New Delhi: In its latest drug safety alert, the apex drug regulatory body, Central Drugs Standard Control Organization (CDSCO) flagged 48 medicine batches for failing to qualify a random drug sample test for the month of March.These drugs samples which are declared not of standard quality include Skymap Pharmaceuticals' Trimetazidine Modified Release Tablets, Hindustan Antibiotics'...

New Delhi: In its latest drug safety alert, the apex drug regulatory body, Central Drugs Standard Control Organization (CDSCO) flagged 48 medicine batches for failing to qualify a random drug sample test for the month of March.

These drugs samples which are declared not of standard quality include Skymap Pharmaceuticals' Trimetazidine Modified Release Tablets, Hindustan Antibiotics' Doxycycline Capsules, Calcium and Vitamin D3 Tablets IP, Theon Pharmaceutical's Trypsin, Bromelain & Rutoside Trihydrate Tablets.

In addition to this, the list also includes TINVISTA 300 (Tinidazole Tablets IP 300 mg) manufactured by Cadila Pharmaceutical and MAYCOXIA-90 (Etoricoxib Tablets IP) manufactured by Akums Drugs & Pharmaceuticals.

This came after analysis and test were conducted by the CDSCO, Drugs Control Departments on 1454 samples. Out of this, 1406 samples were found of standard quality while 48 of them were declared as Not of Standard Quality (NSQ).

A few of the reasons why the drug samples tested failed were the failure of the assay, failure of the Disintegration test, failure of the dissolution test, failure of the sterility test.

The samples collected were tested in four laboratories, namely CDL Kolkata, CDTL Mumbai, RDTL Chandigarh,RDTL Guwahati.

List of Drugs, Medical Devices and Cosmetics declared as Not of Standard Quality/Spurious/Adulterated/Misbranded, for the Month of March – 2022.

Total number of samples tested

Total number of samples declared as of Standard Quality

Total number of samples declared as Not of Standard Quality

Total number of samples declared as Spurious

Total number of samples declared as Misbranded

Name of Drugs/medical device/cosmetics

Batch No./Date of Manufacture/Date of

Doxycycline Hydrochloride Capsules I.P. 100 mg

Mfg dt: 05/2021 Exp dt: 04/2023 Mfd by: M/s. Super

Formulations Pvt. Ltd., 16-B & 15-F, Industrial Area, Maxi Road, Ujjain -456 010

Mfd by: M/s. Ciron Drugs & Pharmaceuticals Pvt. Ltd., Plot No. 35 to 37,

Dewan Udyog Nagar, Aliyali Palghar, Distt.

B. No.: A116 Mfg dt: 11/2020 Exp dt: 10/2023

Mfd by: M/s. Anamika Udyog, 127, Multan Nagar, Meerut (India) Uttar Pradesh.

Threads per dm, Weight in (gm/m2), Foreign Matter, Fluorescence

Doxycycline Capsules I.P. 100 mg

Mfd by: M/s. Rivpra

Formulation Pvt. Ltd., Plot No. 8, Sector-6A, I.I.E., SIDCUL,

Gatoline-100 (Doxycycline Capsules I.P.)

Mfd by: M/s. CMG

Byzyme (Pepsin & Fungal Diastase Syrup), 200ml

Mfd by: M/s. Skymap Pharmaceuticals Pvt. Ltd. B-3, Dev Bhoomi Industrial Estate Puhana Iqbalpur Road, Roorkee -247667 Uttarakhand.

Vitamin A, Vitamin D3, Thiamine Mononitrate, Riboflavin, Pyridoxine Hydrochloride, Calcium Pantothanate, Niacinamide, Vitamin C & Folic Acid Tablets

B. No.: GMB 21 Mfg dt: 03/2021 Exp dt: 08/2022

Mfd by: M/s. Medline Pharmaceuticals Pvt. Ltd., Plot No. 2 & 3, 1st Main Road, EVP Prabhu Avenue, Chinnakulathuvancherr

Description & Assay of 'Vitamin D3', 'Riboflavin', & 'Calcium Pantothanate'.

Bunase 0.5 Respules (Budesonide Nebuliser Suspension BP)

B. No.: RS1195 Mfg dt: 11/2021 Exp dt: 10/2023 Mfd by: M/s.

Village Thana, Baddi, Himachal Pradesh – 173 205.

Compound Benzoin Tincture I.P.

B. No.: W-02 Mfg dt: 05/2021 Exp dt: 04/2023

Mfd by: M/s. Walllis Pharmaceuticals, K- 25, Thakur Complex, SDA Compound,

Weight per ml, Ethanol Content, Total Solids and Assay

Lasudia Mori, Indore Madhya Pradesh.

