CDSCO

CDSCO ne 52 sample fail kiye

CDSCO द्वारा 52 सैंपल फेल पाए गए हैं:

भारतीय दवा नियामक CDSCO द्वारा टेस्टिंग के लिए सैंपल में से 52 सैंपल फेल पाए गये। पेरासिटामोल तथा पैंटाप्राजोल जैसी दवाओं के सैंपल भी फेल पाए गए। कुछ एंटीबायोटिक मेडिसिन भी गुणवत्ता में पास नहीं हो पाई।

उल्लेखनीय बात यह है कि इन सभी फेल दवा के सैंपल में से 22 सैंपल अकेले हिमाचल प्रदेश में निर्मित दवाओं के थे। 22 जून को जारी अलर्ट के अनुसार 52 मेडिसिन के सैंपल फेल हुए हैं।


इस सन्दर्भ में CDSCO में सभी दोषी कंपनीयों को नोटिस जारी कर दिए हैं तथा सभी को मार्किट से दवाओं को वापिस बुलाने को कहा गया। जो मेडिसिन फेल हुई उनमें जीवन रक्षक दवाएं जैसे Clonazepam जो बेचैनी तथा जकड़न की दवा है। इसके अतिरिक्त Diclofenac, Telmisartan, Ambroxol, Fluconazole तथा कुछ मल्टी विटामिन दवाइयां भी शामिल हैं।

फेल हुए सैंपल की सूचि इस प्रकार से है:

Sr No.Name of Drugs/medical device/cosmeticsManufactured ByNSQ Result
1Cyra Tablets, Rabeprazole Sodium Tablets IPMfg By: Mepro Pharmaceuticals Pvt. Ltd, Unit-II, Q Road, Phase – IV, G.I.D.C. Wadhwan – 363035, Dist. Surendranagar, Gujrat.NOT OF STANDARD QUALITY The tablets does not comply in buffer stage for the dissolution test parameter, hence it is NOT OF STANDARD QUALITY.
2Rabedin tablet Tablets, Rabeprazole Sodium GastroResistant Tabelts IP,Mfg By: LV life Sciences VPO Gurumajra, BaddiDistt. Solan(H.P)- 174101. Himachal Pradesh. Mrkt: Odin Healthcare Pvt.Ltd, Plot No. 1, Industrial Area, ChambaghatSolan, H.P. – 173 213.NOT OF STANDARD QUALITY The sample does not meet the acid stage acceptance criteria as per IP specifications, hence it is declared as NOT OF STANDARD QUALITY.
3Moxtas Distab 250 Tablets, Amoxycillin trihydrate dispersible tablets IP.Mfg By: Wings Novitas Healthcare LLP 43 & 44, HPSIDC, Industrial area, Baddi – 173 205. (H.P). Himachal Pradesh.NOT OF STANDARD QUALITY Tablets are with uneven surface and are crumbling while taking out of the strip. Hence failed with respect to the test Description of Tablets.
4Tolcenta-P
Tablets, Tolcenta-P Tablets, Tolperisone
Hydrochloride
and
Paracetamol
tablets,		Mfg By: Zenomed Health Care Pvt.Ltd. (ISO &GMP) Certificed NO. 70-
73, First Cross, Rainbow
Nagar, Vazthuthavuran
Pattai, Navamlkapper,
Villupuram (Dt), Tamil
Nadu – 605102 Tamil
nadu.
Mrkt: Elinova Pharma
Pvt.Ltd, D.No. 5-74/301,
Panchavati Colony,
Hyderabad, Telangana		NOT OF STANDARD QUALITY 1. While Opening the strip,
the tablets are sticky in
nature and adhering to the
foil, hence the sample does
not complies with respect
to description.
2. The assay content of
Tolperisone Hydrochloride
is not within the prescribed
limit, hence the sample
does not complies as per
manufacturing method of
analysis.
5Nagris Pakeezah Art Henna (3 Henna Cones)Mfg By: Nagris Herbs, LN Nagar, Jiyaguda, Hyderabad.NOT OF STANDARD QUALITY A. The sample does not conform to the test for 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 per Section 17Cof Drugs
and Cosmetics ACT, 1940.
6Oxifer-XT Tablets, Ferrous ascorbate elemental iron, Folic acid & Zinc sulphate Tablets,Mfg By: Eminent Remedies Plot No. 9/1/A, Road, NO.14 Near Telangana Foods IDA, Nacharam, Hyderabad – 500076 (TS), Telangana. Mrkt: Organic Pharma, H.No. 7-67/G3, Hyderabad.NOT OF STANDARD QUALITY Sample does not meets the Specifications wrt Assay of elemental Iron (Ferrous Ascorbate).
7Levolets- M Kid Syrups, Montelukast Sodium & Levocetrizine Dihydrochloride syrupMfg By: Rikencare Life sciences villmessaTibba, Pharmaceuticals O Manjholi, TehsilNalagarh, DistSolan, HP174101 Himachal Pradesh. Mrkt: Manvi Life Sciences, 1-1-289, Ashoknagar, Hyderabad – 500020.NOT OF STANDARD QUALITY Sample does not comply Description of syrup and Assay of Montelukast.
8Meazon Plus injection Parentaral Preparations, Mecobalamine, Folic acid & Niacianamideinj 1 ml,Mfg By: Sai parentrals limited D1&D4, Survey No. 280, Phase-V Hyderabad – 500 055 Telangana.NOT OF STANDARD QUALITY Sample does not comply Assay of Folic Acid.
9XERONAC-SP Tablets, Aceclofenac, Paracetamol & Serratiopeptidas
e Tablets		Mfg By: Roma Pharma Pvt.Ltd, Unit-II, Village Nagali, P.O. Barog, Tehsil &Distt. Solan, (H.P) – 173 211, Himachal Pradesh.
Mrkt: Fornax
Pharmaceuticals, No. 6-
Anew no. 17, 2nd Floor,
VOC Colony, 3rd Street,
Amijikrai, Chennai –
600029. TN.		MISBRANDED The label of the drug does not indicate the comon name of the colur used as requied as per Rule 127(2) of Drugs Rules, 1945. Label
only bears the words
Approved colured used.
Hence the drug is not
labelled in the prescribed
manner and is deemed to
be Misbranded drug as per
section 17(c) of the Drugs
and Cosmetics Act 1940.
10Pedxim-200 Tablets, Cefpodoximepro xetil Tablets 200 mg,Mfg By: Ticomapharmaciae-17 Focal Point, Derabassi140507, Distt. Mohali (Punjab) Punjab.MISBRANDED The product name (title) indicated on the label is as CefpodoximeProxetil 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.
11DofloxOZT Tablets, Ofloxacin & Ornid azole TabletsMfg By: Doctor’s VetPharma Pvt.Ltd, P.R. Palem (V), Kovur(M), SPSR Nellore Dist. Andhra Pradesh. Mrkt: Doctor’s Life Sciences (India) Ltd, Survey NO. 263/1, 264/1, P.R. Palem (V), Kovur (M), SPSR Nellore
Dist – 524 137, A.P.
India.		MISBRANDED The drug product Ofloxacin and Ornidazole Tablets is official in Indian Pharmacopoeia. But the letters IP is not mentioned on the strip after the product name Ofloxacin and Ornidazole Tablets. Hence it is Misbranded
Drugs under Section 17(c)
of Drugs and cosmetics act.
12Disinfectants, Surgical Spirit BPMfg By: Transflexjawaharnagar, Raipur, (C.G)- 492001, Chhattisgarh.MISBRANDED As per rule R.124 the drug is included in the current edition of Indian Pharmacopoiea 2022. Hence standards shall be of those as specified in Indian Pharmacopeia 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.
13Sif Alben Suspension, Albendazole Oral Suspension 2.5% w/v (Vet)Mfg By: Siflon Drugs &
Pharmaceuticals
Pvt.Ltd., Plot no. 20&21,
Aleap IE, Gajularamaram
(V), Hyderabad – 55
Telanga.		MISBRANDED The given sample Albendazole oral suspension is official included in the IP and required as per schedule of the Drugs and Cosmetics. Act 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.


