13 Formulations declared Not of Standard Quality as per data provided by states: CDSCO Drug Alert

Written By :  Dr. Divya Colin
Medically Reviewed By :  Dr. Kamal Kant Kohli
Published On 2024-08-31 12:30 GMT   |   Update On 2024-09-02 05:35 GMT
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New Delhi: In line with the 'Not of Standard Quality' data provided by states, the apex drug regulatory body, the Central Drug Standard Control Organisation (CDSCO), in its latest drug safety alert, has flagged 13 medicine batches for failing to qualify for a random sample test for July 2024.

The list of drugs declared not of standard quality includes Cephalexin Oral Suspension manufactured by Nestor Pharmaceuticals, Salbutamol Nebuliser Solution manufactured by Cotec Healthcare, Sodium Valproate Gastro Resistant Tablets manufactured by Unicare India, Cilader - 10 manufactured by Alventa Pharma, Bioglip 1Tablets manufactured IBN Herbals, Ciprofloxacin Hydrochloride manufactured by Wings Biotech, New improved Gentle Daily care Natural protein Shampoo manufactured by Himalaya Wellness, Irinotecan Inj.IP 100 mg vial Supplied by Kerala Medical Services Corporation, Vitamin B Complex tablet supplied by Kerala Medical Services Corporation Ltd, Chlorpromazine Tab Supplied by Kerala Medical Services Corporation, Fluorometholone eye drops IP manufactured by Cotec Healthcare, and Iron and Folic Acid Syrup manufactured by Jackson Laboratories.

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Many factors contributed to the drug samples' failure in the test, such as non-compliance with the IP requirements for the particular drug, failure of the dissolution test, pH, and some assays of the drug test, among others.

Furthermore, the alert noted that NSQ data was not received as per format and in EXCEL SHEET from State Drugs Licensing Authorities of Karnataka (PDF format), and Jharkhand (PDF format), for the month of July 2024.

In addition to the above, the alert mentioned, "State Drugs Licensing Authorities of Andhra Pradesh, Arunachal Pradesh, Assam, Bihar, Chhattisgarh, Goa, Gujarat, Haryana, Himachal Pradesh, Manipur, Rajasthan, Meghalaya, Mizoram, Nagaland, Odisha, Punjab, Sikkim, Tamil Nadu, Pondicherry, , Telangana, Delhi, Uttarakhand, West Bengal, Andaman and 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 July 2024 as per DCG(I) Circular dated09.02.2024."

NOT OF STANDARD QUALITY ALERT FOR THE MONTH OF July - 2024.

B. State Laboratories

S.No

Product/Drug Name

Batch No.

Manufacturing Date

Expiry

Date

Manufactured By

NSQ Result

Reported by

CDSCO Laboratory

1.

Cephalexin Oral Suspension IP

125/500

CHDA-01

04/23

09/24

Nestor Pharmaceuticals

Ltd, 11, Western

Extension Area,

Faridabad

It fails the test Assayand

Descriptive part as per IP

Drugs Testing

Laboratory

Thiruvananthapuram

2.

Salbutamol

Nebuliser

Solution BP 5

mg/ml

CHS-3085

06/23

05/25

Cotec Healthcare

Pvt.Ltd, N.H.No. 74, Roorkee , Dehradun , Highway, Kishanpur, Roorkee Uttarakhand

It fails the testpHas per

BP

Drugs Testing

Laboratory

Thiruvananthapuram

3.

Sodium Valporate Gastro Resistant

Tablets IP 200 mg

SVT1140

09/23

08/26

Unicure India Ltd.,

C-21,22 &23, Sector-3, Noida-201301, Distt.

Gautam Budh Nagar

(UP)

It fails the test ‘Dissolutionas per IP

Drugs Testing

Laboratory

Thiruvananthapuram

4.

Cilader - 10

AGT30720

07/23

06/25

Alventa Pharma Ltd,

Vill, Kishanpura, Baddi- Nalagarh Road, tehsil,

baddi, Dist, Solan (HP)

It fails the test ‘Dissolution’ as per IP

Drugs Testing

Laboratory

Thiruvananthapuram

5.

Bioglip 1

Tablets

BEL23021

09/23

08/25

IBN Herbals, Khasra No. 63, Vill, Juddi Kalan,

Baddi- 173205, Distt.

Solan (HP)

It fails the test‘Dissolution’ as per IP

Drugs Testing

Laboratory

Thiruvananthapuram

6.

Ciprofloxacin Hydrochloride

CPXT- 1016

10/23

09/26

Wings Biotech LLP,

43&44, HPSIDC,

It fails the test ‘Dissolution’

Drugs Testing

Laboratory

Tablets IP 500 mg

Ind.Area, Baddi- 173205 HP

as per IP

Thiruvananthapuram

7.

New improved Gentle Daily

care Natural

protein

Shampoo

B20240005 2

01/24

12/26

Himalaya Wellness

Company, No- 182,

Village Guru Majra, Tehsil, Baddi- 174101 Dist Solan (HP)

It fails the test for “heavy"

metals as lead (Pb)” as per IS 7884:2023

Drugs Testing

Laboratory

Thiruvananthapuram

8.

Irinotecan Inj.IP 100 mg vial

D0368/23- 24

Supplied by Kerala

Medical Services

Corporation Ltd,

Thycaud P.O,

Thiruvananthapuram - 14

It fails the

tests

particulate

matter and

assay as per IP

Drugs Testing

Laboratory

Thiruvananthapuram

9.

Vitamin B

Complex tablet

N.F.I.1

S0004/24-

25

Supplied by Kerala

Medical Services

Corporation Ltd,

Thycaud P.O,

Thiruvananthapuram - 14

The sample

does not

conform to IP standard with respect to theDescriptive partfor

tablets

Drugs Testing

Laboratory

Thiruvananthapuram

10.

Vitamin B

Complex tablet

N.F.I.1

S0003/24-

25

Supplied by Kerala

Medical Services

Corporation Ltd,

Thycaud P.O,

Thiruvananthapuram - 14

The sample

does not

conform to IP standard with respect to theDescriptive partfor

tablets

Drugs Testing

Laboratory

Thiruvananthapuram

11.

Chlorpromazine Tab IP 50 mg

D 0644/24- 25

Supplied by Kerala

Medical Services

Corporation Ltd,

The sample

does not

conform to IP

Drugs Testing

Laboratory

Thiruvananthapuram

Thycaud P.O,

Thiruvananthapuram - 14

standards. It

fails the

Descriptive

part’

12.

Fluorometholone Eye drops IP

CHE 3044

05/23

04/25

Cotec Healthcare

Pvt.Ltd, K.H.No. 593/1 Roorkee , Dehradun ,

Highway, Kishanpur, Roorkee- 247667

Uttarakhand

It fails the testAssay as per IP

Drugs Testing

Laboratory

Thiruvananthapuram

13.

Iron & Folic Acid Syrup IP (JKMSCL Hospital Supply)

SY- 1641

01-08-2023

01-07-2025

Jackson Laboratories Pvt. Ltd 22-24, Majitha Road Bye Pass Amritsar

143001 , India

The sample

fails in the test for pH w.r.t

the sample

portion

received.

CFDL Jammu (J&K)

To View the official notice, click the below link:

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