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The alert issued by the World Health Organisation (WHO) on four `substandard' products of Maiden Pharmaceuticals can dent the brand image of Indian pharmaceutical exports and calls for an immediate investigation, the Pharmaceutical Export Promotion Council (Pharmexcil) said on Thursday.
The council, an arm of the Ministry of Commerce, had also sought information from the Delhi-based Maiden Pharmaceuticals Ltd, which exported the products.
``This is a dent on the brand image of Indian Pharma exports as the alert could also make other countries take a re-look at certain products being exported from India. We have asked the company, which is a member of the Council, to provide information and investigate the reasons of Serious Adverse Events (SAE) and provide information to us,'' R Uday Bhaskar, Director - General, Pharmexcil told BusinessLine today.
The regulators like Central Drug Standards Control Organisation (CDSCO) ,and the Drug Control Administration of Haryana need to investigate further, Bhaskar added.
Sub-standard cough syrup
The WHO's alert, identified four products - Promethazine Oral Solution, Kofexmalin Baby Cough Syrup, Makoff Baby Cough Syrup and Magrip N Cold Syrup - as `substandard' identified in the Gambia.
The manufacturer of the products, Maiden Pharmaceuticals Ltd, Haryana, had not provided guarantees on the safety and quality of the products to WHO till date, the alert said adding that the laboratory tests of these products contain unacceptable levels of diethylene glycol and ethylene glycol as contaminants, WHO said.
``These products have been ``potentially linked’’ with acute kidney injuries and 66 deaths among children, it added.
Maiden Pharma has been registered with Pharmexcil since 2006 as a small scale manufacturer.
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