In this Act, unless there is anything repugnant in the subject or context, 7 [(a) ― 8 [Ayurvedic, Siddha or Unani] drug‖ includes all medicines intended for internal or external use for or in the diagnosis, treatment, mitigation or prevention of 8 [disease or disorder in human beings or animals, and manufactured] exclusively in accordance with the formulae described in, the authoritative books of 9 [Ayurvedic, Siddha and Unani Tibb systems of medicine], specified in the First Schedule;]
9 [(aa) ―the Board‖ means—
(i) in relation to 9 [Ayurvedic, Siddha or Unani] drug, the 9 [Ayurvedic, Siddha and Unani Drugs Technical Advisory Board] constituted under section 33C; and
(ii) in relation to any other drug or cosmetic, the Drugs Technical Advisory Board constituted under section 5;]
1. For Statement of Object and Reasons, see Gazette of India, 1940, Pt. V, p. 34; for the Report of the Select Committee, see ibid., p. 143.
The Act has been applied to all the partially excluded areas in the State of Orissa, see Orissa Government Notification No. 3358-LSG., dated the 25th August, 1941.
2. Ins. by Act 21 of 1962, s. 2 (w.e.f. 27-7-1964).
3. Subs. by the A.O. 1950, for certain words.
4. The words ―except the State of Jammu and Kashmir‖ omitted by Act 19 of 1972, s .2. (w.e.f. 31-5-1972).
5 1st April, 1947; see Notifn. No. F. 28 (10) (3) 45-H (1), dated the 2nd September 1946, Gazette of India, 1946, Pt. I, p.1349.
Chapter IV came into force in the States of Delhi, Ajmer and Coorg on the 1st April, 1947, see ibid., Chapters III and IV came into force in the States of Himachal Pradesh, Bilaspur, Kutch, Bhopal, Tripura, Vindhya Pradesh and Manipur on the 1st April, 1953, vide Notification No. S.R.O.
663, dated the 30th March, 1953, Gazette of India, Pt. II, Sec. 3, p. 451.
Chapter IV came into force in the Union territory of Dadra and Nagar Haveli w.e.f. 1st August, 1968, see Notification No. ADM/Law/117(74), dated the 20th July, 1968, Gazette of India, Pt. III, Sec. 3, p.128. The Act is extended to Dadra and Nagar Haveli by Reg. 6 of 1963, s. 2 and Sch.
I; to Pondicherry by Reg. 7 of 1963. s. 3 and Sch. I; to Goa, Daman and Diu by Reg. 11 of 1963, s. 3 and Sch. and to Laccadive, Minicoy and Amindivi Islands by Reg. 8 of 1965. s.3 and Sch.
6. Added by Act 19 of 1972, s. 2.
7 Ins. by Act 13 of 1964, s. 2 (w.e.f. 15-9-1964).
8. Subs. by Act 68 of 1982, s. 2, for certain words (w.e.f. 1-2-1983).
9. Clause. (a) was relettered as cl. (aa) by Act 13 of 1964 s. 2, (w.e.f. 15-9-1964).
10. 24th August, 1974, vide notifin no. S.O. 2185, dt. 9th August, 1974.
Drugs and Cosmetics Act, 1940 7 1 [ 2 [(aaa)] ―cosmetic‖ means any article intended to be rubbed, poured, sprinkled or sprayed on, or introduced into, or otherwise applied to, the human body or any part thereof for cleansing, beautifying, promoting attractiveness, or altering the appearance, and includes any article intended for use as a component of cosmetic 3 [* * *] ;]
4 [(b) ―drug‖ includes— 5 [(i) all medicines for internal or external use of human beings or animals and all substances intended to be used for or in the diagnosis, treatment, mitigation or prevention of any disease or disorder in human beings or animals, including preparations applied on human body for the purpose of repelling insects like mosquitoes;]
(ii) such substances (other than food) intended to affect the structure or any function of the human body or intended to be used for the destruction of 6 [vermin] or insects which cause disease in human beings or animals, as may be specified from time to time by the Central Government by notification in the Official Gazette;]
7 [(iii) all substances intended for use as components of a drug including empty gelatin capsules; and
(iv) such devices* intended for internal or external use in the diagnosis, treatment, mitigation or prevention of disease or disorder in human beings or animals, as may be specified from time to time by the Central Government by notification in the Official Gazette, after consultation with the Board;]
8 [(c) ―Government Analyst‖ means—
(i) in relation to 9 [Ayurvedic, Siddha or Unani] drug, a Government Analyst appointed by the Central Government or a State Government under section 33F; and
(ii) in relation to any other drug or cosmetic, a Government Analyst appointed by the Central Government or a State Government under section 20;]
10 [* * * * *] 11 [(e) ―Inspector‖ means—
(i) in relation to 9 [Ayurvedic, Siddha or Unani] drug, an Inspector appointed by the Central Government or a State Government under section 33G; and
(ii) in relation to any other drug or cosmetic, an Inspector appointed by the Central Government or a State Government under section 21;]
12 [ 13 [(f)] ―manufacture‖ in relation to any drug 14 [or cosmetic] includes any process or part of a process for making, altering, ornamenting, finishing, packing, labelling, breaking up or otherwise treating or adopting any drug 14 [or cosmetic] with a view to its 15 [sale or distribution] but does not include the compounding or dispensing 16 [of any drug, or the packing of any drug or cosmetic,] in the ordinary course of retail business; and ―to manufacture‖ shall be construed accordingly;]
17 [(g)] ―to import‖, with its grammatical variations and cognate expressions means to bring into 18 [India];
