D and C act 1940 and rules 1945

 Act was passed in 1940, (10th April 1940).
 Oject: To regulate the import,mfg,distribution
and sale of D & C .
 Act also hold control over Ayurvedic,Siddha ,
Unani and Homoeopathic drugs.

The CG and SG appoint bodies for efficient running of the act.
A) Advisory
i. Drug Technical Advisory Board(DTAB)
ii. Drugs consultative committee.(DCC)
B) Analytical
i. The central drugs laboratory.
ii. Drugs control Laboratories in states.
iii. Government analyst.
C) Executive
i. Licensing Authorities
ii. Drug inspectors.
iii. Custom collectors.

 CG appoints DTAB to advice the CG and SG on
technical matters;
Constitutions:
Ex-officio members.
1. The director of General health services, who is chairman
2. The Drugs controller of India.
3. The Director of Central Drugs Laboratory,Kolkatta.
4. The Director of Central Research Laboratory,Kasauli.
5. The Director of Indian Veterinary Research
Institute,Izatnagar.
6. Director, Central Drug Research Institute,Lucknow.
7. The President, Pharmacy Council of India.
8. The President, Medical Council of India.

9. Two persons form among persons who are
incharge of the drugs control in the states.
10. One person from the pharmaceutical industry.
11.Two Government Analysis.

 12. A teacher in Pharmacy,Pharmaceutical chemistry
or Pharmacognosy or the staff of and university or
affiliated college elected by the executive committee
of Pharmacy of India.
 13. A teacher in medicine or therapeutics or the staff
of an university or affilated college elected by the
Executive committee of the Medicinal Council of
India.
 14. One pharmacologist,elected by the Governing
Body of the Indian Council Of Medical Research.
 15. One person elected by the Central Council Of
Indian Medical Association.
 16. One person elected by Council of the Indian
Pharmaceutical Association.
 the nominated and elected holds for 3 years.

 Constituted by CG to advice CG ,SG and DTAB
on any matter to secure uniformity throughout
India.
 Constitution:
 1. Two representatives of CG nominated by CG.
 2. One representative of each SG nominated by
concerned SG.
 Separate “The Ayurvedic Siddha and Unani
Drugs Consultative under sec.33D of the act.

 CG established CDL(Kolkata) under control of Director
 Functions:
 1. To analyze or test samples of D and C send by custom collectors and
 Courts.
 2. To carry out such other duties as may be entrusted to it by CG or SG
with consultation with DTAB.
 3. a. in case of following drugs or classes of drugs, functions of CDL
carried out at Central Research Institute Kasauli.
 i. sera.ii.vaccines.iii.Toxins.iv.Antigens.v.Antitoxins.vi.surgical
ligatures and sutures.
 b. in case of the following drugs or classes of drugs, functions of CDL
are carried out at Indian veterinary Research Institute,Izatnagar or
Mukteshwar.
 i.Antisera.ii.Vaccines.iii.Toxoids.iv.Diagnostic antigens for veterinary.
 4. In case of condoms the functions of CDL is carried out at Central
Indian Pharmacopoeia Laboratory Ghaziabad.
 5. The functions of the laboratory in respect of Homeopathic medicines
shall be carried out at the Homeopathic Pharmacopoeia Laboratory
Ghaziabad

 Every state has Lab. For analysis and testing of
drugs and cosmetics mfg or sold or to be sold
within respective areas.
 Samples sent by DI are analysed in Lab.
 Also analyse sample sent by purchaser of drug
on payment specified fees prescribed in sch.B

 SG appoint GA under sub section (1) of section 20
for analysis and testing of samples of D and C in
DCL.
 CG may also appoint GA for specified category of
drugs.
 GA should have no financial interest in the import,
mfg,or sale of D and C.
 GA for ayurvedic,siddha and Unani drugs are
appointed by SG and CG under section 33F, of act.

