IN FORCE undated

175 Delegation of Power to Sign Licence and Rigistration 2017-Apr-13 2920kb

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F.No. D.21013/39/2017-Dc 2 Government of india _ Ministry of Health and Family Welfare Directorate General of Health Services (Centra! Drugs Standard Control Organization)

FDA Bhawan, Kotla Road, dated New Delhi-110002, the 13" April, 2017

Office Order

Revised channel of submission and level of disposal of cases in respect of various Divisions of CDSCO (HQ) is enclosed for compliance by all concerned with immediate effect, 2, Further, as per Rule 24 of Drugs & Cosmetics Rules, 1940, the Licencing Authority may delegate the powers to Sign Licence & Registration Certificate to any other person with the approval of the Central Government.

(S.K. Tanwar) Dy. Director Admin, (D) Telephone No. 011-23236971 . "e-mail: drugsection@cdsco.nic.in

To

1. All officers /Divisions in CDSCO (HQ) 2) DDCs of all Zones/Sub-Zones 3) Directors, CDSCO Labs

1. PPS to AS (F&D)/ PPS to JS (R)/ 0/o DCG 5) Director (Admin), CDScO (HQ) 6) Guard file.

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REVISED CHANNEL OF SUBMISSION AND LEVEL OF DISPOSAL OF CASES

Common subject matter

||NameofWork/Item<br>Levelthroughwhich iscrosses<br>FinalDecisionmaking<br>No.<br>authority***|
|---|---|
||A} Vaccine/Stem cells<br>ADI-DI-ADC-DDC-JDC-Advisory<br>DCG (I)<br>and cell based<br>Committee (SEC/IND-<br>products/-r-DNA<br>CBBTDEC/TC-Apex)-ADI-DI-ADC-<br>Products<br>ODc-Jpc|
||B) VeterinaryVaccine<br>ADI-DI-ADC-DDC-Advisory<br>DCG (I)<br>Committee-Ministry of<br>Agriculture-ADI-DI-ADC-DDC-JDC|<br>MarketAuthorization Permission{Indigenous in46,46AandimportedproductsinForm<br>45,45A,)|
||A, Vaccineandr-DNA | ADI-DI-ADC-DDC**<br>DCG {I)<br>Products<br>-JDC-AdvisoryCommittee (SEC}-|
||ADI-D!I-ADC-DDC-JDC|
||**Incase ofvaccines parallel|
||review atCDL& in case ofr-DNA|
|, <br>3|productsparallelreviewbyRCGM<br>B. Stem cellandcell<br>ADI-Di-ADC-DDC-JDC-Advisory<br>DCG (1}<br>basedproducts<br>Committee(CBBTDEC-Apex)-ADI-<br>|<br>Di-ADC-DDC-JDC<br>a<br>C.<br>VeterinaryVaccines<br>ADI-DI-ADC-DDC-Advisory<br>DCG {I)<br>Committee-Ministryof<br>ia<br>-3__|Post approvalchanges<br>D. Vaccineandr-DNA<br>ADI-DI-ADC-DDC-CDL,<br>JDC(1)<br>—<br>ADI-DI-ADC-DDC<br>A. Otherbiological<br>ADI-Di-ADC-DDC<br>JOC(1)<br> LL<br>mates et [#2 oCo0e<br>fee<br>Registration Certificatefor<br>ADI-DI-ADC-DDC-JDC<br>DCG {i)<br>imported biological|
||products (Form 41)<br>‘|
||——<br>biological products (inform<br>10)<br>License formanufacture<br>ADI-DI-ADC-DDC-JDC<br>DCG (I)<br>biological productsunder|
||CLAAscheme(Form 28D)|
||Pee<br>eee<br>pe|
||Th|

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----- Start of picture text ----- and banned biological products ee 10 {| Query/clarification raised | ADI-DI-ADC DOC(I)/JDC(I)/DCG(1) on review for all type of On receipt of response same being followed el ee secretariat Consultant = Ministry queries/status notes, other ministerial letters Policy Matters on ADI-DI-ADC-DDC-JDC DGG (i) regulation — ----- End of picture text -----

Revised Level of disposal

***Query letter may be issued by concern Drug Inspector

Post approval changes, protocol amendments, forwarding for expert opinion fetter may be issued by ADC{(i). ,

Approval of CT/MA/RC/Import license may be issued by DDC (I)

Abbreviations:

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ADI:- Asst. Drugs Inspector

Di:- Drugs Inspector

ADC(I):- Assistant Drugs Controller (India)

DDC{I}:- Deputy Drugs Controller (India)

JDC(I):- Joint Drugs Controller (india)

DCGI:- Drugs Controller General of India
CDL:- Central Drugs Laboratory, Kasaull
NIB;- National Institute of Biologicals, Noida

SEC:- Subject Expert Committee

IND:- Investigational New Drug Committee
CBBTDEC:- Cell Biology Based Therapeutic Drug Evaluation Committee TC:- Technical Committee

RCGM:- Review committee on genetic manipulation.

