The Central Drugs Standard Control Organization (CDSCO) has issued a communication (CDSCOIT201822) dated Qg. o 9o4 uv or, addressing all State Drugs Controllers regarding the streamlining of the approval process for manufacturing licenses of Blood Bags and Blood Components under the provisions of Drugs and Cosmetics Rules, 1945. This initiative aims to standardize and facilitate the grant of manufacturing licenses across all states and union territories.
Reference is made to previous directives, including notification number GSR 1(E) dated 03.01.1984 and the Drugs and Cosmetics Rules, 1945. A detailed, step-by-step procedure for applicants is available on the CDSCO website (CDSCO.gov.in) under Drugs and Cosmetics, then Important Links.
In case of any difficulty in accessing or understanding the guidelines, clarification can be sought from the Drugs Controller General of India at CDSCO headquarters.
Dr. S. Eswara Reddy, Drugs Controller General of India, is the contact person.
Copies of this communication have been forwarded to:
1. All Pharma Associations (IDMA, IPA, FOPECI, IPI, FICCI, OPPI, Others)
2. PPS to AS DG, MoHFW
3. PPS to JSR, MoHFW
Key Entities Referenced
Central Drugs Standard Control Organization: A national regulatory body for pharmaceuticals and medical devices under the Directorate General of Health Services, Ministry of Health and Family Welfare, Government of India.
State Drugs Controllers: The regulatory authorities responsible for drug control within individual states of India.
Drugs and Cosmetics Act, 1945: An Act of the Parliament of India which regulates the import, manufacture, distribution and sale of drugs and cosmetics.
Directorate General of Health Services: A directorate under the Ministry of Health and Family Welfare, Government of India.
New Delhi: Capital of India
Dr. S. Eswara Reddy: Drugs Controller General of India
Ministry of Health Family Welfare: A ministry of the Government of India.
IDMAIPAFOPECIPIFICCIOPPIOthers: A list of Pharma Associations
CDSCO/IT/2018-(22)
Government of India
Ministry of Health & Family Welfare
Directorate General of Health Services
Central Drugs Standard Control Organization
FDA Bhawan, New Delhi
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Copy to:
1. All Pharma Associations (IDMA/IPA/FOPE/CIPI/FICCI/OPPI/Others)
2. PPS to AS & DG, MoHFW
3. PPS to JS(R), MoHFW