(Methylcobalamin, Alpha Lipoic Acid, Pyridoxine, Benfotiamine, Biotin & Chromium Polynicotinate Capsule)

B. No.: MHD-1611 Mfg dt: 01/2021 Exp dt: 12/2022

Mfd by: M/s. Medinok Healthcare Pvt. Ltd.,

R.S. No. 2/1, Plot No. 87, 88, 89 Vazhudhavur Main Road, Kurumbapet, Puducherry -605009.

Assay of Alpha Lipoic Acid

Mfd by: M/s. Modern Laboratories, 45-47, Sector D-2, Sanwer Road, Indore, Madhya Pradesh - 452015, India.

Mfd by: M/s. Skymap Pharmaceuticals Pvt. Ltd., B-3, Dev Bhoomi Industrial Estate, Puhana Iqbalpur Road, Roorkee -247667 Uttarakhand.

Amikacin Injection IP 100 mg / 2 ml- 2 ml

Mfd by: M/s. Bharat Parenterals Ltd., Survey No. 144 & 146 Jarod-Samlaya Road, Tal. Savli, City: Haripura, Dist.

Dicyclomine Hydrochloride Injection I.P. 2 ml

B. No.: HLI471D Mfg dt: 04/2021

Mfd by: M/s. Himalaya Meditek Private Limited, Plot No. 35 & 36, Pharmacity,

Selaqui Industrial Area, Dehradun 248197 Uttarakhand.

Mfd by: M/s. Unicure India Ltd., C-21, 22 & 23, Sector – 3, Noida -

201 301, Dist. Gautam Budh Nagar, Uttarpradesh.

Doxycycline Capsules I.P. 100 mg

Mfd by: M/s. Hindustan Antibiotics Ltd., At 11, W.R.A., Faridabad – 121 001, Haryana.

Mfd by: M/s. Unicure India Ltd., C-21, 22 & 23, Sector – 3, Noida -

201 301, Dist. Gautam Budh Nagar, Uttar Pradesh.

Mfg dt: 09/2021 Exp dt: 08/2023 Mfd by: M/s. BVK's

Plot No. 789, Rakanpur Ind Area, Rakanpur, Ta-Kalol,

Calcium and Vitamin D3 Tablets IP (500 mg + 250 IU)

(Calcium 500 mg & Vitamin D3 250 IU)

B. No.: CWTY-103 Mfg dt: 02/2021 Exp dt: 01/2023

Mfd by: M/s. Hindustan

Queencath (Female Catheter, Size 12 fr)

Mfd by: M/s. Morrisons Lifecare Pvt. Ltd. No. 3, Anna Street, Padikuppam, Chennai

Trypsin, Bromelain & Rutoside Trihydrate Tablets

Mfg dt: 11/2020 Exp dt: 10/2022 Mfd by: M/s. Theon

Pharmaceutical Ltd., Vill. Saini Majra, Tehsil Nalagarh, Dist. Solan, Himachal Pradesh –

Description Length Thickness and Width

Telione - 40 (Telmisartan Tablets IP)

Mfd by: M/s. Theon

B. No.: PLUS 21-004 Mfg dt: 07/2021

Exp dt: 06/2023 Mfd by: M/s.

B. No.: JKGJ20001 Mfg dt: 03/2020

Mfd by: M/s. Cadila

B. No.: OBZB02 Mfg dt: 07/2021 Exp dt: 06/2023 Mfd by: M/s. Akums Drugs &

Pharmaceuticals Ltd., 19, 20, 21, Sector 6A, I.I.E, SIDCUL,

Aspirin Gastro- resistant Tablets I.P.

B. No.: APET901 Mfg dt: 05/2021 Exp dt: 04/2023

Mfd by: M/s. Unicure India Ltd., C-21, 22 & 23, Sector-3, Noida-

12.5 mg Tablets IP (TELMA H TABLETS)

Mfg dt: 12/2020 Exp dt: 11/2023 Mfd by: M/s. Dallas Drugs Pvt.Ltd. 156,

D.I.C., Ind.Area Baddi, Distt. Solan, Himachal

Esomeprazole with Domperidone Tablets (ESSOF-D TABLETS)

Mfd by: M/s. ADWIN PHARMA Vill. Rampur Jattan, Trilokpuri Road, Kala-Amb, Tehsil-Nahan, Distt.

Drug Control Department Jammu & Kashmir

Mfg dt: 06/2021 Exp dt: 05/2023 Mfd by: M/s. Tanpal Pharmaceuticals D- 12-13, Focal Point,

Isotretinoin Capsules IP (VISOTIN-10 CAPSULES)

B. No.: VPS-21407D Mfg dt: 11/2021

Exp dt: 10/2024 Mfd by: M/s.

