Regulatory Control to Combat the Menace of Spurious / Counterfeit Drugs

Medicine Drugs Tablets Pills
Picture: Pixabay
K C Aggarwal

Last Updated on March 28, 2024 by K C Aggarwal


Spurious drugs pose a significant threat to patients’ lives, genuine drug manufacturers, and the overall image of our country.

Counterfeit drugs have a deceptive capacity, often resembling the original product from legitimate sources, making purchasers unsuspecting.

The proliferation of low-quality medicines jeopardizes public health at all levels.

Modern therapeutics have dramatically improved human life expectancy, but the rising prevalence of counterfeit drugs undermines their efficacy.

This trend damages the credibility of healthcare systems and leads to illness, disability, and death among consumers.

Efforts to eradicate spurious and counterfeit drugs intensify, but with limited success.

According to Section 17(B), a drug is considered spurious if it:

  • – Is manufactured under another drug’s name.
  • – Imitates or substitutes another drug in a manner likely to deceive.
  • – Bears a fictitious manufacturer’s name.
  • – Is wholly or partially substituted by another substance.
  • – Falsely claims to be a product of a specific manufacturer.

Counterfeit drugs often target antibiotics, hormones, steroids, anti-hypertensive drugs, and even anti-cancer medications.

Varieties of counterfeits include products without active ingredients, with incorrect ingredients, with correct ingredients but fake packaging, and exact copies of genuine products.

Factors Leading to Counterfeiting of Drugs:

  • 1. Lower cost compared to genuine drugs.
  • 2. Inadequate drug legislation and regulation, lacking deterrence.
  • 3. Minimal infrastructure and overhead expenses.
  • 4. Lack of regulatory control.
  • 5. Advanced printing technology mimics genuine packaging.
  • 6. Involvement of organized criminal networks.
  • 7. Lucrative profits.
  • 8. Corruption and conflicts of interest.

Adverse Effects of Counterfeiting:

  • 1. Patients receive ineffective treatment, undermining confidence in healthcare systems.
  • 2. Industries suffer reputation and financial losses.
  • 3. Countries face tarnished global reputations.

Combatting Counterfeit Medicines:

  • 1. Strengthen regulatory control and awareness campaigns.
  • 2. Efficient training of regulators to investigate and monitor drug movements.
  • 3. Training drug inspectors to enhance performance and expedite legal proceedings.
  • 4. Equip drug testing labs with international standard instruments.
  • 5. Conduct thorough surveys to track counterfeit drug movements.
  • 6. Train pharmacists to procure medicines from genuine sources and report suspicions.
  • 7. Establish dedicated task forces to assist drug administrations.
  • 8. Maintain whistleblower policies for public engagement.
  • 9. Impose strict liability on counterfeit drug manufacturers.
  • 10. Release press information to raise awareness.

Recent Instances of Spurious Drugs:

  • – Suspicious stocks of Telma 40 and Telma H tablets found at a retail counter.
  • – Suspected counterfeit Rosvas 10 tablets at the stockist level.
  • – Recent arrest of an individual manufacturing counterfeit anti-cancer drugs.


Spurious drugs endanger lives and thrive on consumer ignorance and ineffective regulations.

Continuous surveillance, regulatory cooperation, and public awareness are crucial to safeguarding patient health and maintaining medication quality.

Author: K.C. Aggarwal
The author is Former Deputy Drugs Controller, Delhi and Registered Advocate – Delhi 

Disclaimer: The views expressed are solely those of the author, and does not necessarily subscribe to them. shall not be responsible for any damage caused to any person / organization, directly or indirectly.

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