CENTRAL DRUGS STANDARD CONTROL ORGANIZATION

(a) Central Authorities Under the Drug and Cosmetics Act, the regulation of manufacture, sale and distribution of Drugs is primarily the concern of the State authorities while the Central Authorities are responsible for approval of New Drugs, Clinical rials in the country, laying down the standards for Drugs, control over the !uality of imported Drugs, coordination of the activities of State Drug Control "rganisations and providing e#pert advice with a view of bring about the uniformity in the enforcement of the Drugs and Cosmetics Act$ Drug Controller %eneral of &ndia is responsible for approval of licenses of specified categories of Drugs such as blood and blood products, &$ '$ (luids, 'accine and Sera$

Central Drugs Standard Control Organization )ead !uarter is located at (DA *hawan, +otla ,oad, New Delhi --.../ and functions under the Directorate %eneral of )ealth Services$ Staff details0 Drugs Controller General of India Dr$ SU,&ND1, S&N%), 2hones0 ("ff$) 3-4--4/5/56367 (D) (a#0 3-4--4/5/56385$ 19ail0 dci:nb$nic$in Joint Drugs Controller of India A$ *$ ,amte;e, 2hone0 /5/5636<(D)= /5/56387 1#t 45->$ De ut! Dire"tor General #Drugs$ N$C Dhawan, 2hone0 /5/56386 (D)= /5/56387 1#t ? /-De ut! Dire"tor Ad%inistration #Drugs$ @ucas @$ +amsuan, 2hone0 /5//.338 (D)= /5/56387 1#t 4 5-. Asst& Drugs Controllers of India Aana; ,aB, 2hone 0 /5/56387 4 1#t ? /./ A$+$ 2radhan 2hone 0 /5/56387 4 1#t ? /.-

9rs$ 9anBula Chandra, 2hone 0 /5/56387 4 1#t 4 5-5 S$2 Shani, 2hone 0//5/56387 4 1#t 4 /-5 Arvind +u;rety, 2hone 0 /5/56387 4 1#t 4 5/5 Te"hni"al Offi"ers A$+$ +hanna$ 2hone0 /5/56387 4 1#t 4 -.7 Dr$ ,avi;ant Sharma, 2hone0 /5/56387 4 1#t ? 5-6C-/3 Somnath *asu, 2hone 0 /5/56387 4 1#t 4 -.-

ZONAL O''ICES O' CENTRAL DRUGS STANDARD CONTROL ORGANISATION #CDSCO$

he Central %overnment have established four Donal offices of the Central Drug Standard Control "rganisation at 9umbai, +ol;ata, Chennai, and %haDiabad$ he Eonal "ffices wor; in close collabration with the State Drug Control Administration and assist them in securing uniform enforcement of the Drug Act and other connected legislations, on all &ndia basis$ he names of the office4in4charge of the Eonal "rganisations, their address and names of the States are as follows0

EAST ZONE
Andaman and Nicobar &sland, Arunachal 2radesh, Assam, *ihar, Ahar;hand, 9anipur, 9eghalaya, 9iDoram, Nagaland, "rissa, Si;;im, ripura F Gest *engal$ 9$9itra, Asstt$ Drug Controller (&) &n4charge "Co Deputy Drugs Controller (&), Central Drug Standard Control "rganisation, 1ast Eone, C$%$"$ *ldgs$, (NiDam 2alace) Gest, / nd (loor, /5>C>, @ower Circular ,oad, +ol;ata ? 8.. ./.$ 2hone 0 "ffi$ 0 .55 ? //<8.7-5 C //<.-53-, %ram 0 ZONDRUG-KOLKATA. (a# 0 .55 4 //<-5<.6 14mail 0 cdscoeD:gmail$com Drug Ins e"tors %$ Nageshwar ,ao *$+$ Samantaray

