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Union of India - Section

Section 3A in The Drugs and Cosmetics Rules, 1945

3A. [ [Substituted by S.O. 1124, dated 15.5.1961 (w.e.f. 20.5.1961).]

(1)The functions of the Laboratory in respect of the following drugs or classes of drugs shall be carried out at the Central Research Institute, Kasauli, and the functions of the Director in respect of the said drugs or classes of drugs shall be exercised by the Director of the said Institute:-
(1)Sera
(2)Solution of serum proteins intended for injection
(3)Vaccines
(4)Toxins
(5)Antigens
(6)Anti-toxins
(7)Sterilized surgical ligature and sterilized surgical suture
(8)Bacteriophages:[Provided that the functions of the Director in respect of Oral Polio Vaccine shall be exercised by the Deputy Director and Head of the Polio Vaccine Testing Laboratory in case of Central Research Institute, Kasauli only.] [Substituted by G.S.R. 445(E), dated 30.4.1992 (w.e.f. 30.4.1992).][(1-A) The functions of the Laboratory in respect of Oral Polio Vaccine shall be carried out by the following Institutes and the functions of the Director in respect of the said drugs shall be exercised by the Director of the respective Institutes:-
(a)Pasteur Institute of India, Conoor.
(b)Enterovirus Research Centre (Indian Council of Medical Research), Haffkine Institute Compound, Parel, Bombay-400012.]
(c)[ The National Institute of Biologicals, NOIDA.] [Inserted by G.S.R. 249(E), dated 4.4.2002 (w.e.f. 4.4.2002).]
(2)[ The functions of the Laboratory in respect of the following drugs or classes of drugs shall be carried out at the Indian Veterinary Research Institute, Izatnagar or Mukteshwar and the functions of the Director in respect of the said drugs or classes of drugs shall be exercised by the Director of either of the said institutes:-
(1)Anti-sera for veterinary use.
(2)Vaccines for veterinary use.
(3)Toxoids for veterinary use.
(4)Diagnostic Antigens for veterinary use.]
(3)[ The functions of the Laboratory in respect of testing of condoms shall be carried out at the Central Drugs Testing Laboratory, Chennai, and the functions of the Director in respect of the said products shall be exercised by the Director of the said Laboratory.] [Substituted by Notification No. G.S.R. 651 (E) dated 9.9.2009 (w.e.f. 21.12.1945).]
(4)[] [Sub-Rule (4) omitted and Sub-Rule (5) renumbered as sub-Rule (4) by G.S.R. 62(E), dated 15.2.1982 (w.e.f. 15.2.1982).] [The functions of the Laboratory in respect of the following drugs shall be carried out at the Laboratory of the Serologist and Chemical Examiner to the Government of India, Calcutta and the functions of the Director in respect of the said drugs shall be performed by the Serologist and Chemical Examiner of the said Laboratory:-VDRL Antigen.] [Added by G.S.R. 2655, dated 25.10.1975 (w.e.f. 25.10.1975)]
(5)[ The functions of the Laboratory in respect of Intra-utrine Devices and Falope Rings shall be carried out at the Central Drugs Testing Laboratory, Thane, Maharashtra and the functions of the Director in respect of the said devices shall be exercised by the Director of the said Laboratory.] [Substituted by G.S.R. 242(E), dated 18.3.1998 (w.e.f. 6.5.1998).]
(7)[ The functions of the Laboratory in respect of Homeopathic medicines shall be carried out at the Homeopathic Pharmacopoeia Laboratory, Ghaziabad and the functions of the Director in respect of the Homeopathic medicines shall be exercised by the Director of the Laboratory.] [Inserted by G.S.R. 246(E), dated 1.5.1991 (w.e.f. 1.5.1991).]
(8)[ The functions of the Laboratory in respect of Blood Grouping reagents and diagnostic kits for Human Immunodeficiency Virus, Hepatitis B Surface Antigen and Hepatitis C Virus shall be carried out at the National Institute of Biologicals, NOIDA and the functions of the Director in respect of the said drugs shall be exercised by the Director of the said Laboratory.] [Inserted by G.S.R. 249(E), dated 4.4.2002 (w.e.f. 4.4.2002).]