 A graduate in medicine or science or pharmacy or
pharmaceutical chemistry of recognised
university,with not less than 5 year experience in
testing and analysing.
 A post-graduate in medicine or science or pharmacy or
pharmaceutical chemistry of recognised
university,with not less than 3 year experience in
testing and analysing.
 Associate diploma of institution of chemist with
analysis of ‘Drugs and Pharmaceutical’ as one of
subject with not less than 3 year exp. Of T and A
Under control of
1.A govt.Analyst or
2.Head of institution for testing and analysing.

 To analyse or test samples of D and C sent to
him by DI or other person and to furnish report
the results of such analyse or test.
 To forward the Govt. the reports of analytical
and research work, with a view to their
publication at the discretion of the
Government.

 The CG and SG appoints Inspectors having a
prescribed qualification under section 21 of the
act.
 A person appointed as a DI should have no
financial interest in the import,mfg or sale of D
and C, DI is a public servant under sec.21 of
Indian Penal Code.

 A graduate in pharmacy or Pharmaceutical sciences
or Medicine with specialization in Clinical
Pharmacology or Microbiology from recognised
university.
 A person appointed as a DI should have:
 1. NLT 18 month exp. In mfg of atleast one of
substance specified in sch.C or,
 2. NLT 18 month exp.nin testing of atleast one of
substance specified in sch.C or
 3.NLT 3 year exp. In inspection of firms mfg any
substance specified in Sch.C during the course of their
service as a DI.

 A. inspect
 B. Take samples of any drug or cometics.
 C. Search.
 D. Enter and search
 E. Stop and search
 F. Give order.
 G. Examine.

 A. Inspect.
 1.any premises where any drug or cosmetic is
being mfg.
 2. any premises where any drug of cosmetics if
sold or stocked or exhibited or offered for sale
or distribution.
 B. Take samples of any D and C
 1. any drug which is being mfg or sold or
stocked or distributed.
 2. from any person,conveying,delivering,or
preparing to deliver any drug or cosmetic to a
purchaser or a consignee.

 C. Search any person in connection with the
offence under this chapter at all reasonable times.
 D. Enter and search at all reasonable times, any
place or premises in which he has reason to believe
that an offence is being committed or has been
committed.
 E. Stop and search any vehicle or other conveyance
which he has reason to believe used for carrying
any D or C in respect of which offence as been or
has being committed.
 F. Give order in writing to the person in possession
of drug or cosmetic in respect of which offence has
been committed or is being committed, not to
dispose stock of such drug or cosmetic for a
specified period not exceeding twenty days or
unless the defect may removed by the possessor of
the drug or cosmetic and may sieze the stock of
such drug or cosmetic.

 A. Duties in relation to the sale of D and C.
 B. Duties in relation to the mfg of D and C.
 A. Duties in relation to the sale of D and C.
 1.To inspect atleast twice a year all establishment license
for sale of drugs.
 2. He can send samples of any imported drugs for testing
and analysing which is being sold or stocked in any
contravention of the act.
 3. To investigate any complaint in writing given to him.
 4. To maintain records relating to all inspections and
actions taken by him and submit copies of such records to
controlling authority.
 5.To detain the imported packages, which are prohibited
for import.
 6. To make inquires and inspection regarding the sale of
drugs in contravention of the act.

 B. Duties in relation to the mfg of D and C.
 1.To inspect atleast twice a year all establishment
license for mfg of drugs.
 2. To inspect premises licensed for mfg of drugs
specified in Sch.C and C(1) and observe process of
mfg,stnadardisation,testing of drugs, storage
condition, qualification of technical staff, and all other
detail of location, construction, administration.
 3.To send after each inspection, a detailed report of
inspection to the controlling authority.
 4.To take samples of Drugs mfg on the premises and
send them for test or anlaysis.
 5.To check all records and registers to be maintained
under the rules.
 6. To institute prosecutions in respect of the breaches of
act.

 CG appoints an authority is called “ Licensing
Authority” to issue license for import,
mfg,distrubution,sale of D or C.
 The licensing authority is also empowered to
cancel or suspend the licenses issued by them,
if licenses fail to observe any of the conditions
of license after giving reasonable opportunity
to explain their case.

 A graduate in pharmacy or pharmceutical
chemistry or in medicine with specialisation in
clinical pharmacology from a recognised
university.
 He has an experience in the mfg or testing of
drugs or enforcement of the provisions of the
act for minimum period of five years.