(EST ZONE
Chattisgarh, %oa, Daman F Diu, %uBarat, 9adhya 2radesh and 9aharashtra$ Dr$ ,$ ,ama;rishna, Asstt$ Drug Controller (&), &n4charge "Co Deputy Drugs Controller (&), Central Drug Standards Control "rganisation, Gest Eone, >th (loor, Central (DA *hawan, %9SD Compound, *ellasis ,oad, 9umbai Central, 9umbai ? >.. ..<$ 2hones0 3-4//4 /5.3/38-C/5..//-7C/5..//83$ (a# 0 3- (//) /5..//8- 14mail 0 cdscowD:gmail$com Drug Ins e"tors Aayant +umar

Su)zonal Offi"e #Ah%eda)ad$ Asst& Drugs Controller Dr$ '$%$ Somani

NORT* ZONE
)aryana, )imachal 2radesh, Aammu F +ashmir, 2unBab, ,aBasthan, Uttaranchal, Uttar 2radesh, N$C$ $ of Delhi F Union erritory of Chandigarh$ Dr$ S$ 1$ ,eddy, Asstt$ Drug Controller (&), &n4charge "Co Deputy Drugs Controller (&), Central Drug Standard Control "rganisation, North Eone, C$%$"$ *uilding4&, +amla Nehru Nagar, )apur Chungi, %haDiabad ? /.- ../ (U$2$)$ 2hone0 "ffi$ 0 3- 4/8-3><5C/87..-5, .-/.4/8.-3/8 (D) (a#0 37-/. ? /8-3><5 %ram 0 ZONDRUGGHAZIABAD. 14mail0 cdsconD:gmail$com Drug Ins e"tors SanBeev +umar %ulshan aneBa Naresh Sharma Smt$ Swati Srivastava

SOUT* ZONE
Andhra 2radesh, +arnata;a, +erala, 2ondicherry and amil Nadu$ Dr$ D$ ,oy, Asstt$ Drug Controller (&), &n4charge "Co Deputy Drugs Controller (&), Central Drug Standard Control "rganisation, South Eone, /nd (loor, Shastri *hawan, Anne#e, /6, )addows ,oad, Chennai ? 6.. ..6$ 2hone 0 "ff$ .>> 4 /</8<-<6$ %ram 0 ZONEDRUG-CHENNAI. ele (a# 0 .>>4/</-5.83$ 14mail 0 roydHin/...:yahoo$com Drug Ins e"tors S$ 9annivannan *$ +umar A$ Sen;athir Sub-Zonal, *!dera)ad A$Chandra Se;ar ,ao, Asstt$ Drug Controller (&ndia), CDSC", Sub4Eone A2,Unit No$ -<, Second (loor, Cargo Satellite *uilding, ,%& Air 2ort, S)A9S)A*AD, ,, Dist$, )yderabad ? 7.- 7-<$ 2hone0 .>. ? />..</56$ (a# 0 .>. ? />..</8., 14mail 0 adchyderabad:gmail$com Drug Ins e"tor 2$*$N$ 2rasad

