Unsafe Medicines: DRAP’s Crackdown on Spurious Drugs

Pakistan’s Drug Regulatory Authority (DRAP) has issued a sweeping nationwide recall of 17 pharmaceutical products—eight for human use and nine for veterinary care—after lab tests revealed alarming safety failures.

The human drugs flagged include Rolekast 10mg tablets, AME-CLOP Injection, DORCIP Infusion, Cipotic-D Eye Drops, Danzen DS tablets, Tebisil tablets, Cefspan 400mg capsules, and Brexin tablets. These products were found to be either substandard, contaminated, or falsely labelled. Some lacked active ingredients entirely, posing life-threatening risks to patients relying on them for critical care.

For example, AME-CLOP Injection contained visible particulate matter, while DORCIP Infusion failed sterility, pH, and endotoxin tests. Cipotic-D Eye Drops were declared spurious under the Drugs Act, 1976, and failed both sterility and pH standards. Several other drugs were mislabelled or had no evidence of being produced by the claimed manufacturers.

Veterinary drugs weren’t spared either. DRAP flagged nine products used in livestock—such as Micrise-2pc, Ivozon, IVERMEC, Selmec, Ivomek, Ivergen, Fosphovetz, Oxyvetz, and OXYZON—for issues ranging from excessive impurities to misleading labelling. These pose serious risks of toxicity and unsafe residues in milk and meat, threatening both animal and public health.

DRAP has directed provincial health departments and its regulatory field force to remove these products from the market immediately. Pharmacists and distributors must quarantine affected batches and halt their supply. Healthcare providers are urged to report suspicious medicines and enhance vigilance across supply chains.

Consumers are advised to stop using the recalled products, consult healthcare professionals if exposed, and only purchase medicines from licensed pharmacies. DRAP emphasized that falsified drugs can lead to treatment failure, worsening illness, and even death.

Tauqeer Ul Haq, Chairman of the Pakistan Pharmaceutical Manufacturers Association (PPMA), noted that such recalls are standard regulatory practice. He explained that DRAP investigates further, and if a drug is confirmed faulty, the entire batch is destroyed. If cleared, the manufacturer may resume supply.

This recall underscores the urgent need for robust pharmaceutical oversight in Pakistan. Ensuring drug safety isn’t just a regulatory duty—it’s a public health imperative.