Home India Ministry of Health and Family Welfare Special condition under which the permission for import of d...
Date: 2021-09-13 Category: Not Applicable State: Union Government Country: India

Special condition under which the permission for import of drug with residual shelf life less than 60% is allowed

Issued by Ministry of Health and Family Welfare · Central Drugs Standard Control Organization

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Executive Summary & Key Takeaways

**Policy Summary:** This circular, issued by the Directorate General of Health Services, Central Drugs Standard Control Organization (CDSCO), extends the effective date of previous circulars (dated April 17, 2020, July 10, 2020, December 18, 2020, and April 13, 2021) regarding the special conditions under which permission is granted for the import of drugs with a residual shelf life of less than 60%. The extension is effective until April 30, 2022, or until further order, whichever is earlier. This extension considers representations received and the ongoing COVID-19 pandemic. The circular, reference number DCGIMisc2020 110, was issued on [Date Missing] by Dr. V. G. Somani, Drugs Controller General of India. The circular has been distributed to all port offices and zonal/subzonal offices of CDSCO, as well as the PS to JS R, Ministry of Health & Family Welfare. The issuing office is located at FDA Bhawan, Kotla Road, New Delhi-110002.

Key Entities Referenced

Directorate General of Health Services: A department of the Government of India responsible for public health. Central Drugs Standard Control Organization: National Regulatory Authority responsible for the regulation of pharmaceuticals and medical devices in India. DCGI Secretariat: The secretariat of the Drugs Controller General of India. FDA Bhawan, Kotla Road New Delhi: Location of DCGI Secretariat Covid19 pandemic: The global pandemic of COVID-19, which influenced the policy regarding drug imports. Dr. V. G. Somani: The Drugs Controller General of India. All Port offices of CDSCO: Offices of the Central Drugs Standard Control Organization located at ports of entry into India. Ministry of Health Family Welfare, Nirman Bhawan, New Delhi: The ministry responsible for health policy in India.
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File No. DCGI/Misc/2020 (110) Government of India Directorate General of Health Services Central Drugs Standard Control Organization (DCGI Secretariat) FDA Bhawan, Kotla Road New Delhi-110002 Dated: )3/q)2<2j Circular Subject: Special Condition under which the permission for import of drug with residual shelf life less than 60% is allowed. In light of representation received and Covid-19 pandemic situation, the effective date of the circular of even no. dated 17.04.2020,10.07.2020, 18.12.2020 and 13.04.2021 issued on subject cited above is extended up to 30.04.2022 or till further order whichever is earlier. ie. oa (Dr. V. G. Somani) Drugs Controller General (India) To: All Port offices of CDSCO. Copy to: All Zonal, Sub-zonal offices of CDSCO. Copy for information to: PS to JS (R), Ministry of Health & Family Welfare, Nirman Bhawan, New Delhi.

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