24th February 2025 (12 Topics)

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Banned Export of Tapentadol and Carisoprodol

Context

The Maharashtra FDA (Food and Drug Administration) issued a stop production order and instructed the withdrawal of export NoCs (No Objection Certificates) and manufacturing licenses for any combination of Tapentadol and Carisoprodol.

Key Drugs Involved:

Tapentadol: It is approved individually in India in 50 mg, 75 mg, and 100 mg tablet forms, as well as in extended-release tablets (100 mg, 150 mg, 200 mg).
- It is used primarily for pain management.
Carisoprodol: It is approved individually in India for muscle spasms.

While these two drugs are approved separately in India, their combination is not approved by the Central Drugs Standard Control Organisation (CDSCO), India's drug regulatory authority.

Central Drugs Standard Control Organisation (CDSCO)

The Central Drugs Standard Control Organisation (CDSCO) is the National Regulatory Authority (NRA) of India.
It operates under the Directorate General of Health Services, which is part of the Ministry of Health & Family Welfare, Government of India.
Legal Framework: CDSCO operates under the Drugs & Cosmetics Act, 1940, and its associated Rules of 1945. This legal framework assigns CDSCO and state regulators the responsibility for regulating drugs and cosmetics in India, ensuring their safety, efficacy, and quality.
Key Responsibilities of CDSCO:
- Approval of New Drugs
- Clinical Trials
- Setting Standards for Drugs
- Regulation of Imported Drugs

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GS Analyst: Daily Current Affairs

24th February 2025 (12 Topics)

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Banned Export of Tapentadol and Carisoprodol

Key Drugs Involved:

Central Drugs Standard Control Organisation (CDSCO)

Still Have Questions?

GS Analyst: Daily Current Affairs

Banned Export of Tapentadol and Carisoprodol

Key Drugs Involved:

Central Drugs Standard Control Organisation (CDSCO)

Still Have Questions?

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