Rapid Alert

CRACKDOWN AGAINST UNLICENSED / UNAUTHORIZED MANUFACTURERS

DRAP Alert No	N^o I/S/10-25-85
Action Date	26th September, 2025
Target Audience	1. Regulatory Field Force of DRAP and Provincial Drug Control departments. 2. Healthcare Professionals 3. Pharmacies and medical stores
Problem Statement	Drug testing Laboratories from Provinces have informed the Drug Regulatory Authority of Pakistan that the samples of below mentioned products have been declared *‘Spurious’* as its packaging falsely claims that it was manufactured by a licensed pharmaceutical company whereas it was not. The details of reports are as under:

The product identification details are as under: –

Therapeutic Good Affected:-

S#	Product Name	Batch	Manufacturer	Remarks
1.	Cipotic – D® Ear Drops Each ml contains Ciprofloxacin (as HCl) … 1 mg Dexamethasone ………. 1 mg	F1538	Purported to be manufactured by M/s Barrett Hodgson Pakistan (Pvt) Ltd. F/423 SITE Karachi.	Sample declared *“Spurious”with regards to Section 3(zb)(i ) & (ii) of the Drugs Act 1976 and ‘substandard’* on the basis of pH & sterility test.
2.	Tablet Danzen DS Each enteric coated tablet contains: Serratiopeptidase ………… 10 mg (20,000 serratiopeptidase units)	3945	Purported to be manufactured by M/s Helix Pharma (Pvt) Ltd. A/56 SITE Mangopir Karachi.	Sample declared *“Spurious”*with regards to Section 3(zb)(i ) & (ii) of the Drugs Act 1976.
3.	Tablet Tebisil 250 mg Each tablet contains: Terbinafine (as HCl) …. 250 mg	517	Purported to be manufactured by M/s Saffron Pharmaceuticals (Pvt) Ltd. 19-Km Sheikhupura Road Faisalabad	Sample declared *“Spurious”* with regards to Section 3(zb)(i ) & (ii) of the Drugs Act 1976.
4.	Capsule Cefspan 400 mg Each Capsule contains: Cefixime …………….400 mg	F0580	Purported to be manufactured by M/s Barrett Hodgson Pakistan (Pvt) Ltd.F/423 SITE Karachi.	Sample declared *“Spurious”* with regards to Section 3(zb)(i ) & (ii) of the Drugs Act 1976.
5.	Tablet Brexin 20 mg Each tablet contains: Piroxicam B-Cyclodextrine eq. to Piroxicam ………………. 20 mg	1206410	Purported to be manufactured by CHIESI FARMACEUTICI S.p.A.- 26/A, Via Palermo -PARMA-ITALY	Sample declared “Spurious” with regards to Section 3(zb)(i ) & (ii) of the Drugs Act 1976.

Risk Statement	The above mentioned purported drug products are confirmed as falsified/spurious, as its packaging falsely claims that it was manufactured by a licensed pharmaceutical company whereas it was not. Laboratory testing has revealed that the product contains no active pharmaceutical ingredient, resulting in complete lack of therapeutic effect. Such falsification poses a serious risk to public health, potentially leading to treatment failure, disease progression, and even life-threatening outcomes, particularly for patients relying on these medications for critical care. The public is strongly advised not to use these purported drug products and to report any suspicious or unverified medicines to DRAP immediately.
Action Initiated	The Regulatory Field Force has been directed to conduct surveillance activities to confiscate the abovementioned Un-Registered/falsified product. All Pharmacists, chemists, and other healthcare professionals working at distributions, pharmacies, healthcare facilities, and other aspects of the supply chain system should immediately check the stock, and information related to the suppliers of such products should be provided to the Regulatory field force (DRAP, Provincial Drug Control Departments) to ensure the removal of these product from the circulation.
Advice for Healthcare Professionals	DRAP requests healthcare professionals to have increased vigilance within the supply chains of institutions/pharmacies/healthcare facilities likely to be affected by above mentioned product. Any adverse events or quality problems experienced with the use of these products should be reported to National or Provincial pharmacovigilance centers using Adverse Event Reporting Form or online through this link. Further information on reporting problems to DRAP is available on this link.
Advice for Consumers	Consumers should not use these products and should contact their physician or healthcare provider(s) if they have experienced any problem related to taking or using the above mentioned products and should report the incident to the Drug Regulatory Authority of Pakistan / National Pharmacovigilance Centre. All therapeutic goods must be obtained from licensed pharmacies and other authorized/licensed retail outlets. The authenticity and condition of products should be carefully checked. Seek advice from your pharmacists or other healthcare professionals in case of any doubt.

