The Gambia has mandated pre-shipment quality testing on all pharmaceutical products exported from India. The requirement will come into effect on 1 July 2023. It can be understood as an after-effect of last year’s scandal whereby India-manufactured cough syrups allegedly claimed the lives of 66 children in The Gambia in 2022 . 

Following the episode, WHO conducted independent testing of the cough syrup samples that had been administered to the children in Switzerland, finding 23 samples contaminated with the industrial chemicals, DiEthylene Glycol (DEG), and Ethylene Glycol (EG).  

In May, following a series of scandals involving contaminated cough syrups both domestically and abroad, India made it mandatory for all exported syrups to undergo testing and certification from a government laboratory from 1 June.  No such requirement yet exists, however, for domestic production. 

However, the new rules regarding exports, as well as imposition of quality-assurance requirements by other countries, such as The Gambia, should further put the industry on alert regarding long standing issues with quality assurance.  

According to a communique sent by the Medicines Control Agency (MCA) of The Gambia to the Drugs Controller General of India (DCGI), and published by the Indian drug control agency, all pharmaceutical products that will be exported to the country shall be inspected and sampled for testing to ensure they conform to quality standards. 

To make sure that the products meet quality-assurance criteria, the MCA has appointed Quntrol Laboratories Private Limited, an independent verification, inspection and testing company, to carry out the process and issue a Clean Report of Inspection and Analysis (CRIA) for each shipment from India to The Gambia, beginning in July. 

“All shipments arriving into The Gambia with bill of lading [export document] dated on or after 1 July 2023 will be required to provide the CRIA for customs clearance at the Ports of Entry in The Gambia,” the communiqué dated 15 June 2023 said. 

The DCGI has circulated the communiqué among all the state drugs controllers, their counterparts at the zonal and sub-zonal levels, and the various manufacturing associations in India. “This is for your information and immediate action,” the letter from the Indian DCGI to the other stakeholders said. 

According to the process outlined by The Gambian MCA, the exporter of the pharmaceutical products is responsible for raising an inspection request with Quntrol Laboratories, which will then retrieve samples from the shipment and send them to be tested in MCA approved labs. Upon successful testing of the samples, a CRIA is sent to the exporter, which shall be shared with the importer. The importer shall use this certificate to take possession of the shipments from The Gambian Ports of Entry. 

Deaths in The Gambia strongly linked to Indian cough syrups

In October 2022, the World Health Organization (WHO) issued a product alert for substandard cough syrups manufactured in India, linked to the deaths of at least 66 children in The Gambia. The syrups were manufactured by Maiden Pharmaceuticals in India. 

India halted production at the plant temporarily after WHO commissioned lab tests found DiEthylene Glycol (DEG) in the range of 1% to 21.30% weight/volume in the cough syrup samples. DEG is completely banned in pharmaceutical products. 

India has, however, also maintained that its tests on the control samples of the cough syrups collected from the batches exported to The Gambia showed no traces of contamination.

Meanwhile, The Gambia had sought the assistance of the US CDC to investigate the sudden spike in AKI in children between June and September 2022. In March 2023, the US CDC released its report that suggested strong links between the cough syrups consumed by the children and their AKI. 

“This investigation strongly suggests that medications contaminated with DEG or Ethylene Glycol (EG) imported into The Gambia led to this AKI cluster among children,” the report stated. 

Other product alerts for Indian cough syrups

In January 2023, WHO issued another alert flagging two products manufactured in India and exported to Uzbekistan and Cambodia as containing “unacceptable amounts” of DEG and/or EG. Both these products were manufactured by Marion Biotech Private Limited in India. The alert came after Uzbekistan alleged that 18 children died after consuming the syrup. 

In April 2023, the WHO issued yet another product alert flagging a contaminated syrup identified in Marshall Islands and Micronesia. The syrup was manufactured by Trillium Pharma in India and also contained “unacceptable amounts of DEG and EG”, as per the WHO report. Trillium Pharma, however, has maintained that it did not sell these products in these countries. 

Within India, as well, communities in states as far-flung as Kashmir and central as Uttar Pradesh have reported a series of adverse events associated with the administration of cough syrups. 

The problems occur primarily in the manufacturing process. When paracetamol syrup or cough syrups are manufactured, they need a solvent to dissolve the active ingredients, add sweetness, and act as a lubricant. The solvents used are either glycerine or propylene glycol, a clear, faintly sweet, and viscous liquid.

Glycerine Indian Pharmacopoeia (IP) grade is supposed to be used in drugs and medicines, in line with good manufacturing practices framed by the WHO.  However, when industrial glycerine, used in chemicals and cosmetics, is used instead, it can contain contaminants such as diethylene glycol and ethylene glycol. 

Image Credits: Photo by Towfiqu barbhuiya on Unsplash.