DRUG AND COSMETICS ACT 1940

Mr. Swapnil Nazarkar

Scbe#ule V
Standards for patent and proprietary medicines and
for patent and proprietary medicines containing
vita mins
" Licensing Aufhorify
^ State Govt.: Each State Licensing Authority issue
license manufacture, saie, distribution drugs / cOsmetics
within the state. They can Issue / refuse license/Cancel
suspend license
^ Central licensing a uthority issue license
drugs
^ DRUGS CONTROLLER OF INDIA IS CENTRAL LICE NSE AP
PROVING AUTHORITY
 ^ Th e fo I I owi ng speci a I p rovi sio n re I ated to b i o logi ca I
or oth e r speci a I p rod u ct m u st com ply.
^ All sc h ed uI e C d rugs must be issu ed in a p revious Iy ste rilized
gl ass contai n e rs sea I ed so as to p revent e ntry of bacteria.
^ Drugs must com p ly with th e stan d ards of strength, qu a
lity & purity as specified in sch ed u I e F.
^ Biologica I prod u cts such as se ra, va ccin e, antige n, a
ntitoxi n, i nsu lin etc. s hou Id be tested for th e a bsen ce
of living &
an aerobic microOrganism.
^ Th e test far ste rility m ust be ca rried out.
 Form no. in wh ich licenses a re iss ued for the
sa ie, stock, exh ibit for sa ie or distribution of
drugs

License Form No.

issu ed Drugs other Sch. C&C1 Sch.X drugs
than Sch. C,C1 drugs
&X
Reta il 20 21 20- F
Restricted 20-A 21-A
Who lesale 20- B 21-B 2O-G
W hOlesal e Or 20- BB 21-B B
distribution from
motor vert icl e
fi?aIe of drug in contravention of any other provision
^ 1-2 years imprisonment & fine on first conviction & 2-4
years imprisonment & not less than Rs. 5,000 fine on
subsequent conviction
Failure to keep records or disclosed required information
^ Imprisonment upto 1 year & or fine upto Rs. 1000
False warranty to purchaser
^ Imprisonment upto 1 year & or fine upto Rs. SOOO on first
conviction & 2 years imprisonment or fine or both on
subsequent conviction.
Une of govt. analyst report or CDL report for advertising
* Fine upto Rs.500 on first conviction & imprisonment upto
1 0 yearn or fine or both on subsequent conviction.