Declaration of Drug Misbranded (Minor Defect) on Testing-reg.(English)

e-U-25/12/NSQ/2022-MedV कर्मचारी राज्य बीमा निगम (श्रम एवं रोजगार मंत्रालय, भारत सरकार) EMPLOYEES' STATE INSURANCE CORPORATION (Ministry of Labour & Employment, Govt. of India) मुख्यालय/ HEADQUARTERS पंचदीप भवन, सी.आई.जी मार्ग,नई दिल्ली 110002 Panchdeep Bhawan,CI.G. Marg, New Delhi-110002 www.esic.gov.in, 011-23604773,dmc-rc@esic.nic in File No.:e-U-25/12/NSQ/2022-MedV (E-12328) सेवा में, 570 Web- Upload Director (Medical) Delhi / Director (Medical) Noida, Dean, All ESIC PGIMSR's, Medical & Dental Colleges Medical Superintendents - AlII ESIC Hospitals, Directors, ESI Scheme, All States विषय : Declaration of Drug Misbranded (Minor Defect) on Testing reg. Sir/Madam It is hereby informed that the Drug/item has been reported as misbranded as the color of the pellets is not mentioned on the label which is violation of rule 127(2) of the drug rules, 1945 (copy of test report enclosed), as detailed below: Sample Name ofItem Name/ Brand RC Batch taken the Firm Name No/ No./ Premises (M/s) Item DOM/ No/ DOE Page Name the Laboratory/ Report No. & Date of Reason No ESIC Model Hospital- Med Rabeprazole 149 Batch Govt. Manor Sodium + 1496 No.- IRB Analyst, Organics Jammu Pvt Ltd, sMosapride Citrate Tab/Cap- 122 Combined Food & Each Tab/Cap to DOM:06- Drugs contain: Rabeprazole Sodium 20mg, Mosapride Citrate 15mg Sustained Release 25 Laboratory DOE:05- - Jammu 27 CFDL/J/ 2025- 2026/666 dated 08.08.2025 The sample is found misbranded as the color of the pellets is not mentioned on the label which is violation of rule 127(2) of the drug rules, 1945.(copy enclosed ). In context to above, it is directed to: 1. Stop use of the batch of the above-mentioned item immediately which has been reported asMisbranded (Minor Defect) on Testing (copy enclosed). 2. Replacement of supplies or cost of the materials is to be recovered (if any) from the firm. 3. Initiate action as per relevant clause of Terms & Conditions of respective DG-ESIC Tender Enquiry/RC 149. 1/3068388/2025 e-U-25/12/NSQ/2022-MedV 1/3068388/2025 Contd. to pre page: 5.. Maintained record of action taken at in respective user units. This issues with the approval of Medical Commissioner (Procurement). संलग्नक: उपरोक्तानुसार भवदीय, Digitally signed by Sanjiv Kochhar Date: 25-09-2025 14:45:31 उप चिकित्सा आयुक्त (दर संविदा) Copy to: 1. The Drug Controller General of India, CDSCO, CIG Road, New Delhi- 110002 (dci@nic.in). 2. CDSCO, Zonal office, Hyderabad, CDSCO BHAVAN, Beside T.В. & Demonstration Centre, S.R. Nagar, Hyderabad-500038, TG (ddchyderabad@gmail.com, cdscohyd@gmail.com. 3. Assistant Drugs Controller (I), CDSCO, Sub Zonal Office, The Survey of India, Survey Chowk Campus, Plot No. 68, 17 EC Road, Dehradun - 248001, Uttarakhand (Email-cdscorishikesh@gmail.com). 4. Med Manor Organics Pvt. Ltd., 16-11-477/45, Sri, Krishna Nilyam, Dilsukh Nagar, Hyderabad 500036 (Email:yoqendra.mishra@medmanor.in, ganesh.jayraman@medmanor.in). 5. Med Manor Organics Pvt Ltd, Unit-II, KH,143/7, Village Raipur Pargana- Bhagvanpur, Tehsil-Roorkee, Distt.-Haridwar. 6. Website Content Manager with request for uploading on ESIC website. 7. Guard file. Smt. JYOTI KANIYALAL B. Pharma Government Analyst J&K/UT Combined Food & Drug Laboratarylamm adduan as aDove lur thesampie porion received. However,the sample is found misbranded as the colour of the pellets is not mentioned on the label which is violation of Rule 127(2) of the Drug Rules ,1945. NO: CFDL/J/2025-20261996 Dated:-30/8/2025 m Govemment Analyst pinion of the undersigned the sample referred to above is of standard quality as defined in the Drugs & Cosmetics Act, 1940 and rules there under is not of standard quality as defined in the Drugs and Cosmeties Act, 1940and rules there under reason given below:- The samole nasses for the tests anplied as ahows fo the somle Mosapride Citrate Dihydrate IP: As Per IP 2022 The content of Mosapride Citrate Dihydrate eq. to Mosapride Citrate in the given capsules of average fill weight of 0.2736 is found to be 14.36mg viz. 95.76% of the claim made. In the pisin fth (limit: 90%-110%) 2. Average fill weight of capsule:- 0.2736gm 3. Uniformity of weight of contents of capsule :- Complies 4. Assay: Rabeprazole Sodium IP: As Per IP 2022 The content of Rabeprazole Sodium in the given capsules of average fill weight of 0.2736 is found to be 18.57mg viz. 92.84% of the claim made. raknan 247661. For the general standards, method given in IP 2022 under the monograph "Capsules"have been followed. 