29 SoP - Compounding of Offences Rules, 2025 2026-Jan-01 2395 KB

Central Drugs Standard Control Organization Authu izcd I'erson11cl On1-"' 1.0 Purpose To lay down a procedure for establishment of a standard approach for processing of applications under the Drugs and Cosmetics (Compounding ofOffences) Rules, 2025. 2.0 Scope This document is applicable for processing of application for compounding of offences received under Section 328 ofthe Drugs and Cosmetics Act by the Compounding Authority. 3,0 Responsibility 3.1 Technical Data Associate/ Sr. Technical Data Associate/ Drugs Inspector shall be responsible for review of Compounding ofoffence application. 3.2 The ADC(I)/DDC(IyJDC(I)/DCG(I) shall be responsible for timely forwarding of reporting authority report called by Compounding Authority. 4.0 Accountability 3.3 Compounding Authority [Additional Director General of Health Services notified vide S.O. No.355l (E) dated I't August 2025. 3.4 Reporting Authority IDrugs Controller General (lndia) being the CLA/CLAA] {'*ffi} 10/ .TITLE Division Name Legal Cell Procedurc for filing, processing, and finalizing applications for compounding of offcnces under Section 32I] of the Drugs and Cosmetics Act, 1940. I)ocumcnt No. Lcgal Ccll -GNL-000 Revision No. 00 Illl'cctive Datc Page No I of4 Prepared By Approved By Authorized By Name Dr. Kailash Chander Malik Namc A. Scnkathir Name Dr. Rajeev Singh Raghuvanshi Dcsignation ADC (I) Designation DDC (r) Designation DCG (r) Sign I !Y .l,gn -lrr,/ Sign 't Date 3O'!.2')o2't 'I)ate 3r/dry' I)atc Ol.o I' 2ozc Control Status I Iormat No. l,egal Cell-GNL-000/F0l -00 5.0 Procedure 5.1.1 Whenever any application under Rule 4 ofDrugs and Cosmetics (Compounding ofOffences) Rules,2025 in the prescribed form is received through physical mode along with an advance copy in email at raj.shree64@cghs.nic.in by the office of Compounding Authority, the e-file ofthe application is required to generate by the concerned department.

{:ffi} \0r' "'.ll--,"' TITLE, Division Namc Procedurc for filing, proccssing, and finalizing applications for compounding of offences undcr Section 32B of the Drugs and Cosmetics Ac 1940. Documcnt No. Legal Cell -GNL-000 Rcvision No 00 Elfective Date Pagc No Prepared By Approved By Name Dr. Kailash Chander Malik Namc A. Senkathir Name Designation ADC (I)-o Dcsignation DDC (t) Dcsignation DCC (r) Sign Sipn -b{ S ign (v Dale 3o,lv;rc;f Dalc HDZ. Datc Authorized Personnel Only l.cgal Cell 2 of4 Aulhorized By Dr. Rajeev Singh uvanshi ol. o l'1 O6 5.1.2 The compounding authority shall call for a report from reporting authority, under whose jurisdiction offence has been committed with reference to the particular furnished in the application. 5.1.3 The reporting authority within 05 days ofreceipt ofapplication shall ask the report from the concemed zonaysub-zonal/port olfice in whose jurisdiction the offence has been committcd with reference to the particulars furnished in the compounding application. 5.1.4 The concemed head of the zonal/sub-zonal/port oflice shall forward their report within l0 days ofreceipt ofapplication with reference to the particulars furnished in the compounding application. 5.1.5 The reporting authority shall forward his report to the compounding authority within one month of receipt of compounding application for the report or within such extended period as may be allowed by the compounding authority. 5.1.6 The compounding authority after taking into the account the content ofthe application may, by order either allow the application indicating the compounding amount and grant him immunity from prosecution in terms of rule 6 of Drugs and cosmetics (compounding of Offences) Rules, 2025 or reject the compounding ofoffence application. 5.1.7 The compounding authority shall afford the personal hearing before rejecting the compounding of offence application and the ground of rejection shall be mentioned in the order passed by the compounding authority. 5.1.8 The every order passed by the compounding authority shall be communicated to the applicant. 5.1.9 The applicant shall within the period of30 days from the date ofreceipt oforder of allowing the compounding of offence, pay the compounding amount as order to be paid by the compounding authority and shall furnish the proof of such payment to the compounding authority. Format No. Legal Cell-GNL-000/F0 t-00 q

