rule C
Quantity of the manufactured goods transferred.
The Drugs and Cosmetics Act and RulesPart VII Part VII
(1) Manufacture :
The manufacture of blood products shall be conducted under the active direction and personal supervision of competent technical staff, consisting of at least one person who shall be a whole time employee, with one year practical experience in the manufacture of blood products / plasma fractionation and possesses –- (a) Post-graduate degree in Medicine–M.D. (Microbiology/Pathology/ Bacteriology/Immunology/Biochemistry); or (b) Post-graduate degree in Science (Microbiology); or (c) Post-graduate degree ib Pharmacy (Microbiology), from a recognized University or Institution.
2. Testing :
The head of the testing unit shall be independent of the manufacturing unit and testing shall be conducted under the active direction and personal supervision of competent technical staff consisting at least one person who shall be a whole time employee. The Head of the testing unit shall have eighteen months practical experience in the testing of drugs, especially the blood products and possesses – (a) Post-graduate degree in Pharmacy or Science–(Chemistry/ Microbiology/ Bio-chemistry); or (b) Post-graduate degree in Medicine–M.D(Microbiology/Pathology/ Biochemistry), from a recognized University or Institution.
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