‘vfangt & Sh weP-33004/99 The Gazette of Gudia EXTRAORDINARY ‘URI —Wvg 3—30-aUE (i) PART I_Scction 3—Sub-seetion (i) ‘wafiraare wafer PUBLISHED BY AUTHORITY #. 108] 7a fee, GRA, WA 7, 2003/7 16, 1924 No. 108 NEW DELIII, FRIDAY, MARCH 7, 2003/PHALGUNA 16, 1924 REGD. NO. D. L.-33004/99 Jere ait oftare aaron darter (Comedia Fatree a wat rains fee) afergerT ‘a feeet, 7 BFF, 2003 “arama, 198( 3 )—sitafa ar rar a Fem, 1965 = she ears a erie fee er ree ate ih ers errit rPafven, 1940 (1940 9H 23) Wh ar 33—— wh TEE oH Hs TONER, ovemeTeG, OTH, GE 3, THE (i) rita 13 arte, 2002 Am, a $56 (29)" re afee farm rn oa ee a at maf @ foes se wafien SA en ita ite gare te me ae a sa rH Ce te a Fea a Rp a TET ses fer enh sera a Gt rel Mert Fea a aa Be re Fre ee TIT atc oan area stig mnt 13-86-2002 ram ah aero Ba TE re an rece vei Hea Bates mt fhe yer Set ae gr fae a rere Sree, 9, Sore rear sas afer er 35-3 gro Re aera aT ee es se ET a FE, 194s sar sieves 5c fore Prefers Freer aera, seh 1&4 fret om afte ota ste emers ama tte (ivi) Fre, 2008 &1 2, A safes 9: more sere en @ wep FA 3. sufi sie wees anf rem, 1945 3%, (35) Fr 155 i aren Freier sin: eatin Fem aren, tei: — “ss oma, feng site art staf i ara fafrator acer a arene waror ut :— ong, fez Tt “Sf Fest hore Pont esr (safc, ) a wa A orate Yat Fen et ore” ates orp, fs ster sat ore fain ae ontarll er ore eR #1" (ea) Freer 157, ak (1) woe fear ia ener fara -sren, ra: — "(a samp, far wi 7 ita at sre faba he a mara a A fee orcas a SOT TET aT atm, Fare ae Pamir ca Paes oreeicora cla rrad sores eT Sige mnferaTa argya a" oT seams Se mem cy, 3 Tew afr re ese a6 1 a a ae” Job «2008 w2 E ‘THE GAZETTE OF INDIA : EXTRAORDINARY [Paerll—Ser. 34 (1) er 26 een Freie ee vin: ene Fey an, te — WHF 2651 (Pram 155-18 frm) ee acer ssenfery fear ar & fi se wen fata ees: ogee, a eget ay & ie Feat sage " "ahah nes ah frm, 1988 ore atten orga ome, fae we hottie wt ore Fehr aT aH Stel at egret eet cag ser ao wed fe Pace onirer wetted oe, HG she tah a Fer orga wert CD Sepest a” Se cers ee Frenette can arte, ate — fae ti aurgitfea;, Pacg atte qart attaftrat a fora ares faPrater wreerat ‘eater on afar ah Ss ferg sm oe rr 2 ore frat ata (ot fs) Perens or 2 (i) strobe 5 Patria 8 ga eee rec earth eich at 8 she ean a a, (i). abo a atiren et, ah net wh eae cA sf ft oe Gil) wah wenferdt frebr sa fae or Civ) tre Fatal situa ot are fora Paved ome t, sar sentra att, Cv) Secarieg axkedi a ga et fine, wrist atqefinenen that & fat & feng det waft Para ote sats wt freee ae Ftp Piva Ss ea erin Ser he Prenton Pres fee Ta SET | ‘ea, cia Ferre Sate afte aiff, 1970 % swe eftge fre she wate she at end ta are atl at oftafirat teh € othe det otafind a arr 8 fra ae a , ore Fabri wefec CLP) 88 a Wee 1 ara Pafrrator weeferat warcarar afta: ‘ean wet 8 eaten fara ers es — G) ait erat a sre wen sie ere; (iD) Peat ser a, Git) Rafe Free orp; iv) tame eH; (v) araterg; (vi) sree arevstiafe sereLan ars 5(i)) SA TT: ATTEN 3 11 Brerear apa — 1.108) safe ats waar argon, Fre tte fh aha Fen fer smc sera ye were fers sth oer fryer vee aT ‘ie Fre’ erage ees we, Te, Het WaTeTa Fret 8 ace eiceM a erara ea, fra ore UT ‘phe ster oa are tee, er jan Freer #1 14 Ca) oR: cert 3 Fr ga an a eA red ere eal a sti ar oe sh Ag Te MeN aA, Fe apr see es wr erry ar fg athe em mar eer sel eh Fai, seer tia a ao rr fore ep fe reer entre ae sue yee HA me ee Se refer th, Far Pr: CO) as ote Fate aires, wh see arse ert gy ofr A wt oH, PETA SL G9) TRE aC erent safer sth eke ears sf aba eam a wae Ra ee A, Fee fr ‘afin stefan oe eigen oro A fie oe SHR & er on wr she one Shafi ar wena ge sae ioe ah tf se Ft Pry Pte aco Os ge a Bs flee & ar a cal Gi) THAT Ae rv A lw he fare once, aR ihe gene eh tet ere (Ras, wr othe Ba) Fert ei she ceed ae wh fred ok aera See he retin Pra a in fer bier rt & eat hates we ae ees Va ah er fara oe mere este Be Sto ‘fara Ser RT reir wea stain oa Ew | iy) ete aa agp ne Pre sent terre eh Fn sda A eraser el rhe Pe Wan Bafa othe efter FA Co) 8A argue th fev st wer oa at we ce erry ey Fy Pre te og Pra fey vate erent att art afi CD Te Te A anfhe ote a gfe Fence He re: Gai Taree tet et STE sete stor sr fore freer a; fare oa a ern ort, TRS fer pre ar Cor atte ae eer ghee wet, sora Te fer, Man ory a gra HP elgatatiage ont 8 fers eh 14 (4) warmer: ‘ert Hg et ea tte Bm wenftret wer ete after at en a fer arth at water ore a 41 (8) arate ar eer: fafa equ ate wetrerensH a rain esther orae ert, forr’ atari on cher ere aE Hg TE aa f, Bre fier SET 1.1: CS) smart ated : Facer, ret sre Ba vit ate, eine ste seta! & ovate wh oheedfeen aaeh ne ifs at act &, RS errata ewe he eT fer rhea res A gery ees ore = TL 11 (a) War: earth a erate er eh sie eters Se ster Pen eae EIA Aa wed aren, een eh site tan sere & stereo & fore gery ah er HT 11 Ca) (31) are arent fe Fear hr st ere fiw ene eh were sft Fen rer fa, seg site sre fry te eh fa Wega ee eri see nore er fare 2B aha omer Be wet a fates wT aH “eer a ree ah ea pe heer eh ene tre, perithe eigen arte ote ate ery one rn pce Bah4 THE GAZETTE OF INDIA: EXTRAORDINARY Prt Se 300) rarer 1a ape wa ea Ae fee et Fee teeta shh at oven ah, aro a atari ah afin are a TT yan aa frsntrn fem ar cee t faree Pe sep afer A azar va const ah serON een on Re aes a ETE 28 orem, ster a Sai stfieers ae Presfafern fatie wel wh aeeth aeafiredl & were} & fey eres ae 1) ers ert west ar 2) abergret weit arnt G) Taser (4) aoltorst afeat (3) Wise afesi ar sete (6) sage, ont (7) were tevgin stegara (8) Ten aine trent ate waqeeartire carat ar ster forge aes soar ah et ae a wafiee ws Boe a MEA A wet MEAT TTS, we a Beefs ere te