Assistant Drugs Controllers at +orts

C*ENNAI Shanthy %unase;haran , Asstt$ Drugs Controller (&ndia) ? 2ort, ,oom No$ /5, &' (loor, Anne#e *ldg$, Custom )ouse, Chennai ? 6.. ..-$ 2hone 0 "ffi 0 7/-/.>-$ %ram 0 D,U%C"N&ND 14mail 0 Shanthy$adc:gmail$com *$+umar, Drug &nspector, Central Drug Standard Control "rganisation, Air Cargo Comple#, 9eenamba;;am Air 2ort, Chennai ? 6.. ./8$ 2hone 0 //76.63<C/7/-/.>-$ COC*IN Shanthy %unase;haran , Asstt$ Drugs Controller (&ndia) Central Drug Standard Control "rganisation, 9inistry of )ealth F (amily Gelfare, Custom )ouse, Cochin ? 6</ ..3 (+erala)$ 2hone 0 .><>4666.>/$ %ram 0 DRUGCONIND$ DEL*I Sunil 9$ Aoshi, echnical "fficer, "Co Asstt$ Drugs Controller (&), Customs )ouse, &ndira %andhi &nternational Airport, New Delhi, 2hone 0 "ffi0 /767>>.<C/767/56.$ ,OL,ATA S$ 9u;hopadhyay, Asstt$ Drug Controller (&ndia), Customs )ouse, -7C-, Strand ,oad, +ol;ata ? 8.. ..-$ 2hones 0 "ffi$ 0 //>56<68$ ,esi$ 0 >5..586$ %ram 0 DRUGCONIND$ S$ 9u;hopadhyay, Asstt$ Drug Controller (&ndia), Air Cargo Comple#, N$S$C$ *ose &nternational Airport, +ol;ata4 8.. .7/$ 2hone 0 /7--3<7-$ -U-.AI D$+$Chauhan, Asstt$ Drug Controller (&ndia), 6th (loor, Anne#e *ldg$, New Custom )ouse, *allard 1state, (ort, 9umbai ? >.. .5<$ 2hones 0 "ffi$ 0 /6--736$ ,esi$ 0 7>-.5</$ %ram 0 DRUGCONIND$ (a# 0 /65>77.$ D$+$Chauhan, Assistant Drugs Controller (&ndia), (Air 2ort), Central Drug Standard Control "rganisation, &nternational Air Cargo Comple#, Sahar 'illage, Andheri, 9umbai ? >.. .33$ 2hone 0 /<5/.-7/ C /6</<-<7 Dr$ A$ ,am;ishan, Assistant Drugs Controller (&ndia), Aawaharlal Nehru 2ort rust C(S (&mports), Nhava Sheva, Navi 9umbai ? >.. 8.8$ 2hones0 ("ffi$) 0 8/>/63<, (,esi$) 0 7>-.5</, (a# 0 8/>.-53$

Central Drugs La)orator! #CDL$

he Central Drugs @aboratory, +ol;ata is the national statutory laboratory of the %overnment of &ndia for !uality control of Drug and Cosmetics and is established under the &ndian Drug F Cosmetics Act, -3>.$ &t is the oldest !uality control laboratory of the Drug Control Authorities in &ndia$ &t functions under the administrative control of the Director4%eneral of )ealth Services in the 9inistry of )ealth and (amily Gelfare$ he functions of the @aboratory include0 &$ Statutory (unctions0

(a) Analytical !uality control of maBority of the imported Drug available in &ndian mar;et$ (b) Analytical !uality control of drug and cosmetics manufactured within the country on behalf of the Central and State Drug Controller Administrations$ (c) Acting as an Appellate authority in matters of disputes relating to !uality of Drug$ &&$ "ther (untions0 (a) Collection, storage and distribution of &nternational Standard &nternational ,eference 2reparations of Drug and 2harmaceutical Substances$ (b) 2reparation of National ,eference Standards and maintenance of such Standards$ 9aintenance of microbial cultures useful in drug analysis Distribution of Standards and cultures to State Iuality Control @aboratories and drug manufacturing establishments$ (c) raining of Drug Analysts deputed by State Drug Control @aboratories and other &nstitutions$

(d) raining of Gorld )ealth "rganisation (ellows from abroad on modern methods of Drug Analysis$ (e) o advise the Central Drug Control Administration in respect of !uality and to#icity of drug awaiting licence$ (f) o wor; out analytical specifications for preparation of 9onographs for the &ndian 2harmacopoeia and the )omoeopathic 2harmacopoeia of &ndia$ (g) o underta;e analytical research on standardisation and methodology of Drug and cosmetics$

