The Drug Registration Board convened 337th meeting on June 28, 2024, in the Committee Room of the Drug Regulatory Authority of Pakistan, Prime Minister National Health Complex, Park Road, Islamabad. The minutes of the meeting are hereby circulated for the information of all stakeholders.
Minutes of 338th meeting of Registration Board held on 4th July, 2024
The Drug Registration Board convened 338th meeting on July 04, 2024, in the Committee Room of the Drug Regulatory Authority of Pakistan, Prime Minister National Health Complex, Park Road, Islamabad. The minutes of the meeting are hereby circulated for the information of all stakeholders.
Bioequivalence and Bioavailability of Drug Products
The Drug Regulatory Authority of Pakistan (DRAP) is committed to ensure that all pharmaceutical drug products shall conform to acceptable standards of safety, efficacy and quality. The submission of bioequivalence studies is requirement of Form-5F (Common Technical Document) notified vide SRO 713(1)/2018 dated 08.06.2018.
The Registration Board, in its 338th meeting on July 4, 2024, resolved that the regulatory approval process for the registration of generic drugs in light of the guidelines of international regulatory agencies will include the implementation of Bio-equivalence studies in adherence to WHO guidelines. The decision of the Registration Board is hereby communicated for implementation.
Minutes of 336th meeting of Registration Board held on 04-06 June, 2024
The Drug Registration Board convened 336th meeting on June 04-06, 2024 in the Committee Room of the Drug Regulatory Authority of Pakistan, Prime Minister National Health Complex, Park Road, Islamabad. The minutes of the meeting are hereby circulated for the information of all stakeholders.
DRAP Finalized Guidelines on Standards for Establishment of Hospital Pharmacies
Guidelines on standard for Establishment of Hospital Pharmacies are intended to serve as a basic guide for the provision of pharmacy services in the hospitals within the country. These guidelines outline a set of services that are expected from hospital pharmacy departments and are aimed at ensuring consistent, high-quality pharmacy services across all hospitals, ultimately benefiting patients and the healthcare system as a whole.
The guidelines cover four key areas:
- Hospital Pharmacy Operations which include aspects like organizational structure, staffing, resources, policies, and procedures for managing medications from procurement and storage to dispensing and monitoring.
- Medicine Use Management where the focus is on optimizing medication use within the hospital. This involves procedures for medication reconciliation, identifying potential issues, and implementing strategies to improve medication effectiveness and avoid medication-related harm.
- Quality Improvement with the believe in continuous improvement! These guidelines outline practices for assessing the effectiveness of hospital pharmacy services, identifying areas for improvement, and implementing corrective actions.
- Human Resources Development for ensuring a competent and skilled pharmacy workforce is crucial. The guidelines address training and development programs for all pharmacy personnel, from pharmacists to technicians.
These guidelines were uploaded on DRAP website as well as shared with the stakeholder as draft document for their inputs and comments in January 2024. After careful consideration of comments and deliberation through multiple virtual meetings, these guidelines have been finalized and being circulated as a guidance document providing minimum standards for establishment and functioning of hospital pharmacies in the country.
Recall Alert: Drug Products; Recall of 12 Substandard Batches from the Market
Recall Alert
| DRAP Alert No | No I/S/05-24-28 |
| Action Date | 14th June 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 Directorate of Drugs Control (DDC) Punjab vide Alert No. 137/2024 and 135/2024 has informed that the following samples of drug products have been declared as Substandard by Drug Testing Laboratories (DTL). The Details of affected product batches is tabulated below. |
Therapeutic Good(s) Affected: –
| S# | Product Name | Composition | Batch No. | Manufactured by | Test Results |
| 01 | Metroin 100ml infusion | Metronidazole | MT23-014 | M/s. Saturn Pharmaceuticals, Lahore. | Substandard |
| 02 | Tozen-D Ophthalmic Suspension | Tobramycin and Dexamethasone | TW019 | M/s. Epharm Laboratories, Karachi. | Substandard |
| 03 | Ann-Vil 50ml Injection | Pheniramine Maleate | V-44423 | M/s. Venus Pharma, Lahore. | Substandard |
| 04 | Arpes 500mg Powder for Injection | Acyclovir | AR-099 | M/s. MTI Medical, Lahore. | Substandard |
| 05 | Torax 60ml Syrup | Acefylline Piperazine and Diphenhydramine | 24-24 | M/s. Siza International, Lahore. | Unacceptable Ethylene Glycol level identified |
| 06 | Zonid 200mg/5ml syrup 120ml | Metronidazole Benzoate | Z396 Z244 Z243 Z413 Z398 Z414 Z397 | M/s. Bloom Pharmaceuticals, Hattar. | Unacceptable Ethylene Glycol level identified |
| Action Initiated | –The manufacturers have been directed to immediately recall the defected batches of their products from the market. All pharmacists and chemist working at distributions and pharmacies should immediately check their stocks and stop supplying these batches of 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, 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 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. |
Rapid Alert: Crackdown Against Spurious/falsified Drug Products
Rapid Alert
| DRAP Alert No | No I/S/06-24-27 |
| Action Date | 14th June 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 vide Alert No. 137/2024 has informed that the following samples of drug products have been declared as “Spurious” by Drug Testing Laboratories (DTL) Multan, Lahore, Rawalpindi, and Faisalabad. Details of affected products are as follows:. |
