Cough syrup deaths | After inspection, India stops Maiden Pharma unit from making drugs

The Central Drugs Standard Control Organisation (CDSCO) and Haryana State Drugs Controller have directed a stop to all manufacturing activity at Maiden Pharmaceuticals Limited in Sonepat on grounds of deficiencies found following local inspection of the company’s facilities, a senior Health Ministry official has confirmed.

The World Health Organization (WHO) had on September 29 informed India’s national drug regulator that it was providing technical assistance and advice to Gambia, where children had died and where a contributing factor was suspected to be the use of medicines manufactured by Maiden Pharmaceuticals, which may have been contaminated with diethylene glycol or ethylene glycol.

The Health Ministry, on Wednesday, also constituted a four-member technical expert committee comprising Dr. Y.K Gupta, Vice Chairperson, Standing National Committee on Medicines (Chair); Dr. Pragya D. Yadav, National Institute of Virology, Indian Council of Medical Research, Pune; Dr. Arti Bahl, Division of Epidemiology, National Centre for Disease Control, Delhi; and A. K. Pradhan of the CDSCO.

“The committee will, after examining and analysing adverse event reports, causal relationship and all related details shared by the WHO, suitably advise and recommend government regulatory authorities about the further course of action. The committee may co-opt any other technical expert as deemed necessary,’’ a Health Ministry official said.

India was also informed by the WHO that according to tentative results received by it, out of the 23 samples of the products under reference which were tested, four samples had been found to contain diethylene glycol/ ethylene glycol. “The WHO has not yet made available the 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 the WHO to the CDSCO, although the CDSCO has requested the WHO twice in this regard,’’ the Health Ministry maintained on Wednesday.

The Ministry added that after being alerted by the WHO, the CDSCO took the matter up immediately with the Haryana State Regulatory Authority, under whose jurisdiction Maiden Pharmaceutical Limited’s the drug manufacturing unit is located.

The CDSCO launched a detailed investigation, with local inspection of the manufacturing premises carried out on October 1, 3, 6 and 11, to ascertain the facts along with the Haryana State Drugs Controller.

From the CDSCO’s preliminary enquiry, it was established that Maiden Pharmaceuticals Limited is the manufacturer licensed by the State Drug Controller for the products under reference — ‘Promethazine Oral Solution BP’, ‘Kofexnalin Baby Cough Syrup’, ‘MaKoff Baby Cough Syrup’ and ‘MaGrip n Cold Syrup’ — and holds manufacturing permission for these products for export only. The company has manufactured and exported these products only to Gambia.

It is the usual practice that the importing country tests medicines on quality parameters and satisfies itself as to their quality before releasing them for usage. In the present case, it’s not clear if these medicines were tested in Gambia before their release.

All four drugs are manufactured only for export by Maiden Pharmaceuticals Limited, and are not licensed for manufacture and sale in India. In effect, none of them is sold domestically in India.

“The samples (controlled samples of the same batch manufactured by M/s. Maiden Pharmaceuticals Limited for all the four drugs in question) have been taken and sent for testing to Regional Drug Testing Lab, Chandigarh by CDSCO, the results of which are awaited,’’ the Health Ministry said.