The Medical Device Board (MDB) of Drug Regulatory Authority of Pakistan in its 57th meeting has deferred the following applications of registration of medical devices due to various deficiencies / shortcomings in the applications dossiers. These applicants are requested to furnish the requisite information / documentations as directed by the Medical Device Board. The detail is provided in the below attachment.
Recall Alert: Medical Devices; Aquavent Neonatal Breathing Circuits by M/s. Armstrong Medical Limited, Ireland
Recall Alert
| DRAP Alert No | No I/V/05-23-23 |
| Action Date | 17th May 2023 |
| Target Audience | -Healthcare Professionals particularly working in the critical care areas of hospitals including Physicians, Pharmacists, and Nurses. -Procurement Officers at Hospitals and Healthcare Institutions, -Pharmacists and Chemists at Distribution, Pharmacies and Medical Stores |
| Product(s) Affected | AQUAVENT NEO Neonatal CPAP limb (Ventilator breathing circuit) Manufactured by: Armstrong Medical Limited, Northern Ireland, Distributed by M/s. Elate C.C (Pvt) Ltd. Karachi, Pakistan Batch No. 230123 (230123 as per the list in the Field Safety Notice) |
| Problem / Issue | Armstrong Medical Limited, Ireland received reports for their Neonatal Breathing Circuits for risk of patient harm as a result of tubing (and a connector attached to the tubing) disconnecting from the elbow within Neonatal Breathing Circuits. Accordingly, the manufacturing company has issued a field safety notice and initiated recall of the defective product from the international market including Pakistan. |
| Action Initiated | -The manufacturing company has initiated a recall of the affected lots of defective products from the market where it was distributed. -All healthcare professionals working in critical care units of hospitals as well as pharmacists and chemists working at distributions and pharmacies should immediately check their stocks and stop supplying these lots of the 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, or through phone at +92 51 910 73 17, 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 increase vigilance within the supply chains of healthcare institutions and hospital pharmacies to identify and return this product’s defective batch(es) to the importer/company. -Adverse reactions or quality problems experienced with this product may 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 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 Medical Device. -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. |
Minutes of 326th meeting of Registration Board held from 14th to 16th March, 2023
The Drug Registration Board convened its 326th meeting from 14th to 16th March 2023 in the Committee Room of the Drug Regulatory Authority of Pakistan, G-9/4, Islamabad. The meeting minutes are hereby circulated for the information of all stakeholders.
DRAP invites Comments on Draft Guidance Document for Submission of Application on Form 5F (CTD) for Registration of Biological Drug Products for Human Use
This guidance is developed to assist manufacturers and importers in developing their applications for registration of human biological drug products. Drug Regulatory Authority of Pakistan (DRAP) has adapted CTD format for registration of all such drugs vide SRO-713(l)/2018 dated 8th June 2018. Detailed guidance regarding the data requirement for CTD format has been provided in ICH M-4 guidelines. Since the DRAP is introducing the CTD in a progressive manner, therefore, initial guidance to applicants would be helpful for harmonization and appropriate data submission to achieve consistency and uniformity of application.
The guideline is intended to provide data requirements of Form-5F (CTD) for registration / market authorization of biological products of all types including New drug products, and Biosimilars. This document provides guidance for importers and local manufacturers of human biological products on how to obtain market authorization / registration in the territory of Pakistan.
This draft guideline is uploaded on the official website of DRAP dated on 9th May, 2023, for seeking comments and suggestions from stakeholders on the draft document. Stakeholders can submit their comments and suggestions within 15 days of uploading this document using prescribed format, (further information on comments submission can access on this link. Comments and suggestions can be forwarded via email to a ahmad.ansari∂dra.gov.pk copying at ahsan.hafiz∂dra.gov.pk , or can be posted at mailing address, Director, Biological Drugs, Drug Regulatory Authority of Pakistan, 4th floor TF Complex, 7th Mauve Area, G-9/4, Islamabad.