ae a saeata Ba" epore a agen”” see ore Mere TT A freer tn dare a a Tate a, te er ws wh te eA fre era a wet aC wT “ak ret orate fs gt fore ort ste a ora we we one, fa ote ral (ener Prt ‘wart wafen) gern rere ge apie serene wea wearer mT He Ser eT HT INET TAT TTT ied smh seep wet ere wh, se eee share fe er ee he eH OMT TTI seat ara & fag “ord srry, wea aT” fine srg wt neh sa wed aH wt wn, ter she set at srediptt she ov rfita ca ont 14 (aX at) dfarrannh : -aot fin raid da ho, aa, Sree ane ghee ws 8 senfer at arer | et soe te ates seaTe tira gd vata oa ary fg ot sis Gare! 31) C8) are mTeT tae ‘wear a Bas Bee rer a rahe i Hs wee aie” Pan eB he rem ee weitere “aren yee ret sere ite at etre er wt eT es ir archer ert Fer tare wear weer ween 8 erat pe tee ee, ae een fee He an” a Sa eo aE Bere apts tore rer ah ft frre tsi sree fre ae frre fie aA we sea Te SAT a Pt aris, fir atte aartt than Bs eg frie stereo ei a sere She & a a Te ETCH oTeTET ‘afta ordeal oareen et ome 1.1 (8) SRO: fai da fet ot fir eget ove ate ea, fre rg reer Petre fr er, 3 rere eT ey wan ear (Pinte entice) wt exec at ach, fae fis asthe elon cerca ah Gene TTT he Pati shed, aol ara 3 sree rer on? 3 Pines otf ah =p an Fra on ws site shir eT GA atric reign ah carer we Priam fer or wie a fs se eee a Pata, serfs a ad send wet AACR) Te RAE, AHH, PTR AT ATTA: ‘are Prine ao ocean nt aya afar rea are a phe rerarg feng aeER Eh 4 He te ees GA eB sient va tee ere, fe te Fe Fe rea fee ore GA eo TCT Fe ferq sate ghee IR eres are, wert ote ah ae aT Sato eM are sa ore gee ote eT rT “ar Fa a 35 germ 2 area at ere at ae he heer ec caree eB ee eae eA tat ah ora ea wee fy ote ara} sahara Tae wD cea fry ot Gent a ora eh(oars 3(i)), TTT 2 TTT 5 224 CW) Fatarar de: ‘faPraten Prevferora wi sft eqerear ait :— Cm) waftres sere Ferg vain Grad; (ax) mented Prt sare Peers te site was Teer Te A ees a fet soem Pahoa sree tee ah Rete he 8 ciara 8 he, BH Oa a Taree aT rH Sa afi TA TEAL 1.18) velit atte area: “tier rr it Faire are ape Pink ae Peat Pe fre we en ot = rear ay sree (Peg at rer aren) ser eH Ren wee, ern TE aT TA sie feat aire Beers, ey, ee, er, rT, ak, Petty, eA, oe, Seer eT te er on A Se faa a Ete era eT Tera fie th TT eH A eal cometary RT AT Fecha en eh erat rhe wafer es 8 ae er BAe Ra gre Eee ah oeeRT a aT “59 ea iva ren att fe rene Tare re ome vate fe se a mata wt wT 201 wef fret Tart | year rats at erg, sree afte worl Preen fre wafera are, wd eT wfivary orftrefiza wt omit efi | 1.102) tre fant siftreter : _rfierart Fah are (re PR otf sree) = ver Oar aR TR Fe TAT, fg she art tier tanh Pa fbn cal PP set A welt at a at wer 8 sr send et edly, Peter Pre some hr loge wee, eae, Stes eer tees tea SR aes eh a site she emer a re, 1940 (1940-3123) weet TTA T whe ong, Fre Sea wt itn eet Pre wr Sea Pra on tet we soko ere et eee ee tee aT, Farge tag ore Fer ra Ser adhe EA safer we See at eer Peer os ST area woe eaten A ee wee aT a He ies, a NM, sat Bae skafea w ak sheet wt den cc, exe, re PPh Bs cor Bw aes Fai tr a er ae Fe “a ath eg afer ea re eo Pret le ore Fra TT fais sel, werd, oer oe att srfaften eter Ss Peter Borge, Fafere oer wiv 8 safer eH Seat ardte, orrerfig, sett ote srerdt i saree Tan aT seer eT aE 1.18) Pear after: aera ste gd Tee TT HITT a HCA aH Gh 8, A srrTeT Bone, Pre te ee atti Bs ea Bs fae ath for her aa er aR ora hc ere A tr A ae | He, ae, Ed, fgg, SRY, Tae ane eh Ge, Pc ot aA a wer wert A eae mere ehh, es Pt era Br eee et ear ar A ra: Tae PR as an ah Ta A nrc Tei #1 11-8) ara Rererrarit at afters: ‘eet, ror fee fry Secret seiner se ar rere ah Fete a Serer HCA Be fre Tes eFoTEST “radi feaPaften elt aro Rare we ares Bs sitet, sa Free wife Parham ra Fg Te orra a he wT een ear Freer a reg Ns Fret pee ae ar freer wit ea Fart wre are at ree A ea, ae TAT et aA et wera ar afar ft eet afore, te Pt ot hers then Frere fre, sare eT | : ster faPrmter re arti, Fae ote at ated Bet By ftorreecs fet wrath fea Be re ‘eas yer afereze renee, Pate Flt fren er a reer ee Fear Pesrer & ferg wen hs eee Fee Fee ae arord ote aen tet afttioend ered F oe OF fired & ar ae ar ete tt6 ‘THE GAZETTE OF INDIA : EXTRAORDINARY Parr Sec. 309} 1.1.) weer Privo : sete organ & ore at et & Fs a ore tft Har ea Br agen weer steerer fy enya et Fron argu fag fe saeren ET te, oT, Fc ste pA hr es Bs gee eT ‘seer &, dh Fran fete star er Be ore Far wfc fr argu eR, ‘erat er aearey, secatinar wenfech a ier arttery tke Roe are sent er Fede ken Alea are sisrostarar A Fremet at on wet #1 sifeerra: 38 afer’ Ptr Ferg ew gee fries Rot wae Pretzer org referers aftemd er, sre s— 1 (1) eater Firm argurn sf 150 er ge aH da va ! (2) wet ate at rant fare Per ger ote Pa ee nt aE 1 (3) ftir afar fre Para after ca ont fire i (4) ee zene ery He ry we a ee ae Pree ae re wh er Tes Tat TGA (5). 