NSQ May 2024 State Labs

NOT OF STANDARD QUALITY ALERT FOR THE MONTH OF MAY – 2024 B. STATE LABORATORIES S.No Name of Batch Date of Date of Manufactured By NSQ Result Reported by Drugs/medical No. Manufactur Expiry CDSCO device/cosmeti e Laboratory cs 1. Cyra Tablets, CA21868 07/2023. 06/2025. Mfg By: Mepro NOT OF STANDARD State Lab Drugs Rabeprazole Pharmaceuticals Pvt.Ltd, QUALITY C o n t r o l Sodium Tablets Unit-II, Q Road, Phase - The tablets does not Laboratory, IP I V , G . I . D . C . W a d h w a n - c o m p l i e s i n b u f f e r s t a g e f o r T e l a n g a n a . 363035, Dist. the dissolution test Surendranagar, Gujrat. parameter, hence it is NOT OF STANDARD QUALITY. 2. Rabedin tablet LV23HT- 08/2023. 01/2025. Mfg By: LV life Sciences NOT OF STANDARD State Lab Drugs Tablets, 034B VPO Gurumajra, QUALITY C o n t r o l Rabeprazole BaddiDistt. Solan(H.P)- The sample does not meet Laboratory, Sodium Gastro- 174101. Himachal the acid stage acceptance Telangana. Resistant Pradesh. c r i t e r i a a s p e r I P Tabelts IP, Mrkt: Odin Healthcare specifications, hence it is Pvt.Ltd, Plot No. 1, declared as NOT OF Industrial Area, STANDARD QUALITY. ChambaghatSolan, H.P. - 173 213. 3. Moxtas Distab MALT- 10/2023. 09/2025. Mfg By: Wings Novitas NOT OF STANDARD State Lab Drugs 250 Tablets, 2019 Healthcare LLP 43 & 44, QUALITY C o n t r o l Amoxycillin HPSIDC, Industrial area, Tablets are with uneven Laboratory, trihydrate Baddi - 173 205. (H.P). surface and are crumbling Telangana. dispersible Himachal Pradesh. while taking out of the tablets IP. strip. Hence failed with respect to the test Description of Tablets. 4. Tolcenta-P ZT22806 12/2022. 11/2024. Mfg By: Zenomed Health NOT OF STANDARD State Lab Drugs Tablets, Care Pvt.Ltd. (ISO & QUALITY C o n t r o l 1 | Pa g eTolperisone GMP) Certificed NO. 70- 1. While Opening the strip, Laboratory, Hydrochloride 73, First Cross, Rainbow the tablets are sticky in Telangana. and Nagar, Vazthuthavuran nature and adhering to the Paracetamol Pattai, Navamlkapper, foil, hence the sample does tablets, Villupuram (Dt), Tamil not complies with respect Nadu - 605102 Tamil to description. nadu. 2 . T h e a s s a y c o n t e n t o f Mrkt: Elinova Pharma Tolperisone Hydrochloride Pvt.Ltd, D.No. 5-74/301, is not within the prescribed Panchavati Colony, limit, hence the sample Hyderabad, Telangana. does not complies as per manufacturing method of analysis. 5. Nagris - Nil Nil Mfg By: Nagris Herbs, NOT OF STANDARD State Lab Drugs Pakeezah Art LN Nagar, Jiyaguda, QUALITY C o n t r o l Henna (3 Henna Hyderabad. A. The sample does not Laboratory, Cones) conform to the test for Telangana. determination of absence of Picramic Acid as per BIS standard IS 17318:2020 as required as per rule 39 (Standard of Cosmetics) 2020. B. As the cautions do not use for coluring eyelashes or eyebrows. Do not use on cut, Irritated or abranded skin as per Bis Standard IS 17318: 2020 is not mentioned on the label of the cosmetic sample. Hence, the sample not labeled in the prescribed manner and deemed to be Misbranded Cosmetics as 2 | Pa g eper Section 17Cof Drugs and Cosmetics ACT, 1940. 6. Oxifer-XT EOX 12/2023. 05/2025. Mfg By: Eminent NOT OF STANDARD State Lab Drugs Tablets, Ferrous 2306 Remedies Plot No. 9/1/A, QUALITY C o n t r o l ascorbate Road, NO.14 Near Sample does not meets the Laboratory, elemental iron, Telangana Foods IDA, Specifications wrt Assay of Telangana. Folic acid & Zinc Nacharam, Hyderabad - elemental Iron (Ferrous sulphate 500076 (TS), Telangana. A s c o r b a t e ) . Tablets, Mrkt: Organic Pharma, H.No. 7-67/G3, Hyderabad. 7. Levolets- M Kid RC24BL- 02/2024. 01/2026. Mfg By: Rikencare Life NOT OF STANDARD State Lab Drugs Syrups, 521 sciences villmessaTibba, QUALITY C o n t r o l Montelukast Pharmaceuticals O Sample does not comply Laboratory, Sodium & Manjholi, Tehsil- Description of syrup and Telangana. Levocetrizine Nalagarh, DistSolan, HP- Assay of Montelukast. Dihydrochloride 174101 Himachal syrup Pradesh. Mrkt: Manvi Life Sciences, 1-1-289, Ashoknagar, Hyderabad - 500020. 8. Meazon Plus 23MP07 10/2023. 09/2025. Mfg By: Sai parentrals NOT OF STANDARD State Lab Drugs injection limited D1&D4, Survey QUALITY C o n t r o l Parentaral No. 280, Phase-V Sample does not comply Laboratory, Preparations, Hyderabad - 500 055 Assay of Folic Acid. Telangana. Mecobalamine, Telangana. Folic acid & Niacianamideinj 1 ml, 9. XERONAC-SP RP- 12/2023. 