High-level panel to examine Gambian death issue, advise on way forward

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 WHO’s October 5 alert in respect of four medical products manufactured by Sonepat-based Maiden Pharmaceuticals.

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 and ethylene glycol in the solvent Propylene Glycol, used to prepare paracetamol cough syrups.

The WHO has flagged the above two contaminants in the four products exported to Gambia and consumed by some of the 66 children who died after acute kidney injuries.

The committee will be chaired by Y.K. Gupta, Vice Chairperson, Standing National Committee on Medicines, and will comprise the following technical experts as members — Pragya Yadav, leading pathogen expert at the National Institute of Virology, Pune; Arti Bahl from the Division of Epidemiology at the National Centre for Disease Control; and A.K. Pradhan, joint drug controller at the Central Drug Standards Control Organisation.

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 about the future course of action.”

The panel will be free to co-opt any other technical expert as deemed necessary.

The health ministry, meanwhile, said today that the WHO was yet to share with India either the causal link report establishing a direct link between the death of Gambian children and the four flagged products or even the certificate of analysis in the matter.

“Both these reports are awaited,” said sources.

A health ministry note today said that the WHO had on September 29 late evening informed DCGI that it was providing technical assistance and advice to Gambia, where children had died and where a contributing factor, is suspected to be the use of medicines which may have been contaminated with Diethylene glycol or Ethylene glycol.

“It was said that DEG and EG were found in some of the samples claimed to have been confirmed by further analysis conducted by WHO,” the ministry said adding that as immediate action in the matter the Indian regulator launched a detailed investigation into the issue and local inspection of the manufacturing premises was done on October 1, 3, 6 and 11 to ascertain the facts and details in collaboration with Haryana Drugs Controller.

“From the preliminary enquiry of CDSCO, it has been made out that Maiden Pharmaceutical Limited, Sonepat, Haryana, is a manufacturer licensed by the State Drug Controller for the products Promethazine Oral Solution BP, Kofexnalin Baby Cough Syrup, MaKoff Baby Cough Syrup and MaGrip n Cold Syrup under reference, and holds manufacturing permission for these products for export only.

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

Importantly, WHO has informed that as per the tentative results it had received from Gambia, out of the 23 samples of the products under reference which were tested, four returned positive for Diethylene Glycol and Ethylene Glycol.

“WHO has not yet made available a certificate of analysis. It has informed that the same will be made available in near future. The exact one to one causal relation of death has not yet been provided by WHO to CDSCO although CDSCO has requested WHO twice in this regard,” said the ministry.

It added that the Haryana drug controller had given licenses to the said Company only for export of the four drugs and none of these four drugs are sold domestically in India.

The ministry said it was awaiting lab results for samples taken from the same batch as flagged by WHO and manufactured by Maiden Pharmaceuticals for all four drugs.

“CDSCO and State Drug Controller Haryana have stopped all the manufacturing activities of M/s. Maiden Pharmaceuticals Limited at Sonepat on October 11 on grounds of deficiencies found in local inspection,” the ministry added.