THE GAZETTE OF JNDf A : EXTRAORDINARY

[PART U—SEC. 3(i)]

MINISTRY OF HEALTH AND FAMILY WFXFARE

(Department of Health)

NOTIFICATION

New Delhi, the 22nd March, 1*82

G.S.R. 262(E).—The following draft of certain rules further

to amend the Drugs and Cosmetics Rules, 1945, which tho

Central Government propose to make, after consultation with

the Drugs Technical

Advisory

Board, in exercise of the

powers conferred by sections 12 and 33 of the Drugs

and

Cosmetics Act, 1940 (23 of 1940), is

hereby

published as

required hy the said sections for the information of all per-

sons likely to be affected thereby aiid notice is hereby given

that the said draft rules will be taken into consideration

after the expiry of H period of 90 days from the date °n

which the copies of the Official Gazette in which this noti-

fication is published are made available to the public.

Any objections or suggestions which may be received from

any person with icspect to the said draft rules before the

expiry of the period so specified will he taken into cons;,

deration by the Central Government.

DRAFT RULES

1, These rules may be called the Drugs and Cosmetics

(2nd Amendment) Rules, 1982.

2. In the Drugs and Cosmetics Rules, 1945—

fl) after rule 124-B the following shall

inserted

namely:—

"124-C. Standards for Surgical Dressings

The standards for surgical dressings shall be such

us are laid down in Schedule F (II)."

OH after Schedule F(T), the following shall be inserted,

namely :—

"Schedule F(II) (See Rule 124-C)

STANDARDS FOR BANDAGF CI.OTH

Synonyms : Bleached Bandage

Cloth, Rolled

Bandages,

Open Wove Bandage; Cotton Bandage Cloth.

Bandaee Cloth consists of cotton cloth of plain weaw

made from machine spun yarn of suitable coupt to comply

with a bleached count between 20 tex and 25 tex

from

warp and between 25 tex to 30 tex for weft. The fabric con-

tains no filling, sizing oi dressing materials; it may

supplied uncut and folded or rut to suitable .size* and rolled.

Description for uncut bandages ;

Cotton cloth of plain

weave, in one continuous

length

showing no joins ot seems, with well formed selvedges; the

cloth is bleached to a good white, is clean and odourless, and

reasonably free from weaving defects as well as from iced

Hnd leaf debries,

For cut bandages :

As for uncut bandages, except for selvedges which shall

not be included in cut bandages; in addition, both, the ex-

n ernes and edges of cut bandages shall bo straight and evenly

cut, with icasonable freedom from loose threads.

Threads per dm ; Warp not less than 150 and weft not lesi>

than 85.

Weight in g/m 2 : 57 ±

Length and width :

The length and width shall not be less than 99 per cent

each of the length and with stated on the label; for

cut

bandages, each of (he bandages in a packing complies with

this requirement,

Foreign matter : Not more than 2 per cent.

Fluorescence :

When viewed under screened ultra-violet light, not more

than occasional points of fluorescence are observed.

Packing, labelling and storage :

Bandage cloth shall be packed securely so as to

allow

normal handling and transport without tearing and exposing

tho contents, In packages of cut and rolled bandage,

each

bandage shall also individually

wrapped in a suitable

paper'. The net content is stated on the label in terms

length and width. Bandage cloth must be stored in packed

condition,

protected from dust. The packings of Bandage

cloth shall be

labelled

prominently

with the words "Non

Sterile".

Standards for Abrorbent Gauze :

Synonyms : Gauze; Unmedicatcd Gauze; Absorbent Cotton

Gauze.

Absorbent Gauze is cotton fabric of plain weave,

supplied in various width and lengths, The Gauze is bleached

and tree from any sizing, dressing or filling material. Tho

yarn used is machine spun cotton yarn, of suitable count

to comply with a bleached count between 17 and 25 tex

in the finished fabric.

Description :

Cotton cloth, plain weave with a simnle selvedge present

on both sides to prevent unravelling of yarn, the cloth is

bleaihed to a good white; is clean, odourless, reasonably free

from fabric defects and adhering sand, debris from cotton

seeds and leaves or any other foreign matter.

Threads

per dm ; Warp not less than

75 and

weft

not

less than 55.

Weight in g/m 2 : 30 ±

Length and width : Not less than 98 per cent each

thr length and width stated on the label.

Absoibcncy : Average

sinking

time not

more than 10

seconds.

Fluorescence : When viewed under screened untra-violet

light not rnpre than occasional points of fluorescence are

observed.

Foreign matter : Not more than 1 per cent.

Sterility : If sterile, the contents comply with the test for

sterility.

