All manufacturing activities in Haryana based pharmaceutical company have been suspended pending investigation
All manufacturing activities in Haryana based pharmaceutical company have been suspended pending investigation
The Central Drugs Standard Control Organization (CDSCO) and Haryana State Drug Controller have directed to stop all manufacturing activities at Maiden Pharmaceuticals Ltd in Sonepat based on deficiencies found after local inspection of the company’s facilities, a senior health ministry official said. has confirmed.
The World Health Organization (WHO) on 29 September informed India’s national drug regulator that it was providing technical assistance and advice to The Gambia, where children died and where a contributing factor was the use of drugs manufactured by Maiden Pharmaceuticals. suspected to be contaminated with diethylene glycol or ethylene glycol.
The Health Ministry on Wednesday also constituted a four-member technical expert committee consisting of Dr. YK Gupta, Vice-Chairman, Standing National Committee on Medicines (Chair); Dr. Pragya D. Yadav, National Institute of Virology, Indian Council of Medical Research, Pune; Dr. Aarti Behl, Department of Epidemiology, National Center for Disease Control, Delhi; and AK Pradhan of CDSCO.
“The committee, after examining and analyzing the adverse event report, causal link and all relevant details shared by WHO, will make suitable advice and recommendations to government regulatory authorities regarding further course of action. A health ministry official said the committee may co-opt any other technical expert as deemed necessary.
India was also informed by the WHO that as per the provisional results obtained by it, out of the 23 samples tested, four samples were found to contain diethylene glycol/ethylene glycol. “WHO has not yet provided the certificate of analysis. It has informed that it will be made available in the near future. The exact one-to-one causal relationship of death has not yet been provided by WHO to CDSCO, although CDSCO has twice requested WHO in this regard,” the health ministry said on Wednesday.
The ministry said that after being alerted by the WHO, CDSCO immediately took up the matter with the Haryana State Regulatory Authority, under whose jurisdiction the drug manufacturing unit of Maiden Pharmaceutical Ltd. is located.
CDSCO initiated a detailed investigation with the Haryana State Drug Controller with local inspection of the manufacturing premises carried out on October 1, 3, 6 and 11 to ascertain the facts.
From CDSCO’s preliminary investigation, it was established that Maiden Pharmaceuticals Ltd. is a manufacturer licensed by the State Drug Controller for products under the references – ‘Promethazine Oral Solution BP’, ‘Cofexanaline Baby Cough Syrup’, ‘Macoff Baby Cough Syrup’ and ‘MaGrip n Cold Syrup’ – and holds manufacturing permission for these products only for export. The company has manufactured and exported these products only to The Gambia.
It is common practice that the importing country tests the drugs on quality standards and satisfies itself about their quality before releasing them for use. In the present case, it is unclear whether these drugs were tested in The Gambia prior to release.
All four drugs are manufactured by Maiden Pharmaceuticals Limited for export only, and are not licensed for manufacture and sale in India. In fact, none of them are sold domestically in India.
“The samples (controlled samples of the same batch manufactured by M/s Maiden Pharmaceuticals Ltd for all the four drugs) have been sent by CDSCO to Regional Drug Testing Lab, Chandigarh for testing, the results of which are awaited,” the health ministry said.