1.Description:- Strip packing of 10 hard gelatin capsules with pink cap/ transparent body containing brown and white pellets. MFG. JUN.2025 EXP. MAY 2027 Mfg. Līc. No. 18/UA/2017 Mfd. By: MED MANOR ORGANICS PVT. LTD. Unit II,Kh. 143M/7 Village: Raipur Pargana-Bhaewannur Tehsil-Roorkee Distt Haridm (As enteric coated pellets) eumg Mosapride Citrate Dihydrate IP eq. to Mosapride Citrate anhydrous.........15mg (As sustained release pellets) Excipients: ....q.s Approved colours used in empty capsule shells and pellets. RNO: IRD Rabeprazole Sodium And Mosapride Citrate Sustained Release Capsules Rabnor-М Each hard gelatin capsule contains:- Rabeprazole Sodium IP. ESI SUPPLY 6. Ile of drugs purporting to be contained in the sample: Rabeprazole Sodium IP & Mosapride Citrate Dihydrate IP Condition of seals on the packet or on portion of sample or container :- The seals (01) are intact and inconformity with the specimen impression used by the Inspector on memo received separately 7. Result oftest or analysis with protocols of test or analysis applied. Rx 2. 3. 1.Name of Inspector from whom received:- Amit Mahajan, Drugs Inspector (Bari Brahmana) District Samba. Serial number and date of Inspector Memorandum: DIJ/Z-IV/S/07-25/03. Dated 23.07.2025. Number of Sample: 01x05x10 Capsules. Uf test or analysis by Government Analyst under section 25[1] of the Drugs and Cosmetics Act, 1940 4. Date of receipt 25.07.2025. 5 Nam Certificate of FORM 13. ISee Rule 461 mg of the drug in question mentioned U/S 34 of Drugs & Cosmetic Act 1940,and with the direction to rectify the said labels for corrections and send the updated batch with corrected labels. 4. Tehsil- Med Manor Urganics Pvt Ltd, Unit-II, Kh.143M/7, Village Raipur Pargana-Bhagwanpur, Roorkee Distt. Haridwar, with instruction to stop the sale/Purchase of the drug in question and provide the Purchase/sale details of the drug in question along with constitution of the firm/along with details of person responsible for manufacturing of the copy to tua: 1. State Drug Controller, Drugs & Food Control Organization, UT of J&K, for favour of information. 2. Deputy Controller, Drugs & Food Control Organization, Jammu for favour of information. 3. Assistant Drugs Controller, Samba for favour of information Conyto tho Drug Control Officer Bari Brabmana, Distt.Samba 4. Stop the supply of drug in question and recall the unconsumed stock of the drug to whom the drug has been supplied under intimation to this office. Encls: Cony of the test renort 1. Name of the dealer/firm from whom drug in question have been purchased and photocopies of the purchase bill/supply order. 2. Details of the total Quantity of Drug Purchased/Supplied. 3. Balance /Stock in hand, You are therefore requested to submit the following information to the office of undersigned within the period of five days from the receipt of this letter: Government Analyst Combined Food & Drug Laboratory, Jammu, vide Test Report No: CFDL/J/2025-2026/999 Dated: 30/08/2025. However Government Analyst (Concerned) in his report has mentioned remarks as, "the sample is found Misbranded as the colour of the pellets is not mentioned on the label which is violation of Rule 127(2) of the Drug Rules, 1945." By: Aorug sample hamely lab. Rabnor-M, B.No. IRB122, Mfg: Jun 2025, Exp: May 2027, Mfd Med Manor Organics Pvt. Ltd, Unit-II, Kh.143M/7, Village Raipur Pargana-Bhagwanpur, Tehsil- Roorkee Distt. Haridwar was lifted by undersigned from the Drug Store of ESIC Hospital, Bari Brahmana for the purpose of test and analysis. The said drug sample has been declared to be of standard quality by 503-05, Dated: 30.08.2025. Madam, A dru Dated: 10.09.2025 Subject: Testing Of Rabnor-M, B.No. IRB122 Mfg: Jun 2025 Exp: May 2027, Mfd By: Med Manor Organics Pvt Ltd, Unit-II, Kh.143M/7, Village Raipur Pargana-Bhagwanpur, Tehsil-Roorkee, Distt. Haridwar. RofCED т/го or In charge Drug Stores ESICH, Bari Brahmana. No: DU/7-1W/09-75/721 To, Medical Officer OFFICE OF THE DEPUTY CONTROLLER, DRUGS & FOOD CONTROL ORGANISATION, MUTHI, JAMMU