Don’t rush to blame or exculpate Maiden Pharma

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Maiden Pharma, whose cough syrup sold in The Gambia was linked to the deaths of 64 children there, is seeking to reopen its factory in Sonepat, Haryana, which was closed by the government after it was detected in four inspections carried out in October to Gambian development suite, violating rules across its testing and manufacturing business.” The company is set to reopen its factory after samples of cough syrup taken from the factory were tested and declared free from any contaminants by the Drugs Controller General of India (DCGI).

The World Health Organization (WHO) had raised the initial alarm over cough syrup made by Maiden Pharma, after tests it carried out at both a lab in The Gambia and another in Switzerland found toxic chemicals diethylene glycol and ethylene glycol in the samples he took cough syrup consumed by the children who later died. After the samples tested healthy, the DCGI wrote to the WHO, informing it of the results of the laboratory tests it had carried out and stressing that the UN agency’s accusations had “undermined the image of Indian pharmaceuticals around the world and caused irreparable damage”. to the pharmaceutical supply chain,” according to a Reuters report.

In response, the WHO said it stands by its findings and the warning it issued against Maiden Pharma’s cough syrup.

How do you reconcile the WHO’s discovery of contaminants, cheap substitutes for glycerin in the manufacturing process, and the failure of India’s drug authorities? This is essential to protect the Indian pharmaceutical industry’s $24.5 billion export market from reputational damage.

There could be two distinct possible explanations. The first is that the sample that was tested in India came from a different batch of medicine than the one that was exported and sold in The Gambia. Another explanation is shantytown in the collection of samples carried out on behalf of WHO in The Gambia. Neither explanation can be dismissed as unrealistic.

Ranbaxy’s exposure following a whistleblower’s disclosures of company malpractice exposed the company’s sleight of hand: providing to test samples it claimed to be his but were in fact drugs produced by companies with impeccable credentials. It wouldn’t take a lot of shenanigans to get the samples of your choice picked up for testing. It could well happen in The Gambia as well, where nations that want to tarnish India’s burgeoning reputation as a global pharmacy could incentivize sample collectors to take deliberately contaminated samples.

The DCGI can be expected to have expertise in the drug testing department, but not necessarily in the detective business. Just because of the absence of WHO-named kidney disease-causing contaminants in the samples it tested, India’s drug regulator cannot say with certainty that the samples in The Gambia were clean.

The only way to be sure Maiden Pharmas cough syrup was free of contaminants is for the drug regulator to directly obtain samples of the suspect cough syrup from The Gambia and test them for the presence of ethylene. glycol, diethylene glycol or any chemical precursor which may be released during improper storage and exposure to light or heat. The Indian Embassy in The Gambia or other trusted agents might be able to source the relevant samples from the parents of the children who unfortunately died after being treated with the cough syrup exported from India. , and samples could be flown back to India for testing. government laboratories.

India should not be seen as being unseemly pressured to exonerate a pharmaceutical company, whose production was halted by Indian government agencies after finding violations of testing and manufacturing protocols. Simply to say that the reputation of India’s pharmaceutical industry is tarnished at the WHO doesn’t exactly help India’s pharmacy.

Trust is vital in any business, but exceptionally in the case of the pharmaceutical industry. Consumers and governments importing medicines trust the reputation of brands and the integrity of India’s regulatory system. It is vital to protect both.

Thorough investigation of the entire sample collection process is essential, apart from sample analysis, to establish either blame or innocence in a case of contamination. It requires thorough due diligence and should be seen and seen by the world as a system of flawless processes.

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