India’s US$ 49 billion pharmaceutical industry has often been described as the ‘pharmacy to the world’, as it is the world’s largest exporter of generic drugs. But the country is having to contend with one scandal after another. After the deaths of scores of children, allegedly due to the consumption of cough syrups made by India’s Maiden Pharmaceuticals in October, there was news
of a similar crisis in Uzbekistan last December. The
culprit this time was Indian drugmaker Marion Biotech. In all, India-manufactured
cough syrups have been linked
to the deaths of around 89 children in the two
countries.Last week, yet another drug contamination case rocked the global
pharma industry. This time, the victims were the consumers in the United
States. The US Food and Drug
Administration (FDA) issued a warning against using an eye drop made by India-based Global Pharma Healthcare. FDA said the Artificial Tears eye drop manufactured by Global Pharma has a potential bacterial contamination and the company has violated current good manufacturing practices (cGMPs). Global Pharma’s plant is situated in Kancheepuram (near Chennai) in the state of Tamil Nadu.As of January 31, the Centers
for Disease Control and Prevention (CDC) had identified 55 patients in 12 states of the US with infections linked to the use of Artificial
Tears. Associated adverse events include hospitalization, one death with bloodstream infection, and permanent vision loss.Artificial tears are widely-used over-the-counter eye-drops used to lubricate dry eyes. In the US, the eye drop manufactured by Global Pharma is distributed by EzriCare LLC and Delsam Pharma.FDA has asked consumers not to purchase and immediately stop using EzriCare Artificial Tears or Delsam Pharma’s Artificial Tears due to potential bacterial contamination.Eye drops with
antibiotic-resistant bacteria The CDC found the product contaminated with an extensively
drug-resistant strain of Pseudomonas
aeruginosa bacteria. This bacteria
is resistant to around 12 antibiotics, and was susceptible to only cefiderocol – an antibiotic that is used to treat complex infections.Pseudomonas bacterial infection is generally acquired at hospital settings, originating mostly in intensive-care units where patients are very sick.On February 2, Global Pharma issued a statement that it is voluntarily recalling all lots within expiry of their Artificial Tears eye drops distributed by EzriCare and Delsam Pharma, to the consumer level, due to possible contamination.The very next day, India’s federal and state drug regulators sent a team to Global Pharma’s contract manufacturing plant near Chennai. The manufacturer was instructed to stop manufacturing all products under the category of ophthalmic preparation until the completion of the investigation. The Tamil Nadu drugs controller collected many control samples of the same batches and sent them for investigation to a government lab in the state. The drugs controller also collected samples of raw materials used in making those batches.During the joint inspection it was found that Global Pharma had exported two consignments of 24 batches that were manufactured in 2021 and 2022. The drug inspectors could not find any clue to the possible contamination.FDA has also placed Global Pharma on import alert for providing inadequate
response to a records request and for not complying with cGMP requirements. The
import alert prevents these products from entering the US.Our viewIndia’s pharmaceutical sector has been growing at a fast clip, and the Indian Pharmaceutical Alliance expects it to reach a market size of US$ 130 billion by 2030. Over the last
decade, exports of pharmaceuticals from India have doubled to nearly US$ 25 billion per annum. And the US is a very important market for India — 29 percent of the country’s total drug exports go to the US.Though India’s drug industry has withstood several setbacks, including the Ranbaxy fraud and
innumerable quality and regulatory
compliance issues, three consecutive instances of contamination over the last four months — first in cough syrups (that had high levels of toxic substances ethylene glycol and diethylene glycol), and then in eye drops (with an antibiotic-resistant bacteria) — is a severe blow to India’s image as the ‘pharmacy to the world’.This year has begun with FDA issuing Form 483s to several big Indian
drugmakers, such as Lupin, Aurobindo Pharma, Sun Pharma and Intas.These three instances of deadly contamination are also particularly damning for India’s drug regulatory system. Last week, India’s health minister said the country will spend US$ 79.6 million to strengthen its drug
regulatory system. More than an increase in regulatory expenditure, Indian
drugmakers and regulators need to show a strong will to work towards regaining
its prestige, and emerge as a haven for safe (and affordable) drugs.
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