Rush not to blame or exonerate Maiden Pharma

Maiden Pharma, whose cough syrup sold in Gambia were linked to the death of 64 children in that country, seeks to reopen its plant in Sonepat, Haryana, shut down by the government after detecting, in four inspections carried out in October in the wake of the Gambian development, violation of rules “across its testing and manufacturing activities”. The company moves to reopen its plant after samples of cough syrup taken from the factory were tested and declared free of any contaminants by the Drugs Controller General of India (DCGI).  

The World Health Organisation (WHO) had raised the initial alarm about the cough syrup manufactured by Maiden Pharma, after the tests it carried out both in a lab in Gambia and in another one in Switzerland found toxic chemicals diethylene glycol and ethylene glycol in the samples it took of the cough syrup consumed by the children who subsequently died. After the samples tested clean, the DCGI wrote to the WHO, informing it of the lab test results it had carried out and pointing out that the UN agency’s accusations had “adversely impacted the image of India’s pharmaceutical products across the globe, and caused irreparable damage to the supply chain of pharmaceutical products”, according to a Reuters report.

In response, the WHO said that it stood by its findings and the alert it had issued against the cough syrup from Maiden Pharma.

How do we reconcile the WHO’s finding of contaminants, cheap substitutes for glycerin in the manufacturing process, and the Indian drug authorities’ failure to find any? This is vital to insulate the $24.5 billion export market of the Indian pharmaceutical industry from reputational damage.

There could be two separate possible explanations. One is that the sample that was tested in India was from a batch of the medicine different from the one that was exported to and sold in Gambia. Another explanation is hanky-panky in the sample collection carried out on behalf of the WHO in Gambia. Neither explanation can be dismissed as unrealistic.

The Ranbaxy expose that followed a whistle-blower’s revelations about company malpractice, brought out the sleight of hand practised by the company: providing for testing samples it claimed were its own but were, in fact, drugs produced by companies with impeccable credentials. It would not require a great deal of skullduggery to have the samples of your liking picked up for testing. This could well happen in Gambia as well, where nations that want to tarnish India’s burgeoning reputation as the world’s pharmacy could induce sample collectors to pick up deliberately contaminated samples.

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

The only way to ascertain that Maiden Pharma’s cough syrup was free of contaminants is for the drug regulator to directly get hold of samples of the suspect cough syrup from Gambia and test these for the presence of ethylene glycol, diethylene glycol or any precursor chemicals that could release either in the course of improper storage and exposure to light or heat. The Indian Embassy in Gambia or other trusted agents could, perhaps, procure the relevant samples from parents of the children who, unfortunately, died after being treated with the cough syrup exported from India, and the samples could be flown back to India for testing in the government’s labs.

India should not be seen to be in any unseemly hurry to exonerate a pharma company, whose production India’s government agencies shut down after finding violations across testing and manufacturing protocols. Simply saying the reputation of India’s pharmaceutical industry is being damaged at the WHO does not exactly help Indian pharma.

Trust is vital in any business, but unusually so in the case of the pharma industry. Consumers and drug-importing governments go by the reputation of brands and the integrity of the regulatory apparatus in India. It is vital to protect both.

Thorough investigation of the entire process of sample collection is vital, apart from sample analysis, to establish either blame or blamelessness in a case of contamination. This calls for thorough due diligence, and to be seen and regarded by the world as a system of impeccable processes.

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