11/2025. Mfg By: Roma Pharma MISBRANDED S t a t e L a b D r u g s Tablets, T243/C Pvt.Ltd, Unit-II, Village The label of the drug does Control Aceclofenac, Nagali, P.O. Barog, not indicate the comon Laboratory, Paracetamol & Tehsil &Distt. Solan, name of the colur used as Telangana. (H.P) - 173 211, requied as per Rule 127(2) 3 | Pa g eSerratiopeptidas Himachal Pradesh. o f D r u g s R ules, 1945. Label e Tablets Mrkt: Fornax only bears the words Pharmaceuticals, No. 6- Approved colured used. Anew no. 17, 2nd Floor, Hence the drug is not VOC Colony, 3rd Street, labelled in the prescribed Amijikrai, Chennai - manner and is deemed to 600029. TN. be Misbranded drug as per section 17(c) of the Drugs and Cosmetics Act 1940. 10. Pedxim-200 TBL- 04/2023. 03/2025. Mfg By: MISBRANDED S t a t e L a b D r u g s Tablets, 2676 Ticomapharmaciae-17 The product name (title) Control Cefpodoximepro Focal Pont, Derabassi- indicated on the label is as Laboratory, xetil Tablets 200 140507, Distt. Mohali CefpodoximeProxetil Telangana. mg, (Punjab) Punjab. Tablets 200 mg instead of CefpodoximeProxetil Dispersible Tablets 200 mg. The label of the product does not state that the tablets should be dispersed in water immediately before use. Hence the product is not labeled in the prescribed manner and is deemed to be Misbranded drug as per section 17(c) of Drugs and Cosmetics Act. 11. DofloxOZT DDX230 06/2023. 05/2026. MfgBy: Doctor's Vet- MISBRANDED S t a t e L a b D r u g s Tablets, 1 Pharma Pvt.Ltd, P.R. The drug product Ofloxacin Control Ofloxacin&Ornid Palem (V), Kovur(M), and Ornidazole Tablets is Laboratory, azole Tablets SPSR Nellore Dist. official in Indian Telangana. Andhra Pradesh. P h a r m a c o p o e i a . B u t t h e Mrkt: Doctor's Life letters IP is not mentioned Sciences (India) Ltd, on the strip after the Survey NO. 263/1, product name Ofloxacin 264/1, P.R. Palem (V), and Ornidazole Tablets. 4 | Pa g eKovur (M), SPSR Nellore Hence it is Misbranded Dist - 524 137, A.P. Drugs under Section 17(c) India. of drugs and cosmetics act. 12. Disinfectants, SS- 05/2023. 04/2025. Mfg By: MISBRANDED S t a t e L a b D r u g s Surgical Spirit 053011 Transflexjawaharnagar, As per rule R.124 the drug Control BP Raipur, (C.G)- 492001, is included in the current Laboratory, Chhattisgarh. edition of Indian Telangana. Pharmacopoiea 2022. Hence standards shall be of those as specified in Indian Pharmacopoiea 2022. But the subject drug Surgical spirit bears the letters B.P after the drug name instead of IP. As per rule 96 and 104 as the drug shall be in accordance with standards set out in Indian Pharmaopoiea, the name of the drug surgical spirit shall be followed by the letters IP. As the subject drug is not confirming to the said labelling requirements the drug shall be deemed to be Misbranded as per section 17. 13. Sif Alben AL80012 05/2023. 04/2025. Mfg By: Siflon Drugs & MISBRANDED S t a t e L a b D r u g s Suspension, 3 Pharmaceuticals The given sample Control Albendazole Pvt.Ltd., Plot no. 20&21, Albendazole oral Laboratory, Oral Aleap IE, Gajularamaram suspension is official Telangana. Suspension (V), Hyderabad - 55 included in the IP and 2.5% w/v (Vet) Telanga. r e q u i r e d as per schedule of the Drugs and Cosmetics 5 | Pa g eAct 1940. The given sample shall comply with the standards set out in IP but, the designation IP is conjunction with the official tittle Albendazoleoral suspension on label of the drug product was not mentioned as indication that the drug product purports to comply with IP standards. Hence the Drug product shall be deemed to be Misbranded drug as per section 17 of Drugs and Cosmetics Act. NOTE: # Based on the data received from respective state laboratories. 1. NSQ data was not received as per Format & in EXCEL SHEET from State Drugs Licensing Authorities of Jharkhand, Jammu & Kashmir (MD and ED not appropriate), Kerala (Expiry date not specified). for the Month of May, 2024 as per DCG(I) Circular dated 09.02.2024. 2. Sate Drugs Licensing Authorities of Goa have stated that the NSQ data as “NIL” for the Month of May, 2024. 3. State Drugs Licensing Authorities of Andhra Pradesh, Arunachal Pradesh, Assam, Bihar, Chhattisgarh, Gujarat, Haryana, Himachal Pradesh, Maharashtra, Manipur, Meghalaya, Mizoram, Nagaland, Odisha, Punjab, Rajasthan, Sikkim, Tamil Nadu, Uttarakhand, West Bengal, Andaman & Nicobar, Dadar and Nagar Haveli; Daman and Diu, Lakshadweep have not submitted any data in respect of the Not of Standard Quality (NSQ) Alert for the Month of May, 2024 as per DCG(I) Circular dated 09.02.2024. 6 | Pa g e