Cough syrup samples fail quality tests: central drug regulator’s report
- July 24, 2024
- Posted by: OptimizeIAS Team
- Category: DPN Topics
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Cough syrup samples fail quality tests: central drug regulator’s report
Subject: Sci
Sec: Health
Context:
The CDSCO report classified these batches as “not of standard quality” (NSQ) due to issues with diethylene glycol (DEG), ethylene glycol (EG), assay, microbial growth, pH, and volume. Some of these samples contained the same toxins found in cough syrups linked to the deaths of children in Gambia, Uzbekistan, and Cameroon.
CDSCO:
- CDSCO is the Central Drug Authority for discharging functions assigned to the Central Government under the Drugs and Cosmetics Act, 1940.
- Major functions of CDSCO:
- Regulatory control over the import of drugs
- Approval of new drugs and clinical trials
- Approval of certain licences as Central License Approving Authority.
- Ministry: Ministry of Health & Family Welfare
- Statutory body
- Major functions of CDSCO:
– CDSCO is a statutory body established under the Drugs and Cosmetics Act, 1940 and is responsible for regulating the manufacture, sale, and distribution of drugs in India.
Ethylene Glycol and Diethylene Glycol:
- Toxic alcohols with a slightly sweet taste.
- Contamination of cough syrups with these glycols can occur, especially in products containing paracetamol.
- Paracetamol in cough syrups is good and safe for children with infections. It is a pain killer which is good at reducing fever.
- Diethylene glycol and ethylene glycol are adulterants that are sometimes illegally used as solvents in liquid drugs as an alternative to non-toxic solvents such as glycerine or propylene glycol to cut costs.
- Symptoms of contamination may not appear until large amounts have been consumed.
- Its use in antifreeze, ethylene glycol is used as an ingredient in hydraulic fluids, printing inks, and paint solvents and diethylene glycol is used in the commercial preparation of antifreeze, brake fluid, cigarettes, and some dyes.
What are the Risks Associated with Substandard Cough Syrups?
- Presence of Harmful Substances:
- Substandard cough syrups may contain high levels of diethylene glycol and ethylene glycol, which can damage the kidneys and pose a serious health risk.
- Unscientific Combinations:
- Unscientific combinations of chemical components that can interact with each other and potentially cause harm.
- Lack of Therapeutic Relevance:
- Adverse Effects on Children:
- Certain cough syrups containing codeine can be addictive and even lethal if given to children. Drowsiness, dizziness, blurred vision, nausea, and difficulty in verbalizing can also be experienced, indicating potential harm.
Regulations in India:
Drugs and Cosmetics Act, 1940:
- The Drugs and Cosmetics Act, 1940 and Rules 1945 have entrusted various responsibilities to central and state regulators for regulation of drugs and cosmetics.
- It provides the regulatory guidelines for issuing licenses to manufacture Ayurvedic, Siddha, Unani medicines.
- It is mandatory for the manufacturers to adhere to the prescribed requirements for licensing of manufacturing units & medicines including proof of safety & effectiveness, compliance with the Good Manufacturing Practices (GMP).