DRAP Alert No	N^oI/S/10-25-84
Action Date	09th October, 2025.
Target Audience	· National Regulatory Field Force of DRAP and Provincial Drug Control Departments. · Healthcare Professionals-Veterinarians · Farmers/consumers
Problem / Issue	Drug Testing Laboratories from Provinces informed the Drug Regulatory Authority of Pakistan that the samples of below mentioned Veterinary products have been declared as ‘*Substandard*’.

S#	Product Details	Batch #	Manufacturer details	Remarks
1	Injection Micrise-2% 50ml Ivermectin: 20 mg/ml	MR-075	M/s Biorise Pharmaceuticals. 19-Km, Lahore Road, Multan. (DML # 000934)	The sample is declared as “Sub-Standard” on the basis of Assay Test and Chromatographic Purity Test.
2.	Injection Ivozon 2% 10 ml Ivermectin: 20 mg/ml	AP/INJ-G/25-83	M/s. Amazon Pharmaceutical (Pvt) Ltd. Plot No. 10/A & 29/B, Small Industrial Estate, Bhimber, AJK (DML # 000975)	The sample is declared as “Sub-Standard” on the basis of Assay Test and Test for Related Substances.
3.	Injection IVERMEC 1% 50ml Ivermectin: 10 mg/ml	GI – 25E 140	M/s Grand Pharma (Pvt) Ltd. Plot No. 5-A Street No. N-5 National Industrial Zone Rawat (DML # 000680)	The sample is declared as “Sub-Standard” on the basis of Chromatographic Purity Test.
4.	Injection Selmec 50 ml Ivermectin: 20 mg/ml	SN-116	M/s Selmore Pharmaceuticals (Pvt) Ltd. 36 Km Off. Multan Road Lahore. (DML # 000507)	The sample is declared as “Sub-Standard” on the basis of Assay Test and Test for Related Substances.
5.	Injection Ivomek 2% 10 ml Ivermectin: 20 mg/ml	NI-807	M/s Nawal Pharmaceuticals. Plot No. 11-A Punjab Small Industrial Estate Taxila. (DML # 000735)	The sample is declared as ‘Misbranded’ as per section 3(s)(vi) of the Drugs Act 1976 & 3(g)(i) of the Drugs (Labelling and Packing) Rules 1986, and “Substandard” on the basis of Assay Test and Chromatographic Purity Test.
6.	Injection Ivergen 50ml Ivermectin: 10 mg/ml	594.IV	M/s Symans Pharmaceuticals (Pvt) Ltd. 10-Km Sheikhupura Road Lahore. (DML # 000323)	The sample is declared as “Sub-Standard” on the basis of Assay Test and Test for Related Substances
7.	Injection Fosphovetz Each ml contains: Butaphosphan (MS)……100mg Cyanocobalamine (B.P)..50mcg Taurine (USP)……………37.3mg Nicotinamide (B.P) ……….23mg DL-Methionine (B.P) ….18.7mg	24119013	M/s Vetz Pharmaceutical (Pvt) Ltd. Plot No. Q-1 SITE Kotri Sindh (DML # 000813)	The Sample is declared as “Sub-Standard” on the basis of Assay of Cyanocobalamine and Bacterial Endotoxin Test (BET).
8.	Oxyvetz 5% 100ml Injection Each ml contains: Oxytetracycline HCI BP….50mg	25157083	M/s Vetz Pharmaceutical (Pvt) Ltd. Plot No. Q-1 SITE Kotri Sindh (DML # 000813)	Sample is ‘Sub-standard’ with regards to Bacterial Endotoxins Test and Misbranded with regards to Labelling (as per Section 3 (s) (iv) of The Drugs Act 1976).