5 eel a ars onda erst ref, ond te rere rae ote tae seme ca 8, wake ree ie wt unter eT (6) sthafirdl & fre Prartt ong werent stk woe srtensit a sft TT (7) 8 Rae, sh Be es rer, Frg, rt ah an Ft eck, dec shia mr ort Frrott fear afte Freie Patter were we (2) Pa Fafa ste aire rhe, sag wren” aa ath ge" ne it fa ERT sind arte afer aie car oTeT (9) ear, em ate I Fre Ta rT we, oT OTB Hea thf engi, Are hee ‘ait 8 earn amar a oq me, sper Pra eT . ° (10) a ara aretha ar Re eigen a ae aw fe @ we, sha ever A fore tex fazer one (11) entire Pree arp 3 a 8 apn Pear een BAA GG) mR af, Fare ae, sett Faoen Seta eng are, 1970 (1970 wr 48) a orga 2 srieraramare sae Frat seat 12 ara ae after Se a ete Fe re TEAR Perce fara Fearn reer order, ae kee er era rere we he # Gi) fatter qe st ere 3 (ii) Fae fen ener Paeiam sre ete Preseargere A enteral Fria ‘sri feet arrears orgs Fre 8 art teh ween & tate afte ener ah safe fre 16085 Bore acer gre Fra Git) ergata ah rf ead at ast er 2g) sacha 1.2 Proffaroy zeae & fee arta: 1.2 (a1) fafrator aa: fretiar, oar fee, ert te fe ori Fain fore RA gers weft da at reer at met a PAPAS. eo 8 pe es & fay saree ara er Sa Ae Fre Te wt eee rt ote eee eS HEA TT ‘oem ag were ene en HRA a aH fe ei ara Fam Fer aren, ga ater tenia ae ara Freier (a freee) ae ara @ Pretier frarare ate Oh arty Se eae a Ten are TCC Freicel a ear weno fares st aie at ret stk sats Trem athe: ier afer cer ace Protery Bea ase re =A, eee ath ‘ase at we & Ferg. safrter Frater Pray fata fre et gti, Fc sh apie fan a ar Sitoarett & chars Afters Heer ard feet orem BS ase & oho at sia-eentia area a wie = or ht sm fine var ome(arr n—as 30) STU TH | NTT 1 aa are wie sage fe at hr ats Hh Pa a te okt ah fle gare at 9 eet te iva Fa este 58 aioe fer en et omg, firs oe er tetas Fafa aoe, fare ok si omer Y Prfterea fivaran Tevet, et 2 rome, Praia fare sire somal 3s el & Fe eet rene watson wwe PAT TT | aft ea Protngpa send st a, ee eee ‘eer a waft Par ore 123m) dquo atte Rearor as oferta rat: (5) eaten we 8 ern re Bs ere ke a Patni se ert a Poon aed Ae ETT TT (9) arene Oa Se eae gle Core wT eT CT nya Frome th teen we (8) Prtergy seael 8 ere ete seme Preteen ag wana wt after oT Ce) Tabet as at drepret end ais at ore oth tee al a srt GEST site Tare arin a atom at ret ore (3) wet ote amet tet ore srern sre A sr re ea Fi eed ig Ag a “afte 8 fe Pr sear aa eaves you A en wt emt (ce) argent ora rps wert te, sta ifs frre yl ifie seo B aeci SeOTT at ie A ite erm A sec ener 8 ores eon ee fir Probe free ofr es ree, ara okey, fea, Te, fear ote Prob 38 ae 38 ore ih oe seer an TET wea (a) agi, Fre att at ate Pes see Fam Be fr vata a rise tn, seme ste ATO fafrato feed a ah trie eet ere aes eee har Fe ee fafa Be ere ween at on i oe ce faired a orci ahs, ai tee sree sw ion wa ire at sad, staf ar ser orifeen =e ‘ae weitere Fare fafiato ear ferefen at gt 1 2 3 4 ste roe fuuwifes pecs nf Fro cafes, sreerfica asi ae unt stuf at afer fafa at ot Fhaoowi rem afters oe sta on 1, sieeve roo wi ge merhigerteten wee ws crvaTe Fret‘THE GAZETTE OF INDIA : EXTRAORDINARY PaarllSoe. 309) 2 qinerie eet sia fe at th Pe ph vevervaidien, wevEy Reaper atteternes wart WVIAC TS ERT ore fare eer reese teva 3 200ml ye 10 wi ge som ge wow ge 100 wt ye 100 wi ge 00 mt Fe som ge 200ml Fe 100 7 Fe roo wi Fe root Fe 4 tren fratrveeaarser Frm saree ere are Fire, xem Freon dinars fio aa, afore, werea ae, Petal at gene stare feng TIT stefan at a Pretan fer pa UTR Rese fre) wet aT A wed, water ae bv eRe, Fert ‘Rete Te, a we, Pree (Fre tae) WEARER, Pree dan, wee aa arate ie % fire Freat % ay, Prter firs, WE TR wert, Bate wie wher, wv Afier ath fafraten were Freer: ten site weer She stogren tit SRT, Frater, nba er, a sors he wera eT! 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FR. 648( 91) THE 16-9-2002 Bre fire re‘THE GAZETTE OF INDIA : EXTRAORDINARY Par Sec 300] MINISTRY OF HEALTH AND FAMILY WELFARE (Department of Indian Systems of Medicine and Homoeopathy) NOTIFICATION New Dethi, the 7th March, 2003 GSR 198(E)— Whereas a draft of certain rules further to amend the Drugs and Cosmetics Rules, 1945, was published as required by section 33-N of the Drugs and Cosmetics Act, 1940 (23 of 1940), in the Gazette of India Extraordinary Part - II Section 3, sub-section (i) dated 13% August, 2002 vide GSR No. 566(E},- inviting objections and suggestions from persons likely to be affected thereby and notice was given that the said draft will be taken into consideration’ after the expiry of 45 days from the date on which copies of the Official Gazette containing the notification were made available to the public; And whereas the said Gazette Notification was made available to the public on 13.8.2002; : And whereas objections and suggestions from the public on the said draft have been considered by the Central Government. Now, therefore, in exercise of the powers conferred by section 33-N of the said Act, the Central Government, hereby makes the following further amendments in the Drugs and Cosmetics Rules 1945, namel 1. These rules may be called the Drug and Cosmetics (Gri Amendment) Rules, 2003. 2. ‘They shall come into force on the date of publication in the Official Gazette. 3. In the Drugs and Cosmetics Rule, 1945, (a) after rule 155- the following shall be inserted, namely: “155-B Certificate of award of of Irves The certificate of Good Manufacturing Practices (GMP) to manufcturers of Ayurved-Siddha or Unani drugs shall be issued to licensee who comply with the requirements of Good Manufacturing Practices (GMP) of Ayurveda, Siddha and Unahi drug as laid down in Schedule ™.