Drug & Cosmetic Act 1940

7/21/2019 Drug & Cosmetic Act 1940

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Drugs and Cosmetics Act 1940

Presented By: Dr.Anurag Mishra

MBA (Health & Hospital)



HistoryBritish misrule-Providing poor healthcare system to Indian citizens

Observations made by-Drugs Enquiry Committee, Indian edical!ssociation

"eports in- Indian edical #azette during $%&'-('

$%)' * Drugs and Cosmetics !ct

$%)+ * "ules under the !ct

E tended to hole o. India //



Objectives

0o regulate the import, manufacture, distribution and sale o. drugs 1cosmetics through licensing 2

anu.acture, distribution and sale o. drugs and cosmetics by qualified persons only.

0o prevent substandard in drugs, presumably for maintaining highstandards of medical treatment.

0o regulate the manu.acture and sale o. Ayurvedic, Siddha and Unanidrugs.

0o establish Drugs echnical Advisory !oard"D A!# and Drugs$onsultative $ommittees"D$$# for Allopathic and allied drugs andcosmetics 2



he salient features of the Drugs % $osmeticsAct, &'() are as follo*s+

a imum penalty life imprisonment and fine of s. &) la-hs or timesthe value of the confiscated goods , hichever is more2

3ome o. the o..ences cogni/able and non0bailable.

Besides o..icers .rom the Drug $ontroller1s Office, other ga/ette officers also authorized to launch prosecution under the Act2

3pecially designated courts .or trial o. o..ences covered under the !ct4

Provision .or compounding o. minor o..ences .



Definitions

Drugs +

!ll medicines .or internal or e ternal use o. human beings or animals and all

substances intended to be used .or or in the diagnosis, treatment,

mitigation or prevention o. any disease or disorder in human beings or

animals2

$osmetic +

!ny article intended to be rubbed, poured, sprin5led or sprayed on, or

other ise applied to, the human body or any part thereo. .or cleansing,

beauti.ying, promoting attractiveness, or altering the appearance, and

includes any article intended .or use as a component o. cosmetic2



3isbranded drugs +

i. it is so coloured, coated, po dered or polished that damage is concealed

i. it is not labelled in the prescribed manner4 or

i. its label or container or anything accompanying the drug bears anystatement, design or device hich ma5es any false claim .or the drug orhich is .alse or misleading in any particular2

Adulterated drug +) i. it consists, in hole or in part, o. any filthy, putrid or decomposed

substance 4 or) i. it has been prepared, pac5ed or stored under insanitary conditions

hereby it may have been contaminated ith .ilth or hereby it may havebeen rendered in6urious to health4 or

) i. its container is composed in hole or in part, o. any poisonous or

deleterious substance hich may render the contents in6urious to health2



Spurious drugs +i. it is imported under a name hich belongs to another drug 4 or

i. it is an imitation o. or a substitute .or another drug or resemblesanother drug in a manner li5ely to deceive or bears upon it or upon itslabel or container the name o. another drug2or

i. it has been substituted holly or in part by another drug or substance2



Administration of the a t and rules

A ) Ad!isory :

1)Drugs Technical Advisory Board-DTAB

2)Drugs Consultative Committee-D.C.C.

B) Analyti al :

1)Central Drugs a!oratory - CD

2)Drug Control a!oratory in states

")#overnment Analysts

") #$e uti!es :1) icensing authorities

2)Controlling authorities

")Drug $ns%ectors



Drugs %e hni al Ad!isory Board(D%AB)

One person, to be elected by the E ecutive Committee o. the4harmacy $ouncil of 5ndia , .rom among teachers in pharmacy orpharmaceutical chemistry on the sta.. o. an Indian university or acollege a..iliated2

One person, to be elected by the E ecutive Committee o. the 3edical$ouncil of 5ndia , .rom among teachers in medicine or therapeutics onthe sta.. o. an Indian university or a college a..iliated2

One pharmacologist to be elected by the #overning Body o. the IndianCouncil o. edical "esearch2

One person to be elected by the Central Council o. the 5ndian 3edicalAssociation 2

One person to be elected by the Council o. the 5ndian 4harmaceuticalAssociation 2



6unctions+0o advise the Central #overnment and the 3tate #overnments ontechnical matters arising out o. the administration o. this !ct2

0o carry out the other .unctions assigned to it by this !ct2

70he nominated and elected members o. the Board shall hold o..ice .orthree years, but shall be eligible .or re-nomination and re-election8



Drugs $onsultative $ommittee"D$$#It is also an advisory body constituted by central government2

$onstitution+0 o representatives o. the $entral 7overnment

One representative o. each State 7overnment

6unctions+0o advise the Central #overnment, the 3tate #overnments and theDrugs 0echnical !dvisory Board on any other matter tending to secureuniformity throughout 5ndia in the administration o. this !ct2

0he Drugs Consultative Committee shall meet *hen required

9as po er to regulate its o n procedure2



"entral Drug a'oratory("D )

&sta!lished in "al utta ' under the control o( a director a%%ointed !y the Central#overnment

un tions:

Analysis or test o( sam%les o( drugs cosmetics sent !y the custom collectors orcourts.