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----- Start of picture text ----- Revised Channel of Submission and Level of Disposal of Cases / common subject matters ----- End of picture text -----

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----- Start of picture text ----- Level Final Name . through decision of work /item which it making crosses authori Matters / Issues related to DCC/DTAB ; Convening meetings of DCC and DTAB, | TDA/ADL-DI- ; preparation of agendas for the respective meetings, | STC (LK) - DCG(I) correspondence with the members, follow up of the |DDC ~ JDC recommendations of the committees, processing of proposais relating to amendments of D&C Rules, processing of amendments, compilation of comments received and finalisation of draft rules ) published by Mo H & FW, providing necessary technical inputs for the annual reports, etc. , Matters /issues related to Risk Based Inspections: Planning meetings related to Risk Based inspections (RBI), correspondence to all State /UT Licensing authorities for confirmation of manufacturing sites ready for RBI teams planned | TDA/ADI— for inspections, updating information based on | DI—DDC - DCG(I) . reports received for review based on requirements | JDC of Sch. M and Sch. L1 of D&C Rules, evolving the strategy and forwarding directions to the concerned SLAs for effective implementation of the provision of Act and Rules in the country, Follow up of action ) taken by SLAs on Risk Based Inspections, Review of Inspection data and monitoring inspections phase wise. ----- End of picture text -----

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ENFORCEMENT DIVISION

Revised Channel of Submission and Level of Disposal of Cases

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----- Start of picture text ----- S. | Name of the work/item Level Final No through decision which it making Issues/Complaints crosses authori Spurious regarding _ sub-standard/ TDA/ADI-DI- |DCG() mail drugs: Complaints received by Post/e- |DDC regarding manufacturing/sale _licenses, throughout India, Sub-Standards/Spurious drugs and other miscellaneous correspondence with State Regulatory Authorities, Zonal/Sub Zonal Offices of CDSCO and other Ministry Govt. references. Matters related to NSQ drugs and prosecutions: - ;ADI-DI-DDC- DCG(I) 1. Recommendations for NSQ Drug Screening by | JDC(VGS) CDSCO Zonal/Sub Zonal offices. 2. Meetings of the NSQ Drug Screening Committee. 3. Communication of decision/approval of the Competent Authority to CDSCO Zonal/Sub Zonal offices: 4. Various representations wrt. screening committed decisions. 3 | Compilation of Countrywide data: Compilation of | different TDA/ADI-DI- DCG(D data w.r.t. Spurious/NSQ/Expired drugs, | functioning DDC States/UTs, of regulatory authorities from Parliament Laboratories, Port Offices for answering for Questions, Delivery Monitoring Unit and information to Ministry etc. Joint Surprise Check: Monthly joint surprise check | are TDA/ADI-DI- DcG(D regularly carried out in different states by | drawing DDC of drugs samplesby CDSCOof differentDrugs Inspectorstherapeuticto categoriescheck the quality of drug samples from Government Hospitals, Retail & wholesale Dealers Drug Alert: List of Drugs, Medical Devices and TDA/ADI-DI- |DCG) Cosmetics declared as not of standard |DDC quality/spurious/adulterated/misbranded by CDSCO Drugs Testing Laboratories are being regularly uploaded month-wise in the web site of CDSCO and letters are communicated to the concerned Licensing Authorities of States/U.Ts along with the test reports ofNSQs for necessary action in the matter. Processing of Parliament Questions related to TDA-DI- DCG) spurious/NSQ/adulterated/Misbranded drugs and | DDC(SD)- AYUSH Ministry related issues. DDC(AKP)- JDC(VGS ----- End of picture text -----

