Answer

Introduction

India, hailed as the “Pharmacy of the World”, meets 60% of global vaccine demand, supplies 40% of generics to the US and 25% to the UK, with pharma exports crossing $25 billion in 2023. Yet, this global trust is threatened by the rising menace of Substandard and Falsified (SF) drugs.

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Negative Impact of Substandard and Falsified (SF) Drugs in India

• Public Health Crisis: SF drugs cause direct harm, failed treatment, and even deaths.
  Eg: Contaminated cough syrups linked to deaths of children in Gambia, Uzbekistan, and Cameroon.
• Erosion of Trust in Healthcare: Patients lose faith in doctors, pharmacies, and the health system, which is difficult to rebuild.
  Eg: WHO estimates 1 in 10 medical products in low- and middle-income countries is falsified.
• Aggravation of Antimicrobial Resistance (AMR): Ineffective or spurious drugs accelerate drug resistance, making routine infections harder to treat.
  Eg: Ineffective antibiotics worsen the global AMR crisis.
• Undermining National Health Schemes: Fake drugs dilute the impact of initiatives like Ayushman Bharat and Jan Aushadhi.
  Eg: Threatens universal healthcare goals for over 500 million Indians.
• Global Credibility at Risk: Damages India’s status as “Pharmacy of the World” and threatens exports worth $25 billion annually.
  Eg: 200+ countries import Indian medicines; trust now shaken by repeated safety lapses.

Challenges in Reducing the Spread of SF Drugs

• Weak Enforcement & Surveillance: Regulatory guidelines exist but are inconsistently applied across states.
• Supply Chain Opacity: Lack of real-time tracking allows infiltration of counterfeit drugs into legitimate pharmacies.
  Eg: Even urban pharmacies face risks due to poor traceability mechanisms.
• Limited Public Awareness: Consumers rarely know about verification tools like QR codes.
  Eg: Rural India most vulnerable to unlicensed pharmacies and fake medicines.
• Fragmented Institutional Capacity: Poor coordination between central and state drug authorities delays effective crackdowns.
  Eg: CRISIL study estimates ~20% of Indian medicines could be counterfeit or substandard.
• Profit-driven Criminal Networks: Counterfeit drug trade is lucrative and hard to eradicate.
  Eg: Market size estimated at over ₹20,000 crore; penalties often treated as minor technical violations.
  

Comprehensive Multi-Stakeholder Strategy

• Regulatory Strengthening: Treat SF drugs as criminal acts threatening human life, not just technical violations; ensure stricter penalties.
  Eg: Union health ministry moves like QR codes and lab upgrades are first steps.
• Industry Responsibility: Pharma companies must adopt tamper-proof packaging, serialization, and supply chain tracking.
• Public Awareness & Access to Tools: Nationwide campaigns to educate people on verifying medicines via QR codes and track-and-trace systems.
• Inter-Agency Collaboration: Stronger coordination among state drug controllers, health ministry, and law enforcement to ensure uniform compliance.
  Eg: Seizure of illegal consignments across states shows the need for integrated efforts.
• Retailer & Pharmacist Vigilance: As gatekeepers, they must verify suppliers and reject uncertified stock.
  Eg: Pharmacies can stop counterfeit drugs from reaching patients if vigilance is enforced.

Conclusion

Counterfeit medicines endanger lives, erode trust, and risk India’s pharma leadership. To preserve its image as a reliable global health partner, India must ensure that every “Made in India” drug guarantees safety, efficacy, and integrity.

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