In a shocking move that’s sent ripples through the pharmaceutical industry, the Indian Government has pulled the plug on 14 fixed-dose combinations (FDC) drugs. Claiming a lack of therapeutic justification, this unexpected ban takes into account the potential harm to public health.
Fixed dose combinations, or FDCs, amalgamate two or more medicines in a predefined proportion. Some FDCs, which are novel and hitherto uncombined, can be classified as new drugs. The use of FDCs, while often advantageous for patient compliance, has been under scrutiny due to concerns about their safety and effectiveness.
The Health Ministry’s Verdict – Is Your Favourite Drug on the List?
According to insider sources in the Union Health Ministry, these now-prohibited mixed dose combinations have been deemed detrimental to public health. The spotlight on these FDCs has become intense following the 59th report from the Parliamentary Standing Committee on the operations of the Central Drugs Standard Control Organisation (CDSCO).
Critics have long voiced concerns about state licensing authorities granting manufacturing licenses for FDCs without prior clearance from the CDSCO. This unregulated process has led to a market flooded with FDCs that have not undergone rigorous testing for safety and effectiveness, placing patients at a significant risk.
The CDSCO’s Action Plan – Safety and Efficacy Take Centre Stage!
Following this concerning disclosure, the CDSCO has encouraged drug controllers from every state and Union Territory to require manufacturers to establish the safety and effectiveness of their FDCs within a period of 18 months. Non-compliance could potentially lead to these FDCs being evaluated for prohibition.
Among the blacklisted drugs are popular names such as Paracetamol combined with Nimesulide, Phenylephrine, and Caffeine; and Amoxicillin coupled with Bromhexine. A full list is available on the CDSCO’s official website.
This timely intervention by the government and the health ministry offers much-needed reassurance to the public about their commitment to safeguarding public health. Although it may cause a temporary disruption in the medical field, it is a vital step toward fostering a safer pharmaceutical landscape in India.
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