These episodes have encompassed distressing incidents like the deaths of children in Gambia and Uzbekistan due to adulterated cough syrup, contaminated chemotherapy drugs and contaminated eye drops causing blindness. Triggered by these events, public health campaigners across the globe are urging for stricter monitoring and a reconsideration of global supply chains.
In the last few months, pharmaceuticals export arm Pharmexcil and the ministry of commerce and industry have expressed significant concerns regarding these incidents and raised the issue with the ministry of health and family welfare as well as the department of pharmaceuticals.
“We have asked the health ministry to do something that sends a strong message to global regulators that we are serious about fixing these lapses and we are on it,” a senior government official said.
Driven by this, India also made a move by bringing in additional checks over cough syrups meant for exports. But it will require a significantly greater effort to resolve this chaotic situation than what we have currently invested.
Reputation being tarnished in the global arena
Unfortunately, these incidents are tarnishing India’s reputation in the global arena. Also, a majority of these incidents have been announced by the World Health Organization, including the deaths of children in Gambia, contaminated cough syrup in the Marshall Islands and circulation of contaminated anti-cancer drugs in Lebanon and Yemen.
Such frequent alerts by WHO are serious and embarrassing unless we prefer to live in denial and opt to maintain the theory of “witch hunting” against India. Global media is also increasingly adopting a harsh and critical tone.
Financial Times labelled the Gambia incident as “the world’s worst scandal related to the sales of over-the-counter medicines”. Bloomberg, an American news agency, in its latest article on the spate of deadly manufacturing incidents labelled these events “scandals”.
“The deaths and drug recall also come at a critical time for Prime Minister Narendra Modi’s government, which is selling the South Asian nation to investors as an alternative to China for high-quality manufacturing,” the article stated. “The Biden administration has warned about the preponderance of drug supplies from countries like India, and pushed to produce more medicine domestically.”
No, it’s not only small and medium pharma firms
A top government officer, in an informal conversation, told me that India must move away from the concept of “medium and small enterprises” in drug manufacturing to end the series of shameful and awkward lapses.
“We should not allow any firm to manufacture drugs if their turnover is below Rs 200 crore. Maintaining quality needs a lot of money. Running a firm to match US FDA (Food and Drug Administration) standards is an extremely expensive process,” the officer said.
The officer further said India must stop taking pride in promoting medium and small scale firms in the pharmaceutical industry. “Thank god, these small players do not export to heavily regulated markets in Europe and North America,” the officer added.
In hindsight, it may sound apt.
Sample this: It was the Haryana-based Maiden Pharmaceutical drug maker behind the cough syrup controversy in the Gambia case, whereas Noida-based Marion Biotech was behind the Uzbekistan cough syrup-related deaths.
Health authorities in Lebanon and Yemen red-flagged a cancer drug made by Celon Labs in Hyderabad, whereas Punjab-based QP Pharmachem has been blamed for exporting contaminated cough syrup to the Marshall Islands and Micronesia.
But in an aerial view, issues within India’s pharmaceutical industry extend way beyond small manufacturers. Since the beginning of 2022, Indian drugmakers have been issued nine FDA warning letters, and a majority of these drugmakers are India’s top pharma firms.
From questioning the safety and efficacy of drugs to pointing out the documentation practices, Sun Pharma, Lupin, Cipla among others have come under the radar of the American regulator deemed to be the world’s strictest.
In January, the US health regulator, pulled up Sun Pharma for manufacturing lapses that included failure to follow certain processes to prevent microbiological contamination of drug products. Similarly, for Lupin’s Tarapur plant, the FDA said in the warning letter: “Because your methods, facilities, or controls for manufacturing, processing, packing, or holding do not conform to CGMP, your API is adulterated…”
From upgrading Schedule M to regulate good manufacturing practices (GMP), tightening surveillance and enforcement of violations, increasing audits and putting additional checks before the final rollout of products for export or local market – it’s time for India to bounce back urgently if it still wants to claim the mantle of the “pharmacy to the world”. Fixing quality issues is no more an urgency but an emergency.
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