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The lack of a drug recall law in India

Published: 11th May, 2023

Context

‘Abbot’, a multinational pharmaceutical company, published a public notice in newspapers to alert people about a mislabelled batch of medicine that it had inadvertently shipped to the market.

So, what’s the big deal?

Drug Recall

A drug recall occurs when a prescription or over-the-counter drug is removed from the market because of its harmful or side effects. In some cases, drug manufacturers may voluntarily recall their drugs if they discover a problem with their drug.

  • There is nothing special about this development as such recalls take place regularly in the U.S., including by Indian companies.
  • However, such domestic or foreign pharmaceutical companies recall substandard or mislabelled drugs does not take place in India.

Why India is lacking behind?

  • For a nation that seeks to claim the mantle of “pharmacy to the world,” India is scandalously short on regulatory oversight.
  • There exists no law in India that mandates such medicine be removed from the market to this day.
  • Though the country has been mulling the creation of a mandatory recall law for substandard drugs since 1976. In 1976, the Drugs Consultative Committee discussed the issue of drug recalls, but no development.
  • In 2012, certain recall guidelines were published by the CDSCO, but they lacked the force of law.

India’s drug industry

  • India is the largest provider of generic medicines, producing 20% of the world’s supply, according to the government’s Economic Survey.
  • Its $50 billion drug-manufacturing industry exports medicines to over 200 nations and makes 60% of all vaccines.
  • It boasts “the highest number” of US Food and Drug Administration compliant plants outside America, and indeed, some of its generic pharmaceutical companies produce high-quality medicines. 

How does it impact?

  • People, including children, are probably likely dying or suffering from bad health consequences as a result of poor pharmaceuticals remaining on the market for too long.
  • Hundreds of medications flunk random testing in government laboratories every month.

What happens when substandard drugs are not recalled?

  • People, including children, are almost certainly dying or suffering from adverse health events because substandard drugs are not swiftly removed from the market.
  • Every month, dozens of drugs fail random-testing in government laboratories. Ideally, these drugs will be necessarily recalled in a transparent manner, with the people being informed of the failures.
    • If this were to actually happen in India, the people would be flooded with alerts on an almost daily basis, which then would increase the pressure on drug regulators to institute extensive reforms.
    • If the bureaucracy’s intention is to avoid accountability, it might prefer to keep quiet and let substandard drugs, even those with dangerous consequences for consumers, circulate in the market.
  • This has been their modus operandi for decades, until recently, when drug failures overseas brought attention to this issue. Yet nothing has changed on the ground.
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