Ccntral Drugs Standard Control Organization Authorized Personnel Only 1-ffi-i , G8 .J 5.1.l0 The compounding amount once paid on the order ol compounding authority shall not be refundable except in cases where court reject grant of immunity from prosecution grant by the compounding authority. 5.l.llTheapplicantcannotclaim,asofright,thattheoffencetobecompounding. 5.1.12 The compounding authority may grant Immunity from prosecution with such conditions as deemed fit for the offence with respect to the case covered by the Compounding of offence under the Drugs and Cosmetics (Compounding of Offences) Rules, 2025. The immunity shall be grant if the compounding authority is satisfied that the applicant has cooperated in the proceeding and has made full and true disclosure of facts relating to the case. 5.1.13 'I'he Immunity from prosecution in certain cases shall stand withdrawn, if person fails to pay sum ofspecified order ofCompounding passed by the compounding authority. 5. I . l4 The immunity granted to the applicant, may be withdrawn by the compounding authority, if satisfied that such applicant had, in the course of compounding proceedings, concealed any particulars. material or had given false evidence, and thereupon such person may be tried for the offence with respect to which immunity has been granted or for any other offence that appears to have being committed by him in connection with the compounding proceedings and their upon the provision ofthe Act, shall apply as no such immunity has been granted. TITI,E Division Name Legal Ccll Procedure for filing, processing, and finalizing applications for compounding of offences under Section 32B of the Drugs and Cosmetics Act, 1940, Document No. Legal Cell -GNL-000 Revision No. 00 Effective Date Page No. 3 of4 Prepared By Approved By Authorized Bv Namc Dr. Kailash Chander Malik Name A. Scnkathir Namc Dr. Rajeev Singh Raghuvanshi [)csignation Ar)c (l) Designation DCG (l) Sign Sign -h/ Sign ( $r, I)rtc gi'tt':.o>{ Date *4,'l{ Datc 6l'o l. 2oZC Format No. l-egal Cell-CNL-000/F0l-00 Designation DDC (l)

8.0 References 8.0 Abbrel iation 9.0 Rcvision Histo Authorized Personnel Onl;- Legal Ce Il 00 Dr. Rajecv Sineh Ra vanshi ol.o I o76 Reason(s) for Revision I {#) \g.i "''"i-l;' Division Name Procedurc for filing, processing, and finalizing applications for compounding of offences under Scction 32B of the Drugs and Cosmetics Act, 19,10. Document No. Legal Cell -CNL-000 Revision No Ell'ective Date 4 ol'4 Authorized By Prcpared By Approved By Namc Dr. Kailash Chander Malik Namc A. Scnkathir Namc Designation ADC (I) Designation DDC (r) Designation DCG (r) Sign I Sign W Sign Date 30'12',lorj: Datc 3r/Pd I)atc Annexure/Format No- 'l'itlc Annexure-l I Cell-GNL-000/F02-00 Application form as per rule 4 Annexure-ll Legal Cell-GNL-000/F02-00 Compounding ofoffence process flow chart Doc. No- Title I I)ru and Cosmetics Compoundi ofOffcnces Rules.2025 Acron Full Form CA Compounding Authority [Additional Director General of Health Services st 2025 dated 0l '1 Au as notified as CA S.O. No. 3551 E RA R rtin Authorit CLAA/CLA inted by the Central Government QMS Quality Management System SOP Standard Operating Procedure CDSCO DCG(I) Drugs Controller General (lndia) JDC(I) Joint Drugs Controller (lndia) DDC(I) Deputy Drugs Controller ( Ind ia) ADC(I) Assistant Drugs Controller (lndia) DI Drugs Inspector STDA Sr. Technical Data Associate I'DA Technical Data Associate DEO Data Entry Operator Revision No. 00 F'ormat No. Legal Cell-GNL-000/F0 t -00 New TITLE Page No. {. 8.0 Annexure / Format- .l

