Gambia deaths: 4 states had red-flagged Maiden Pharma

Centre claimed that the State Drug Controller of Haryana had given the Sonipat-based firm a manufacturing license to export only to The Gambia, raising questions

Several Indian states and at least one foreign country have red-flagged the quality of medicines manufactured by Maiden Pharmaceutical, whose contaminated cough syrups has reportedly led to the deaths of more than 60 children in The Gambia, in west Africa, prompting the WHO to issue an alert.

The Union Health Ministry on Thursday claimed that the State Drug Controller of Haryana had given the Sonipat-based firm a manufacturing license to export only to The Gambia, raising questions about why a pharmaceutical firm would invest in manufacturing multiple products if its targeted market is only a tiny African nation.

While the ministry said none of the four medicines — Promethazine Oral Solution BP, Kofexnalin Baby Cough Syrup, MaKoff Baby Cough Syrup, and MaGrip n Cold Syrup — were sold in India, the World Health Organisation (WHO) did not rule out the possibility of these medicines being distributed in other countries.

Also read | Gambia urgently recalls syrups blamed for 66 child deaths

Door-to-door campaign

The Gambia has begun a door-to-door campaign to recall the medicines that were linked to the deaths of children due to kidney injury since August.

But it is not the first time the quality of medicines produced by Maiden Pharma has come under the scanner. At least four Indian states — Gujarat, Kerala, J&K and Bihar — flagged quality issues with medicines they procured from the company in the last decade.

In 2011, Bihar blacklisted the company for five years once it found that drugs were “not of standard quality” and “spurious”. It was also blacklisted by Vietnam in 2014. The company was fined by a court in Kerala, and there are court cases against Maiden Pharma in Sonipat.

“Given the wonderful track record of this company, does it not beg the question on what basis does the CDSCO provides assurance via the CoPP (Certificate of Pharmaceutical Product) to buyers overseas that it has inspected and ensured that the exporting pharma company complies with WHO cGMP standards,” tweeted Dinesh S Thakur, a public health activist, who has authored a book on India’s drug regulatory system.

On the Central Drug Standard Control Organisation’s (CDSCO) role, health experts outside the government claimed that the central agency could not escape its responsibilities because the company would require its approval for export.

However, health ministry sources told DH that manufacturing licenses for export purposes were given by the state only and the CDSCO had no role. The CDSCO in 2019 certified the company as one of the 2,000-odd Indian pharmaceutical firms with WHO-GMP-certified manufacturing units.

Meanwhile, none of the two offices of the company in Delhi and Sonipat was open on Thursday. The firm neither responded to the media queries nor issued any statement.

Haryana Health Minister Anil Vij said in Chandigarh that samples of the four cough syrups were sent to the Central Drugs Laboratory in Kolkata for examination.