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April 16, 2018

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Punjab lab declares large number of medicines as substandard

LAHORE: The Drug Testing Laboratory, Punjab, has declared overwhelming number of medicines of various brands, prescribed for various diseases and surgical treatments, substandard after samples were found unfit for human consumption.

While examining the samples collected from primary, secondary and tertiary care hospitals of Punjab during the period from August 30, 2017 to April 7, 2018, the Drugs Testing Laboratory Punjab has collected samples of wide-ranging medicines used in all medical and surgical treatment procedures only to reach perilous findings of overwhelming number of medicines as substandard.

The Young Doctors Association, Punjab, senior vice President Dr Atif Chaudhry lashed out at the Punjab government and the bureaucracy heading the primary and secondary as well as specialised healthcare departments for their inefficiency in controlling menace of spurious medicines in public and private sector in the province. “The recent laboratory examination of nearly 80 percent medicines prescribed for all diseases and surgical treatments have been found ‘fake’, which the bureaucracy erroneously terms ‘substandard’ to mitigate the extent and effect of wrongdoing,” he said, adding that if a medicine has just 20 percent efficacy it would do more harm than good to the patients. In another anomaly, he said, the bureaucracy’s modus operandi to hoodwink the medical community and general public was that it gets lab approval of medicines through their international standard samples, but later they sent supply of those medicines from local Lohari Medicine Market, which is a hub of counterfeit medicines of nearly 37 percent of the entire stock.

He blasted the government for ‘distributing death’ among the poor patients and put the entire blame on doctors to hide their own negligence, inefficiency and corruption. He further alleged that the water supply in all hospitals had also been found contaminated as it contained Psudomonas Aeruginosa, which is resistant to common antibiotics and sterilisation. “It needs special antibiotics with heavy and extra dosages to counter their effects, which has its own side-effects,” he added.

The Drug Testing Laboratory, Punjab, in its report compiled on the details during the period spanning over seven months and eight days, declared Tab Calamox 375mg substandard on August 30, 2017, suspension Augmentin DS was also declared substandard on April 7, 2018.

Among other medicines, including some manufactured for veterinary use, were declared substandard included Cap Gexim 400mg, Veterinary Medicine Solution Deltaback, Veterinary Injection Pred CPM 50ml (substandard and misbranded), Cap Omicin 500mg (Adulterated), Aqua-P water for Injection 5ml, eye drops Eyebradex 5ml, suspension Metzil 60ml, suspension Nocer 10mg/5ml, Veterinary Injection Prednobak 50ml (substandard and misbranded), several other batches of medicines have been declared substandard by the DTL Punjab and subsequently prosecuted by the Provincial Quality Control Board (PQCB), Punjab on September 8, 2017. Gadolinium-based Contrast Agents for Magnetic Resonance Imaging - no harmful effects were identified with brain retention, suspension Tempol 6+ 60ML (Approx.), stop using homeopathic teething products marketed by Hyland’s, Chlorhexidine Gluconate - rare but serious allergic reactions, Intraocular Vancomycin may cause HORV leading to blindness, risk of QT-Interval with Hydroxyzine, federal DRAP Fluoroquinolones include Levofloxacin and Ciprofloxacin should be reserved, Infusion Ciprofloxacin (Quilox-Bosch) with adverse drug event reported from DHQ Layyah, reduce the use of antibiotics in food-producing animals to prevent the spread of antibiotic resistance.

Steven Johnson Syndrome (SJS), Cap Sona Plus Amsaki Amber Wala suspected by allopathic ingredient “Sildenafil Citrate”, Cap Millan suspected by allopathic ingredient “Sildenafil Citrate”, suspension Nocer, patients with cow’s milk allergy should not use Methylprednisolone injectable medicine that contains Lactose (Solu-Medrol 40mg), suspension H2-foz, syrup Bronchilate, lotion Benzo, Biotin (Vitamin B7). Supplements can cause incorrect lab test results, Tab Vascam, Cap Mogalis suspected by allopathic ingredient “Sildenafil Citrate”, suspension Ambpofen, syrup Denol-DM, avoid concomitant use of Omeprazole and Clopidogrel. France orders international recall of Celia Lactalis over Salmonella fears following contaminated batches, Infosan orders international recall of Gromore (milk) over Salmonella Agona contamination, drug interaction IV Ceftriaxone-Calcium Gluconate, an awareness into the H1N1 Influenza (Swine Flu) virus infection.

Provincial Drug Control Unit (PDCU) has issued a guideline for prevention and early detection of Steven Johnsons Syndrome (SJS) and Toxic Epidermal Necrolysis (TEN) on January 9, 2018, consider points for prevention of Adverse Drug Reactions (ADRs) and Provincial Drug Control Unit (PDCU) has issued a guideline for ADRs prevention, Tab Vega 100 suspected to contain allopathic ingredient “Sildenafil Citrate”, Black Cobra 125 suspected to contain allopathic ingredient “Sildenafil Citrate”, a case report of mouth sores related to Oral Azithromycin was released on January 11, 2018.

Federal DRAP issued withdrawal/recall of the Synthetic Recombinant Bovine Somato-Tropin (RBST), Tab. Penagra-100 suspected to contain allopathic ingredient “Sildenafil Citrate, Tab Sizzle, Relenza (Zanamivir) for inhalation is available in the market for treatment or prevention of influenza. FDA warns against use of Codeine and Hydrocodone in Paeds, PDCU received a case report of Anaphylaxis related to Injection Anti-Snake Venom (ASV) and that of Omeprazole Allergy on January 25, 2018.

Syrup Menstrol suspected to contain ingredient “Ferrous Sulphate”, Tab Loprid, PDCU received various reports of oral Moxifloxacin related hypotension in cardiac patients, report of Erythropoietin related hypertensive crisis in a patient with chronic kidney disease, and multiple reports of Infusion Ciprofloxacin related allergic symptoms from multiple health facilities in Punjab on January 26, 2018.

Tab Lectec, syrup Amvit, suspension Vefec, anti-diarrhea medicine Loperamide (Imodium) may have crisis, Tab, Phrenno, Tab. H-Fan, suspension Granid, “Cotton Wool”, Tab Dilzem, suspension Parokal, recall of Sancos Syrup 120ml to ensure complete withdrawal. PDCU received a case report of gastrointestinal symptoms and pancreatitis due to long term use of Piroxicam, licence of Everest Pharmaceuticals has been cancelled on March 12, 2018.

Eyedrops Ophth-Biovisc, Tab Phenobar, Tab Calamox on March 14, 2018 again, Tab Calamox (6 batches) again on March 27, 2018, Tab Cure-C 400mg, Tab Blomic, suspension Enceph 250mg/5ml, Inj Haemic, Cap Esofin (Esomeprazole 20mg), Tab Simva, suspension (dry) Amoxil 125mg/5ml, Tab Anac, and Suspension Augmentin DS were also declared substandard on April 7, 2018.

When contacted, Drug Testing Lab Punjab director Dr Shafiqur Rehman confirmed the report, saying that up to 84 observations had been made during the period from August 30, 2017 to April 7, 2018 with regard to declaring several brands of medicines substandard, hence unfit for human consumption. With regard to withdrawal of these substandard medicines from the shelves, he said Provincial Quality Control Board (PQCB), which is the organisation concerned, must act on emergency basis and ensure recall of all medicines declared substandard from the market to prevent any further damage.

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