(eres 3) Si TTA : ETT B {b) in rule 157, after condition (1), the following shall be inserted, namely: *(1A) For getting a certificate of Good Manufacturing Practices of Avurveda Siddha-Unani drugs, the applicant shall make an application on a plain Paper, providing the information on existing infrastructure of the manufacturing unit, and the licensing authority shall after verification of the requirements as per Schedule “T", issue the certificate within a period of 3 months in Form 26E-I", (©) after Form 26E, the following form shall be inserted, namely:- “Form 26E-I (See rule 155-B) (Cortifieate of Good Manufacturing Practices (GMP) to manufacturer of Ayurveda, Siddha or Unani drugs): Certified that manufacturing unit licensee, namely situated at State.: License No. comply with the requirements of Good Manufacturing Practices (GMP) of Ayurveda-Siddha-Unani drugs as laid down in Schedule T of the Drugs and Cosmetics Rules, 1945. This certificate is valid for a period of three years. Dated: Signature . Designation/ Place: Licensing Authority for Ayurveda/ Siddha/Unani Drugs.” (d) for Schedule “T", the following shall be substituted, namety:- “@CHEDULE ‘T’ (See rule 157) GOOD MANUFACTURING PRACTICES FOR AYURVEDIC, SIDDHA AND UNAM! MEDICINES ‘The Good Manufacturing Practices (GMP} are prescribed as follows in Part I and Part Il to ensure:- (i) raw materials used in the manufacture of drugs are authentic, of prescribed quality and are free from contamination; (i) the manufacturing process is as has been prescribed to maintain the standards;a ‘THE GAZETTE OF INDIA : EXTRAORDINARY_ _ [Par l—See, (i)] (iii) adequate quality control measures are adopted; (iv) the manufactured drug which is released for sale is acceptable quality; (vy) to achieve the objectives listed above, each licensee shall evolve methodology and procedures for following the prescribed process of manufacture of drugs which should be documented as a manual and kept for reference and inspection. However, under IMCC Act 1970 registered Vaidyas, Siddhas and Hakeems who prepare medicines an their own to dispense to their patients and not selling such drugs in the market are exempted from the purview of Good Manufacturing Practices (GMP). PARTI GOOD MANUFACTURING PRACTICES Factory Premises: ‘The manufacturing plant should have adequate space for:- () receiving and storing raw material; (i) manufacturing process areas; (ii) Quality Control section; (iv) finished goods store; () office (vi) rejected goods/drugs store. Lat General Requirements: 14a) Location and surroundings: ‘The factory building for manufacture of Ayurveda, Siddha and Unani medicines shall be so situated and shall have such construction as to avoid contamination from open sewrage, drain, public lavatory or any factory which produces disagreeable or abnoxious odour or fumes or excessive soot, dust or smoke. LB) Buildings: ‘The building used for factory shall be such as to permit production of drugs under hygienic conditions and should be free from cobwebs and insects/rodents. It should have adequate provision of light and ventilation. The floor and the walls should not be damp of moist. The premises used for manufacturing, processing, packaging and labeling will be in conformity with the provisions of the Factory Act. It shall be located so as to be:{an I—ws30) ATT: TTT (i) Compatible with other manufacturing operations that may be carried out in the same of adjacent premises. (1) Adequately provided with working space to allow orderly and logical placement of equipment and materials to avoid the risk of mix up between different drugs or components thereof and control the possibility of cross contamination by other drugs or substances and avoid the risk of.omission of any manufacturing or control step. (IM) Designed, constructed and maintained to prevent entry of insects and rodents. Interior surface (walls, floors and ceilings) shall be smooth and free from cracks and permit easy cleaning and dis-infection. The walls of the room in which the manufacturing operations are carried out shall be impervious to and be capable of being kept clean. The flooring shall be smooth and even and shall be such as not to permit retention or accumulation of dust of waste products. (VY) Provided with proper drainage system in the processing area. The sanitary fitting and electrical fixtures in the manufacturing area shall be proper and safe. (¥)_ Fumace/Bhatti section could be covered with tin roof and proper ventilation, but sufficient care should be taken to prevent flies and dust. (vi) There should be fire safety measures and proper exits should ke there. (vily Drying Space:- There be separate space for drying of raw material, in process medicine or medicines require drying before packing. This space will be protected from flies/insects/dusts etc., by proper flooring, wire- mash window, glass pans or other material. 2.44C) ‘Water Supply: ‘The water used in manufacture shall be pure and potable quality. Adequate provision of water for washing the premises shall be made. 1.1(D) Disposal of Waste: From the manufacturing section and laboratories the waste water and the residues which might be prejudicial to the workers or public health shall be disposed off. + 1.48) Container’s Cleaning: In factories where operations involving the use of containers such as glass bottles, vials and jars are conducted, there shall be adequate Srrangements separated from the manufacturing operations for washing, cleaning and drying of such containers.THE GAZETTE OF INDIA: EXTRAORDINARY. Pant Sec. 36) 1.107) Stores: ‘Storage should have proper ventilation and shall be free from dampness. It should provide independent adequate space for storage of different types of material, such as raw material, packaging material and finished products. 