Pharmaceuticals 28, Industrial Area, Johron Trilokpur Road, Kala Amb, Distt. Sirmour Himachal Pradesh -

Drug Control Department Himachal Pradesh

Calcitriol and Calcium Capsules (BIO-D3 PLUS CAPSULES)

B. No.: ACB2008A Mfg dt: 09/2020 Exp dt: 08/2023 Mfd by: M/s. MACLEODS

P.O. Lodhimajra, Tehsil Baddi, Dist. Solan, Himachal Pradesh, India-

Olmesartan Medoxomil and Amlodipine Tablets (OLMISAVE AM-40 TABLETS)

Mfd by: M/s. Cosmas Pharmacls Ltd.

Buranwala Road, Village: Kotla, P.O.: Barotiwala, Solan Himachal Pradesh -

Drug Control Department Jammu & Kashmir

VETERINARY INJECTION IP VET. (5 OXYTOCIN

UNITS/ML, 0.5 W/V CHLORBUTOL PHENOL IP

Mfd by: M/s. NEELAM CHEMICAL WORKS

B.O.M.G. Road, Bada

Particulate matter, Sterility and the Assay of Oxytocin Activity

OXYTOCIN INJECTION (VET) OXYTOCIN 5 IU/ML,

0.5% W/V PHENOL OR CHLOROBUTOL IP

Mfg dt: 01/2022 Exp dt: 12/2024 Mfd by: M/s. Super

R.B. Road, Bihar Pin:

Particulate matter, Sterility and the Assay of Oxytocin Activity

OXYTOCIN INJECTION IP (VET) 10 OXYTOCIN UNIT PER ML, 0.5% W/V PHENOL IP

B. No.: Not Mentioned Mfg dt: N.M.

Mfd by: M/s. Super Vaishali Address: Not Mentioned

Particulate matter, Sterility and the Assay of Oxytocin Activity

Ibuprofen and Paracetamol Tablets IP (IBUCON TABLETS)

Mfg dt: 07/2021 Exp dt: 06/2023 Mfd by: M/s.Progressive

Lifesciences Pvt. Ltd. Latherdevahoon, P.O. Jhabrera, Roorkee, Distt. Haridwar-

Drug Control Department Himachal Pradesh

Lignocaine Hydrochloride Gel IP (LIGNOMARK JELLY)

B. No.: E1C060 Mfg dt: 03/2021

Mfd by: M/s. Smayan

Mfd by: M/s. Jackson Laboratories Pvt. Ltd. 22-24, Majitha Road,

Bye Pass, Amritsar- 143001 (India) Punjab.

Particulate matter Bacterial Endotoxins and Sterility

Mfd by: M/s. Lars Medicare Private Limited, Kila No.: 16- 17, Sultanpur, Opp. Sports Authority of India, Near Bahalgarh

Description, kinking of the tubing & Leakage Test

B. No.: LPST-004 Mfg dt: 05/2021 Exp dt: 04/2024

Mfd by: M/s. Laborate Pharmaceuticals India Ltd.(Unit-II), #31,

Rajban Road, Nariwala, Paonta Sahib, Himachal

B. No.: PLO7AK04 Mfg dt: 05/2020 Exp dt: 04/2022

Mfd by: M/s. Akums

Drug Control Department Arunachal Pradesh

Plot No.-26A, 27-30,

Sector 8A, I.I.E.,

Ofloxacin and Ornidazole Tablets I.P.

B. No.: UUF2002 Mfg dt: 02/2020 Exp dt 07/2022

Mfd by: M/s. Coral

Drug Control Department Arunachal Pradesh

Paracetamol IP 500 mg Phenylephrine HCI IP 5 mg

Caffeine IP 30 mg Diphenhydramine HCI IP 25 mg

Mfd by: M/s. Maxrelief Health Care, Vill: Anji, Solan, Himachal

B. No.: MT-20E12 Mfg dt: 05/2020

Mfd by: M/s. MARTIN & BROWN BIO- SCIENCES, K.No.

918/419, Malkumajra, Nalagarh Road, Baddi, Distt. Solan, Himachal

Amoxicillin and Potassium Clavulanate Tablets IP

Mfd by: M/s. Jackson

Susmita Roy, Bpharm, Mpharm Pharmacology, graduated from Gurunanak Institute of Pharmaceutical Science and Technology with a bachelor's degree in pharmacy. She holds a master ’s degree in pharmacology. She is currently employed at Haldia Institute of Pharmacy as an assistant professor. She has been a part of Medical Dialogue since March 2021. She can be contacted at editorial@medicaldialogues.in