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

**Summary:** This circular, issued by the Directorate General of Health Services, Central Drugs Standard Control Organization (CDSCO), extends the special condition under which permission for the import of drugs with a residual shelf life of less than 60 is allowed. This extension, initially established in circulars dated April 17, 2020, July 10, 2020, December 18, 2020, and April 13, 2021, is now valid until April 30, 2022, or until further notice, whichever occurs first. The extension is a response to representations received and the ongoing COVID-19 pandemic. The circular was issued by Dr. V. G. Somani, Drugs Controller General of India, on [Date: 3q22j - Assuming this refers to March 2022 for the summary]. Copies of the circular have been distributed to all port offices and zonal/subzonal offices of the CDSCO, as well as the PS to JS (R), Ministry of Health & Family Welfare. The File No. for this circular is DCGIMisc2020 110.

Key Entities Referenced

Dr. V. G. Somani: Drugs Controller General of India at the time of the circular. Directorate General of Health Services: A department under the Government of India responsible for public health. Central Drugs Standard Control Organization: National Regulatory Authority of India, under the Ministry of Health & Family Welfare, responsible for regulation of pharmaceuticals and medical devices. DCGI Secretariat: The office of the Drugs Controller General of India. FDA Bhawan, Kotla Road New Delhi: Location of DCGI office in Delhi. Covid19 pandemic: The global pandemic of COVID-19 that began in 2020. Ministry of Health Family Welfare: A ministry of the Government of India. Nirman Bhawan, New Delhi: Location of the Ministry of Health and Family Welfare office in Delhi.
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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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