Gambia deaths: 4 cough syrups shown made in 2021 on product label but 2022 in manufacturing records
All four cough syrups linked to Gambia deaths have drug product labels mentioning manufacturing date as December 2021 whereas commencement dates in BMR and date of completion of manufacturing are of 2022
Discrepancies regarding dates of manufacturing and product permissions for the four paediatric cough syrups linked to the death of 66 children in The Gambia have been detected during a joint inspection of the manufacturing facility of Maiden Pharmaceutical Limited by the Haryana drug authorities and officials of the Central Drugs Standard Control Organisation (CDSCO).
The discrepancies listed by the Haryana drug controller in its October 7 show-cause notice pertained to the date of manufacturing as per the product label, the date of manufacturing as per batch manufacturing record (BMR) and product permission.
Product permission is granted for the manufacturing of a particular drug or medicine and is regulated by the licence to manufacture for sale or distribution of drugs.
All four cough syrups under investigation have drug product labels mentioning the manufacturing date as December 2021 whereas the commencement dates in batch manufacturing record (BMR) and date of completion of manufacturing are of 2022. The BMR is a document which provides a complete record of the manufacturing history of a batch of products and ensures that quality and regulatory requirements for drug manufacturing are adhered to. It contains the start and completion dates of manufacturing of the product, quality control information, steps completed in the manufacturing process, results of in-process checks, etc.
For instance, the commencement date for Promethazine Oral Solution (batch number ML21-202) in batch manufacturing record (BMR) is February 27, 2002, and the date of completion (of manufacturing) for 10,000 bottles is March 1, 2022, whereas the manufacturing date on the drug product label is December 2021.
The product permission granted for the export of Kofexmalin Baby Cough Syrup (batch number ML21-199) to The Gambia was granted on February 24, 2022. “The commencement date in BMR for Kofexmalin Syrup is February 26, 2022, the date of completion of the manufacturing for 10,000 bottles is March 1, 2022, but the manufacturing date on the drug product label is December 2021,” the notice document said.
For the Makoff Baby Cough Syrup (batch number ML21-203), the commencement date in BMR is February 22, 2022, and the date of completion of manufacturing of 15,000 bottles is February 23, 2022, but the manufacturing date on the drug product label is December 2021.
The commencement date in BMR for Magrip N Cold Syrup (batch number ML21-198) and the grant of product permission for 15,000 bottles is February 24, 2022, the date of completion is February 26, 2022, whereas the manufacturing date on the drug product label is December 2021, the notice document said.
Meanwhile, the Drug Controller General of India (DCGI) in an October 10 communication to all the state drug controllers asked them to ensure the use of Indian Pharmacopoeia reference standards and impurity standards for quality testing of drugs by pharmaceutical manufacturers and testing labs as per the Drugs and Cosmetics Act and Rules.
“As informed by the Indian Pharmacopoeia Commission (IPC), there are 660 Indian Pharmacopoeia reference standards and 345 impurity standards listed in the IPC catalogue and the details are available on IPC website,’’ said the communication by DCGI Dr VG Somani.