New Delhi: Maiden Pharmaceuticals has been at the centre of a controversy after the deaths of 66 children in Gambia were linked to the consumption of cough syrups manufactured and exported by the company. The Union Health Ministry has appointed a four-member committee for further investigation. The committee will, after examining and analysing adverse event reports, causal relationships and all related details shared by WHO, suitably advise and recommend Drug Controller General of India (DCGI) about the further course of action. The committee may co-opt any other technical expert as deemed necessary.
The four-member committee comprises the following technical experts: Dr YK Gupta, Vice Chairperson, Standing National Committee on Medicines (Chair), Dr Pragya D Yadav, NIV, ICMR, Pune, Dr Arti Bahl, Division of Epidemiology, NCDC, New Delhi and AK Pradhan, JDC(I), Central Drugs Standard Control Organisation (CDSCO).
The World Health Organisation (WHO) on October 5, 2022, warned that four ‘contaminated’ cough syrups allegedly produced by the Haryana-based company could be the reason for the deaths in the West African nation.
WHO on September 29, 2022, informed the DCGI that WHO is providing technical assistance and advice to Gambia, where children have 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 (in some of the samples it was claimed to have been confirmed by further analysis conducted by the WHO).
CDSCO took up the matter immediately with the Haryana State Regulatory Authority, under whose jurisdiction the drug manufacturing unit of Maiden Pharmaceutical Limited, Sonepat is located. CDSCO launched a detailed investigation (local inspection of the manufacturing premises was done on October 1, 3, 6 and 11) to ascertain the facts/ details in the matter in collaboration with State Drugs Controller, Haryana.
State Drugs Controller, Haryana and CDSCO preliminary reports show violations of good manufacturing practices (GMP) by Maiden Pharmaceuticals. A report has been submitted to the Ministry of Health & Family Welfare (MoH&FW) which appointed a committee for further investigation.
Naresh Goyal, Managing Director, Maiden Pharmaceuticals has denied the allegations. He said the Gambia government is carrying out a quality control analysis of his products and it’s premature to taint his company with accusations that children have died due to cough syrups manufactured by Maiden Pharmaceuticals.
Goyal said his company follows WHO-approved manufacturing practices and is certified by International Organisation for Standardisation. “Medicines Control Agency (national medicines regulator of The Gambia) only recalled the products. They never said that they resulted in deaths,” said Goyal. “The deaths have been due to paracetamol syrup and not due to our cough syrups.”
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.
The WHO has informed that as per the tentative results received by WHO, out of the 23 samples of the products under reference which were tested, four samples have been found to contain diethylene glycol/ 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.
The State Drug Controller had given licenses to the said Company only for the export of these four drugs namely Promethazine Oral Solution BP, Kofexnalin Baby Cough Syrup, MaKoff Baby Cough Syrup and MaGrip n Cold Syrup.
All these four drugs are manufactured only for exports by Maiden Pharmaceuticals Limited and are not licensed for manufacture and sale in India. In effect, none of these four drugs of Maiden Pharmaceuticals is sold domestically in India.
The samples (controlled samples of the same batch manufactured by Maiden Pharmaceuticals Limited for all four drugs in question) have been taken and sent for testing to the Regional Drug Testing Lab, Chandigarh by CDSCO, the results of which are awaited.
CDSCO and the State Drug Controller of Haryana stopped all the manufacturing activities of Maiden Pharmaceuticals Limited at Sonepat on October 11, 2022, on grounds of deficiencies found in the local inspection.