India inspects drug factories as Gambia controversy lingers
MUMBAI, Dec 27 (Reuters) – India’s pharmaceuticals regulator has begun inspecting some drug factories across the country, the health ministry said on Tuesday, as it tries to ensure high standards after an Indian company’s cough and cold syrups were linked to deaths in Gambia.
India is known as the “pharmacy of the world” and its pharmaceuticals exports have more than doubled over the past decade to $24.5 billion in the past fiscal year.
The deaths of at least 70 children in Gambia has dented the industry’s image, though India says the drugs made by New Delhi-based Maiden Pharmaceuticals Ltd. were not at fault.
“Joint inspections are being conducted all over the country as per standard operating procedures,” the Ministry of Health and Family Welfare said in a statement. “This will ensure high standards of quality compliance with respect to drugs manufactured in the country.”
The ministry said it was inspecting “drug manufacturing units” that were at risk of making non-standard, adulterated, or spurious drugs but did not name any company.
Some health experts say India’s drug regulations are lax, especially at the level of states where thousands of factories operate.
The government in October suspended all of Maiden’s production, based in the state of Haryana, for violation of manufacturing standards.
But India’s main drugs officer told the World Health Organization this month that tests of samples from the same batches of syrups that Maiden sent to Gambia were compliant with government specifications. Maiden too said its drugs were fine.
The WHO said labs contracted by it in Ghana and Switzerland found excess levels of ethyleneglycol and diethyleneglycol contaminants in the Maiden syrups.
A Gambian parliamentary committee said last week that Maiden was responsible for the deaths of at least 70 children from acute kidney injury and called on the government to pursue legal action.
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