DRUG AND COSMETIC ACT 1940

(only schedules)

by RAHUL
challarahul77@g a!l"c#

$IRST SCHEDULE%
Ayurvedic, Siddha or Unani drug includes all medicines intended for internal or external use for or in the diagnosis, treatment, mitigation or prevention.

SECOND SCHEDULE. Standards of quality

standards to be complied with by imported drugs and by drugs manufactured for sale, vold, stoc ed or exhibited for sale or distributed

SCHEDULE &E'. !oisonous substance

List of poisonous substances under the Ayurvedic (including Siddha) and Unani Systems

SCHEDULE &('
"he fees for test and analysis shall be those specified in Schedule #.

SCHEDULE &) &* symbol )R)

import licence means a licence in Form !A to import drugs " e#cluding those specified

SCHEDULE &C &OR &C &+1,*

potency

$rohibition of import after e#piry of

$o biological or other special product specified shall be imported after the date shown on the label, wrapper or container of the drug as the date up to which the drug may be expected to retain a potency not less than, or not to ac%uire a toxicity greater than, that re%uired, or as the case may be, permitted by the prescribed test.

SCHEDULE &$' +1, *standard for certain imported drugs

$o drug shall be imported unless it complies with the standard of strength, %uality and purity

SCHEDULE &M' AND SCHEDULE &M-III'

&very application in 'orm () shall be made up to ten items for each category of drugs categorised in and shall be accompanied by a licence fee of rupees six thousand and an inspection fee of one thousand and five hundred for every inspection or for the purpose of renewal of the licence

SCHEDULE &U'"
lot of the raw material used by him for the manufacture of his products and also each batch of the final product and shall maintain records. "he records or registers shall be retained for a period of * years from the date of manufacture

SCHEDULE &$'
"he licence shall provided and maintain an ade%uate staff and ade%uate premises and plant for the proper manufacture and storage of the substances in respect of which the licence is issued.

SCHEDULE &R'"
"he date of manufacture. "he date up to which the contraceptive is expected to retain its properties. "he storage conditions necessary for preserving the properties of the contraceptive up to the date indicated in sub+clause (b, .

SCHEDULE &G' *-A#&--.$/ 0' 1&2.3.$&S

labelled with the words 43aution5 it is dangerous to ta e this preparation except under medical supervision6 7 conspicuously printed and surrounded by a line within which there shall be no other words

SCHEDULE &H' *-A#&--.$/ 0' 1&2.3.$&S

-abelled with the symbol 8x and conspicuously displayed on the left top corner of the label . -abelled with the following words "o be sold by retail on the prescription of a 8egistered 1edical !ractitioner only.

SCHEDULE &.-1'* !A39.$/ 0' 28U/S

"he pac si:es of drugs meant for retail sale shall be as prescribed. &g; "he pac si:es for li%uid 0ral preparations shall be <=ml (paediatric only, >= ml?@== ml?(== ml?)*= ml.

SCHEDULE &/'0
!rovided further that any application received after one year of the grant of approval for the import and sale of new drug. A fee of fifteen thousand rupees and such information and data as re%uired by Appendix . or Appendix .+A.

SCHEDULE &A'
'or the purpose of this rule, #lood #an means a place or organi:ational unit or an institution or other arrangement made by such organi:ational unit or institution for carrying our all or any of the operations of manufacture of human blood components, or blood products or whole human blood for its collection, storage, processing, distribution from selected human donors.

SCHEDULE &1'% &A&1!".0$

"he drugs specified in shall be exempted from the provisions of 3hapter .B of the Act and the 8ules made there under to the extent and subCect to the conditions specified in that Schedule.

SCHEDULE &2'% S"A$2A82S '08 !A"&$" 08 !80!8.&"A8D 1&2.3.$&S

"he standards for patent or proprietary medicines shall be those laid down in Schedule B and such medicines shall also comply with the standards laid down in the Second Schedule to the Act.

SCHEDULE &$ +II,' ;Standards for Surgical %ressings

&he standards for Surgical %ressing shall be such as are laid down

SCHEDULE &$+III,' ;Standards for Sterilised Umbilical tapes

&he standards for Sterilised Umbilical tapes shall be as laid down

SCHEDULE &R-1'"
Standards for 'edical %evices() the standards for the 'edical %evices shall be such as are laid down

SCHEDULE &D'; *+*'$&,-. -F /-S'*&,/S

3osmetics specified shall be exempted from the provisions of 3hapter ... of the Act and the 8ules made there under to the extent and subCect to the conditions specified .

SCHEDULE &3'. /-S'*&,/ &- /-.&A,. %0*S1 /-L-U2S A.% $,3'*.&S

$o 3osmetic shall contain 2yes, 3olours and !igments other than those specified by the #ureau of .ndian Standards (.S5)E=E !art @ as amended,

SCHEDULE &U+1,'
the licensee shall eep records of the details of each batch of cosmetic manufactured by him and of raw materials used therein as per particulars specified in Schedule U(@, and such records shall be retained for a period of three years.

SCHEDULE &T'
'or getting a certificate of 4/ood 1anufacturing !racticesF of Ayurveda Siddha+ Unani drugs, the applicant shall made application on plain paper, providing the information on existing infrastructure of the manufacturing unit, and the licensing authority shall after verification of the re%uirements as per Schedule 4"6 issue the certificate within a period of < months in form (>+&

SCHEDULE &E' +1,0

"he container of a medicine for internal use made up ready for the treatment of human ailments shall, if it is made up from a substance specified in Schedule & (@,, be labelled conspicuously with the words 43aution5 "o be ta en under medical supervision6 both in &nglish and Gindi language.

SCHEDULE &D +II,'

.nformation re%uired to be submitted by the manufacturer or his authori:ed agent with the Application 'orm for the registration of a bul drug?formulation?special product for its import into .ndia. "he format shall be properly filled in and the detailed information, secret in nature, may be furnished on a 3omputer 'loppy.

SCHEDULE &$$'. S"A$2A82S '08 0!G"GA-1.3 !8&!A8A".0$S

be sterile when dispensed or when sold in the unopened container of the manufacturer, except in case of those ophthalmic solutions and suspensions which are not specifically re%uired to comply with the test for 4Sterility6 in the !harmacopoeia

SCHEDULE" &I'
particulars as to proportion of poison in certain cases

SCHEDULE &4'
2iseases and ailments (by whatever name described, which a drug may not purport to prevent or cure or ma e claims to prevent or cure.

SCHEDULE &L'

SCHEDULE &N'
list of minimum equipment for the efficient running of a pharmacy

SCHEDULE &O'
standard for disinfectant fluids the disinfectants shall be classified as follows5 (A,blac fluids ; coal tar acid or similar acids (b,white fluids; without hydrocarbons, and?or other phenolic compounds, and their derivatives.

SCHEDULE &.'; -.'& !&8.02 0' 28U/S

period in months (unless otherwise specified, between date of manufacture and date of expiry which the labelled potency period of the drug shall not exceed under the conditions of storage specified

SCHEDULE &S' ; S&A.%A2%S F-2 /-S'*&,/S ,. F,.,S4*% F-2'

Shall conform to the .ndian Standards specifications laid down from time to time by the <H#ureau of .ndian Standards (#.S,I.

SCHEDULE &5'%
.$S&8"&2 AS !&8 /.0... $0".'.3.A".0$ $0. /S8 (E(&, 2" @E.@.@JK@ A$2 2&-&"&2 AS !&8 /.0... $0".'.3A".0$ $0. /S8 J)(&, 2" K.(.(===.