Rapid Alert: Falsified Sildenafil Citrate 100mg Tablets identified in the market
Rapid Alert
Falsified and Unregistered Sildenafil Citrate 100mg Tablets
| DRAP Alert No | NoI/S/02-23-18 |
| Action Date | 3rd May 2023 |
| Target Audience | 1. Regulatory Field Force 2. Pharmacists and Chemists at Distribution, Pharmacies and, Medical Stores 3. General Public |
| Problem Statement | Federal Inspector of Drugs Karachi seized a sample of an unregistered product “Viagra 100mg Tablet” from the market and also sent the samples to Central Drug Laboratory, Karachi for testing/analysis. Federal Government Analyst has declared the sample as Spurious under section 3(z-b) (i) of the Drugs Act 1976. The product detail as mentioned on the label is as under: – |
Therapeutic Goods Affected:-
| Sr | Product Name | Composition as per label | Batch # | Manufactured by (as stated on label) |
|---|---|---|---|---|
| 1 | Viagra 100mg Tablets Mfg. Date: 03-2021 Exp. date: 03-2025 | Sildenafil Citrate | 19990544AG | Ms. Brooklyn, Ne. |
| Risk Statement: | Consequences of the use of unregistered, Spurious/ Falsified Drugs include but are not limited to the followings: · Falsified/Spurious drugs may contain toxic ingredients which are manufactured under unhygienic conditions without the proper inspection and approval of the product, which are highly injurious to human health. · Poor-quality medicines compromise the treatment of diseases and may intensify the existing condition. |
| Action Initiated | The Regulatory Field Force has been directed to increase surveillance throughout the supply chain to confiscate the 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 supplier of such products 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 within the supply chains of institutions/pharmacies/healthcare facilities likely to be affected by these batches of above-mentioned products. -Adverse reactions or quality problems experienced with the use of these product 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 not use this product and shall contact their physician or healthcare provider if they have experienced any problem related to taking or using this drug product 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. |
Stakeholders’ Comments are invited on the Draft Guidelines on Patient Information Leaflet
The Patient Information Leaflet (PIL) provides essential information to patients and caregivers on the use of drug products ensuring their safety, efficacy, and quality. It describes the information for patients that ensures the safe and effective use of medicine under most circumstances. The PIL is a document that is updated as new data emerges related to drug product safety, efficacy, and quality or use. The registration/market authorization holder is responsible shall supply any new information without delay which may require the variation of the marketing authorization/registration including the revision of PIL.
The guideline is intended to provide supportive information for preparing a Patient Information Leaflet (PIL) for registration/market authorization of pharmaceutical and biological products of all types including New drug products, Generic drug products, and Biosimilars. This guideline provides advice on the principles of presenting information in the PIL.
This draft guideline is uploaded on the official website of DRAP dated 5th May 2023, for seeking comments and suggestions from stakeholders on the draft document. Stakeholders can submit their comments and suggestions within 15 days of uploading this document using the prescribed format. For further guidelines on submitting comments, visit DRAP website or click here. Comments and suggestions can be emailed to haseeb.tariq∂dra.gov.pk, copied at addl-dir.pe.reg∂dra.gov.pk, or posted at the mailing address, Director, Pharmaceutical Evaluation & Registration, Drug Regulatory Authority of Pakistan, 4th-floor TF Complex, 7th Mauve Area, G-9/4, Islamabad.
