Harmful drugs and their regulation
- India’s apex medical regulatory body, Central Drugs Standard Control Organisation (CDSCO) & state authorities have opened investigations into cough syrups of Maiden Pharmaceuticals after WHO alert.
Background
- 66 children allegedly died in Gambia after consuming the medicines manufactured by the Haryana-based pharma company.
- According to WHO, its laboratory analysis of samples of these syrups revealed the presence of “unacceptable amounts of diethylene glycol and ethylene glycol”.
- Toxic to humans
- Can result in abdominal pain, vomiting, diarrhoea, inability to pass urine, headache, and altered mental state.
- Can also lead to acute kidney injury that can prove fatal in children.
Current issue and drug regulation in India
- Preliminary inquiries revealed that Maiden Pharmaceuticals manufactured the four cough syrups only for export to Gambia.
- No reason for relaxing regulatory scrutiny on them in the country of their manufacture.
- Under the Drugs and Cosmetic Act, 1940 the primary remit for monitoring the manufacture and sale of drugs is that of state authorities.
- Drugs that fail quality tests in one state continue to be sold in others.
- Reason: No binding mechanism that stipulates the nationwide recall of such medicines.
- CDSCO survey (2014-2016)
- ~ 5% of Indian drugs failed the quality test.
Conclusion
- The country’s pharma industry has largely been in denial over quality-related concerns expressed by national and international observers.
- Industry bodies need to do more, including setting up mechanisms for cooperation on quality control amongst firms.
- Adverse reports on Indian medicines could dent the country’s well-earned reputation of being the pharmacy of the Third World.
Prelims Takeaway
- Central Drugs Standard Control Organisation (CDSCO)
- Drugs and Cosmetic Act, 1940