(h) Analysis of Cosmetics received as survey samples from Central Drug Standard Control "rganisation$ (i) Iuic; analysis of life saving Drug on an All4&ndia basis received under National Survey of Iuality of 1ssential Drug 2rogramme from Eonal "ffices of Central Drug Standard Control "rganisation$ &n addition to the above functions the Central Drug @aboratory also actively collaborates with the Gorld )ealth "rganisation in the preparation of &nternational Standards and Specifications for &nternational 2harmacopoeia$ &t also underta;es collaborative study on behalf of the &ndian 2harmacopoeia Committee$ he senior "fficers of the @aboratory have been appointed as %overnment Analysts on behalf of most of the States of the Union for analysis of drug samples$ he Director of CD@ is Dr$2$+$%uha, Director, Central Drugs @aboratory, 5, +yd Street, +ol;ata ? 8.. .-6$ 2hone 0 .55 4///337>-, %ram 0 *&"S AN@A*$ (a#0 .554///335<.$

Central Drugs Testing La)orator! #CDTL$ Chennai

Central Drug esting @aboratory is one of the four National @aboratories in &ndia engaged in the research and analysis of Drug and Cosmetics as per Drug and Cosmetics Act, -3>.$ he Director of the CD @ Chennai is,

Dr$ N$ 9urugeshan, Director &n4charge, Central Drug esting @aboratory, %ovt$ of &ndia, 58, Naval )ospital ,oad, 2eriamet, Campus %$9$S$D$, Chennai ? 6.. .85$ 2hone 0 .>>4/76-.>./C /76-./.7, %ram 0 D,U%S@A*, (a# 0 .>> 4/76-.3.6 14mail 0 cdtl:dataone$in

Central Drugs Testing La)orator! #CDTL$ -u%)ai

he Central Drugs esting @aboratory ? 9umbai is another national statutory laboratory of the %overnment of &ndia, functioning under administrative control of the Drug Controller %eneral (&ndia), D%)S, 9inistry of )ealth and (amily Gelfare$ he maBor functions of the laboratory include0 esting of imported bul; drugs and formulations referred by ADCs, 9umbai, Nhava Sheva F Chennai, Survey and Gatchers samples referred by Deputy Drugs Controller (&ndia), Gest Eone$ @ately, new drugs and formulations are also being referred by the Drugs Controller %eneral (&ndia)$ he laboratory is notified as Apellate @aboratory for Copper &ntra4Uterine Contraceptive Device and ubal ,ings under the Drugs and Cosmetics ,ules, (9edical Stores) F ,egional Directors of Department of (amily Gelfare and procurement and field samples of "ral Contraceptive 2ills, Copper and ubal ,ings referred by the Dept$ of (amily Gelfare$ he Director of the @aboratory is Dr$ (9rs) %opa %hosh, Director &n4charge, Central Drugs esting @aboratory4 9umbai, %overnment 9edical Stores Depot Compound,*elasis ,oad, "pp$ Sahil )otel, 9umbai Central, 9umbai >....< $ 2hones 0 "ffi$ 0 .// 4 /5../5.3, (,esi$) 0 /56/./35, %ram 0 D,U%S@A*, elefa# 0 /5.33/>.$ e4 mail0 cdtlmumbai:rediffmail$com

Regional Drugs Testing La)orator! #RDTL$ Gu/ahati

he ,egional Drugs esting @aboratory %uwahati is the one of the five National @aboratory of the %ovt of &ndia for !uality control of Drugs and Cosmetic and is established under the &ndian Drugs F Cosmetics Act -3>. functioning under administrative control of the Drugs Controller %eneral of &ndia and sub ordinate office under Directorate %eneral of )ealth Services, 9inistry of )ealth F (amily Gelfare$ he laboratory was set up in the year /../ for entire North 1astern State including Si;;im and is housed in its own building at %uwahati$ 0& Statutor! 'un"tion1 a$ Analytical !uality control of drugs and cosmetic manufactured within the country on behalf of the Central and State Drugs Controller Administration$ b$ o assists the Central Drugs Standard Control "rganiDation in the testing of Drugs and cosmetic$ he laboratory is headed by Dr$ 2arthaByoti %ogoi, Director4in4Charge ,egional Drugs esting @aboratory, Directorate %eneral of )ealth Services, %uwahati48<- .58 (Assam) 2hones 4"ff4 .56-4/55<777C/55.777((a#) , ,esi4.56-4/558/8/C/55.<33 e4mail 0 parthaByoti:sancharnet$in pBgogoi:gmail$com pig$rdtl:assam$nic$in

