India is known as the pharmacy of the world, but the country has also been battling the challenge of counterfeit drugs for long. While the list includes many life-saving drugs and currently fake Remdesivir and oxygen concentrators, a fake COVID-19 vaccine can dampen the efforts of governments and add to the already overwhelming healthcare system in India, says an expert.

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The second wave of Coronavirus in India has had a greater impact on the country's healthcare system. People have been running helter-skelter to get medicines, oxygen cylinders, concentrators, masks, PPE kits and other essential life-saving things. The sudden surge in demand, unfortunately, boosted the trade of fake medicines and other essentials for COVID treatment.

Early this month, four people were arrested in Pune for selling fake vials of Remdesivir for Rs 35,000, a price far above the official Rs 2,000 price cap for the original medicine. Police said the men had sold at least seven vials filled with liquid paracetamol to a relative of a coronavirus patient. In Mysuru, a nurse at a private hospital was arrested for selling Remdesivir vials that had been refilled with antibiotics and saline solution. There are many such cases.

But what if the COVID vaccine gets adulterated?

"We have strong immunisation networks, however, we need to be extra vigilant in this case, as any adverse situation will have a long impact. The COVID vaccine can save a life, but a falsified vaccine will kill human beings as well erode public confidence in healthcare systems, healthcare professionals, and government agencies", Nakul Pasricha, Chief Executive of Pharma Secure, a company that offers drug verification technology to pharmaceutical companies in India stated. "Greater risk of harm to consumers will result in greater liability for healthcare providers. Circulation of falsified or fake vaccines will add to the already overwhelming crisis that the country is facing thus hampering the efforts of our governments, healthcare organisations, and our frontline warriors," he added.

What causes these rampant counterfeits?

"Scarcity breeds falsification and counterfeiting, that is a fact. Adding to that, the absence of anti-tampering, anti-counterfeiting and traceability measures is making their task quite easy" Pasricha noted, adding "counterfeiters are becoming smarter, and we need to stay one step ahead of them". Similar to global companies, measures must be taken at a brand level to ensure the product supply chain integrity, safety, and security, he said.

While physical solutions, such as tamper-evident packaging, eradicate product tampering, digital solutions such as QR codes or barcodes ensure supply chain integrity along with data intelligence. At the regulator level, most of the countries in the world have anti-counterfeiting regulations for pharma and healthcare, Pasricha said. "Protecting COVID -19 vaccines and other essential products from falsification and diversion require cutting-edge authentication and traceability solutions, public-private collaboration, and national-level support", he added.

To secure the vaccine supply chain, Pasricha recommends three steps:

(a) Implementation of serialisation-and-traceability authentication on product packaging.

(b) Training staff at healthcare centres to differentiate genuine vaccines from falsified ones.

(c) Contingency plan to alert stakeholders in case falsified products are discovered in the supply chain.

"It is high time that we must implement these regulations within India the way we have been doing while exporting vaccines and drugs for almost a decade. Fighting counterfeiting is a long-term battle and we need to start somewhere. We have to start now, and we have the ways and means to do it", emphasised Pasricha, who is also the President, Authentication Solution Providers' Association (ASPA), a non-profit organisation. Counterfeiting is also not just confined to India, but is a global problem, causing a tremendous impact on public and economic health. The World Health Organisation, in March, issued a warning about counterfeit and stolen COVID -19 vaccines being sold on the dark web.

Doses of AstraZeneca, Sputnik, Sinopharm and Johnson & Johnson vaccines are being offered for prices between $500 and $750 on the dark web, according to media reports. From about 20 dark web vendors in November 2020, the number grew to 600 in January and more than 1,200 by March this year, showed a report from the cybersecurity firm Check Point. Besides the COVID-19 jabs, vaccine passports and faked negative test papers are also being sold. While COVID-19 is a current pandemic, counterfeiting is an ongoing menace and every stakeholder's role is important in combating it.