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Cocktail Drugs
Context:
According to a gazette notification issued under Section 26A of the Drugs and Cosmetics Act of 1940, the Union Health Ministry has immediately banned 156 “irrational” fixed-dose combination (FDC) medicines or cocktail drugs, including commonly used antibiotics, painkillers, and multivitamins for treating fever, cough, and infections.
More on news:
- Among the notable pain-relief medicines on the list is the combination of Aceclofenac 50 mg and Paracetamol 125 mg tablets.
- The Central government is satisfied that the use of this Fixed Dose Combination drug is likely to pose risks to human health, while safer alternatives are available.
- Other fixed-dose combination drugs on the list include Mefenamic Acid + Paracetamol injection, Cetirizine HCl + Paracetamol + Phenylephrine HCl, Levocetirizine + Phenylephrine HCl + Paracetamol, Paracetamol + Chlorphenamine Maleate + Phenylpropanolamine, and Camylofin Dihydrochloride 25 mg + Paracetamol 300 mg.
Drugs and Cosmetics Act, 1940
The Drugs and Cosmetics Act, 1940 is a significant piece of legislation in India that regulates the import, manufacture, distribution, and sale of drugs and cosmetics. The primary objective of the Act is to ensure that drugs and cosmetics sold in India are safe, effective, and conform to quality standards.
Key Features:
- Scope and Coverage: The Act applies to all drugs and cosmetics manufactured, imported, or sold in India.
- Definitions: The Act defines “drugs” broadly, including substances used for diagnosis, treatment, mitigation, or prevention of diseases in humans or animals. “Cosmetics” are defined as products intended for beautifying or cleansing the human body, excluding soaps.
- Standards of Quality: Section 16 establishes standards for the quality of drugs and cosmetics, ensuring that they meet specific safety and efficacy criteria.
- Regulatory Authority: The Act empowers the Central Drugs Standard Control Organization (CDSCO) to oversee the enforcement of its provisions. This includes the authority to issue licences for manufacturing and selling drugs and cosmetics.
About Cocktail Drugs
- FDCs also known as “cocktail” drugs, are medications that combine more than one active pharmaceutical ingredient (API) in a single pill.
- Active Pharmaceutical Ingredients (APIs) are the chemical compounds that give a drug its therapeutic effect. They are the core components of medications, responsible for the desired pharmacological action.
- These are designed to treat multiple symptoms or conditions simultaneously by combining various APIs, such as painkillers, antipyretics (fever reducers), anti-inflammatory agents, and sometimes antibiotics.
- Although these combinations aim to provide convenience and comprehensive treatment, they can pose significant risks.
- Many FDCs lack randomised controlled trials to evaluate their safety and efficacy, making their prescription and use irrational.
- For example, combining two analgesics (painkillers) or a painkiller with an antihistamine is considered an irrational FDC.
- When antibiotics are included in these combinations, it can contribute to the development of antibiotic resistance, a major global health threat.