 No person shall be qualified to be a controlling
authority under the act.
 1.A graduate in pharmacy or pharmceutical
chemistry or in medicine with specialisation in
clinical pharmacology from a recognised
university.
 He has an experience in the mfg or testing of
drugs or enforcement of the provisions of the act
for minimum period of five years.

 The law relating to customs or goods, import of
which is prohibited, is time being applicable for the
drugs and cosmetics .
 Custom collectors or any officer authorized may
detain any imported package which he suspect to
contain any drug or cosmetic import which is
prohibited any report such detention to drug
controller, India and if required forwards sample
to CDL.

License
Issued
Forms
Drugs other
than Sch. C,C(1)
Drugs specified in
Sch. C,C(1)
Drugs Specified in
Sch.X
Retail 20 21 20-F
Restricted 20 –A 21—A --
Wholesale 20—B 21—B 20—G
Wholesale or
Distribution from
motor vehicle
20—BB 21—BB --
Form of licenses

 A. Dispensing and compounding of drugs.
 B. Supply of Schedule C drugs by retail.
 C. Supply of other drugs.
 D. Sale of drugs specified in Sch.H and Sch.X
 E. Dispensing of Sch.H and Sch.X drugs.
 F. Storage of Sch.X drugs.
 G. Records of Purchase.
 H. Wholesale supply of drugs.
 I. The description to be displayed on a premises.
 J. Storage condition of Veterinary use/medicine.
 K. supply of sch.X Drugs.

 Manner of Labeling: (edible ink)
 i.Name of drug, batch number, mfg name,etc.
 ii. Date of expiry.(potency).
 iii. Official standard.
 iv. Care of handling, use, distribution,etc.
 v. Particular to related storage,manner of
use,etc.
 Vi. General information such as physician
sample, not to be sold, etc.

 1.Name of the Drug.
 2.Statement of net content.(wt, ml,no.of units)
 3.The content of active ingredient expressed in terms
of.(oral liquid,liq.parentral,solid,tab,cap,)
 4.The name and address of manufacturer.(except
ampoule)
 5. Distinctive batch number.(Batch no,B.No,Lot No or
Lot.)
 6. Mfg license number.(Mfg.Lic.No or M.L.)
 7. Date of mfg.
 8. Date of expiry of potency.
 9. Labeling of Mechanical Contraceptive.(date of
mfg,exp.date, storage condition necessary for preserving
the properties of contraceptives.)

•Name of drug
•Content
•Active ingredient
•Oral liquid
•Name and address of mfg.
•Batch No.
•Mfg Lic No.
•Date of mfg
•Date of Expiry

 Medicines for Internal use:
 1. If drug is of Sch.G Caution should be given as “It so
dangerous to take except under medical supervision” should be
printed and underlined.
 2.if drug is of Sch.H
 i. symbol Rx displayed on left top corner.
 ii. Warning: “To be sold by retail on the prescription of RMP
only”.
 iii. If drug is of NDPS Symbol NRx displayed on left top corner
of label.
 IV. If drug is of Sch.X label as symbol XRx in red conspicuously
displayed on left corner of label.
 Warning: “To be sold by retail on the prescription of RMP
only”.
 V. In case of lotion, liniment liquid antiseptic should be labeled
as “For External Use Only”.
 Vi. Pharmacopoeial and other official standards.
 Name or synonym as specified as I.P, B.P,U.S.P,B.P.C etc.

 A. ophthalmic solution or suspension.
 1.use the solution within month after opening the
container.
 2.Name and concentration of preservative used.
 3.The words “Not For Injection”.
 4.Instruction like storage,warning,direction etc.
 5. Warning: “If irritation persist or increases,
discontinue the use and consult to physician”
 “Do not touch the dropper tip or other dispensing
tip which may cause contamination”

 Medicines made up
ready for the
treatment of animals.
 1. The words “Not for
human use. For
animal use only”
 2. Symbol depicting
the head of domestic
animal.

D and C act 1940 and rules 1945

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D and C act 1940 and rules 1945