Risk Statement:	Laboratory testing identified serious quality defects including assay failure, excessive impurities/related substances, misbranding of label information, and failure of bacterial endotoxin and sterility-related tests. These medicines are widely used for livestock and food-producing animals (e.g., cattle, sheep, goats) for parasitic control, metabolic support, and infection treatment. Their use can lead to ineffective therapy, toxic reactions, contamination risk, and unsafe drug residues in milk and meat, posing both animal health and public health hazards. classified as high-risk veterinary medicines requiring immediate regulatory attention.
Action Initiated	– The regulatory field force of DRAP and Provincial Drug Control departments has been directed to immediately conduct market surveys for detection and removal of these products from the market. – All pharmacists and chemists working at distributors and pharmacies should immediately check their stocks and stop supplying these products. The remaining stocks should be quarantined and returned to the supplier/company. –Distributors and pharmacies are advised to be vigilant and report any suspected batch of the product(s) in the supply chain to the DRAP using the online form, or by Email at gsms∂dra.gov.pk. –Regulatory field force of all federating units (DRAP, Provincial Health Departments, and States) has also increased the surveillance in the market to ensure the effective recall of defective product(s).
Advice for Veterinarian	This alert applies strictly to the specific batches listed above and does not apply to other batches of the same products. Veterinarians are therefore advised not to prescribe, administer, or stock these identified batches under any circumstances. In case any of the above-mentioned batches have already been administered, treated animals should be closely monitored for possible signs of infection, treatment failure, or adverse reactions, and appropriate supportive care must be provided. Any suspected adverse events or quality-related problems linked to these batches should be reported immediately to DRAP’s Pharmacovigilance Centre and to the Provincial Livestock & Dairy Development Departments. Practitioners are further advised to ensure that only alternative registered and quality-assured batches are used in veterinary practice.
Advice for Farmers and Livestock Owners	Farmers, dairy owners, and animal keepers are strictly advised not to use these identified batches for their cattle or other livestock, as they may cause serious illness, infection, treatment failure, or even death in animals. If any of these batches have already been given, animals should be observed carefully for unusual symptoms such as fever, weakness, swelling at the injection site, or lack of recovery, and immediate veterinary assistance should be sought. Farmers are further advised to return such products to their supplier and use only safe, registered, and quality-assured veterinary medicines and vaccines to protect the health of their animals and avoid financial losses.

S#	Product Name	Batch No.	Purported Manufacturer	Remarks
1.	Tablet Levitra 20mg Each film coated tablet contains: Vardenafil (as HCl trihydrate) ……… 20mg	BXNZ2488	Purported to be manufactured by M/s Bayer Pharma AG Germany	The sample has been declared ‘Unregistered / falsified’ .

Drug Regulatory Authority of Pakistan

Month: October 2025

RAPID ALERT – FALSIFIED / UNAUTHORIZED MANUFACTURER

Rapid Alert

Therapeutic Good Affected:-

Recall Alert – Veterinary Drug Products (Substandard)

Recall Alert

Therapeutic Goods (s) Affected: –

RAPID ALERT: UNREGISTERED & SUBSTANDARD — LEVITRA 20 mg TABLET (Batch BXNZ2488)

Rapid Alert

Therapeutic Good Affected:-

Guidelines for Referring the Cases for Prosecution under the DRAP Act, 2012 and the Drugs Act, 1976

Minutes of 350th Meeting of the Registration Board

Minutes of M-99 of the Medical Devices Board