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Picture Courtesy: Indian Express

Context:

Recent deaths of children in Madhya Pradesh and Rajasthan linked to contaminated cough syrups have caused widespread concern among parents.

Current Status:

• 14 children died in Madhya Pradesh and Rajasthan after consuming Coldrif cough syrup, which was found to be contaminated with high levels of diethylene glycol (DEG), a toxic industrial solvent.
• World Health Organization (WHO) issued an alert for another Indian-made cough syrup, Cold Out, which was also found to contain excessive levels of DEG and ethylene glycol (EG). Previous fatal incidents involving contaminated syrups made by Indian companies in 2022 and 2023 harmed children in Gambia and Uzbekistan, as well as in India in 2020 and 1998.

Risks of contaminated medicine:

• Presence of Toxic Contaminants: Some low-quality syrups may be contaminated with diethylene glycol or ethylene glycol—toxic industrial solvents that can lead to acute kidney damage. 

• Unsafe Chemical Combinations: Incompatible or unscientific combinations of ingredients that can interact negatively within the body.  

• Lack of Therapeutic Effectiveness: Substandard syrups may not effectively treat the underlying cause of the cough. 

• Harmful Effects on Children: Some cough syrups, especially those containing codeine, pose additional risks to children. 

Challenges in eradicating contaminated medicines in India:

• Weak Oversight and Corruption: Many low- and middle-income countries, including India, struggle with weak regulatory enforcement. India is ranked 96th out of 180 countries in the 2024 Corruption Perceptions Index (CPI), published by Transparency International.  

• India’s pharmaceutical laws, primarily under the Drugs and Cosmetics Act of 1940, are outdated and ill-equipped to tackle modern threats such as online drug sales. 

• Authorities like the Central Drugs Standard Control Organization (CDSCO) face shortages of trained inspectors, testing labs, and modern equipment. 

• Legal proceedings related to counterfeit drug offenses are slow, often taking years to resolve  

• Counterfeit medicines often closely resemble genuine products, making them difficult to detect 

• Rapid rise of online pharmacies and the use of social media for drug sales allow counterfeit medicines to reach consumers quickly and widely. 

• Many consumers are unaware of the dangers posed by substandard or fake medicines. 

• Scandals involving contaminated medicines, like recent cough syrup-related deaths, undermine public trust in both the healthcare system and government regulatory bodies. 

Regulatory Mechanisms in India:

• The Drugs and Cosmetics Act, 1940: This Act, along with the Drugs and Cosmetics Rules, 1945, governs the manufacture, sale, and distribution of drugs in India. Key provisions include:

1. Mandatory licensing for drug manufacturers
2. Requirements to prove safety and efficacy
3. Compliance with Good Manufacturing Practices (GMP)
4. Guidelines for both modern and traditional medicines (e.g., Ayurveda, Unani, Siddha)

• Central Drugs Standard Control Organisation (CDSCO): The CDSCO serves as the national regulatory authority for pharmaceuticals. It is responsible for:

• Regulating drug imports and approving new drugs
• Supervising clinical trials
• Granting central licenses for specific drug categories as the Central Licensing Authority 

Way Forward:

• Introduce stricter penalties for the manufacture and sale of counterfeit drugs to act as a strong deterrent.

• Increase the number of trained drug inspectors to expand field surveillance. 

• Launch nationwide awareness campaigns to educate consumers, pharmacists, and healthcare providers on identifying counterfeit medicines. 

• Work closely with international agencies such as WHO, INTERPOL, and UNODC to tackle cross-border trafficking of counterfeit drugs. 

• Adopt serialization and track-and-trace systems to monitor drug movement across the supply chain in real-time. 

Source: Indian Express and The BMJ