Notice on Tender opening for provision of high speed internet
Tender opening for provision of high speed internet which was due on Monday, 14th of October 2024 is postponed in lieu of local holiday by Federal Govt in Islamabad. The same will now be opened on Thursday, 17th of October 2024 at 02:00 pm in committee room of DRAP. The closing date for submission of bids will however remain same i.e. Monday 14th of October 2024.
Invitation to bid (for stationery & other miscellaneous items)
Switch over from Web Based One Customs (WEBOC) to Pakistan Single Window (PSW) for submission and issuance of all types Drug Import Licenses (DILs) and issuance of electronic release orders through PSW’s Single Declaration (SD) system.
We are pleased to announce that, effective October 8, 2024, the clearance of commercial imports (HC type) of all commodities (Drugs) requiring a Drug Import License (DIL) mandated by the Drug Regulatory Authority of Pakistan (DRAP) being imported at customs stations of Peshawar and Islamabad are being switched from WeBOC to PSW system. All the DRAP-related commodities (Drugs) will be completely shifted over to PSW, and clearance will be subject to the electronic issuance of a Release Order by DRAP through the filing of a Single Declaration (SD) on all customs stations located in Peshawar and Islamabad.
All traders/importers engaged in the import of these commodities falling under the purview of DRAP are informed to file Single Declaration (Imports) through PSW System for issuance of electronic Release Order from DRAP and Customs clearance of their import consignments w.e.f. 08th October 2024.
Rapid Alert: Drug Product; Suspected Falsified Rabies Vacine
Rapid Alert
| DRAP Alert No | No I/S/09-24-37 |
| Action Date | 27th September 2024 |
| Target Audience | · Regulatory Field Force. · Healthcare Professionals – Physicians, Pharmacists, and Nurses. · Hospitals, Clinics, Pharmacies and other Healthcare Institutions · General Public. |
| Problem Statement | DRAP has received information about the presence of a suspected rabies vaccine in the supply chain. The product is not registered by DRAP and may be a falsified product. |
| Product Name | Batch/Lot No. | Stated Manufacturer | Mfg. date | Exp. date |
| Rabies Vaccine, Human IP (SURE RAB) (unregistered) | RO10821 | M/s Bio-Med Private Limited, C-96, SITE No. 1, B.S. Rd. Indi, AREA, Ghaziabad (U.P.) – 201009,INDIA. | 10-2023 | 10-2026 |
| Threat to Public Health | Rabies vaccine is used for the prevention of rabies in children and adults resulting from dog bite. Falsified rabies vaccines pose a significant threat to public health as the safety and efficacy of such products cannot be established therefore failing to provide adequate immunity, leaving individuals vulnerable to rabies infection |
| Action Initiated | The Regulatory Field Force has been directed to increase surveillance throughout the supply chain system including healthcare facilities to confiscate/seize this product from the market without any delay. 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 to halt the distribution/supply of this product. Information related to the supplier of this product should be provided to the Regulatory field force (DRAP, Provincial Health Departments, and States) to ensure the removal of this product. |
| Advice for Healthcare Professionals | -DRAP requests increased vigilance at hospitals and within the supply chains of institutions/pharmacies/healthcare facilities likely to be affected by this product. -Adverse Drug Reactions (ADR) or quality problems experienced with the use of these products shall be reported to the National Pharmacovigilance Centre (NPC), DRAP using Adverse Event Reporting Form or online through this link. -Please click here for further information on problem reporting to DRAP. |
| Advice for Consumers | Consumers should stop using this product and shall contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this drug product and 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. |
Recall Alert: Drug Products; Recall of 11 Substandard Batches from the Market
Recall Alert
| DRAP Alert No | No I/S/09-24-36 |
| Action Date | 26th September 2024. |
| Target Audience | – National Regulatory Field Force. – Pharmacists and Chemists at Distribution, Pharmacies and Medical Stores – Healthcare Professionals- Physicians, Pharmacists, and Nurses at hospitals and clinics – General Public |
| Problem / Issue | The Directorate of Drugs Control (DDC) in Punjab has identified the following substandard batches of pharmaceutical products based on analyzing their samples from Drug Testing Laboratories, revealing out-of-specification results. The Details of affected product batches are tabulated below:- |
Therapeutic Good(s) Affected: –
Human Use Products
| S# | Product Name | Composition | Batch No. | Manufactured by | Test Results |