1.1(F(A) Raw Materials: All raw materials procured for manufacturing will be stored in the raw materials store. The manufacture based on the experience and the characteristics of the particular raw material used in Ayurveda, Siddha and Unani system shall decide the use of appropriate containers which would protect quality of the raw material as wes prevent it from damage due to dampness, microbiological contamination or rodent and insect infestation, ete. If certain raw materials require such controlled environmental conditions, the raw materials stores may be sub-divided with proper enclosures to provide such conditions by suitable cabinization. While designing such containers, cupboard or areas in the raw materials store, care may be taken to handle the following different categories of raw material:- (1) Raw material of metallic origin. (2) Raw material of mineral origin. (3) Raw material from animal source. (4) Fresh herbs, (8) Dry herbs or plant parts. (6) Excipients etc. (7) Volatit2 oils/perfumes and flavours. (8) Plant concentrates/extracts and exudates/resins. Each containers used for raw material storage shall be properly identified with the label which indicates name of the raw material, source of supply and will also clearly state the status of raw material such as “UNDER TEST’ or “APPROVED” or “REJECTED". The labels shall further indicate the identity of the particular supply in the form of batch no. or lot no. and the date of receipt of the consignment, All the raw materials shall be sampled and got tested either by the in- house Ayurvedic, Siddha and Unani experts (Quality. Control technical person) or by the laboratories approved by the Government and shall be used only on approval after verifying. The rejected raw material should be removed from other raw material store and should be kept in separate room. Procedure of ‘First in first out’ should be adopted for raw materials wherever necessary. Records of the receipt, testing and approval or rejection and use of raw material shall be maintained.[werner 30) i So UE : TETRA 1.1(F(B) Packaging Materials: : All packaging materials such as bottles, jars, capsules etc., shall be stored properly. All containers and closure shall be adequately cleaned and dried before packing the products. 1.14F(C) Finished Goods Stores: The finished goods transferred from the production area after proper packaging shall be stored in the finished goods stores with an area marked ‘Quarantine’. After the quality control laboratory and the experts have checked the correctness of finished goods with reference to its packing/labeling as well as the finished product quality as prescribed, then it will be moved to ‘Approved Finished Goods Stock’ area. Only approved finished goods shall be dispatched as per marketing requirements. Distribution records shall be maintained as If any Ayurvedic, Siddha and Unani drugs needs special ‘stotage conditions, finished goods store shall provide necessary environmental requirements. 1.140) Working space: The manufacturing area shall provide adequate space (manufacture and quality control) for orderly placement of equipment and material used in any of the operations for which these are employed so as to facilitate easy and safe working and to minimize or to eliminate any risk of mix-up between different drugs, raw materials and to prevent the possibility of cross contamination of one drug by another drug that is manufactured, stored or handled in the same premises. 1.1(8) Health Clothing, Sanitation and Hygiene or Workers: All workers employed in the factory shall be free from contagious diseases. The clothing of the workers shall consist of proper uniform suitable to the nature of work and the climate and shall be clean. The uniform shall also include cloth or synthetic covering for hands, feet and head wherever required. Adequate facilities for personal cleanliness such as clean towels, soap and scrubbing brushed shail be provided. Separate provision shall be made for lavatories to be used by men and women, and such lavatories shall be located at places separated from the processing rooms. Workers will also be provided facilities for changing their clothes and to keep their personal belongings. plates 3 .“THE GAZETTE OF INDIA: EXTRAORDINARY Part 36)) 2.10) Medical Services: ‘The manufacturer shall also provide:- (a) Adequate facilities for first aid; (b) Medical examination of workers at the time of employment and periodical check up thereafter by a physician once a year, with particular attention being devoted to freedom from infections. Records thereof shall be 1.49) Machinery and Equipments: For carrying out manufacturing depending on the size of operation and the nature of product manufactured, ‘suitable equipment either manually operated or operated semi-sutomatically (Electrical or steam based) or fully automatic machinery shall be made available, These may include machines for use in the process of manufacture such as crushing, grinding, powdering, boiling, mashing, burning, roasting, filtering, drying, filling, labeling and packing etc. To ensure ease in movement of workers and orderliness in operations a suitably adequate space will be ensure between two machines or rows of machines. These machinery and equipments have to be properly installed and maintained with proper cleaning, List of equipments and machinery recommended is indicated in Part I A. Proper Standard Operational Procedures (SOPs) for cleaning, maintaining and performance of every machine should be laid down. 1.4K) Batch Manufacturing Records: ‘The licensee shall maintain batch manufacturing record of each batch of Ayurvedic, Siddha and Unani drugs manufactured irrespective of the type of product manufactured (classical preparation or patent and proprietary medicines). Manufacturing records are required to provide an account of the list of raw materials and their quantities obtained from the store, tests conducted during the various stages of manufacture like taste, colour, physical characteristics and chemical tests as may be necessary or indicated in the approved books of Ayurveda, Siddha and Unani mentioned in the First Schedule of the Drugs and Cosmetics Act, 1940 (23 of 1940). These tests may include in-house or pharmacopoeial test adopted by the manufacturer in the raw material or in the process material and in the finished product. These records shall be duly signed by Production and Quality Control Personnel respectively. Details of transfer of manufactured drug to the finished products store including dates and quantity of drugs transferred along with record of testing of the finished product, if any, and packaging, records shall be maintained. Only after the manufactured drugs have been verified and accepted quality shall be allowed to be cleared for sale.