Author: Asad Ullah
Training on Pakistan Single Window for DRAP Module
Pakistan Single Window-PSW is working on the automation of trade-related business processes of the Drug Regulatory Authority of Pakistan (DRAP). The existing business processes of issuance of License, Permits, Certificates and Others (LPCOs) by DRAP has been mapped in consultation with DRAP._
In this context, Pakistan Single Window-PSW would like to invite you for a hybrid Training Session for the Drug Regulatory Authority of Pakistan-DRAP Module. In this session our Domain and System Experts will provide you the walkthrough of filling Entity Registration, License Registration (DML), Product Registration and SECP Verification.
The meeting is scheduled for Friday, 25th August 2023 from 03:30 PM till 04:30 PM. Manufacturers/DML holders working in Karachi are requested to join us physically at Main Conference Room, Fifth Floor, Bahria Complex-1, M.T Khan Road, Karachi.
Interested members are requested to register themselves by clicking below:
Registration Link: https://us06web.zoom.us/webinar/register/WN_42ArK1qtS1Sf9Xm2bcTi9g
Relevant members of Pharma Industry and associations are encouraged to get themselves register for this session for better understanding of new module. Pease note, only registered members will be allowed to attend this training session.
Minutes of 329th meeting of Registration Board held on 6th to 8th June, 2023
The Drug Registration Board convened its 329th meeting held on June 06-08, 2023 in the Committee Room of the Drug Regulatory Authority of Pakistan, G-9/4, Islamabad. The minutes of the meeting are hereby circulated for the information of all stakeholders.
S.R.O. 1067(I)12023: Schedule of Charges for GMP Certificate and Panel Inspection
Rapid Alert; Drug Product: Unregistered and Falsified Hyp-Rho-D injection (Rho(D) immune globulin Injection
Rapid Alert
Unregistered and Falsified Hyp-Rho-D injection (Rho(D) immune globulin Injection
| DRAP Alert No | No I/S/08-23-30 |
| Action Date | August 02, 2023 |
| Target Audience | 1. Regulatory Field Force 2. Pharmacists and Chemists at Distribution, Pharmacies, and Medical Stores 3. Healthcare Professionals- Physicians, Pharmacists, and Nurses at hospitals and clinics etc. 4. General Public |
| Problem Statement | The Provincial Inspector of Drugs in Mansehra obtained a sample of the Hyp-Rho-D Injection from M/s. Abdullah Medical Store, located inside the Naseem Surgical Center, Upper Chennai Abbottabad Road, Mansehra. This particular product is not registered with the DRAP and is suspected to be falsified. The product detail as under: – |
Therapeutic Goods Affected:-
| Sr | Product Name | Composition | Batch # | Mfg. Date | Exp. Date | Manufactured by (as stated on label) | Remarks |
|---|---|---|---|---|---|---|---|
| 1 | Hyp-Rho-D Injection Registration No: Nil | Rho (D) immunoglobulin (Human) for injection | 09181943 | — | Aug-2024 | M/s. Woolmar Chemical Corporation, USA. Importer / Distributor: Ms. Zaryab Traders Lahore. | The product is not registered and is also suspected to be falsified. |
| Risk Statement: | The product claimed to contain immune globulin (anti-D immune globulin or RhIG), which is a commercial biological antibody derived from human plasma that targets red blood cells (RBCs) positive for the Rh (D) antigen (also referred to as the D antigen). It is used to treat immune thrombocytopenic purpura (ITP) in patients with Rh-positive blood. The claimed product is unregistered which infers that the quality and safety attributes of the product are not accepted and approved by DRAP. Unregistered Injectable products may cause severe and lethal adverse effects as the safety and quality attributes of the product are unknown. |
| 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 the above-mentioned products. -Adverse reactions or quality problems experienced with the use of this 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. |
Rapid Alert: Medical Devices; Unregistered Intravenous Medical Devices in the market
Rapid Alert
Unregistered Intravenous Medical Devices in the Market
| DRAP Alert No | No I/S/08-23-31 |
| Action Date | 10th August 2023 |
| Target Audience | 1. Regulatory Field Force 2. Pharmacists and Chemists at Distribution, Pharmacies, and Medical Stores 3. Healthcare Professionals- Physicians, Pharmacists, and Nurses at hospitals and clinics etc. 4. General Public |
| Problem Statement | The Medical Device Rules 2017 provides the regulatory framework for medical devices in the country. SRO 224(I)/2023 dated 27-02-2023 extended the transition period for the registration of medical devices to licensed importers and manufacturers as per risk-based classifications. However, medical devices specified in Schedule D and E of this SRO are always mandatory to be registered with DRAP before marketing in the country. DRAP has received reports/complaints that some unregistered medical devices (e.g., IV cannulas, infusion sets, syringes, etc.) are being proliferated in the open market. The product detail as under: – |
Therapeutic Goods Affected:-
| Sr | Product Name | Manufacturer/importer (as stated on label) | Illustration of unregistered medical devices |
|---|---|---|---|
| 1 | Euro Plus Infusion Set | Apex Medical Devices |   |
| 2 | Chiron Infusion Set | Not mentioned |  |
| 3 | Health Plus Infusion Set | Not mentioned |  |
| 4 | O’Divine Infusion Set | Not mentioned |  |
| 5 | Cath-Tec I.V Cannula | Nilhol Enterprises East Lane Business Park Wemby, UK |  |
| 6 | Healthflon I.V. Cannula | Healthylife medical equipment Trading, Alfajar Business Centre, airport road, Dubai, UAE |  |
