Amid instances of Indian pharmaceutical companies coming into the limelight for bad reasons, the government has made it mandatory for “cough syrups” to be exported only after their testing at designated laboratories.

The Directorate General of Foreign Trade (DGFT) in its latest notification has made amendments in Chapter 30 of Schedule 2 of the ITC (HS) Export Policy related to the export of “cough syrup” from June 1, 2023.

"Cough syrup shall be permitted to be exported subject to the export sample being tested and production of a certificate of analysis (CoA) issued by any of the following laboratories," says the DGFT notification.

The list of designated government laboratories includes Indian Pharmacopoeia Commission, Ghaziabad, UP; CDL, Kolkata, West Bengal; CDTL, Chennai, Tamil Nadu; CDTL, Mumbai, Maharashtra; CDTL, Hyderabad, Telangana; RDTL, Chandigarh; RDTL, Guwahati, Assam, and Any NABL accredited State Drugs Testing Laboratory.

Following the notification, the export of "cough syrup" under ITC (HS) Codes will be permitted only after samples are tested and procurement of the CoA issued by these laboratories, the authority said.

The notification comes days after dozens of deaths were reported from Uzbekistan and Gambia as children consumed cough syrups with high levels of diethylene glycol (DEG) and ethylene glycol (EG) that were supplied by some Indian manufacturers. There have been a series of instances in the past few months where Indian companies have come under the World Health Organisation (WHO) radar.

Last month, the WHO said a cough syrup made by Punjab-based company, QP Pharma, was found to be "contaminated" and that these were being sold in the Marshall Islands and Micronesia. The global body had said the syrup, Guaifenesin Syrup TG Syrup, was found to have contained "unacceptable amounts of diethylene glycol and ethylene glycol as contaminants", which are considered toxic to humans. The company, however, rejected these claims, saying someone might have ‘duplicated the product’ (cough syrup) to ‘defame’ the Government of India.

Before that, Indian pharma company Maiden Pharmaceuticals had also come under scanner in October 2022 after the WHO issued a 'global alert' over the deaths of 66 children in The Gambia. The WHO had warned the four cough syrups made by the company's Haryana unit could be linked to children's deaths in the African nation. However, in a letter to the WHO on December 13, India’s drug regulator DCGI stated the sample of all four products in question was sent for quality testing to a government laboratory. The results said the products were found to be "complying with all specifications".

The health ministry of Uzbekistan on December 27, 2022, had also linked another Indian pharma company, Marion Biotech, Noida, to the death of 18 children in Uzbekistan.

Meanwhile, the US Food and Drug Administration (USFDA) has recommended testing of samples from all containers of all lots of high-risk drug components like “glycerin and propylene glycol” before it is used in the manufacture or preparation of drug products.

The US FDA says the guidance is intended to alert pharmaceutical manufacturers, compounders, repackers, and suppliers to the potential public health hazard of glycerin and other high-risk drug components as these deaths were caused due to the presence of DEG- or EG-contaminated components in the products.

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