A government notification released on Saturday mandates Indian pharmaceutical firms to comply with new manufacturing standards this year.
However, smaller companies have requested a postponement, pointing to their significant debt burden.
In response to a series of overseas deaths associated with drugs manufactured in India since 2022, the central government has increased its oversight of pharmaceutical plants to improve the reputation of the industry, which is worth $50 billion.
The notification, dated 28 December, stated that the manufacturer is obligated to guarantee the quality of the pharmaceutical products.
"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.
It said that the companies must market a finished product only after getting "satisfactory results" on tests of the ingredients and retain a sufficient quantity of the samples of intermediate and final products to allow repeated testing or verification of a batch.
The health ministry said in August that inspections of 162 drug factories since December 2022 found an "absence of testing of incoming raw materials". It said fewer than a quarter of India's 8,500 small drug factories met international drug manufacturing standards set by the World Health Organization (WHO).
The notification said those concerns must be addressed by large drug-makers within six months and small manufacturers in 12 months.
Smaller firms had requested a deadline extension, cautioning that the financial commitments needed to comply with these standards could lead to the closure of almost 50 per cent of them due to their existing high levels of debt.
The WHO and other health authorities have linked Indian cough syrups to the deaths of at least 141 children in Gambia, Uzbekistan and Cameroon.
Kuldeep is Senior Editor (Newsroom) at Swarajya. He tweets at @kaydnegi.
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