Packing, labelling and storage :

Absorbent ,Guu;e is folded and packaged with such ma-

terials and so secutely ns to protect its absorbency and allow

normal handing and transport without tearing and exposing

I he contents. The net content is stated on the label in terms

of length and width. The packages will be labelled prominen-

tly with the words "Non Sterile".

If sterile, it is so stated

350/1

on the lable, and the packing method and material should

be such as to maintain the sterility. The absorbent gauze must

also comply with the sterility Test, Absorbent Gauze must

be stored in packed condition, protected from moisture, and

dust.

METHODS OF TESTS

1. Defect in fabric

The sample is unfolded, opened and held against difused

day light and spread on black topped lable to locate

and

identify prominently visible defects in yarn and fabric con-

struction. The fabric shall be reasonably free from holes,

slubs, snarls and nnps as well as tho following :—

Odour : Musty odour, or any objectionable smell like that

of chemicals or materials used in sizing and bleaching.

Skewness : ffor Bandage cloth only) A condition

where

warp and weft do not keep at right angles to each other.

Defective Selvedge

The selvedge tearing and allowing yarn to unravel, and loop

formation at selvedge.

Crock's : Piominent streaks of space or gaps between warp

or weft yarns.

Double ends : More warp threads woven as one, due to

wrong draw.

Sloughing : Entanglement in the fabn: of a bulk, of yarn

that has slipped off the weft pfrn due to loose winding.

Measurement or length and width.

Length is the distance from end to end, along one edge

of the fabric, and width is the perpendicular distance from

one edge to the opposite edge.

Length :

Fix a metre scale to a table or mark off the division of

one metre on a table edge, Starting from one end, spread

the fabric flat on that table in a single layer keeping one

selvedge parallel to the scale; smootheu the fabric without

stretching it to avoid creases and mark off with a coloured

pencil, on the selvedge exactly one metre. Shift the fabric

and

measure in the

same

way

the

second

metre

and so on for the entire length of the fabric marking

mark at each metre. Note down the total length in metres.

Repeat this at the opposite slevedge, as well as on

the

fabric folded approximately about the middle. The average

of the three readings is the length. For cut bandages,

one

measurement at the middle of the bandage by folding

length-wise will suffice.

Width.:

Lay the portion of the fabric to b* measured flat

and

sn.ujlh on a table, but do not stretch fabric except suffi-

ciently to render it creaseless. At the place where mark had

been made on the selvedge in measuring, the length measure

the perpendicular distance to the opposite selvedge with

metre scale. Note the width, repeat this at every mark made

in measuring the length, The average of all the readings is

the width of the fabric. For cut bandages, width shall

measured at every 50 cm., and average reported as width.

Threads per dm : (for samples not less than 15m.

Length)

Weft t

At the third metre from one extreme locate three places

one at about 5 cm. below the top selvedge, a second

the middle and third at about 5 cm. above the bottom sel-

vedge, all three in a vertical row. Take a rectangular plate,

(made of suitable material such as plastic or aluminium) with

the rectangular opening of 5 cm, x 10 cm. cut in it. Keep

the plate on the fabric horizontally so that the left 5 cm.

side and bottom (10 cm. side) edges of the opening coincides

with a weft and warp yarn respectively: count the number of

weft yarns within the opening for the length of 10 cm. Re-

peat this at the other two selected places, and note

down

the avcrrifie of three readings. Repeat this at every

third

metre in the samp'e and calculate (he average weft per dm.

Warp;

Keep the rectangular plate, this time vertically with left

flO cm. side) and bottom (5 cm. side) edge of opening coincid-

ing with a weft and warp yarn respectively. Count

tho

number of warp yarns within the opening for 10 cm.

and

note down. Repeat this for about 10 selected places in the

samples taking care that the same set of warp yarns is not

counted more than twice and calculate the average warp

per dm. Magnifying glass moulcd on stand may be used foi

counting.

For samples less than 15 cm. in length, locate as many

different places as the dimension of the fabric permits, the

total being not less than 10 for ouch sample, and calculating

the warp and weft per dm. as above. For cut bandages, all

the warp threads in the samples are counted, taking care to

leave 5 mm. at the cut edge, and weft is counted at every

50 era. ut any place about the middle of 'he bandage.

Wei^lith per unit area

Cut out pieces of fabric from the entire length of

tha

sample, representative placcs being taken from areas

every third or fourth metre so that Lhc total area of all the

pieces so collected is not less than 3 sq. metre for a sample

not Jess than 15 m. in length. Weigh the piece.* taken accura-

tely, and calculate the area and weight of all the pieces.

From the average area and average of weight thus obtained,

calculate the area pet sq. metre.