Annexure-I- Application for Compounding of Offences (Undcr the Drugs and Cosmetics (Compounding of Offences) Rules, 2025) Directorate (leneral ofHealth Services, Ministry ofHealth and Family Welfare, Government oflndia fDA Bhavan. ITO. Kotla Road. New Delhi -l10002 FORM (Sce Rule 4) i'*
cDraolrr,lkD(o i ffi"r Sr. No. Particulars Details Checklist (Yes / No / NA) I Full name and address ofthe applicant trYestrNonNA 2 Address for communication EYesnNotrNA 3 Name and composition ofthe product nYesnNonNA .1 Manufacturing Licence / Import Licence / Registration Certificate details (including address, email, and contact details) 5 Manufactured or Imported by trYestrNotrNA Marketed by, if any trYestrNotrNA 7 Export or lmport Code Number (if applicable) !YestrNotrNA 8 Certi{icate of Analysis of Manufacturer or NABL accredited laboratory (ifany) EYesnNotrNA 9 Details of sample (if applicable) trYesnNotrNA l0 Date of sample drawn (Form 17 of Drugs Rules, 1945 / Form COS-10 of Cosmetics Rules, 2020 / Form MD-36 of Medical Device Rules, 2017) trYesDNotrNA t1 Date of test report received (Form 13 or Form 2 ol Drugs Rules, 1945 / Form COS- l4 or Form COS-2 I of Cosmetics Rules, 2020 / Form MD-32 or Form MD-31 of Medical Device Rules,20l7) !YestrNotrNA t2 The contravention of provisions of the Drugs and Cosmetics Act, 1940, against which prosecution is instituted or contemplated I3 Date of seizure (if any) trYesnNonNA l.l Brief facts of the case and particulars of the offence(s) charged nYestrNonNA Whether Show Cause Notice or Chargesheet issued EYesENotrNA t6 Whether this is the first offence under the Drugs and Cosmetics Act, 1940 (if !YestrNotrNA Iormat No. Legal Ccll-GNL-000/F02-00 trYestrNonNA 6 !YesnNotrNA l5 Page I of2

Annexure-I- Application for Compounding of Offences (Undcr the Drugs and Cosmetics (Compounding of Offences) Rules, 2025) i-ffi,-"', '\ff.d Directorate General ofHealth Services, Ministry ofHealth and Family Welfare, Government oflndia FDA Bhavan, ITO, Kotla Road, New Delhi -l 10002 not, provide details ofprevious cases) 17 Whether any proceedings for lhe same offences are contemplated under any other law (if so, provide details) !YesnNotrNA Declaration: I hereby declare that the information provided above is true and correct to the best of my knowledge and belief. I undertake to provide any further information or documents as may be required by the Compounding Authority. Place: Date: Signature of the Applicant: Designation & Seal (if applicable): Format No. Legal CeJl-GNL-000/F02-00 Page 2 of 2 Name (in block letters): _

i-m) \s.c Annexu rc-II- Process flow chart Directorate General ofHealth Services, Ministry ofHealth and Family Welfare, Govemment oflndia FDA Bhavan, ITO, Kotla Road, New Delhi -l10002 Process Flow Chart l Submission of Application Applicant submits application under Rule 4 in prescribed format in physical copy along with advance copy through email at raj.shree64@cghs.nic.in by the office of Compounding Authority 3. Mark Application E-file marked to Compounding Authority 7. Report of Reporting Aulhority: Reporting Authority shall forward his report within I month or extended period as allowed by compounding authority from the date ofreceipt ofreceipt ofapplication. 2. Receipt of Application by the Compounding Authority Application received by Compounding Authority office [Office of Add. Director Ceneral of Health Services, MoHFW, Govemment of India] Action: Generate e-file b staff/division SU rl rn 4. Request Report Compounding Authority calls report from Reporting Authority IDCG(l)] 5, Request from officer under whose jurisdiction offence has been committed: Reporting Authority IDCG(l)] within 05 days of receipt ofcompounding application shall ask report w.r.t. facls mentioned in the compounding application from the concerned zonallsub-zonal/port offi ce 6. Report of concerned head of zonaVsub-zonal/port oIlice Concerned head of zonallsub-zonal/port office within l0 days ofreceipt of compounding application shall forward their report w.r.t. facts mentioned in the compounding application. 8. Compounding Authority Decision Reviews application & report lication Decision : --- Allow A lication or Re ect A FormatNo. Legal Cell-GNL-000/F'02-00 Page I of2 + + +

Annexure-II- Process flow chart Directorate Gencral ofHealth Scrvices, Ministry ofHealth and Iramill well'arc. Government oflndia l.'l)A Bhavan. ITO. Kotla Road. Ncrv Delhi - I 10002 12. Withdrawal of Immunity . Applicant may be tried for offence . Act lies as if immuni 9. Allow Application . Order indicating compounding amount . Grant immunity under Rule 6 . Communicate order to applicant . Applicant pays within 30 days & fumishes proof of payment (non-refu ndable) 10. Reject Application . Personal hearing to applicant . Grounds ofrejection recorded . Order communicated to a licant I l. Immunity Conditions . May impose conditions . Immunity if cooperation & full disclosure Decision : - Concealment / false evidence ---+ Ste ll

• Failure to amOunt ---+ l0 - Otherwise -- Immuni maintained FormatNo. Legal Cell-GNL-000/F02-00 Page 2 of 2

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