1. Ins. by Act 21 of 1962, s. 4 (w.e.f. 27-7-1964).
2. Clause. (aa) relettered by Act 13 of 1964, s. 2 (w.e.f. 15-9-1964).
3. omitted by Act 68 of 1982, s.3, certain words.
4. Subs. by Act 11 of 1955, s. 2, for cl. (b).
5. Subs. by Act 68 of 1982, s. 3 (w.e.f. 1-2-1983).
6. Subs. by Act 13 of 1964, s. 2, for ―vermins‖ (w.e.f. 15-9-1964).
7. Ins. by Act 68 of 1982, s.3 (w.e.f. 1-2-1983).
The Central Government has specified (vide S.O. 1468 (E), dated 6-10-2005) the following devices intended for external or internal use in human beings or drugs with immediate effect, namely:-
(i) Cardiac Stents (ii) Drug Eluding Stents (iii) Catheters (iv) Intra Ocular Lenses (v) I.V. Cannulac (vi) Bone Cements
(vii) Heart Valves (viii) Scalp Vein Set (ix) Orthopaedic Implants (x) Internal Prosthetic Replacements
8. Subs. by Act 13 of 1964, s. 2, for cl. (c) (w.e.f.15-9-1964).
9. Subs. by Act 68 of 1982 s.2, for ―Ayurvedic (including sidda) or Unani‖ (w.e.f. 1-2-1983).
10. Cl. (d) omitted by Act 19 of 1972, s. 3. 15. Subs. by Act 68 of 1982, s.3, for ―sale and distribution‖(w.e.f. 1-2-1983).
11. Subs. by Act 13 of 1964, s. 2, for cl. (e) (w.e.f. 15-9-1964). 16. Subs. by Act 21 of 1962 s. 4, for ―or the packing of any drug‖.
12. Ins. by Act 11 of 1955, s. 2. 17. Cls.(c), (d) and (e) relettered as cls. (g), (h) and (i) respectively by Act 35 of 1960, s. 2 (w.e.f. 16-3-1961).
13. Clause. (bbb) relettered as cl. (f) by Act 35 of 1960, s. 2 (w.e.f. 16-3-1961).
14. Ins. by Act 21 of 1962, s. 4 (w.e.f. 27-7-1964). 18. Subs. by Act 3 of 1951, s. 3 and Sch., for ―the States‖.
Drugs and Cosmetics Act, 1940 8 1 [ 2 [(h)] ―patent or proprietary medicine‖ means,—
(i) in relation to Ayurvedic, Siddha or Unani Tibb systems of medicine all formulations containing only such ingredients mentioned in the formulae described in the authoritative books of Ayurveda, Siddha or Unani Tibb systems of medicine specified in the First Schedule, but does not include a medicine which is administered by parenteral route and also a formulation included in the authoritative books as specified in clause (a);
(ii) in relation to any other systems of medicine, a drug which is a remedy or prescription presented in a form ready for internal or external administration of human beings or animals and which is not included in the edition of the Indian Pharmacopoeia for the time being or any other Pharmacopoeia authorised in this behalf by the Central Government after consultation with the Drugs Technical Advisory Board constituted under section 5;]
3 [ 2 [(i)] ―prescribed‖ means prescribed by rules made under this Act.]
4 [* * * * *] 5 [3A. Construction of references to any law not in force or any functionary not in existence in the State of Jammu and Kashmir.—Any reference in this Act to any law which is not in force, or any functionary not in existence, in the State of Jammu and Kashmir, shall, in relation to that State, be construed as a reference to the corresponding law in force, or to the corresponding functionary in existence, in that State.]