VETERINARY DRUG PRODUCTS DECLARED SUBSTANDARD BY PROVINCIAL DRUG TESTING LABORATORIES.

VETERINARY DRUG PRODUCTS DECLARED SUBSTANDARD BY PROVINCIAL DRUG TESTING LABORATORIES.

DRAP Alert No	No I/S/09-25-73
Action Date	18 September, 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’.

Therapeutic Goods (s) Affected: –

S#	Product Details	Batch #	Manufacturer details	Remarks
1	Inj. Rasomycin-5 50ml Oxytetracycline HCl – 50 mg /ml	VM800	M/s Star Laboratories (Pvt) Ltd. 23 Km Multan Road Lahore. (DML # 000130)	The Drug Testing Laboratory, Bahawalpur has declared the product ‘misbranded’ under Section 3(s)(iv) of the Drugs Act, 1976, and ‘substandard’ due to failure in the Bacterial Endotoxin Test.
2.	Inj. Duralin -50 Oxytetracycline (as HCl) -50mg/ml	5807	M/s Mylabs (Pvt) Ltd. Khanka Sharif Tehsil and District Bahawalpur. (DML # 000747)	The Drug Testing Laboratory, Multan has declared the product ‘misbranded’ under Section 3(s)(iv) of the Drugs Act, 1976, and ‘substandard’ due to failure in the  Sterility Test.

Risk Statement:	These quality defects directly compromise animal safety, therapeutic effectiveness, and indirectly pose risks to public health through the livestock production chain. Therefore, the products are 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.