(or i—w53)) SES : TTT It should he essential to maintain the record of date, manpower, machine god eguipments used and fo keep in process record of various shodhana, Bhavana, burning in fire and specific grinding in terms of internal use. 1.4fk) Distribution Recards: Regards of sale and distribution of each batch of Ayurveda, Siddha and Unani shall be maintained in order to facilitate prompt and complete recall of the batch, if necessary. The duration of record keeping should be the date of expire of the batch, Certain category of Ayurvedic, Siddha and Unani medicines lke Bhasme, Rasa, Kupi-pakva, Parpati, _Sindura, Karp ap /puram, kushta, Asava-arista etc. do not have expiry date, in raat thet ef efficacy increases with the passage of time, Hence, records need fo be maintained upto 5 years of the exhausting of stock. 1,10) ‘Record of Market Complaints: ees shall maintain a register to record all reports of market complainta received regarding the products sold in the market. The manufacturer shall enter all data received on such market complaints, investigations carried out by the manufacturers regarding the complaint as well as any corrective aetion initiated to prevent recurrence of such market somplainta shall also be recorded. Once in a period of six months the manufacturer shell submit the record of such complaints to the Licensing Authority, The Rogister shall also be available for inspection during any inspection of the premises. Report of any adverse reaction resulting from the use of Ayurvedic, ‘Siddha and Unani druge shall also be maintained in separate register by each manufacture; the manufacture shall investigate any of the adverse reaction to find if the same is due to any defect in the product, and whether such reactions are already reported in the literature or it is a new observation. 110n Quality Control: Every licensee ia required to provide facility for quality control section in his own premises or through Government approved testing laboratory. The test shall be as per the Ayurveda, Siddha and Unani pharmacopocial standard. Where the tests are not available, the test should be performed according to the manufacturer specification or other information available. The quality control ‘sectian shall verify all'the raw materials, monitor in process quality checks and eontrol the quality of finished product being released to finished goods ‘store/ware house. Preferably for such quality control there will be a separate expert, The quality control section shall have the following facilities: (1) There should be 150 sq. ft, area for quality control section. For identification of raw drugs, reference books and reference samples should be maintained. (3) Manufacturing recard should be maintained for the various processes.‘THE GAZETTE OF INDIA : EXTRAORDINARY. [Part Sec. 9} (4) To verify the finished products, controlled samples of finished products of each batch will be kept for till the expiry date of product. (5) To supervise and monitor adequacy of conditions under which raw materials, semi-finished products and finished products are stored, (6) Keep record in establishing shelf life and storage requirements for the drugs. (7) Manufacturers who are manufacturing Patent Proprietary Ayurveda, Siddha and Unani medicines shall provide their own specification and control reference in respect of such formulated drugs. (8) The record of specific method and procedure of preparation, that is, ‘Bhavana’, Mardana’ and ‘Puta’ and the record of every process carried out by the manufacturer shall be maintained. (9) The standards of identity, purity and strength as given in respective pharmacopoeias of Ayurveda, Siddha and Unani systems of medicines published by Government of India shall be complied with. (10) All raw materials will be monitored for fungal, bacterial, contamination with a view to minimize such contamination. A (11) Quality Controi Section will have a minimum of: (i) One person with Ayurveda/Unani/Siddha qualification recognized under Schedule I of Indian Medicine Central Council Act 1970. Two other persons one each_~—with_—- Bachelor qualification —in Botany/Chemistry/Pharmacy could be on part time or on contractual basis. (i) The manufacturing unit shall have a quality control section as explained under Section 35 (ii). Alternatively, these quality control provisions will be met by getting testing etc., from a recognized laboratory for Ayurveda, Siddha and Unani drugs; under Rule 160-A of the Drugs and Cosmetics Act. The manufacturing company will maintain all the record of various tests got done from outside recognized laboratory. (ii) List of equipments recommended is indicated in Part II C. 1.2 Requirement for Sterile Product: 1.2(a) Manufacturing Areas: For the manufacture of sterile Ayurvedic, Unani and Siddha drugs, separate enclosed areas specifically designed for