| 01 | Painsa 75mg/3ml Injection Reg. No. 077269 | Diclofenac Sodium | PA415 | M/s. Wimits Pharmaceuticals (Pvt.) Ltd., Lahore. | Substandard |
| 02 | Metroin Infusion 100ml Reg.No 071279 | Metronidazole 500mg/100ml | MT24-058, MT24-060, MT24-061, MT24-062, MT24-063 | M/s. Saturn Pharmaceuticals (Pvt.) Ltd., Lahore. | Substandard |
Veterinary Use Products
| Sr. | Product Name | Composition | Batch No. | Manufactured by | Test Results |
|---|---|---|---|---|---|
| 03 | Oxytocin Injection Reg.No 019928 | Oxytocin 10 I.U/ml | V6-143 | M/s. ISIS Pharmaceutical & Chemical Works, Karachi. | Substandard |
| 04 | Selmec Injection 50ml Reg.No. 071087 | Ivermectin 20mg/ml | SN-113 | M/s. Selmore Pharmaceuticals (Pvt.) Ltd., Lahore. | Substandard |
| 05 | Rasomycin-10 Injection Reg.No. 003791 | Oxytetracyclin 100mg/ml | VJ. 1340 | M/s. Star Laboratories (Pvt.) Ltd., Lahore. | Adulterated |
| 06 | Rasomycin LA 20% Injection Reg.No. 003791 | Oxytetracyclin 200mg/ml | VG. 1626 | M/s. Star Laboratories (Pvt.) Ltd., Lahore. | Adulterated |
| 07 | Rasomycin-5 Injection Reg.No 003791 | Oxytetracyclin 50mg/ml | VK. 1467 | M/s. Star Laboratories (Pvt.) Ltd., Lahore. | Adulterated |
| Action Initiated | –The manufacturers have been directed to immediately recall the defective batches of their products from the market. All pharmacists and chemists working at distributions and pharmacies should immediately check their stocks and stop supplying these batches of the abovementioned product. The remaining stock 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, by phone at +92 51 9255969, or by Email at gsms∂dra.gov.pk. -The regulatory field force of all federating units (DRAP, Provincial Health Departments, and States) has also increased market surveillance to ensure the effective recall of defective product(s). |
| Advice for Healthcare Professionals | DRAP requests to enhance vigilance within the supply chains of institutions/pharmacies/healthcare facilities likely to be affected by this defective batch of the product. -Adverse reactions or quality problems experienced with this product may be reported to the National Pharmacovigilance Centre(NPC), DRAP using the Adverse Event Reporting Form or online through this link. -Please click here for further information on problem reporting to DRAP. |
| Advice for Consumers | -Consumers should stop using these products bearing the affected batch number(s). They shall contact their physician or healthcare provider(s) if they have experienced any problem that may be related to using this product. -All therapeutic products must be obtained from authorized licensed pharmacies /outlets. Their authenticity and condition should be carefully checked. If you have any doubts, please seek advice from your pharmacist. |
Rapid Alert: Crackdown Against Spurious/falsified Drug Products
Rapid Alert
| DRAP Alert No | No I/S/09-24-35 |
| Action Date | 24th September 2024 |
| Target Audience | · Regulatory Field Force. · Healthcare Professionals – Physicians, Pharmacists, and Nurses. · Procurement Managers at Hospitals, Clinics, Pharmacies and other Healthcare Institutions · General Public. |
| Problem Statement | The Directorate of Drugs Control (DDC) Punjab has detected the following falsified drug products based on their analysis from Drug Testing Laboratories (DTLs).The details of identified products and their batch details are as under: |
| S# | Product Name | Composition | Batch No. | Manufactured by (as per label) | Test Results |
| 01 | Solveron 10mg Tablets | Dydrogesterone 10mg | SVN-001 | M/s. Solvay, Plot# 32, Sector 2, Highway Petaro Road, Jamshoro. | Spurious |
| 02 | Carenol Syrup 450ml | Ammonium chloride 125mg/5ml, Sodium Citrate 55mg/5ml, Chlorphenramine Maleate 2.5mg/5ml | CL-012 | M/s. Well Care Pharmaceuticals, A/7 P.S.I.E. Sargodha. | Spurious and Misbranded |
| 03 | Procain Penicillin Fort 4000000 I.U. Injection | Procaine Penicillin 3000000 I.U., Benzyl Penicillin 1000000 I.U | 140475 | M/s. Yanzhou Xier Kangtai Pharm. Co. Ltd., China. Sole agent: United International, 301 Madian Center, Plot No. MR-1/122, 3rd Floor, Kutchi Gali No. 2, Marriot Road, Karachi. | Spurious |
| 04 | Simgesic Tablet | Tramadol HCl 37.5mg, Paracetamol 325mg | B1985 | M/s. Siam Pharmaceutical, Plot No. 217, Industrial Triangle, Kahuta Road, Islamabad. | Spurious and Misbranded |
| 05 | Meronem 500mg Injection | Meropenem 500mg | 4B23D121 | ACS Dobfar S.p.A Viale Addetta 4/12, Tribiano, Milan Italy. Packed and Marketed by: Pfizer Pakistan Limited Karachi. | Spurious and Substandard |
| 06 | Meronem 1g Injection | Meropenem 1gm | 4A23A31 | ACS Dobfar S.p.A Viale Addetta 4/12, Tribiano, Milan Italy. Packed and Marketed by: Pfizer Pakistan Limited Karachi. | Spurious and Substandard |
| Threat to Public Health | Spurious or falsified pharmaceuticals may contain harmful levels of toxic substances, posing a significant risk of widespread poisoning. These substandard medications have the potential to undermine the efficacy of disease treatment and exacerbate preexisting medical conditions. The safety and quality of the falsified products referenced in this alert is unknown. |
