This notice, issued by the Drugs Controller General of India on an unspecified date (reference number 79121 100), concerns the review of 294 Fixed Dose Combinations (FDCs) in accordance with directions from the Supreme Court of India. It follows previous communications dated December 12, 2018, April 12, 2019, and August 27, 2019. The notice grants manufacturers and stakeholders an extension until May 30, 2020, to submit data and information related to 49 FDCs and 17 FDCs. It further stipulates that failure to submit the required data by the deadline will result in a decision based on the information available to the office, in consideration of the Supreme Court's judgement. The notice was issued by Dr. V. G. Somani, Drugs Controller General of India, and copied to the PS to JSR, Ministry of Health and Family Welfare, all State/UT Drugs Controllers, CDSCO Zonal and Sub-Zonal offices, the Indian Drug Pharmaceuticals Association Forum, and the CDSCO website.
Key Entities Referenced
Supreme Court of India: The highest judicial body of India, mentioned in the context of a case regarding Fixed Dose Combinations (FDCs).
FDCs: Fixed Dose Combinations, the subject of the Supreme Court case and the notice.
Directorate: Refers to the issuing authority of the notice, likely a directorate within the CDSCO.
Dr. V. G. Somani: Drugs Controller General of India, the signatory of the notice.
Ministry of Health and Family Welfare: The government ministry to which the Drugs Controller General of India reports.
Nirman Bhawan, New Delhi: Location of Ministry of Health and Family Welfare office.
CDSCO: Central Drugs Standard Control Organization, likely the parent organization of the Directorate and Dr. V. G. Somani.
All StateUT Drugs Controllers: Refers to Drugs Controllers of all States and Union Territories of India
FDA Bhawan, Kotla road,
New Delhi
Dated: 79121 100
Notice
Subject:- Consideration of the directions of Hon’ble Supreme Court of India in
the case of 294 FDCs-regarding.
This is in continuation to this Directorate letters and notice of even number
dated 12.12.2018, 12.04.2019 and 27.08.2019. In view of representations received in
the matter for extension of time for submission, it has been considered that
manufacturers/stakeholders may submit the information/data w.r.t 49 FDCs as well
as 17 FDCs by 30.05.2020. Further, it may be informed that in case of failure to
submit the data/information by 30.05.2020, the decision will be made on basis of
information available before this office in light of the judgement of the Hon’ble
Supreme Court.
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(Dr. V. G. Somani)
Drugs Controller General (India)
Copy to:-
1. PS to JS(R), Ministry of Health and family Welfare, Nirman Bhawan, New
Delhi
OF All State/UT Drugs Controllers
CDSCO Zonal and Sub-Zonal offices
Indian Drug/Pharmaceuticals Association Forum
Web site of CDSCO
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