the purpose shall be provided. These areas shall be provided with air locks for entry and shall be essentially dust free and ventilated with an air supply. For all areas where aseptic manufacture has to be carried out, air supply shall be filtered through bacteria retaining filters (HEPA Filters) and shall be at a pressure higher than in the adjacent areas. The filters shall be checked for performance on installation and periodically thereafter the record of checks shall be maintained. All the surfaces in sterile manufacturing areas shall be designed to facilitate cleaning and dis- infection. For sterile manufacturing routine microbial counts of all Ayurvedic, Siddha and Unani drug manufacturing areas shall be carried out during operations. Results of such count shall be checked against established in-house standards and record maintained.(artis 3@) SRO TIT : TERT ‘Access to manufacturing areas shall-be restricted to minimum number of authorized personnel. Special procedure to be followed for entering and leaving the manufacturing areas shall be written down and displayed. For the manufacturing of Ayurvedic, Siddha and Unani drug that can be sterilized in their final containers, the design of the areas shall preclude the possibility of the products intended for sterilization being mixed with or taken to be products already sterilized. In case of terminally sterilized products, the design of the areas shall preclude the possibility of mix up between non-sterile and sterile products. 1.28) Precautions against contaminetion and mix: (a) Carrying out manufacturing operations in a separate block of adequately isolated building or operating in an isolated enclosure within the building. {b) Using appropriate pressure differential in the process area. () Providing a suitable exhaust system. (4) Designing laminar flow sterile air systems for sterile products. (e) The germicidal efficiency of UV lamps shall be checked and recorded indicating the burning hours or checked using intensity. () Individual containers of liquids and opthalmic solutions shall be examined against black-white background fitted with diffused light after filling to ensure freedom from contamination with foreign suspended matter. (@) Expert technical staff approved by the Licensing Authority shall check and compare actual yield against theoretical yield “before final distribution of the batch. All process controls as required under master formula including room temperature, relative humidity, volume filled, leakage and clarity shall be checked and recorded.“THE GAZETTE OF INDIA : EXTRAORDINARY. PART - LIST OF RECOMMENDED MACHINERY, EQUIPMENT AND MINIMUM MANUFACTURING PREMISES REQUIRED FOR THE MANUFACTURE OF VARIOUS CATEGORIES OF AYURVEDIC, SIDDHA SYSTEM OF One machine indicated for one category of medicine could be used for the manufacturing of other category of medicine also. Similarly some of the manufacturing areas like powdering, furnace, packing of liquids and Avaleha, Paks, could also be shared for these items. [Parr See. 3} Parpati, Category of Minimum Machinery /equipment Medicine | manufacturing space recommei : required. (a) i (3) 4) 7200 sq. ft. covered area with separate cabins or partitions for each activity. If Unani medicines are manufactured in same premises an additional arca of 400 sq. ft. will be required. 1. [Anjana/Pisti 100 sq. ft. Kharal/mechanized /motorized Kharal, End runner/Ball-Mill Sieves/Shifter. 2. | Chuma/ 200 sq. ft. Grinder /Disintegrator/ Nasya Pulverisar/Powder mixer/ Manjan/ Sieves/Shifter. Lepa Kwath Churn 3. | Pills/Vati/ TO0 sq. ft. Ball Mill, Mass Mixer/Powder Gutika Matrica mixer, Granulator drier, tablet and tablets. compressing machine, pill/vati cutting machine, stainless steel trays/container for storage and sugar coating, polishing pan in case of sugar coated tablets, mechanized chattoo, (for mixing of guggulu) where required. @,_|Kupi pakva/ 150 sq. ft. Bhatt, Karahi/stainless steel Ksara/ vessels/Patila flask, Multani Matti/Plaster_of Paris, Copperfort —we 3@)) SI TNT: TATA Lavana Rod, Earthen container, Gaj Put Bhasma Bhatt, Muflle furnace Satva/ (electrically operated) End/ Edge Sindura Runner, Exhaust Fan, Karpu/ Uppu/ Wooden/S.S. Spatula. Param 3. | Kajal 100 99. ft Earthem lamps for collection of Kajal, Triple Roller Mill, End Runner, Sieves, S.S. Patila, Filling packing and manufacturing room should be provided with exhaust fan and ultra violet lamps. 6. | Capsules 100 sq, ft Air conditioner, De-humidifier, aH hygrometer, thermometer, capsule filling machine and balance. 2 7. | Ointment] 100 sq, ft Tube filling machine,: Crimping Marham Pasai medicine/Ointment mixer, End Runner/Mill (where required), $.8. Storage container, $.S. _____| Patila._ SEEe | Pak/Avaleh/ 100 34, ft Bhatti with Khand/ ‘ exhaust fan and should be fly Modak/ proof, iron kadahi/S.S. Patila Lakayam and S.S. Storage container. 9. | Panak, Syrup/ 150 8q. fe Tinctum press, exhaust fan Pravahi Kwath fitted and ‘fly proof, Bhatti Manapaku. section, Bottle washing machine, Filter press/Gravity filter liquid filling machine, P.P. Coping machine. 