Fixed-Dose Combination (FDC) Medicines

Why in news?

• The Central Government of India has issued a gazette notification banning 14 fixed-dose combination (FDC) medicines commonly used to treat cough, fever, and infections.
•  The ban, which takes immediate effect, follows recommendations from an expert committee appointed to assess the efficacy of these drug combinations.

 Reason for the Ban:

• The ban follows the recommendations of the expert committee and the Drugs Technical Advisory Board.
• The committee concluded that the banned FDCs lack therapeutic relevance and may pose risks to human beings.

About Central Drugs Standard Control Organisation (CDSCO):

• The CDSCO is the Central Drug Authority for discharging functions assigned to the Central Government under the Drugs and Cosmetics Act 1940.
• It comes under the Ministry of Health & Family Welfare.

Major Functions of CDSCO under Drugs and Cosmetics Act:

• Approval of new drugs
• Conduct of clinical trials
• Laying down the standards for drugs
• Control over the quality of imported drugs in the country
• Coordination of the activities of State Drug Control Organizations by providing expert advice with a view to bring about the uniformity in the enforcement of the Drugs and Cosmetics Act.
• CDSCO along with state regulators, is also 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.

PRACTICE QUESTION

Which of the following are the functions of Central Drugs Standard Control Organisation?

1. Approval of new drugs

2. Conduct of clinical trials

3. Ensuing quality of imported drugs

How many of the statements given above are correct?

(a) Only one

(b) Only two

(c) All three

(d) None

Answer