Analytical .". o( the im%orted sam%les.

*re%aration o( referen e standards and their maintenance.

+aintenance o( mi ro'ial ultures.Any other duties entrusted !y Central #overnment.

Acting as an appellate authority in matter o( dis%utes.



7overnment analyst0hese o..icers are appointed by the central or state governmentand per.orm the duties2

8ualification of government analysis+

9aving a degree in medicine, !yurveda, siddha or unani systemand not less than three year post graduate e perience in theanalysis o. drugs in a laboratory under control o. a governmentanalyst2

Duties+

0he #overnment !nalyst shall cause to be analyzed or tested suchsamples or drugs and cosmetics as may be sent to him byInspectors2

! #overnment !nalyst shall .rom time to time .or ard reports tothe #overnment giving the result o. analytical or5 and researchith a vie to their publication2



9icensing authority

8ualification+

#raduate in Pharmacy on Pharmaceutical Chemistry or in edicine ithspecialization in clinical pharmacology or microbiology .rom a :niversityestablished in India by la 4 and

E perience in the manu.acture or testing o. drugs a minimum period o. .iveyears, Provided that the requirements as to the academic quali.ication shallnot apply to those inspectors 2

Duties+0o inspect all establishments licensed .or the sale o. drugs ithin the areaassigned to him4

0o satis.y himsel. that the conditions o. the licenses are being observed4

0o procure and send .or test or analysis, i. necessary, imported pac5ages2

0o investigate any complaint20o maintain a record o. all inspections made and action ta5en by him in theper.ormance o. his duties,

0o ma5e such enquiries and inspections as may be necessary to detect thesale o. drugs in contravention to the !ct4



$ontrolling authority

8ualification+

#raduate in Pharmacy or Pharmaceutical Chemistry or in edicineith specialization in clinical Pharmacology or microbiology .rom a:niversity established in India by la and

E perience in the manu.acture or testing o. drugs or en.orcement o.the provisions o. the !ct .or a minimum period o. .ive years;



Drug 5nspector8ualification

! government analyst

! chemical e aminer

9ead o. an institution2

4o*er+

a8 5nspect, 00

!ny premises here in any drug or cosmetic is being manufactured 2

!ny premises here in any drug or cosmetic is being sold , or stoc-ed or e:hibited or offered .or sale, or distributed 4

7b8 a-e samples of any drug or cosmetic,00

<hich is being manufactured or being sold or is stoc-ed or e:hibited or offered .or sale, or is being distributed 4

=rom any person ho is in the course o. conveying , delivering orpreparing to deliver such drug or cosmetic to a purchaser or aconsignee2



Provision o. !ct

Import

anu.acturing

3ales



Import o. Drugs$lasses of drugs prohibited to import+

3isbranded drugs

Drugs o. substandard quality

Adulterated drugs

Spurious drugs

Drugs hose manufacture, sale;distribution are prohibited inoriginal country, e cept .or the purpose o. test, e aminationand analysis2

Patent>Proprietary medicines hose true formula is notdisclosed.



Cosmetics prohibited to import

3isbranded cosmetics

Spurious cosmetics

Cosmetic containing harmful ingredients

Cosmetics not of standard qualityhich contains more than-& ppm Arsenic , &' ppm lead, $''ppm heavy metals

3 f



3anufacture

Prohibition o. anu.acture

Drug not o. standard quality or misbranded, adulterated orspurious.

4atent or 4roprietary medicine

is-y to human beings or animals

Drugs *ithout therapeutic value

Preparation containing cyclamates



anu.acture o. cosmetics

Prohibited .or the .ollo ing classes o. drug;

3isbranded or spurious cosmetics and o.substandard quality

Cosmetics containing he:achlorophene or mercury compounds

Cosmetics containing color hich contain more than-

- & ppm o. arsenic

- &' ppm o. lead

- $'' ppm o. heavy metals

<ye preparations containing coal0tar color



Sale

$lass of drug prohibited to sale

3isbranded, spurious, adulterated and drugs not o. standardquality

4atent;4roprietary drugs ith undisclosed .ormula

<:pired drugs 2

Drugs used .or consumption by government schemes such as,!rmed .orce2

4hysician1s samples



Drugs and $osmetics

"Amendment# Act, =))>3alient .eatures o. the !ct;-

3ubstantial enhancement in punishment

?i.e imprisonment .or o..enders involved inmanu.acture, sale and distribution o. spurious andadulterated drug li5ely to cause grievous hurt

inimum punishment o. seven years hich may e tendto li.e imprisonment

Provision .or compensation to a..ected person

Drug & Cosmetic Act 1940

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