18 medicines manufactured by top companies found substandard

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Rajashtan govt sounds alarm asks J&K, other states to withdraw these drugs from market forthwith

Afaq Bhat

Srinagar, Aug 12: Government of Rajashtan recently sent a circular to the Drug Controller of Jammu and Kashmir to withdraw as many as eighteen medicines, comprising mostly of antibiotics and other widely used salts, from the market and hospitals as these drugs were found to be substandard.
The circular issued by Drugs control organization Rajashtan states: “Particulars of the samples declared as not of standard quality on test /analysis reveal that these medicines are not fit for the human consumption. Authorities should ensure that the stocks of these drugs are not consumed anymore and appropriate safeguard to the consumers is provided by withdrawing the available stock and take action as per provisions of Drugs & Cosmetics Act 1940.”
The circular has been sent to the Drugs Controllers of Andhra Pradesh/Gujarat/Himachal Pradesh/Pondicherry/ Madhya Pradesh/ Uttrakhand/ Assam/ Arunachal Pradesh/Andaman Nicobar/Bihar/Chattisgarh/Daman/Delhi/Dadar & Nagar Haveli/ Maharashtra/ Goa/ Haryana/Jammu & Kashmir/Jharkhand/ Kerala/ Lakshadweep/ Manipur/MeghalayaMizoranT/Nagaland/Orissa/Punjab/Sikkim/Tripura/UttarPradesh/West Bengal/ and Karnataka. It has also been sent to Joint Drugs Controller (India), North zone and others.
The drugs which have been declared unsafe for consumption are already in the market and by now these would have been consumed, a said an expert.
The drugs which have declared substandard are: Pantoprazole & Domperidone Tablets (CUPAN-D) G527/480, OCT 2018 manufactured by M/s Elfin Drugs Pvt. Ltd., Vill. Berson, Nalagarh (Himachal Pradesh ) does not conform to the claim as it does not contain Domperidone, states the report.
It states that Montelukast Sodium & Levocetirizine Hydrochloride Tablets (Montair-LC) SA65947, SEP. 18 manufactured by Cipla Ltd, Kumrek, Rangpo, Sikkim does not conform to the claim with respect to Assay of Levocetirizine Hydrochloride and as it does not contain Montelukast (Nil).
Enteric coated Pantoprazole Sodium & Domperidone SR Capsules (Pantop-DSR) B452J037, AUG.2019 manufactured by Aristo pharmaceuticals pvt ltd, village Makhnumajra, district Solan (HP) does not conform to the claim with respect to assay of Domperidone & it does not contain Pantoprazole.
Pantoprazole Gastro resistant Tablets IP (Pantop 40) S171K017, Mar.2020 manufactured by Aristo Pharmaceuticals Pvt. Ltd district Solan (HP) does not conform to the claim as it does not contain Pantoprazole (Nil).
Cefpodoxime Tablets IP 200mg (Monocef-0 200), B198H197, Jul.2019 manufactured by Aristo pharmaceuticals pvt ltd does not conform to the claim as it does not contain Cefpodoxime.
Cefpodoxime Tablets IP 200mg (Monocef-0 200) B198J017, Aug.2019 manufactured by Aristo pharmaceuticals does not conform to the claim as it does not contain Cefpodoxime.
Amoxicillin and Potassium Clavulanate Tablets LP. (CLAVAM 625) 7170784, Mar 2019 manufactured by Alkem laboratories limited (unit- II), village-Thana district Solan Himachal Pradesh does not conform to the claim with respect to assay of Amoxicillin and it does not contain Clavulanic acid.
The Calcium Supplement with vitamin D3 Chewable Tablets (CAL D3 tablets) GSMT-019, 09/2018 manufactured by Laborate Pharmaceuticals India Ltd., unit-2, Rajban Road, Nariwala, Paonta Sahib (HP) does not conform as it does not contain vitamin D3.
Cefixime Tablets I.P. (Taxim-0 200) 7181490, 08/2019 manufactured by M/s Alkem Health Science, A unit of Alkem laboratories limited, Samardung, Karek Block Namthang South Sikkim does not conform to the claim as it does not contain Cefixime and found Ofloxacin 207.62mg/tab.
Pantoprazole Gastro Resistant Tablets IP (PAN 40), 7133275, E 04/20 manufactured by M/s Alkem Laboratories Limited, Central Pendam Block, Dugailaka, Kumrek, Rangpo, East Sikkim does not conform to the claim as it does not contain Pantoprazole.
Enteric Coated Pantoprazole Sodium and Sustained Release Domperidone Capsules (Pantocid DSR) EMS 2060, 06/2019 manufactured by M/s Sun Pharma Laboratories Ltd Namli Block.. Ranipool, East Sikkim-737135 does not conform to the claim with respect to assay of Domperidone & it does not contain Pantoprazole and found Omeprazole 21.69 mg/cap.
Azithromycin Tablets I.P. (AZIPRIME-250) TNAP-476, 08/2018 manufactured by M/s Accurate Pharmaceuticals, C-3 (A&B) Gondpur Industrial Area, Paonta Sahib (HP) does not conform to the claim with respect to Assay of Azithromycin.
Glimepiride & Metformin Hydrochloride Tablets (GLIMICUT-M1) AP6334, Oct. 18 M/s Affy Parenterals, Vil. Gullerwala, P.O.-Baddi, D-‘stt.-Solan-173205 (H.P.) The sample does not conform to the claim with respect to Assay of Glimepiride.
Telmisartan Tablets IP 40mg (TEMI-40), DVTC1672, 08/18manufactured by M/s Digital Vision, 176, Mauzaogli, Nahan Road, Kala Amb, Distt. Sirmour (H.P.) does not conform to the claim with respect to dissolution.
Calcium Carbonate, Magnesium Hydroxide Zinc& Cholecalciferol Suspension (CaljonD3 Suspension 200ml) YS-7084, OCT.2018 manufactured by M/s Yacca Life Sciences Pvt. Ltd., 156, Raipur, Bhagwanpur, Roorkee-247661 does not conform to the claim with respect to Assay of Cholecalciferol.
Diclofenac Sodium Tab. I.P. 50mg, DFT17013, 08/19 manufactured by M/s Vivek Pharmachem (I) Ltd., NH-8, Chimanpura, Amer, Jaipur does not conform to the claim as per IP 2014 with respect to test for uniformity of weight.
Hydrocoxtisone Sodium Succinate Inj. IP 100mg HCL16048, 07/2018 manufactured by M/s Vivek Pharmachem (I) Ltd., NH-8, Chiit-anpura, Amer, Jaipur declared as not of standard quality as it does not conform to IP standards with respect to test for sterility.
Pantoprazole & Domperidone Tab. (TOP-D) G-177, 08/2018 manufactured by M/s Care-Well Healthcare, 142, Mahagujarat, Ind. Estate, Moraiya Sarkhej Bavia Road, Ahmedabad 382210 does not conform to the claim with respect to Assay Pantoprazole & Domperidone.