10. | Asava/Aristha 200 sq. fi. ‘Same as mentioned above. Fermentation tanks’ containers and distillation plant where necessary, Filter Press. ii, [Sura 100 sq. fi. [Same as mentioned above plus | distillation plant and transfer pump. 12,_| Ark/Tnir 100 sq. fi. Maceration tank, Distillation plant, Liquid filling tank with tap/Gravity filter/Filter press, Visual inspection box. 13. | Tail/Ghnit/Ney 100 sq. fe Bhatti, Kadahi/S.S. Patila S.S. Storage containers, Filtration equipment, filling tank with tap/ Liquid filling machine.THE GAZETTE OF INDIA: EXTRAORDINARY. [Par S0c.369) 14. | Aschyotan/ 100 sq. ft. Hot air oven electrically heated Netra-Malham with thermostatic control, kettle Panir, Karn gas or electrically heated with Bindu suitable mixing arrangement’ Nasabindu. collation mill or ointment mill, tube filling equipment, mixing and storage tanks of stainless steel or of other suitable material sintered glass funnel, seitz filter or filter candle, liquid filling a equipment, autoclave. 15, | Each 200 sq. ft. manufacturing unit will have a separate area for Bhatti, furnace, boilers, puta have proper ventilation, removal | of smoke, prevention of flies, insects, dust ete. The furnace section could have tin roof.(err — wes 3(i)) AAO TIA: ATTY B. LIST OF MACHINERY, EQUIPMENT AND MINIMUM MANUFACTURING PREMISES REQUIRED FOR THE MANUFACTURE OF VARIOUS CATEGORIES OF UNANI SYSTEM OF MEDICINES. One machine indicated for one category of medicine could be used for the manufacturing of other category of medicine also. Similarly some of the manufacturing areas like powdering, furnace, packing of liquids could also be shared for these items. SW | Category of Misinam Machinery /equipment Medicine | manufacturing space recommended required | (4) (2) {3) {4) 1200 sq. ft. covered area with —_ separate cabins, partitions for cach activity. If} , Ayurveda/Siddha medicines are also manufactured in same premises an additional areas of 400 sq. ft. will be required. 1. [Terifal Tiryaq/ 100 sq. ft. Grinder/Puiveriser, Sieves, Majoon/Lavoq/ powder mixer (if’ required), Jawarish/ SS. Patilas, Bhatti and other Khamiras. accessories, plant mixer for Khamiras. 2. | Araq 100 sq. f. Distillation plant (garembic) S.S. storage tank, boiling vessel, gravity filter, bottle filling! “machine, " bottle washing machine, bottle drier. 3._|Habb (Pills) and 100 sq. ft. Ball Mill, Mass Mixer/Powder tablets. mixer, Granulator drier, tablet compressing machine, pill/vati cutting machine, stainless _steel__—_trays/ container for storage and sugar coating, polishing pan in case of sugar coated tablets, mechanized chattoo, (for mixing of guggul) where required. s.r (o3— 4‘THE GAZETTE OF INDIA: EXTRAORDINARY Paar ll—See. 340] unit will fave a ‘separate area for Bhatti, 4. | Sufoof (Powder) 200 sq. ft. Grinder/Pulveriser, _Sieves, Trays, scoops, Powder mixer a {where required). 5. ,[Raughan (Oils) 100 sq. ft. Oil expeller, S.S. Patilas oil (Crushing and filter bottle, filling machine, Boiling) bottle drier, Bhatti. 6. | Shiyaf, Surma, 100 sq. ft. End runner, mixing 8S. Kajal. vessel. 7. |Marham, Zimad 100 39. ft Kharal, Bhatt, End runner, (Cintment) Grinder, Pulveriser, Triple ie roller mill (if required). 8. | Qurs (Tab) 100 sq, ft. Grinder /Pulveriser, sees] power mixer (where needed), Granulator, Drier, Tablet compressing machine, Die “ punches. ‘Trays, OT. Apparatus, Balance with weights, Scoops, Sugar coatirig pan, Polishing pen, a Heater. 9. | Kushta 100 sq, ft. Bhatti, Kharal, Sil Bata, | Be Earthen pots. 10. | Murabba 100 sq. ft. ‘Aluminium vessels 50-100 Bhatti. ii. | Capsule 100 sq. ft. Pulveriser, Powder mixer (where needed), capsule machine, Air conditioner, De-humidifier balance with weights, storage containers, 12, |Sharbat and 100 sq. ft Tinctum press, exhaust fan Joshanda fitted, bhatti section, bottle washing machine, Filter press gravity filter, Liquid filling tank with tap/liquid filing machine, sir oven electrically with ‘Thermostatic camel: kettle. 13. | Qutoor-e- 100 sq. fe Hot air oven electrically Chashm and heated with Thermostatic Marham (Eye control, kettle. drops, eye ointment) 14, | Each 200 sq. ft. manufact(ws) CH TOT: FATT C. LIST OF EQUIPMENT RECOMMENDED FOR IN HOUSE QUALITY CONTROL SECTION. {Alternatively unit can get the testing done from the Government approved laboratory). CHEMISTRY SECTION {B) PHARMACOGNOSY SECTION ‘Alcohol Determination Apparatus {complete set). ‘Microscope Binocular. Volatile Oil Determination Apparatus. Lal seedling Mi Boiling Point Determination tus. Microtome ‘Melting Point Determination Apparatus. Physical Balance Refractometer. ‘Aluminium Slide trays. Polarimeter. ‘Stage Micrometer. ‘Viscometer. Rei) A) S| Camera Lucida (Prism and Mirror Type). Tablet Disintegration Apparatus. je ‘Chemicals, Giass-ware etc. Moisture Meter ‘Muffle Furnace Electronic Balance ‘Magnetic Stirrer. Hot Air Oven. Refrigerator. Glass/Steel Distillation Apparatus LPG Gas Cylinders with Burners Water Bath (Temperature Controlled). Heating Mantles/Hot Plates. TLC apparatus with all Accessories (Manual) Paper Chromatography apparatus with accessories.B ‘THE GAZETTE OF INDIA: EXTRAORDINARY. [Panr See. 3(i)] cC 21. [Sieve size 10 to 120 with Sieve shaker. 22. | Centrifuge machine 23. | De-humidifier 24. | pH Meter. 25. | Limit Test Apparatus Note: The above requirements of machinery, equipments, space are made subject to the modification at the discretion of the Licensing Authority; if he is of the opinion that having regard to the nature and extent of the manufacturing operations it is necessary to relax or alter them in the circumstances in a particular case. [F.No.K. 11020/5/97-DOCASM)} L PRASAD, It. Secy. Footnote :—The Principal rules were published inthe Official Gazette vide notification No F.28-10/45-H(1), dated the 21st ‘December, 1945 and last amended vide GSR 648(E) dated 16-09-2002. Prine by the Manager, Govt of India Press, Ring Road, Mayapuri, New Dethi110064 land, Published by the Controller of Publications, Defhi-110084 or ae