For samples less than 15 m. in length, take pieces in such

manner that the total afea of the selected pieces isⁿ°t l^e'^s

tthan 20 per cent of the total ;irea of the sample.

For cut bandages, pieces of 50 cm. in length, cut from 5

different cut bandages in a packing

should be taken and

weight calculated as an average of 5 readings.

Absorbcncy

Take a glass through of approximate size-height 30 x width

30 x depth 25 cm. with straight thick walls and flat bottom.

Fill it almost full with distilled water leaving only

about

5 cms. from the top rim of trough. Maintain the water at

27 "C.

Cut out from any five places located equidistant down the

length of the entire sample, square pieces, each weighing a

em.

( + 10 per cent).

Fold each piece in such a manner

that a square of approximately 5 cm. X 5 cm. is obtained.

Keep one of the folded test speciments between two

glass

plates and place 1 kf

weight on the top for 10 minutes.

Remove the weight. Lift the specimen with ferceps and gently

•?lace it on to the surface of vvater (the specimen should be

'ightly pinched in the middle with n blunt forceps having no

;errations). Simultaneous to the specimen touching the water

surface start a stop watch which is stopped when the entire

sample disappears below

the surface of the water. Record

the time taken. Repeat the test with the other four test speci-

mens. Calculate the average time in seconds.

Foreign Matter

Dry about 5 gin. of the sample to constant weight

105°C and weight the dried sample accurately. Extract the

dried sample with chloroform for one hour'in an apparatus

for the continuous extraction of drugs. Remove tho extracted

sample to a beaker and allow the evaporation of

residual

chloroform. Wash the material 12 Umes with hot

water,

using about 10OO mg. for each washing and wringinji

the

material by hand after each washing; pass all waters through

a fine sieve (100 mesh). Place the washed material and any

loose threads or fibres from the sieve in a beaker, cover with

a 0.5 per cent aqueous solution of diastase and maintain at

50 °C until free from starch

Allow to cool, filter the solu-

tion through a sieve; return sample and loose fibres to a

b'akcr. Repeat the washing process as before with, hot water

Dry the material to constant weight at 105"C, and determine

the loss in weight. Calculate the percentage of foreign matter

which is equal to the loss in weight, with, reference to the

sample dried to constant weight at 105°C.

Tf the sample is tested with indine and is known lo

tiee from starch, the treatment wirh solution of diastase and

the second series of washing with hot water may be omitted

350/2

THE GAZETTE OF INDIA : EXTRAORDINARY

[PART II—§EC. 3(i)]

Specifications for cloth for manufacture of Plaster of Paris

Bandages; cut Snd uncut:

Synwnyms.:

Bleached Bandages Cloth for

Plaster of Paris;

Rolled

Bandage for Plaster of Paris.

CLOTH FOR PLASTER OF PARIS BANDAGES

Consists of cotton cloth of leno weave made from

yarn.

It may be supplied cut or uncut of various

widths

and

lengths.

Description

(a) For uncut bandages :

Cotton cloth of leno weave, in one continuous

length

showing no joints or seems, and with sejlvedges. The

cloth

is bleached to a good white, is clean and odourless and reas-

onably free from weaving defects as well as from seed and

leaf debris; the cloth may be dressed if necessary and if so,

shall not dust off when unrolled.

(b) For cut bandage :

As for uncut bandage except for selvedges which shall not

be included and the bandages shall be cut evenly with straight

edges and be reasonably free from loose threads.

Threads per dm :

Warp : average not less than 150 dm; and weft: average

not less than 75 dm.

Weight in gm|m 2 : 35 ± 5

Length and width :

The length and width for uncut bandages shall not

less than 98 per cent each of the length and width stated

on the tabel. For cut Bandages a tolerance of + 5 cm. in

length and + 0.5 cm in width may be allowed, and each

of the bandages in a packing complies with these requirements.

Fluorescence :

When viewed under screened

ultra-violet light not more

than occasional points of fluorescence are observed.

Paking, labelling and storage :

Bandage cloth for Plaster of Paris shall be packed securely

so as to allow normal handling and transport without tear-

ing and exposing the contents. In packages of cut and rolled

bandages, each bandage shall also individually be wrapped

in suitable paper. The package shall be labelled as "Cloth

for Plaster of Paris Bandage". The net content is stated on

the label in terms of number of rolls and length and width.

Bandage cloth for Plaster of Paris must be stored in packed

condition protected from dust."

[No. X-11O013/8/81-DMS&PFA]

R. K. SINGHAL, Jt. Secy.

PRINTED BY THE MANAGER, GOVT. OF INDIA PRESS, RING ROAD, NEW DELHI-110064

AND PUBLISHED BY THE CONTROLLER OF PUBLICATIONS, DELHI-110054,

1982