Indian pharma Centre initiates probe after WHO red flags four products from Indian drug maker

The Health Ministry has launched an investigation, after a medical product alert was issued by the World Health Organization on four contaminated medicines from an Indian drugmaker, “potentially linked” to acute kidney injuries and 66 deaths among children in Gambia.

The four medicines are cough and cold syrups produced by Maiden Pharmaceuticals Limited. The products were reported to have been contaminated with diethylene glycol or ethylene glycol. While investigations are underway, at the WHO and Indian regulatory levels, experts worry at the impact this could have on the Indian pharmaceutical industry.

The Central Drugs Standard Control Organisation (CDSCO) had commenced its probe after the WHO first alerted them on September 29. The regulator has since been in touch with Haryana’s State Regualtory Authority, where the company’s manufacturing unit is located.

An official from the Health Ministry pointed out that an importing country usually tests products on quality parameters, and satisfies itself before their release for use in the country. The WHO has been requested to share with the CDSCO the report on establishment of causal relation to death with the medical products in question, photographs of labels/ products etc. That report is awaited.

The note clarified that the product has been exported only to Gambia and the company did not have permission to sell in India. Controlled samples of the same batch of the four products have been sent to the Regional Drug Testing lab, Chandigarh, and its results would guide future action, it added.

Concerned that these ‘substandard’ products could impact the brand image of Indian pharmaceutical exports, the Pharmaceutical Export Promotion Council (Pharmexcil) — an arm of the Commerce Ministry — has also sought information from the company on the development.

“This is a dent on the brand image of Indian pharma exports as the alert could also make other countries take a relook at certain products being exported from India. We have asked the company 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.

Maiden Pharma has been registered with Pharmexcil since 2006 as a small scale manufacturer.

Meanwhile, Naresh Kumar Goyal, a Maiden director, told Reuters it heard about the deaths only on Thursday morning and were trying to find out details. “We are trying to find out with the buyer and all that what has happened exactly. We are not selling anything in India.”

(Source: Business Line)