The Central Drugs Standard Control Organization (CDSCO) has issued a directive to all State and Union Territory Drug Controllers to review and ensure compliance with the NDCT Rules 2019 under the Drugs & Cosmetics Act 1940. This follows concerns about the manufacturing and marketing of unapproved Fixed Dose Combination (FDC) drugs without proper evaluation of safety and efficacy, posing significant public health risks.
The Central Drugs Standard Control Organization (CDSCO) has raised concerns regarding the manufacturing and marketing of unapproved Fixed Dose Combination (FDC) drugs in India.
These FDCs have been licensed without prior evaluation of their safety and efficacy, violating the NDCT Rules 2019 under the Drugs & Cosmetics Act 1940. This practice poses serious risks to public health, including adverse drug reactions and drug interactions.
The CDSCO has directed all State and Union Territory Drug Controllers to review their approval processes and ensure strict compliance with the Act and Rules.
A list of unapproved FDCs, which were previously licensed but later cancelled or voluntarily surrendered, has been provided for reference.
The CDSCO emphasizes the urgency and seriousness of this matter, urging authorities to prioritize public health and safety.