The Centre will allow the export of cough syrups only after samples are tested at specified government laboratories, the Directorate General of Foreign Trade said in a notification on Monday.
The development came after deaths of dozens of children in the Gambia and Uzbekistan last year were linked to cough syrups made in India.
The notification on Monday said that all cough syrups must have a certificate of analysis issued by the government laboratories before they are exported. The new rules will be effective from June 1.
The samples can be tested at the Central Drugs Lab in Kolkata, Central Drug Testing Labs in Chennai, Hyderabad and Mumbai, Regional Drug Testing Labs in Chandigarh and Mumbai and any state government laboratories accredited to the National Accreditation Board for Testing and Calibration Laboratories.
In October, the World Health Organization found that cough syrups made by Indian manufacturer Maiden Pharmaceuticals contained dangerous levels of toxins known as diethylene glycol and ethylene glycol, leading to the deaths of 70 children in the Gambia.
In December, the Uzbekistan health ministry said that 18 children had died in the country because of side effects from Dok 1 Max Syrup produced by Noida-based Marion Biotech Limited. Investigation showed the cough syrup contained ethylene glycol.
The deaths dented India’s image of being the “pharmacy of the world”. Another Indian drugmaker was also found by the World Health Organization to have exported contaminated cough syrup to the Marshall Islands and Micronesia.
In March, Central and state drug regulators in India had cancelled or suspended licences of 18 companies as part of action taken against pharmaceutical firms for producing spurious or adulterated medicines.
Also read:
India’s cough syrup testing regime has a deadly blind spot
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