PYQ Relevance:[UPSC 2014] While doctor’s prescription is a must to get drugs, many people buy them over the counter without prescription. Discuss the contributors to the emergence of drug-resistant diseases in India? What are the available mechanisms for monitoring and control? Critically discuss the various issues involved. Linkage: The wider discussion about checking drug quality and the difficulties in doing so is very important to stop unsafe drugs, like cancer medicines, from reaching patients. This question is relevant because it looks into how drugs are monitored and the problems faced in keeping them safe. |
Mentor’s Comment: A major global investigation by the Bureau of Investigative Journalism, reported by The Hindu, has revealed that poor-quality and unsafe cancer drugs, many of them from India, have been sent to over 100 countries. These faulty medicines have caused serious health problems, including the deaths of children in Yemen, Colombia, and Saudi Arabia. The report highlights serious regulatory weaknesses in low- and middle-income countries, and shows that the WHO’s warning system only acts after harm is done. This is especially worrying because it affects cancer patients, one of the most vulnerable groups.
Today’s editorial talks about the poor-quality and unsafe cancer drugs. This topic is important for GS Paper II (Health & Governance) in the UPSC mains exam.
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Let’s learn!
Why in the News?
Recently, a major global investigation by the Bureau of Investigative Journalism, reported by The Hindu, found that low-quality and unsafe cancer drugs.
| The Bureau of Investigative Journalism (TBIJ) is an independent, non-profit news organization based in the United Kingdom. It was founded in 2010 with the aim of producing in-depth, public interest journalism that holds power to account. |
What are the major quality risks in cancer drug manufacturing and distribution?
- Contamination during manufacturing: Risk of bacterial contamination from improper disinfection, untrained staff, or poor cleanroom discipline. Even small errors like air movement or touching non-sterile items can spread bacteria.
- Poor quality control: Failure to test raw ingredients, clean equipment, or filter water properly can make life-saving drugs toxic or lethal.
- Distribution chain vulnerabilities: Changes in temperature, humidity, or poor handling during transport can degrade drug quality. The complex journey from raw materials to patient requires strict monitoring at each stage.
Why are poorer countries more exposed to unsafe cancer drugs?
- Weak Regulatory Frameworks: Many low-income countries lack strong drug regulatory authorities and legal frameworks to ensure medicine quality. Eg: In Nepal, there is no effective testing or monitoring of imported drugs due to limited institutional capacity.
- Lack of Testing Infrastructure and Experts: These countries often do not have certified laboratories or trained personnel to check for contamination, dosage accuracy, or manufacturing faults. Eg: Nepal and similar nations lack verified experts or facilities to evaluate drug safety before market entry.
- Inability to Track Drugs Through Supply Chains: Poor digital and logistical infrastructure leads to ineffective drug tracking, making it easier for substandard or counterfeit drugs to infiltrate the system. Eg: In countries with porous borders and no tracking systems, drugs can be repackaged or sold without oversight.
- Corruption and Weak Enforcement: Corruption in customs, licensing, and procurement processes allows unverified drugs to enter public hospitals and pharmacies unchecked. Eg: In some regions, low-cost cancer drugs without proper quality assurance enter due to bribery and lack of regulatory follow-up.
- Dependence on Low-Cost Imports Without Verification: Due to budget constraints, poorer nations rely heavily on cheap generic imports without adequate checks for Good Manufacturing Practices (GMP) or source validation. Eg: In Yemen (2022), at least 10 children died after receiving contaminated methotrexate, highlighting the consequences of poor import verification.
How does WHO ensure drug safety?
- Rapid Alert System for Dangerous Drugs: WHO operates a global Rapid Alert System to identify and inform member countries about harmful or substandard medicines. Eg: If contaminated cancer drugs are reported in one country, WHO sends out a global alert so others can take preventive action.
- Global Benchmarking and Certification Tools: WHO uses tools like the Global Benchmarking Tool to assess national regulatory systems and ranks them from Level 1 (weakest) to Level 4 (strongest). Eg: In 2023, 70% of member countries were rated at Level 1 or 2, showing limited capacity to regulate drug safety.
- Prequalification, GMP, and CoPP Systems: WHO runs prequalification programs to approve safe drugs, ingredients, and labs; enforces Good Manufacturing Practices (GMP); and issues the Certificate of Pharmaceutical Product (CoPP) to confirm quality of exported drugs. Eg: A CoPP acts like a passport for medicines, verifying they are approved and safely made in the exporting country.
What are the steps taken by the Indian Government?
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Way forward:
- Establish a National Drug Quality Monitoring Authority: Create a centralised, independent regulatory body to oversee real-time quality audits, enforce uniform GMP standards, and ensure accountability across manufacturing units.
- Invest in Testing Infrastructure and Skilled Workforce: Strengthen drug testing laboratories, equip them with modern technology, and train qualified professionals to carry out rigorous inspections and batch verifications at every stage.
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