The details of affected products and their batches are as under: –
| S# | Product Name | Batch No. | Purported to be Manufactured by (as per label) | Batch No. |
| 01 | Powder Amox 500 (1kg) (veterinary use) | 0010823 | Imported by: M/s. Brand Station, Lahore. Mfg. by: M/s. The North Star Import Export Joint Stock Company, Can Tho City, Vietnam. | Spurious |
| 02 | Nutricare Syrup 450ml | NC-457 | M/s. Care Pharmaceuticals. | Spurious |
| 03 | Velosef 500mg Capsule | 847M | M/s. GSK, Karachi. | Spurious |
| 04 | Pyodine Solution 60ml | 04813 | M/s. Brookes Pharma, Karachi. | Spurious |
| 05 | Pyodine Solution 450ml | 08913 | M/s. Brookes Pharma, Karachi. | Spurious |
| 06 | Tanzo 0.5g Injection | PN220142 | M/s. Bosch Pharmaceuticals, Karachi. | Spurious |
| 07 | Dydowen 10mg Tablet | 736 | M/s. Weather Fold Pharmaceuticals, Hattar. | Spurious |
| 08 | Duphaston 10mg Tablet | 230672 230092 | Mfg. by: Highnoon Laboratories Lahore. Mfg for: Abbott Laboratories, Karachi. | Spurious |
| 09 | Cefspan 400mg Capsule | D6780 | M/s. Barrett Hodgson Pakistan, Karachi. | Spurious |
| 10 | Phenobar 30mg Tablet | QA023 | M/s. Star Laboratories, Lahore. | Spurious |
| 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. |
Decisions of 68th Meeting of Medical Device Board (Deficiency letter for Medical Devices Applications)
The Medical Device Board (MDB) of the Drug Regulatory Authority of Pakistan in 68th 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.
Series of Training on National Pharmacovigilance System for Registration holders (Manufacturers and Importers)
The Drug Regulatory Authority of Pakistan (DRAP) has established the National Pharmacovigilance Centre (NPC) under the Division of Pharmacy Services. This initiative is aimed at ensuring the safety of therapeutic goods. With its endeavour, Pakistan became the 134th full member of the Programme for International Drug Monitoring (WHO-PIDM), Uppsala Monitoring Centre in 2018.
Subsequently, the DRAP notified Pharmacovigilance Rules, 2022 which outline the roles and responsibilities of pharmacovigilance stakeholders, including registration holders of therapeutic goods. The DRAP has also developed Guidelines on Good Pharmacovigilance practices for registration holders that outline step-by-step guidelines on the establishment of pharmacovigilance systems in pharmaceutical companies. The NPC has dedicated tools in place for the collection of adverse drug reaction reports (ADRs) from pharmaceutical companies (registration holders) such as E2B XML submission through dedicated email, and hard copy submissions via mailing address
Despite the above efforts of DRAP, very few pharmaceutical companies have established their pharmacovigilance centres and nominated their qualified persons for pharmacovigilance. Implementing pharmacovigilance rules, 2022 and establishing an effective pharmacovigilance system by all stakeholders, including registration holders is a prerequisite for ensuring the safety of medicines in Pakistan. This will reduce the risks associated with medications, thereby ensuring patient safety. This is why DRAP feels that there is a need to enhance the capacity of registration holders in respect to pharmacovigilance.
In this regard, the NPC, Division of Pharmacy Services, DRAP intends to conduct training of pharmaceutical companies (registration holders) on pharmacovigilance rules, guidelines and pharmacovigilance systems including collection and reporting of pharmacovigilance data. Three virtual training session will be conducted in the month of July 2024.
Rapid Alert: Busting of Illegal Manufacturing Site producing Unregistered Boostin (RBST) Injections
Rapid Alert
| DRAP Alert No | No I/S/05-24-25 |
| Action Date | 10th June 2024 |
| Target Audience | · National Regulatory Field Force. · Distribution, Pharmacies and Medical Stores · Healthcare Professionals – Veterinarians, Chemists · Farmers/Consumers |
| Problem Statement | During a joint raid by DRAP and FIA, illegal manufacturing of Boostin Injections (Synthetic Recombinant Bovine Somatotropin Hormone) was unearthed at Chandio Village, Clifton, Karachi. A large quantity of raw materials used in the manufacturing of Boostin Plus 2g Injections, finished goods, empty cartridges/containers with needles, packing materials/stickers, and packing machinery were seized from the premises as per Form-2 under Section 18(1) of the Drug Act 1976. |
| Threat to Public Health | RBST (a synthetic recombinant Bovine Somatotropin hormone) injected into animals for enhancing their milk production was banned in the country due to serious side effects on health of animals and impact on those consuming milk and meat of such animals. The product is also banned in Europe, Canada, Australia etc. |
| Action Initiated | The Regulatory Field Force has been directed to increase the surveillance activities in markets to confiscate the product. All Pharmacists and chemists working at distributions and Pharmacies should immediately check the stock and stop supplying this product. The stock should be quarantine immediately, and supplier(s) information should be provided to the Regulatory field force in order to ensure the removal of this products. Regulatory action will be taken against the persons involved in manufacturing/ storage /distribution/sale and use of this product. |
| Advice for Veterinarian | DRAP requests increased vigilance within the supply chains of institutions/pharmacies/healthcare facilities likely to be affected by this product. Further information of reporting problems to DRAP is available on this link |
| Advice for Farmers/Consumer | Farmers/Consumers should not use this product. They shall contact their physician or healthcare provider(s) if the animal experienced any problem that may be related to using this product. |
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.