| Action Initiated | The Regulatory Field Force has been directed to increase surveillance throughout the supply chain system including healthcare facilities to confiscate/seize this product from the market without any delay. 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 to halt the distribution/supply of this product. Information related to the supplier of this product should be provided to the Regulatory field force (DRAP, Provincial Health Departments, and States) to ensure the removal of this product. |
| Advice for Healthcare Professionals | -DRAP requests increased vigilance at hospitals and within the supply chains of institutions/pharmacies/healthcare facilities likely to be affected by this product. -Adverse Drug Reactions (ADR) or quality problems experienced with the use of these products shall be reported to the National Pharmacovigilance Centre (NPC), DRAP using Adverse Event Reporting Form or online through this link. -Please click here for further information on problem reporting to DRAP. |
| Advice for Consumers | Consumers should stop using this product and shall contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this drug product and 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. |
Invitation to Bid (Provision of high speed redundant internet connectivity services at DRAP Headquarters, Islamabad)
Recall Alert: Drug Product; Promass 1g/100mL Inf by M/s Treat Pharmaceutical, Bannu
Recall Alert
| DRAP Alert No | No I/S/09-24-34 |
| Action Date | 23rd September 2024. |
| Target Audience | – National Regulatory Field Force. – Pharmacists and Chemists at Distribution, Pharmacies and Medical Stores – Healthcare Professionals- Physicians, Pharmacists, and Nurses at hospital and clinics – General Public |
| Problem / Issue | The Provincial Drug Inspector, Dera Ismail Khan, KPK collected the samples of Promass 1g Infusion and sent for analysis. The provincial Drug Testing Laboratory, KPK, Peshawar has declared batch No 034 of Promass 11g Inf, manufactured by the M/s Treat Pharmaceutical Industry, Bannu, as a substandard product. |
Therapeutic Good(s) Affected: –
| Product Names | Composition | Batch Details | Manufactured by |
|---|---|---|---|
| Promass 1gm/100ml Inf Reg.No. 075336 | Paracetamol | Batch No. 034 Mfg Date:01-07-2023 Exp Date:30-06-2025 | M/s. Treat Pharmaceutical Industry (Pvt.) Ltd, Kohat Road, Bannu |
| Risk Statement: | Identification of visible particles in infusion products is a serious indicator of substandard quality, which can lead to significant health risks including severe reactions such as shivering, high fever, arterial blockages, infarction and more serious adverse events. |
| Action Initiated | –The manufacturer has been directed to immediately recall the defective batch of product from the market. All pharmacists and chemists working at distributions and pharmacies should immediately check their stocks and stop supplying this batch of products. The remaining stock should be quarantined and returned to the supplier/ company. The regulatory field force of all federating units (DRAP and Provincial Health Departments) also increased surveillance in the market to ensure the effective recall of defective products(s). –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 Healthcare Professionals | DRAP requests to enhance vigilance within the supply chains of institutions/pharmacies/healthcare facilities likely to be affected by this defective batch of the product. -Adverse reactions or quality problems experienced with this product may be reported to the National Pharmacovigilance Centre(NPC), DRAP using the Adverse Event Reporting Form or online through this link. -Please click here for further information on problem reporting to DRAP. |
| Advice for Consumers | -Consumers should stop using these product bearing the affected batch number(s). They shall contact their physician or healthcare provider(s) if they have experienced any problem that may be related to using this product. -All therapeutic products must be obtained from authorized licensed pharmacies /outlets. Their authenticity and condition should be carefully checked. If you have any doubts, please seek advice from your pharmacist. |
Decisions of 69th Meeting of Medical Device Board; Deficiency letters for Medical Devices Applications
The Medical Device Board (MDB) of the Drug Regulatory Authority of Pakistan in 69th meeting has deferred the following applications of registration/enlistment of medical devices due to various deficiencies/shortcomings in the applications dossiers. These applicants are requested to furnish the requisite information/documentation as directed by the Medical Device Board. The detail is provided in the below attachment.