The Medical Device Board (MDB) of Drug Regulatory Authority of Pakistan in its 59th 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.
Month: August 2023
The National Pharmacovigilance Center, DRAP urge the manufacturers and importers to nominate Pharmacovigilance Officer to ensure safe use of drugs.
Pharmacovigilance is the science and practice of monitoring the safety and efficacy of drugs, both before and after they are marketed. It is a vital aspect of ensuring public health and patient safety, as well as complying with regulatory requirements and ethical standards.
Pharmacovigilance officers are professionals who are responsible for collecting, analyzing, and reporting data on adverse drug reactions, drug interactions, and other potential safety issues. They also conduct risk assessments, implement risk management plans, and communicate with health authorities, health professionals, and patients.
The National Pharmacovigilance Centre at Drug Regulatory Authority of Pakistan urges the pharma industry to nominate or appoint pharmacovigilance officers for their products, as this will ensure the highest standards of quality and safety for their customers and patients. Pharmacovigilance is not only a legal obligation but also a social responsibility. Focusing on pharmacovigilance can enhance reputation, credibility, and competitiveness of a product in the global market.
According to the Pharmacovigilance Rules, 2022, notified by the Drug Regulatory Authority of Pakistan (DRAP), it is the legal obligation of the pharma industry to nominate or appoint a pharmacovigilance officer for products registered under the DRAP Act, 2012. The pharmacovigilance officer is required to perform the following duties:
- To collect, record, and report adverse events and other safety data related to the product to the National Pharmacovigilance Centre (NPC) within the specified time frame.
- To conduct periodic safety update reports (PSURs) and risk-benefit assessments of the product and submit them to the NPC.
- To implement risk management plans (RMPs) and risk minimization measures (RMMs) for the product as per the NPC’s recommendations.
- To ensure compliance with the pharmacovigilance rules and guidelines issued by the NPC and DRAP.
- To maintain pharmacovigilance records and documentation for at least 10 years.
“The NPC was established by DRAP in July 2022 under the Pharmacovigilance Rules, 2022, with the aim to enhance the pharmacovigilance activities in the country . The NPC is responsible for collecting, analyzing, monitoring, and preventing adverse effects of therapeutic goods, as well as reviewing and assessing safety data, conducting risk evaluations, and communicating with health authorities, health professionals, and patients. The NPC also provides training, guidance, and support to the provincial or regional pharmacovigilance centres, public health programs, and product registration holders.”
SRO.1092(I)/2023 dated 22nd Aug, 2023: Fixation of Maximum Retail Price (MRP) of Drugs
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. |
Relocation of Manufacturing Units from Residential Area to Industrial Area
DRAP issued directions to the manufacturers vide No.F.1-78/2018-DD(H&OTC)(Pt) dated 2nd September, 2019 for those whose manufacturing units were situated in the residential area to relocate their manufacturing sites to the industrial areas to ensure the environmental safety and protection of public health. Following DRAP guidelines, another large manufacturer of alternative medicines has relocated its facility from a residential to an industrial area. Consequently, EEC has cancelled previous enlistment certificates (Form-6 and Form-7) and issued revised enlistment certificate for the new manufacturing site in the residential area.