Regional Drugs Testing La)orator! #RDTL$ Chandigarh

,egional Drugs testing laboratory, Chandigarh has become operational since November, /..8$ 2resently the laboratory is testing the drugs at an average of 7. samples per month, primarily to cater the re!uirements of CDSC"

(North Eone)$ he laboratory is in the process of upgradation in infrastructure and manpower in order to increase the testing capacity$ Director &n4charge, ,D @ Chandigarh Dr$ Arun *hardwaB, 2hone 0 .-8/ 4 /6565-6

Central Drug La)orator!2 CRI ,asauli

Central drug laboratory at C,& +asauli is a Central laboratory engaged in the testing of vaccines$ &t is a notified laboratory under the Drugs and cosmetics Act, -3>. to function as Central drugs laboratory for testing of the following drugs or classes of drugs= i) ii) iii) iv) v) vi) vii) viii) Sera Solution of serum proteins intended for inBection 'accines o#ins Antigens Anti4to#ins SteriliDed surgical ligature and steriliDed surgical suture *acteriophages, including "ral 2olio vaccine$

he Director of the Central ,esearch &nstitute is an ex-officio member of D A*$ he Director of C,& ;asauli is Dr$ +$,$9ani, 2hone0 .-83/4/8/.6., /8/.73, /8/-->= (a#0 .-83/ 4/8/.>3

Indian +har%a"o oeial Co%%ission #I+C$

&ndian 2harmacopoeial Commission is an Autonomous &nstitution under the 9inistry of )ealth F (amily Gelfare, %ovt$ of &ndia dedicated for setting of standards for drugs, pharmaceuticals and healthcare devicesC technologies etc besides providing ,eference Substances and raining$ &ts functions are 0 a) o develop comprehensive monographs for drugs to be included in the &ndian 2harmacopoeia, including active pharmaceutical ingredients, e#cipients and dosage forms as well as medical devices, and to ;eep them updated by revision on a regular basis$ o accord priority to monographs of drugs included in the national 1ssential Drugs @ist and their dosage forms$ o prepare monographs for products that have normally been in the mar;et for not less than / years e#cept for certain special categories of new drugs li;e antiretrovirals, antituberculosis and anticancer drugs and their formulations introduced more recently, which may be accorded priority attention o give special attention to the methods of manufacture used by the indigenous industry in selecting the pharmacopoeial tests for monitoring the to#ic impurities of the concerned drug$

b) c)

d)

e) f) g) h)

o ta;e note of the different levels of sophistication in analytical testingCinstrumentation available while framing the monographs$ o accelerate the process of preparation, certification and distribution of &2 ,eference Substances, including the related substances, impurities and degradation products re!uired$ o collaborate with pharmacopoeias li;e the 2h 1ur, *2, US2, A2 and &nternational 2harmacopoeia with a view to harmoniDing with global standards$ o organiDe educational programs and research activities for spreading and establishing awareness on the need and scope of !uality standards for drugs and related articlesC materials$

he &ndian 2harmacopoeia Commission has been registered as a Society under the provisions of the Societies ,egistration Act, -<6.(Act No$ /- of -<6.) for the registration of @iterary, Scientific and Charitable Societies, on .3 December /..>$ he Director of &ndian 2harmacopoeial Commission is Dr$ %$N$ Singh, ,aB Nagar, Sector 4/5, %haDiabad /.-../ (U$2) 2hone0 37-/.4/8<5>.-(D) /8<5558= (a#0 .3- 4/>8<55--, 14mail 0 ipclab:vsnl$net