The cough syrup investigation: a timeline

Feature

Betsy Goodfellow and James Spargo from Pharmafocus explore the investigation around contaminated cough syrups following a timeline that includes products manufactured by Maiden Pharmaceuticals, Marion Biotech and other companies

July 2022

Children begin dying from acute kidney injuries in the Gambia.1,2

August 2022

One child is reported to have died in Indonesia after being treated with a paracetamol cough syrup from a health centre in south Jakarta, Indonesia; laboratory diagnosis showed that the child had excessive levels of urea and creatinine, both waste products that build up once the kidneys shut down.3

Pre-September 2022

Preliminary investigations find a connection between reports of children becoming unwell in the Gambia and cough syrup produced by Maiden Pharmaceuticals in India.4

September 2022

Four products with a possible connection to children becoming unwell are identified in the Gambia and reported to the World Health Organization (WHO): Promethazine Oral Solution, Kofexmalin Baby Cough Syrup, Makoff Baby Cough Syrup and Magrip N Cold Syrup, all manufactured by Maiden Pharmaceuticals.5

October 2022

BPOM (Indonesia’s food and drug regulatory authority) reports that a number of children have died from kidney failure.6

5 October - WHO releases a Medical Product Alert for the four syrups manufactured by Maiden Pharmaceuticals, which have led to at least 66 deaths in the Gambia to date. Laboratory analysis found that the products contained ‘unacceptable amounts of diethylene glycol and ethylene glycol as contaminants’ according to WHO.7

November 2022

6 November - WHO releases a Medical Product Alert for various products identified in Indonesia. The products are: Termorex syrup (batch AUG22A06 only), Flurin DMP syrup, Unibebi Cough Syrup, Unibebi Demam Paracetamol Drops, Unibebi Demam Paracetamol Syrup, Paracetamol Drops (manufactured by PT Afi Farma), Paracetamol Syrup (mint) (manufactured by PT Afi Farma) and Vipcol Syrup.8

December 2022

21 December - A parliamentary committee in the Gambia recommended prosecution for Maiden Pharmaceuticals, however this is still pending.9

January 2023

11 January - WHO issues a Medical Product Alert for products manufactured by Marion Biotech sold in Uzbekistan. The products are Ambronol syrup and DOK-1 Max syrup; laboratory analysis suggests they have ‘unacceptable amounts of diethylene glycol and/or ethylene glycol as contaminants’, according to WHO.10

23 January - WHO issues a ‘Call to Action’ for all 194 member states with guidelines for governments and regulators, manufacturers and suppliers, and distributors.11
The guidance for governments and regulators suggests they:

‘Detect and remove from circulation […] any substandard medical products that have been identified in the WHO medical alerts […] as potential causes of deaths and disease’11

‘Ensure that all medical products […] are approved for sale by competent authorities and obtainable from authorised/licensed suppliers’11

‘Assign appropriate resources to improve and increase risk-based inspections of manufacturing sites […] in accordance with international norms and standards’11

‘Increase market surveillance including risk-based targeted testing for medical products released […]’11

'Enact and enforce, where relevant and as appropriate, laws and other relevant legal measures to help combat the manufacture, distribution and/or use of substandard and falsified medicines’.11

Manufacturers are asked to:

‘Only purchase pharmaceutical grade excipients from qualified and bona fide suppliers’11

‘Conduct comprehensive testing upon receipt of supplies and before use in manufacture of finished products’11

‘Provide assurance of product quality including through certificates of analyses based on appropriate testing results’11

‘Keep accurate, complete and proper records of purchase of materials, testing, manufacture and distribution to facilitate traceability during investigations in case of incidents’.11

Suppliers and distributors are advised to:

‘Only purchase pharmaceutical grade excipients from qualified and bona fide suppliers’11

‘Conduct comprehensive testing upon receipt of supplies and before use in [the] manufacture of finished products’11

‘Provide assurance of product quality including through certificates of analyses based on appropriate testing results’11

‘Keep accurate, complete and proper records of purchase of materials, testing, manufacture and distribution to facilitate traceability during investigations in case of incidents’.11

24 January - WHO begins investigating cough syrup sold in Indonesia, manufactured by: PT Yarindo Farmatama; PT Universal Pharmaceutical; PT Konimex and PT AFI Farma.12

March 2023

21 March - Families in Indonesia are granted permission by the Indonesian Court to bring a class action lawsuit against the Indonesian government and eight pharmaceutical companies, as the investigation continues.13

23 March - Uttar Pradesh, a state in India, cancels Marion Biotech’s manufacturing licence after products made at its Noida city facility were linked to the deaths of children in Uzbekistan. Three employees from this facility have been arrested.14

Maiden Pharmaceuticals
Maiden Pharmaceuticals Ltd is a pharma company established in 1990, with a manufacturing plant based in Kundi-Haryana, India, and a corporate office in Delhi, India. The company focuses on manufacturing dosage forms such as tablets, hard gelatine capsules, liquid syrups and suspensions, liquid injections, powder for injections, ointments, creams and gels, among other forms and medications.

Marion Biotech
Marion Biotech is a biotech company established in 1999 and based in Noida, India. The company manufactures over 100 healthcare products including over-the-counter medications, herbal drugs and prescription medications. The company manufactures for the Indian market and also exports its products to other countries.

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