इन 22 दवाओं में हिमाचल प्रदेश में बनी हुई थी उनमें पांवटा साहिब स्थित Zee Laboratories तथा Daxin Pharmaceuticals जैसी काफी कंपनियां भी शामिल हैं।

22 में से 16 कंपनियां Baddi, 5 पांवटा साहिब, कला आम्ब तथा 1 सैंपल una में बनी थी। 2023 में कुल 120 सैंपल फेल हुए थे जो हिमाचल प्रदेश में बनी थी।

जिस संख्या में दवा के सैंपल फेल जो रहें हैं यह चिंता की बात है तथा लोगों की सेहत से हो रहे खिलवाड़ पर सर्कार चिंतित नजर आ रही है। सरकार का इस तरफ ध्यान देने की जरुरत हैं।

As-per: Economic Times of India. 

सन्दर्भ (References):

  1. Economic Times of India [https://health.economictimes.indiatimes.com/news/pharma/regulatory-update/52-drug-samples-fail-regulatory-bodys-quality-test/111270811-Website]
  2. Clonazepam [https://www.drugs.com/clonazepam.html-Drugs.com]
  3. Ambroxol [https://laafon.com/2023/02/ambroxol-terbutaline-guaiphenesin-and-menthol-syrup-ftox-am-syrup.html-Laafon.com]
  4. Telmisartan [https://www.1mg.com/generics/telmisartan-210783-1mg]
  5. टाइम्स ऑफ़ इंडिया [https://timesofindia.indiatimes.com/city/shimla/drug-samples-fail-quality-test-in-himachal-pradesh-majority-from-baddi/articleshow/111216164.cms]