GOVERNMENT BANS 14 COMBINATIONS DRUGS

 

Latest Context

14 fixed-dose combination (FDC) medications that are often used to treat coughs, fevers, and infections have been banned by the Central Government of India, according to a gazette notification.

• An expert group tasked with evaluating the effectiveness of various medicine combinations made recommendations that led to the prohibition, which is effective right away.

What are FDC Medicines?

• FDCs are defined as products with one or more active ingredients used for a specific indication(s) by the Central Drugs Standard Control Organisation (CDSCO).

Causes for the Ban:

• The expert committee's and the Drugs Technical Advisory Board's recommendations were followed in enacting the prohibition.
• The committee came to the conclusion that the prohibited FDCs had no therapeutic value and may be harmful to people.

Challenges of FDC

High Risk of Side Effects:

• Multiple active ingredients combined in FDC medications can raise the likelihood of harmful drug interactions and increase sensitivity to side effects.
• Due to the fixed combination, it may be challenging to detect and treat certain patients' increased sensitivity to or allergic responses to one or more FDC medication ingredients.
• For example, a single FDC medicine including Paracetamol, Bromhexine, Phenylephrine, Chlorpheniramine, and Guaifenesin may raise the likelihood of adverse effects like sleepiness, dizziness, and high blood pressure.

Regulatory Challenges:

• Due to the difficulties in determining the safety and effectiveness of several active ingredients in a single formulation, FDC medications can be difficult to regulate.
• In comparison to single-component treatments, FDC pharmaceuticals require more stringent quality control and standardisation.

Overuse and Misuse:

• FDCs can contribute to medicine abuse and overuse. Patients may unwittingly ingest several active chemicals needlessly or in unsuitable combinations, which might have negative effects on their health.

Lack of Evidence-based Clinical Data:

• The effectiveness and safety characteristics of several FDC medications may have been supported by scant or insufficient clinical data.
• Concerns concerning the suitability and dependability of FDC medications for particular medical diseases may arise in the lack of solid scientific data.

Facts about Central Drugs Standard Control Organisation (CDSCO)

• For the purposes of carrying out duties entrusted to the Central Government under the Drugs and Cosmetics Act of 1940, the CDSCO serves as the Central Drug Authority.

Functions:

• Regulatory oversight of clinical studies, new medicine approval, and drug importation.
• various licences being approved by the Central Licence Approving Authority

Drug Controller General of India (DCGI)

• In India, the DCGI is in charge of approving licences for a certain category of pharmaceuticals, such as serum, IV fluids, vaccinnes, and blood and blood products.
• It came under the Ministry of Health and Family Welfare.

 

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