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  • USFDA set to increase...

USFDA set to increase inspections at Indian drug manufacturing units

Written By : Ruchika Sharma |Medically Reviewed By : Dr. Kamal Kant Kohli Published On 2024-02-28T15:30:06+05:30  |  Updated On 21 March 2024 5:48 PM IST
Zydus Lifesciences Rifaximin Tablets bags USFDA tentative approval for irritable bowel syndrome with diarrhoea
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FDA Country Director (India) said the Indian pharma industry needs to invest more in automation for better compliance.

The U.S. drug regulator is set to increase the number of inspections at Indian drug manufacturing units in 2024 amid growing concerns over the quality of drugs, a top executive for the Food and Drug Administration (FDA) told Reuters.

The FDA conducted more than 200 inspections in 2023 in India, picking up after a lull in unannounced inspections during the pandemic.

"We are putting every effort into increasing the number of inspections ... (and) requesting more drug investigators to be stationed here," FDA Country Director (India) Sarah McMullen said on Tuesday.

The development comes as India's $42-billion pharmaceuticals industry works to grow its global presence, with the government pushing drug producers to implement good manufacturing practices to match global standards.

The World Health Organization last year had linked the deaths of dozens of children in Gambia to India-made drugs.

The United States accounts for 30% of India's total pharmaceutical products exports.

McMullen said the Indian pharma industry needs to invest more in automation for better compliance.

While the Indian government is investing in the growing pharmaceutical industry, what is also necessary is investment in growing the resources of the country's drug regulatory body for better monitoring of the industry, McMullen added

Read also: Expanded Indication for Gilead Biktarvy for HIV with suppressed viral loads, pre-existing resistance gets USFDA okay

Original news source: https://www.reuters.com/business/healthcare-pharmaceuticals/us-fda-boost-inspections-drug-manufacturing-units-india-2024-02-27/

UFSDAUSFDA inspection
Ruchika Sharma
Ruchika Sharma

    Ruchika Sharma joined Medical Dialogue as an Correspondent for the Business Section in 2019. She covers all the updates in the Pharmaceutical field, Policy, Insurance, Business Healthcare, Medical News, Health News, Pharma News, Healthcare and Investment. She has completed her B.Com from Delhi University and then pursued postgraduation in M.Com. She can be contacted at editorial@medicaldialogues.in Contact no. 011-43720751

    Dr. Kamal Kant Kohli
    Dr. Kamal Kant Kohli

    Dr Kamal Kant Kohli-MBBS, DTCD- a chest specialist with more than 30 years of practice and a flair for writing clinical articles, Dr Kamal Kant Kohli joined Medical Dialogues as a Chief Editor of Medical News. Besides writing articles, as an editor, he proofreads and verifies all the medical content published on Medical Dialogues including those coming from journals, studies,medical conferences,guidelines etc. Email: drkohli@medicaldialogues.in. Contact no. 011-43720751

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