Why is it in the News?

The Central Drugs Standard Control Organisation (CDSCO) has prohibited the use of anti-cold fixed drug combinations in children below four years of age.

What are Fixed Dose Combination (FDC) Drugs?

• Fixed-dose combination (FDC) drugs, also referred to as combination products, embody a formulation containing two or more active drugs within a single dosage form.
• The United States Food and Drug Administration (FDA) defines a combination product as a composition involving a drug and a device, a biological product and a device, or a combination of a drug, device, and biological product.
• While the conventional approach favours formulating drugs as single compounds, the acceptance of fixed-ratio combination products hinges on two key criteria:
• Dosage Requirements: Each ingredient in the combination must meet the dosage criteria tailored to a specific population group.
• Proven Advantages: The combination should demonstrate a clear advantage over administering individual compounds separately in terms of therapeutic effect, safety, or compliance.
• FDCs have witnessed significant popularity in the Indian pharmaceutical market, experiencing notable growth in recent years.

About the Central Drugs Standard Control Organization (CDSCO):

• The Central Drugs Standard Control Organization (CDSCO) serves as the National Regulatory Authority (NRA) in India, overseeing the medical devices industry per the Drugs & Cosmetics Rules.
• Positioned under the Ministry of Health & Family Welfare, it is led by the Drugs Controller General of India (DCGI) with its headquarters situated in New Delhi.
• Operationalizing under the provisions of the Drugs and Cosmetics Act, CDSCO is entrusted with several crucial responsibilities, including the approval of new drugs, the facilitation of clinical trials, the establishment of standards for drugs, ensuring control over the quality of imported drugs, and coordination of activities among State Drug Control Organizations.
• One of its significant roles lies in collaboration with state regulators for granting licenses related to specialized categories of critical drugs.
• These encompass vital medical components such as blood and blood products, I.V. fluids, vaccines, and sera.
• The CDSCO plays a pivotal role in upholding standards, ensuring quality, and fostering coordination across the regulatory landscape for the benefit of public health in India.