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Indian regulator says 36% of inspected drug-making units had to be shut

Rishika Sadam
·2-min read
FILE PHOTO: INDIA-DRUG QUALITY/REGULATOR

By Rishika Sadam

BENGALURU (Reuters) - More than 36% of the 400 drug manufacturing units inspected since last year in India were ordered to be shut, the country's drug regulator said on Thursday, after deaths linked to sub-standard cough syrups prompted an increase in scrutiny.

The country, regarded as the world's pharmacy given the volume of drugs it produces, is working to restore confidence after Indian-made cough syrups were linked to deaths of children in Gambia, Uzbekistan, and Cameroon.

India's Central Drugs Standard Control Organization (CDSCO) chief Rajeev Raghuvanshi said that after one and a half years of inspections, he was "not very happy to say that more than 36% of them (manufacturing units) had to be closed".

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The issues in the Indian pharma industry relate to "non-compliance which leads to quality issues," he told an event in Mumbai.

He did not elaborate or name any companies.

Cough syrups made in India and Indonesia have been linked to the deaths of more than 300 children globally. The medicines were found to contain high levels of two known toxins, diethylene glycol and ethylene glycol, leading to acute kidney injury and death.

India is the world's third largest maker of drugs by volume after the United States and China. India's pharma export sales are expected to reach $55 billion by 2030, according a government-backed trade body Pharmaceuticals Export Promotion Council of India (Pharmexcil). Export sales in 2023-2024 were $27.85 billion.

Prime Minister Narendra Modi's government late last year also issued revised guidelines to ensure compliance with global standards and made it mandatory for all of country's drug manufacturing units to adhere to them.

"We have not had any complaint from World Health Organization (WHO) or any other agency since last July .. we've been able to control the issues that were happening from a quality point of view," Raghuvanshi said.

(Reporting by Rishika Sadam; Editing by Aditya Kalra and Barbara Lewis)