• WHO on 29.09.2022 informed DCGI, the National Drug Regulator of India, that WHO it is currently providing technical assistance and advice to Gambia, where children have died and where a contributing factor, is suspected to be the use of medicines which may have been contaminated with Diethylene glycol or Ethylene glycol (in some of the samples it was claimed to have been confirmed by further analysis conducted by WHO).
• CDSCO took up the matter immediately with Haryana State Regulatory Authority, under whose jurisdiction the drug manufacturing unit of M/s Maiden Pharmaceutical Limited, Sonepat is located. Further, a detailed investigation was launched to ascertain the facts/ details in the matter in collaboration with State Drugs Controller, Haryana.
• From the preliminary enquiry of CDSCO, it has been made out that M/s Maiden Pharmaceutical Limited, Sonepat, Haryana is a manufacturer licensed by the State Drug Controller for the products Promethazine Oral Solution BP, Kofexnalin Baby Cough Syrup, MaKoff Baby Cough Syrup and MaGrip n Cold Syrup under reference, and holds manufacturing permission for these products for export only. The company has manufactured and exported these products only to Gambia.
• WHO said that Diethylene Glycol (DEG) or ethylene glycol is toxic to humans when consumed and can prove fatal. It can cause kidney and neurological toxicity and has been associated with several cases of mass poisoning when consumed via drugs.
• According to a paper in the National Library of Medicine under the National Center for Biotechnology Information, the chemical is used in antifreeze, brake fluids, cosmetics, and lubricants and causes renal insufficiency and failure and could even lead to coma and death.
• The chemical tastes sweet and is water-insoluble. The toxic effects of the chemical include abdominal pain, vomiting, diarrhoea, inability to pass urine, headache, altered mental state, and acute kidney injury. The NIH paper pointed to at least 10 mass poisoning events that have taken place due to the toxic chemical in the past.
• Diethylene glycol and ethylene glycol are used in antifreeze and brake fluids and other industrial applications but also as a cheaper alternative in some pharmaceutical products to glycerine, a solvent or thickening agent in many cough syrups.
• Diethylene glycol is used as an illegal adulterant in medications and can result in renal and neurological toxicity. Because of its toxicity, it is not allowed in food or drugs. But because of its solubility, some drug makers have inappropriately substituted it for nontoxic ingredients such as glycerine in pharmaceuticals such as cough syrups and acetaminophen.
• It can cause abdominal pain, vomiting, diarrhoea, headache and severe renal injury.
• Toxic effects of Diethylene glycol/Ethylene glycol can include abdominal pain, vomiting, diarrhoea, bladder dysfunction, headache, altered mental state, and acute kidney injury, which may lead to death.
• Diethylene glycol/Ethylene glycol looks like Propylene glycol. Propylene glycol is generally considered safe and non-toxic.

Propylene glycol

• Propylene glycol is widely used as a solvent in drug manufacturing. This means it dissolves other substances (usually solid) without changing their fundamental structure or composition.
• The use of propylene glycol in foods is common and generally considered to be safe. When consumed, propylene glycol breaks down in the body quite quickly —within 48 hours—and is changed to an energy source.
• Unlike similar substances like ethylene glycol, propylene glycol does not form harmful crystals as it’s being broken down in the body. Amounts not broken down and metabolized are passed out of the body in urine.

Some of the ways propylene glycol is used in food include:

1. As an anticaking agent, helping to prevent lumps from forming in food
2. As a solvent in food flavorings, helping to dissolve and mix ingredients in them
3. As a dough strengthener
4. To improve flavors in food
5. As a preservative, its antimicrobial properties help to kill or prevent the growth of microorganisms like bacteria and mold
6. As a food thickener
7. To help retain moisture in food

• Propylene glycol is safe for consumption, and the FDA approves its use in food at certain concentrations. It may form up to 97% of the contents of seasonings and flavorings, 24% of confections and frosting, and 5% of alcoholic beverages and nuts/nut products.
• The maximum concentrations of propylene glycol are 2.5% for dairy products and 2% for all other food products.
• Propylene glycol is widely used as a solvent in drug manufacturing. This means it dissolves other substances (usually solid) without changing their fundamental structure or composition.

Fish Samples Test Positive for Formalin

• Formalin is the one of the preservatives used to preserve biological specimens. Formalin is used for the preservation of biological specimen. Formalin is 30-40% of water in Formaldehyde or methanol.
• Formalin is a colourless strong-smelling chemical substance usually used in the industry of textiles, plastics, papers, paint, construction, and well known to preserve the human corpse. It is derived from formaldehyde gas dissolved in water.
• Formalin or formaldehyde is sprayed on the fish or injected into the fish or the fish is dipped into the solution. This helps keep the fish fresh for a longer time.
• Formalin causes irritation in the eyes, throat, skin, and stomach. In the long run, continued exposure causes harm to the kidneys, liver and can even cause cancers.

Asbetsos in Johnson & Johnson that its Baby Powder (talcum powder) 

• Talc or talcum is a naturally occurring clay mineral mined from the earth which is used in baby powder because of its ability to absorb moisture. Talc is the softest known mineral and is mined from underground deposits. Chemically, it is hydrous magnesium silicate.
• Mines that collect talc also contain asbestos that has been linked to health risks like mesothelioma and asbestosis.
• In 2013, the Maharashtra medicines regulator revoked the J&J  company’s license after discovering that the plant producing the powder used ethylene oxide, a carcinogen.

Central Drugs Standard Control Organization:

1. The Central Drugs Standard Control Organisation (CDSCO) under Directorate General of Health Services, Ministry of Health & Family Welfare, is the National Regulatory Authority (NRA) of India.
2. Under the Drugs and Cosmetics Act, CDSCO is responsible for approval of Drugs, Conduct of Clinical Trials, laying down the standards for Drugs, control over the quality of imported Drugs in the country.
3. It also does the coordination of the activities of State Drug Control Organizations by providing expert advice with a view of bring about the uniformity in the enforcement of the Drugs and Cosmetics Act.
4. Further CDSCO along with state regulators, is jointly responsible for grant of licenses of certain specialized categories of critical Drugs such as blood and blood products, I. V. Fluids, Vaccine and Sera.
5. Within the CDSCO, the Drug Controller General of India (DCGI) regulates pharmaceutical and medical devices, under Ministry of Health and Family Welfare.
6. The DCGI is advised by the Drug Technical Advisory Board (DTAB) and the Drug Consultative Committee (DCC).