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The Employees' State Insurance Corporation declares the drug batch Rabnor-M as misbranded because the product label does not state the color of the pellets. This defect violates rule 127(2) of the drug rules, 1945. User units must stop the use of batch IRB 122 immediately. The user units must recover the replacement of supplies or the cost of the materials from the firm. The units must also take action under the terms and conditions of the tender enquiry.
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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, C.I.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) / 570 Web- Upload
सेवा में, Director (Medical) Delhi / Director (Medical) Noida, Dean, All ESIC PGIMSR's, Medical & Dental Colleges Medical Superintendents - All 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 taken Premises | Name of the Firm | Item Name/Name (M/s) | Brand Name | RC No/ Item No/ Page No | Batch No./ DOM/ DOE | Name of the Laboratory/ Report No. & Date | Reason |
|---|---|---|---|---|---|---|---|
| ESIC Model Hospital-Jammu | Med Manor Organics Pvt Ltd, | Rabeprazole Sodium + Mosapride Citrate Tab/Cap- | |||||
| Each Tab/Cap to contain: | |||||||
| Rabeprazole Sodium 20mg, | |||||||
| Mosapride Citrate 15mg Sustained Release | Rabnor-M | 149 1496 | Batch No.- IRB 122 | ||||
| DOM: 06-25 | |||||||
| DOE: 05-27 | Govt. Analyst, Combined Food & Drugs Laboratory - Jammu | ||||||
| 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:
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:
Email RCCell
Fwd: Testing of drug sample-reg
From : DMC RC dmc-rc@esic.nic.in Subject : Fwd: Testing of drug sample-reg To : RCCell rc-hqrs@esic.nic.in Reply To : DMC RC dmc-rc@esic.nic.in
Fri, Sep 12, 2025 05:12 PM 1 attachment
महोदय/महोदया, उपरोक्त विषयांतर्गत आपके सादर सूचनार्थ एवं आवश्यक कार्रवाई हेतु संलग्न प्रेषित है। Please find herein attachment for your kind information & necessary action.
धन्यवाद, उप चिकित्सा आयुक्त (आर सी वी पी सी, शाखा ५) क रा बी निगम मुख्यालय VOIP No. 10011026
From: "ESIC Hospital Jammu" ms-jammu@esic.nic.in
To: "DMC RC" dmc-rc@esic.nic.in
Cc: "yogendra mishra" yogendra.mishra@medmanor.in, jayraman@medmanor.in, "ganesh jayraman" ganesh.jayraman@medmanor.in, "Shaheen Chaudhary" dr.shaheen.chaudhary@esic.nic.in, "AKHIL GAHLOT" akhil.gahlot@esic.nic.in
Sent: Friday, September 12, 2025 3:59:29 PM
Subject: Testing of drug sample-reg
महोदय/ महोदया Madam/Sir,
A drug sample namely Tab Rabnor-M, B.No.IRB122,Mfg June 2025 Exp May 2027, Mfd By Med Manor Organics Pvt Ltd, Unit-II, KH, 143/7, Village Raipur Pargana- Bhagwanpur, Tehsil-Roorkee, Distt.-Haridwar, was taken up by Drug Control officer Bari Brahmana Samba from the drug store of Esic Model Hospital Bari Brahmana Jammu, during routine inspection dated 22/7/2025. The said drug sample has been declared to be of sub standard quality by government analyst combined food & drug laboratory, Jammu vide test report no CFDL/J/2025-2026/666 Dated 30/08/2025.In his report has mentioned remark as" 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. The Details of said drugs given below-
| NAME OF DRUGS | BATCH NO. | MFG DATE | EXPIRY DATE | NAME OF THE DEALER/FIRM | PURCHASE ORDER NO & DATE | TOTAL QUANTITY OF DRUGS PURCHASED | BALANCE/STOCK IN HAND |
|---|---|---|---|---|---|---|---|
| RABNOR-M CAPS. | IRB 122 | Jun-25 | May-27 | MED MANOR ORGANIC | |||
| S PVT LTD | PO1960625000256 & 05/06/2025 | 40000 | 39800 |
The drug control officer requested to stop the supply/Distribution of above mentioned drug. Copy of test report attached
Thanks, with regards:
Office of the / का कार्यालय: चिकित्सा अधीक्षक / Medical Superintendent क.रा.बी.नि. आदर्श अस्पताल / ESIC Model Hospital, बारी-ब्राह्मण, जम्मू / Bari-Brahmana, Jammu - 181133. Ph.: 01923-221105. VOIP: 41923007 (P.A Cell) Please consider the environment before printing this email.
[Image omitted. See the official document.]
FORM 13 [See Rule 46] Certificate of test or analysis by Government Analyst under section 25[1] of the Drugs and Cosmetics Act, 1940
Rx Rabeprazole Sodium And Mosapride Citrate Sustained Release Capsules Rabnor- M ESI SUPPLY
Each hard gelatin capsule contains:- Rabeprazole Sodium IP...........................................................................20mg (As enteric coated pellets) 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. B.NO: IRB122 MFG. JUN.2025 EXP. MAY 2027 Mfg. Lic. No. 18/UA/2017 Mfd. By: MED MANOR ORGANICS PVT. LTD. Unit II, Kh. 143M/7 Village: Raipur Pargana-Bhagwanpur Tehsil-Roorkee, Distt. Haridwar Uttarakhand. 247661.
For the general standards, method given in IP 2022 under the monograph "Capsules" have been followed.