| Risk Statement: | The use of unregistered medical devices poses significant risks to patients as they may not meet the necessary standards of safety, quality, and performance. Such medical devices can be nonsterile, or their sterility can be compromised from damage during shipping and storage. The hazards associated with the use of unregistered medical device includes inaccurate or unreliable results, Infection or other adverse reactions, Failure of the device’s intended purpose, and Injury or death. |
| Action Initiated | The Regulatory Field Force has been directed to increase the surveillance activities at Health facilities (Hospitals) in addition to markets and confiscate these products where available. All Pharmacists and chemists working at distributions and Pharmacies should immediately check the stock and stop supplying these products. Any remaining stock should be quarantined immediately, and supplier(s) information should be provided to the Regulatory field force (DRAP, Provincial Health Departments, and States) in order to ensure the removal of these unregistered products. |
| 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 these products. -Procurement staff in healthcare settings must obtain the registration status of medical devices falling in schedules D and E of the Medical Device Rules, 2017, from the suppliers. It’s imperative to note that authorized manufacturers and importers hold the exclusive right to provide medical devices in the market. -Adverse reactions or quality problems experienced with the use of this 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 stop using this product and shall contact to 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. |
Minutes of 43rd Meeting of Clinical Studies Committee
Developing National Medicine Policy; Meeting of Technical Working Group on 1-2 August 2023 at Islamabad
National Medicine Policy is a high-level guiding document that outlines the national perspective and strategies to promote health sector for enhancing national capacities with the aim to increase access to and rational use of high quality and affordable medicines and health products in the country.
DRAP has significance role in the development and implementation of National Medicine Policy. As a country, we need to undertake measures to make drugs accessible to our populations and future generations through ensuring high-tech manufacturing capabilities, their proper distribution and having trained professional workforce to prescribe and administer these drugs. With the growing population, our needs for essential drugs are also growing for treating various diseases. To meet the objective, a holistic approach is needed in which all the stakeholders work for ensuring that patients get access to quality assured, safe and effective drugs.
TWG Meeting on National Medicine Policy, 1-2 Aug, 2023 at Islamabad
A National Medicine Policy is a crucial framework which provides strategic directions and guidelines for safe, effective, and accessible use of drugs within a country. It has huge significance as it impacts the public health directly. A well-developed NMP ensures equitable access to essential medicines and contributes to disease management and control.
2023 ISPE Singapore Affiliate Conference & Exhibition, 23-25 August 2023 (Complimentary Registration for Regulators and Pharma Manufacturers)
The ISPE Annual Conference & Exhibition, 2023 for Pharmaceutical and biomanufacturing professionals is happening from 23-25 August, 2023 at Suntec, Singapore & online. This conference is aimed at highlighting global and regional best practices in process, technology and innovations. International and Asian manufacturers, regulatory agencies and subject matter experts share knowledge from manufacturing facility design to finished product.
The conference is known as showcasing latest technologies and services, workshops and discussion sessions. This year, participants can join the conference both in-person or virtually.
lSPE Singapore Affiliate Conference & Exhibition, 23-25 August 2023
Online & Suntec Singapore
Free Registration for Regulators, Pharma and Biomanufacturers
The organizers of ISPE Conference and Exhibition, 2022 have offered free registration for regulators and industry professionals who can get register for free to attend the ISPE Singapore conference in august, either online or in person.
Interested applicants are required to fill out the google form provided on the this link or by open the below the link in the browser https://www.cognitoforms.com/ISPESingapore1/ISPESingaporeConferenceExhibition2023ComplimentaryDelegatePass
Please note that these complimentary delegate passes are subject to approval by the organizer and may be limited;
Recall Alert: Medical Devices; Disposable Infusion Set by M/s Rehman Rainbow (Pvt), Lahore
Recall Alert
| DRAP Alert No | No I/07-23-28 |
| Action Date | 27th July, 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. |
| Problem / Issue | Central Drugs Laboratory, Karachi received samples of Surgee Disposable Infusion Set manufactured by the M/s Rehman Rainbow (Pvt) Ltd , Industrial Estate, Kot Lakhpat, Lahore for testing. CDL has declared the sample as substandard based on the analysis for not complying the sterility criteria. Accordingly, the manufacturing company had been directed to recall all the defective product from the market. |
Therapeutic Goods Affected:-
| Product Names | Product Description | Batch No | Manufacturer |
|---|---|---|---|
| Surgee Disposable Infusion Set Mfg Lic No 000510 Reg No 071602 | Intravenous Infusion set | Batch No IV0523 Mfg date 05.2023 Exp 04.2028 | M/s Rehman Rainbow (Pvt) Ltd Lahore |
| Risk Statement: | Use of Non sterile IV set poses a serious risk of patient harm and due to non-sterility can lead to bacteremia and sepsis. |
| 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 to enhance vigilance within the supply chains of institutions/pharmacies/healthcare facilities likely to be affected by these defective lots of the Medical Device. -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. |