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Drug Combination Banned by Central Government


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Importer & Manufacturer   |   CDSCO
12 August, 2024
Enforcement Date: 12 August, 2024
Drug Combination Banned by Central Government

The Central Government has banned the manufacture, sale, and distribution of the fixed dose combination drug Etodolac + Paracetamol with immediate effect. This decision follows a recommendation from the Drugs Technical Advisory Board (DTAB) and is based on the finding that the drug has no therapeutic justification and may pose risks to human health.


Central Government Bans Etodolac + Paracetamol Combination The Central Government has banned the manufacture, sale, and distribution of the fixed dose combination drug Etodolac + Paracetamol with immediate effect. This decision comes after a recommendation from the Drugs Technical Advisory Board (DTAB) and is based on the finding that the drug has no therapeutic justification and may pose risks to human health. Key points:

  • Ban Effective Immediately: The ban was implemented on August 12, 2024.
  • DTAB Recommendation: The DTAB recommended the ban after reviewing the drug's safety and efficacy.
  • Lack of Therapeutic Justification: The DTAB found that the combination of Etodolac + Paracetamol has no proven therapeutic benefits.
  • Potential Risks: The drug may pose risks to human health.
This decision is a significant step in ensuring the safety and efficacy of drugs available in India. The Central Government's action highlights its commitment to protecting public health.

Applicable For: Importer & Manufacturer
Reference Number: CG-DL-E-13082024-256319 Notification Link

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