REGISTERED No. D. (D.N.)-72
The Gazette of India
EXTRAORDINARY
PART II—Section 3—Sub-section (i)
PUBLISHED BY AUTHORITY
No. 89] NEW DELHI, MONDAY, MARCH 22, 1982 CHAITRA 1, 1904
Separate paging is given to this Part in order that it may be filed as a separate
compilation
(347)
1470 GI/81
348 THE GAZETTE OF INDIA : EXTRAORDINARY [PART II—SEC. 3(i T|349
THE GAZETTE OF JNDf A : EXTRAORDINARY [PART U—SEC. 3(i)]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 ± 5
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 :
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 be 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 bo 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 be wrapped in a suitable paper'. The net content is stated on the label in terms of 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 ± 5.
Length and width : Not less than 98 per cent each of 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
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 a 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 it 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 a 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 be measured at every 50 cm., and average reported as width.
Threads per dm : (for samples not less than 15m. in
Length)
Weft t
At the third metre from one extreme locate three places one at about 5 cm. below the top selvedge, a second in 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.
350/1
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 at 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 is n°t le'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 at 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 be 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
Weight in gm|m 2 : 35 ± 5
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.
Length and width :
The length and width for uncut bandages shall not be 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 :
Description
When viewed under screened ultra-violet light not more
than occasional points of fluorescence are observed.
(a) For uncut bandages :
Paking, labelling and storage :
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.
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