INDIAN PHARMACEUTICAL REGULATORS MUST TIGHTEN THE LOOSE ENDS!

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  • The most important aspect that came to the fore during the once-in-a-century pandemic was the lack of preparedness of the pharmaceutical companies in India without the availability of critical raw ingredients. These pharmaceutical ingredients were sourced from China and restrictions imposed during the pandemic created a great hurdle in producing drugs. Not for nothing India is considered the pharmaceutical capital of the world with the majority of life-saving drugs produced here. However, as reported extensively in the newspapers over the last year, the spurious drugs being exported to some of the countries have resulted in deaths, including innocent children. The country’s reputation is at stake even as more cases of spurious drugs hit the headlines.

Pandemic Laboratory Preparedness - SciLifeLab

PC: SciLifeLab

  • The moot point to ponder over here is what the regulators are doing to address the malaise harming the assiduously built reputation of the country’s pharma sector. The resultant outcome of India’s weak drug regulation is the spreading of the problem from Africa to America causing immense reputational damage. Sadly, India’s drug regulators have been caught napping once again. Various pills made by Maharashtra-based Aveo Pharmaceuticals have been linked to the opioid mayhem in Ghana, Nigeria, and Cote d’Ivoire. But it took a BBC documentary for the state and central regulators to conduct a raid and then announce manufacturing and export curbs. These hardly amount to the systemic overhaul that experts have been crying for since fiascos.

Indian-Made Syrups Linked To Child Deaths In Gambia: US Body Report

PC: NDTV

  • Remember that Indian cough syrups have led to children’s deaths in Gambia, Uzbekistan, and Cameroon. At this rate, the days when India earned vast goodwill in Africa, by saving lives with cheap generics against AIDS, will soon become a distant memory. The opioid story also risks putting India directly in Trump’s crosshairs. The US has found Indian companies trafficking precursor chemicals for fentanyl, which ultimately kills Americans and devastates their communities. This will simply rile the maverick president no end since his ranting against India’s tariff is gaining currency of late. On the African front, Indian authorities have often taken the position that importing countries need to toughen regulations.

Fda News: Approvals, Recalls, Breakthroughs and More

PC: STAT News

  • Unfortunately, Indian regulators themselves have been shown up as incompetent at best, and compromised at worst, by the US FDA. Even keeping aside the ethics, or business effects, of exporting substandard, even dangerous, drugs, the idea that the domestic market can be firewalled from such doctoring, is silly. Further, a Haridwar lab supplies govt hospitals antibiotics that turn out to be just talcum powder mixed with starch, patients fear buying medicines from any but trusted pharmacies, and a significant proportion of officially tested samples are found to be substandard, repeatedly. Proactive, as opposed to reactive, regulation, which needs better coordination between central and state agencies is urgently needed.