Minutes of the meetings of Clinical Studies Committee (CSC) conducted in the light of Bio Study Rules 2017
Minutes of 1st Meeting of CSC
Minutes of 2nd Meeting of CSC
Minutes of 3rd Meeting of CSC
Minutes of 4th Meeting of CSC
Minutes of 5th Meeting of CSC
Minutes of 6th Meeting of CSC
Minutes of 7th Meeting of CSC
Minutes of 8th Meeting of CSC
Minutes of 9th Meeting of CSC
Minutes of 10th Meeting of CSC
Minutes of 11th Meeting of CSC
Minutes of 12th Meeting of CSC
Minutes of 13th Meeting of CSC
Minutes of 14th Meeting of CSC
Minutes of 15th Meeting of CSC
Minutes of 16th Meeting of CSC
Minutes of 17th Meeting of CSC
Minutes of 18th Meeting of CSC
Minutes of 19th Meeting of CSC
Minutes of 20th Meeting of CSC
Minutes of 21st Meeting of CSC
Minutes of 22nd Meeting of CSC
Minutes of 23rd Meeting of CSC
Minutes of 24th Meeting of CSC
Minutes of 25th Meeting of CSC
Minutes of 26th Meeting of CSC
Minutes of 27th Meeting of CSC
Minutes of 28th Meeting of CSC
Minutes of 29th Meeting of CSC
Minutes of 30th Meeting of CSC
Minutes of 31st Meeting of CSC
Minutes of 32ndMeeting of CSC
Minutes of 33rd Meeting of CSC
Minutes of 34th Meeting of CSC
Minutes of 35th Meeting of CSC
Minutes of 36th Meeting of CSC
Minutes of 37thMeeting of CSC
Minutes of 38th Meeting of CSC
Minutes of 39th Meeting of CSC
Minutes of 40th Meeting of CSC
Minutes of 41st Meeting of CSC
Minutes of 42nd Meeting of CSC
DRAP issued a Draft of Guidelines on the Lot Release of Biological Drugs
The lot release of biological products is a part of the regulation of biological products. It involves the independent assessment of each lot of a licensed biological product before it is released in the market. In addition to manufacturing, the complexity inherent to biological products, proper storage conditions and efficient supply chain management must be ensured to preserve these products’ sensitivity and limited shelf life properties. For the reasons stipulated above, a careful independent review of manufacturing and quality control data on every lot of product as stated is, therefore, necessary before use. Lot release program enables National Regulatory Authority (NRA) to ascertain the safety, quality, and effectiveness of every lot of these products.
This draft guideline is uploaded on the official website of DRAP dated 5th May 2023, for seeking comments and suggestions from stakeholders on the draft document. Stakeholders can submit their comments and suggestions within 15 days of uploading this document using the prescribed format, (further information on comments submission can access at this link. Comments and suggestions can be forwarded via email to ayub.naveed∂dra.gov.pk, copied at director∂nclb.dra.gov.pk, or can be posted at the mailing address, The Director, National Control Laboratory for Biologicals, Drug Regulatory Authority of Pakistan, Prime Minister’s National Health Complex, Park Road, Chak Shehzad, Islamabad.
Recall Alert: Drug Product; Fluorazine 1mg Tablet (Batch # T-2065) CKD Pharmaceuticals Pak (Pvt) Ltd, Karachi
Recall Alert
| DRAP Alert No | NoI/S/04-23-20 |
| Action Date | 11th April 2023 |
| Target Audience | 1. Pharmacists and Chemists at Distributions, Pharmacies and Medical Stores 2. Healthcare Professionals- Physicians, Pharmacists, and Nurses at Hospitals, Clinics and Healthcare Providing Institutions 3. General Public |
| Product(s) Affected | Fluorazine 1mg Tablets Composition: Trifluoperazine HCl Manufactured by: M/s. CKD Pharmaceutical, Karachi Batch No. 2040006 |
| Problem / Issue | Provincial Drug Inspector, Karachi took the sample of Fluorazine 1mg Tablet. Provincial Government Analyst/Director, Drug Testing Laboratory, Karachi has declared the Batch No. T-2065 of the product as of substandard quality. |
| Action Initiated | -The manufacturing company/registration holder has been directed to immediately recall the defective product batch from the market. -All Pharmacists and chemists working at distributions and Pharmacies should immediately check their stocks and stop supplying this product batch. 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, or through phone at +92 51 910 73 17, 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 increase vigilance within the supply chains of healthcare institutions and hospital pharmacies to identify and return this product’s defective batch(es) to the importer/company. -Adverse reactions or quality problems experienced with this product may 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 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 taking or using this product. -All drug 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. |