after obtaining “satisfactory results” from tests on ingredients. Additionally, they must retain an ample quantity of samples of intermediate and final products to facilitate repeated testing or verification of a batch.

Concerns raised by the health ministry in August highlighted an “absence of testing of incoming raw materials” during inspections of 162 drug factories since December 2022. Shockingly, 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).

The notification sets a six-month deadline for large drugmakers to address these concerns and a 12-month deadline for smaller manufacturers. Small companies, burdened with heavy debt loads, had requested an extension, cautioning that meeting the standards would lead to the closure of nearly half of them.

The World Health Organization (WHO) and other health authorities have previously linked Indian cough syrups to the tragic deaths of at least 141 children in countries such as Gambia, Uzbekistan, and Cameroon.