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----- Start of picture text ----- ‘ |7 | ofProcessing of RTI applications: Prompt processing |TDA/ADI-DI- | CPIO RTI applications related to this Division is carried |DDC out. PMO references: - Various complaints and received | at TDA/ADI-DI- DCG PMO and forwarded through Ministry of Family |DDC Health and Welfare are examined and suitable reply sent. DDC inal Correspondences/Follow up related to the Survey of | Extent TDA/ADI-DI- DCG) of Problems of Spurious and Not of Standard |DDC Quality (NSQ) drugs in the Country being conducted under the guidance of supervision of Director l/c NIB, Noida. ; DDC Admin 12 | Notification of Central Labs/Govt. Analyst TDA/ADI-DI- | DCG() , 1. Correspondence with Central Labs for | DDC Government Analyst notification. 2. Correspondence with SLAs regarding notification of Central Laboratory Analysts as Govt. Analysts of respective states. AYUSH Matters: - ADI-DI-DDC | DCG(D) 1. Supervision of communication / correspondences of AYUSH related matters with AYUSH Ministry and other applicants. 2. Inspections of Ayurvedic medicine manufacturers for grant of Certificate of Pharmaceutical Products and(COPP) along with personnel ofAYUSH Ministry . State AYUSH Authority and work related to issuance of COPPs. 3. The list of COPP holders is regularly uploaded in ‘ the CDSCO website. ) 4. Attended various meeting at the Ministry of AYUSH. ----- End of picture text -----

Cosmetics Division

Revised Channel of Submission And Level of Disposal of Cases

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|Sr. <br>No.||NameoftheWork/item||NameoftheWork/item|:||Levelthrough<br>/| Final<br>which iscrosses |Decision|Levelthrough<br>/| Final<br>which iscrosses |Decision||
|---|---|---|---|---|---|---|---|
|||||||making||
|1.||CosmeticsImportRegistrationApplications <br>:||||ADCO”-DI-|authori<br> |DCG()||
||||||DDC()-JDC(D-|||
||||||DCG(I|||
|2.|ApplicationsforNOC/Clarification relating honeEF <br>tocosmeticumport<br>DDC(1)-JDC()-||||||Deeg)||
||||||DCG|||
|3. |RTIqueries|||||ad|CPIO||
||||||DDC(D-CPIO|||
||BIS<br>letters<br>/<br>correspondences|other||Government <br>‘||NBC<br> DDC()-JDC()-|DCGD||
||||||DCG||'|
|3.|;<br>:<br>ParliamentQuestions||||ADI/DI-<br>ADC()-|DCG()||
||||||DDC(1)-JDC()-<br>DCG|||
||.<br>VIP<br>reference letters/Ministryletters||||ADI/DI-<br>ADC()-|DCG)||
||||||DDC(1)-JDC(1)-|||
||||||DCG(d|||
|Le|Representations/Grievances ofstakeholders <br>/public/NGOs/Consumer forumsetc.||||oa<br>DDC()-JDC(D-|DCG||
||||||DCGd|||

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AERA

REVISED CHANNEL OF SUBMISSION AND LEVEL OF DISPOSAL OF CASES

||1|§.|||Nameofwork/item|Levelthrough which|Final|
|---|---|---|---|---|---|---|---|
|||No.||||crosses|decision|
||||||||making|
||||||||authori|
||||Medical Device Division|||||
||||(i)||CLAApproval|ADYDI-ADC()-DDC()-||DCG(D|
|||||||JDC(D-DCGd)||
||||(ii)||GrantofCTapproval|ADIY/DI-ADC(D-DDC(D-|DCG(D|
||||(iii)||GrantofNewDrugApproval|JDC()-DCG())<br>|ADI/DI-ADC()-DDC(D- <br>IDC()-DCG(D||DCG()|
||||(iv)||GrantofRegistration<br>Certificate|ADIVDI-ADC()-DDC(I)-<br>JDC)||JDC)|
||||(v)||Renewal ofRC|ADI/DI-ADC(D-DDC(I)|DDC()|
||||(vi)||GrantofImportlicense/TL|ADI/DI-ADC(D-DDC(D-||DDC(D|
|||||||JDC)||
||||(vii)||QueryRaised|ADI/DI-ADC(D-DDC(D|ADC(I)|
|.|||(viii) Parliament matters,VIP<br>References, Ministry|||ADI/DI-ADC(I)-DDC(I)- <br>JDC()-DCG(1)||DCG()|
||||||References|||
||||FDC Division|||||
||||(i)<br>(ii)||GrantofCTNOE<br>GrantofNewDrugPermission|ADYDI-ADC(D-DDC()- <br>JDC(1)-DCG()<br> |ADI/DI-ADC()-DDC(I)-||DCG(D<br>|DCG(D)|
|||||||JDC(D-DCGD||
||||(iii)||GrantofBA/BENOC|ADI/DI-ADC(D-DDC()-||JDC)|
|||||||JDC()||
||||(iv)||GrantofTL/CDTLNOC|ADI/DI-ADC(D-DDC(D-|DDC(D|
||||(v)||QueryRaised|JDC(1)-DCG()<br>ADI/DI-ADC()-DDC() =|ADC(I)||
||||(vi)|Parliamentmatters,VIP<br>References, Ministry||ADI/DI-ADC()-DDC(I)- |DCG(1)<br>JDCQ)-DCG()||
|||||References||||

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