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Central Government Imposes Stricter Standards on Pharma Companies, Small Firms Seek Reprieve

Updated: Jan 06, 2024 03:56:13pm

Central Government Imposes Stricter Standards on Pharma Companies, Small Firms Seek Reprieve

New Delhi, Jan 6 (KNN) Indian pharmaceutical firms are required to adhere to new manufacturing standards this year, as stated in a notification issued by the central government on Saturday.

However, smaller companies have requested a postponement, citing their existing debt burden.

In response to a series of international fatalities associated with drugs manufactured in India since 2022, the central government has intensified its examination of pharmaceutical factories. This effort aims to enhance the reputation of the $50 billion industry.

"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," stated the notification, dated December 28.

The notification stipulates that companies are obligated to market a finished product only upon obtaining "satisfactory results" from ingredient tests.

Additionally, they must retain an ample quantity of intermediate and final product samples, facilitating repeated testing or batch verification.

In August, the health ministry reported that inspections conducted at 162 drug factories since December 2022 revealed a "lack of testing of incoming raw materials."

The ministry further highlighted that less than a quarter of India's 8,500 small drug factories complied with the international drug manufacturing standards set by the World Health Organization (WHO).

The notification outlined that major pharmaceutical companies must address these concerns within six months. Smaller manufacturers, on the other hand, have been granted a 12-month deadline.

In response to this directive, small companies requested an extension, expressing concerns that the required investments to meet the standards could potentially force the closure of nearly half of them, given their already substantial levels of indebtedness.

(KNN Bureau)


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