Indian pharmaceutical companies must meet new manufacturing standards this year, according to a government notification released on Saturday, although small companies have asked for a delay, citing their debt load.
Jolted by a string of overseas deaths linked to Indian-made drugs since 2022, the Centre has stepped up scrutiny of pharmaceutical factories to clean up the image 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," said the notification, dated Dec. 28.
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.
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. Small companies had asked for the deadline to be extended, warning that investments required to meet the standards would shut down nearly half of them because they are already heavily indebted.
The WHO and other health authorities have linked Indian cough syrups to the deaths of at least 141 children in Gambia, Uzbekistan and Cameroon.
(Except for the headline, this story has not been edited by NDTV staff and is published from a syndicated feed.)
Featured Video Of The Day
"Reforms Focus Not For Editorials, But To Make Country Strong": PM's I-Day Speech
US Regulator's Scrutiny On Indian Drug Makers To Remain Intense: Crisil Advent, Baxter Set To Submit Bids For India's Gland Pharma: Report More Inspections Due to Rising Drug Imports From India: USFDA 2 French Rafale Jets Collide Mid-Air, Instructor, Pilot Missing "Pivotal Moment": Key Doctor Body Resumes Strike 2 Days After Calling It Off Ayatollah Khamenei Warns Of "Divine Wrath" If Iran Backs Down Against Israel "Pivotal Moment": Key Doctor Body Resumes Strike 2 Days After Calling It Off Navalny's Wife Rejects Finding He Died From "Combination Of Illnesses" After Night Of Vandalism, Forensic Team Reaches Kolkata Hospital: 10 Points Track Latest News Live on NDTV.com and get news updates from India and around the world.