High-level panel to study all aspects related to death of Gambian infants

Aditi Tandon

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New Delhi, October 12

The government on Wednesday constituted a high-level committee to examine all aspects related to the death of 66 Gambian infants and the WHO’s October 5 alert with respect to four medical products manufactured by Sonepat-based Maiden Pharmaceuticals.

The committee will be chaired by YK Gupta, Vice-Chairperson, Standing National Committee on Medicines, and will comprise three technical experts as members — Pragya Yadav, head of Biosafety Level lab at the National Institute of Virology, Pune; Arti Bahl from the Division of Epidemiology at the National Centre for Disease Control and AK Pradhan, Joint Drug Controller at the Central Drugs Standard Control Organisation (CDSCO).

4-member committee

• YK Gupta, Vice-Chairperson, Standing National Committee on Medicines (panel head)
• Pragya Yadav, head of Biosafety Level lab at National Institute of Virology, Pune
• Arti Bahl from Epidemiology Division at National Centre for Disease Control
• AK Pradhan, Joint Drug Controller at CDSCO

In a note today, the Health Ministry said, “The committee will, after examining and analysing adverse event reports, causal relationship and all related details shared with India by the WHO, suitably advise and recommend the Drugs Controller General of India (DCGI) about the future course of action.”

The constitution of the committee followed joint action by the Centre and the Haryana Government to halt all production at the firm where inspection teams found 12 critical flaws, including absence of testing for toxic contaminants diethylene glycol (DEG) and ethylene glycol (EG) in solvent propylene glycol, which is used to prepare paracetamol cough syrup formulations. The WHO flagged the above two contaminants in the four products exported to Gambia and consumed by some of the 66 children who died starting late July until now after acute kidney injuries.

The ministry said the WHO had not yet shared with India two critical reports on the matter — the causal link report establishing a direct link between the deaths and the four flagged products and the certificate of analysis. “Both reports are awaited,” said sources, a day after the WHO told The Tribune that establishing a direct causal link was hard.

Ministry sources also said the WHO had on September 29 informed the DCGI that it was providing technical assistance and advice to Gambia. “The WHO said that DEG and EG were found in some of the samples, claimed to have been confirmed by further analysis conducted by the WHO,” the ministry officials said today, adding that as an immediate action, the DCGI launched an investigation and the flagged unit was inspected on October 1, 3, 6 and 11 to ascertain facts.

The ministry said it was awaiting lab results for samples taken from the same batch as flagged by the WHO and manufactured by Maiden Pharmaceuticals for all four drugs. “Apex drug regulator CDSCO and the Haryana Drug Controller stopped all manufacturing by Maiden Pharmaceuticals on October 11 on grounds of deficiencies found during inspection,” ministry sources said.

The government reiterated that from the preliminary enquiry of the CDSCO, it had been made out that Maiden Pharmaceutical was a manufacturer licensed by the State Drug Controller for the four products in question—Promethazine Oral Solution, Kofexmalin Baby Cough Syrup, Makoff Baby Cough Syrup and MaGrip N-Cold Syrup— and held manufacturing permission only for export.

“The company exported these products only to Gambia. It is a usual practice that the importing country tests imported medicines on quality parameters and satisfies itself as to the quality of the products before allowing the products for usage. In the present case, it is yet not clear whether these medicines were tested before release in Gambia,” said ministry officials.

12 critical Flaws at maiden pharma

Absence of testing for toxic contaminants DEG and ED in solvent propylene glycol were among 12 critical flaws detected at Maiden Pharma, Sonepat

Awaited from WHO

1 Causal link report on direct link of deaths with the four flagged cough syrups

2 Certificate of analysis