|
CDSCO declares 196 drug samples tested in April as NSQs
|
|
Gireesh Babu, New Delhi
May 22 , 2025
|
|
|
The drug regulators in the country have reported a significant jump in the number of Not of Standard Quality (NSQ) drug samples in the routine regulatory surveillance activity during the month of April, 2025.
The Central and state drug laboratories have declared a total of 196 drug samples tested during the month as NSQs, as compared to a total of 131 NSQs declared in the month of March, and 103 in the month of February.
Out of the 196 NSQs, a total of 136 were identified and reported by the States, while the rest of 60 samples were tested in the Central Drugs Laboratories under the Central Drugs Standard Control Organisation (CDSCO).
This is despite 16 states and five Union Territories not submitting any data in respect of the NSQs identified in their respective territories during the period.
The States of Andhra Pradesh, Arunachal Pradesh, Bihar, Chhattisgarh, Gujarat, Haryana, Madhya Pradesh, Manipur, Meghalaya, Mizoram, Nagaland, Odisha, Rajasthan, Sikkim, Uttar Pradesh, and Uttarakhand did not submit any data with the Central authority.
The Union Territories which did not submit data during the month of April are Andaman & Nicobar Islands, Chandigarh, Dadar and Nagar Haveli; Daman and Diu, Lakshadweep, and Ladakh.
"This action of identifying NSQ and Spurious medicines is taken on a regular basis in collaboration with state regulators to ensure that these drugs are identified and removed from the market," said the drug regulator in a statement.
The 136 samples declared as NSQ by the States include a sample of Petben (benzoyl peroxide shampoo 2.5%), and amoxycillin and potassium clavulanate tablets IP 625 mg from public sector undertaking Hindustan Antibiotics Ltd; Ahaglow Face Wash Gel 50 gm from Torrent Pharmaceuticals; chlorpheniramine maleate IP & noscapine IP oral syrup (Coscopin Linctus) from Biological E Ltd; and clotrimazole and selenium sulfide suspension, Candid TV from Glenmark Pharmaceuticals.
Almost 18 samples of oxfendazole & ivermectin bolus (Vet.) under the brand name Wellmox-1 from Argon Remedies Pvt Ltd, Uttarakhand; six samples of albendazole tablet IP 400 mg from Samkem, Madhya Pradesh; and three samples - one each of lidocaine hydrochloride and gabapentin gel (Gabaneuron Gel), Progaba Gel (lidocaine hydrochloride & gabapentin gel), and ondansentron tablets IP 4mg - from Pure & Cure Healthcare Pvt Ltd, a subsidiary of Akums Drugs & Pharmaceuticals Ltd were also declared as NSQ during the month.
The list of NSQs tested in the CDLs include samples of glimepiride tablets I.P. 1 mg from public sector undertaking Karnataka Antibiotics & Pharmaceuticals Limited; ciprofloxacin tablets IP 250 mg (Ciprodac 250) from Cadila Pharmaceuticals; bupivacaine hydrochloride injection IP (Bupicain-0.5%) from Themis Medicare Limited; and oxcarbazepine tablets IP 300 mg (Oxcarbajaj 300) from Bajaj Healthcare Ltd.
Besides, 13 drug samples from Gidisha Pharmaceuticals, Gujarat; eight drug samples from Captab Biotec, Himachal Pradesh; five samples from Reyoung Pharmaceutical Co. Ltd, Shandong Province, China; and four samples from Martin & Brown Biosciences, Himachal Pradesh, were also declared as NSQs during the month.
The CDSCO has said that the sample of Dmex Colecalciferol (Vitamin D3) tablets from Aeron Lifesciences Pvt Ltd, declared as NSQ in the month of January, this year, is purported to be spurious as per the investigation report. The actual manufacturer - as per the label claim - has informed the regulator that the said batch of product has not been manufactured by them and it is a spurious drug.
Similarly, the drug regulator said that the sample of nandrolone decanoate injection IP 50 mg/ml (Deca Durabolin 50 injection), identified as NSQ in the month of April, is purported to be spurious. The product is marketed by Zydus Healthcare, and according to the drug regulator, the company has informed that the said batch of the product has not been manufactured by them and it is a spurious drug.
While the drug regulator said that product is purported to be spurious, it added that the same is subject to the outcome of investigation.
The Drugs Controller General (India) [DCGI] had in February, 2024, issued a circular seeking the regional drug regulators to submit their data in specific format.
While the drug regulator lists the drugs labelled as manufactured by these firms and identified as NSQs, there are also chances that these batches might be produced by some other players and the label has been used to mislead the regulators and the customers.
|
|
|
|
|
|
|
|
TOPICS
|
Shanghai-based Hualian Pharmaceutical Machinery Company Limited, a family-run enterprise with roots going back to 1986, ...
|
|
|
|
|