Govt Orders New Drug-Making Standards After Overseas Deaths

India Pharma Outlook Team | Monday, 08 January 2024

 India Pharma Outlook Team

Indian pharmaceutical companies must fulfill new manufacturing requirements this year, according to a Union Health Ministry announcement, but tiny companies have requested a delay, citing their financial load.

Under the revised Schedule the guidelines, pharmaceutical companies will have to intimate the licensing authority about recalling a drug and also report product defects, deterioration or faulty production. Till now there was no provision for informing the licensing authority about drug recall,as per economic times.

Following a succession of abroad deaths connected to Indian-made medications since 2022, Prime Minister Narendra Modi's government has increased scrutiny of pharmaceutical companies in an effort to clean up the reputation of the $50 billion pharmaceutical business.

The new guidelines announced on December 28 stipulate that the maker must be responsible for the quality of the items "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".

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, it says.

In August, the health ministry stated that examinations of 162 medication companies since December 2022 shown a "absence of testing of incoming raw materials". According to the report, fewer than a quarter of India's 8,500 small pharma manufacturers meet international drug production criteria established by the World Health Organization (WHO).

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