Year: 2022
DRAP finalizes Guidelines on the Preparation of Summary of Product Characteristics (SmPC)
The Summary of Product Characteristics (SmPC) are the basic information for healthcare professionals on the use of drug products to ensure safety, efficacy and quality, and also provides a basis for preparation of the Patient Information Leaflet (PiL). SmPC describes the set of characteristics of a drug product as determined through the assessment process during registration of a drug product.
SmPC guidelines are intended to provide supportive information for preparation of Summary of Product Characteristics (SmPC) for registration / market authorization of pharmaceutical and biological products of all types including New drug products, Generic drug products and Biosimilars.
Rule 26 of the Drugs (Licensing, Registering & Advertising) Rules, 1976, as amended vide S.R.O 713(I)/2018 dated 8th June 2018, under 26(1) section 1.5.14 requires that in order to obtain registration/marketing authorization of drug product, a Summary of Product Characteristics (SmPC) is required to be included in the application dossier. The SmPC is part of drug registration / marketing authorization approval, and its contents can only be changed with the approval of Competent Authority. In this context, Registration Board has deliberated the contents of summary of Product Characteristics for pharmaceutical and biological drug products. This document transforms the decisions and advices of Registration Board into a guidance document for preparation of SmPC with application dossier submission in the CTD module.
The draft guidelines were prepared three years ago and was available on the DRAP’ s website. Stakeholders have submitted their comments on the draft document and accordingly guidelines have been finalized after careful consideration of stakeholder’s comments.
Please click to view the final document, GUIDELINES ON Preparation of Summary of Product Characteristics
For more information on Regulatory Guidelines published by DRAP, please navigate to Publications tabs on our website.
Minutes of 321st meeting of Registration Board held on 20th to 22nd September, 2022
The Drug Registration Board convened its 321st meeting on 20th – 22nd September, 2022 in the Committee Room of Drug Regulatory Authority of Pakistan, G-9/4, Islamabad. The minutes of meeting are hereby circulated for information of all stakeholders.
Suspected Falsified Alert; Drug Products; Regulatory Field Force reported the presence of suspected falsified products in market
Suspected Falsified Alert
| DRAP Alert No | NoI/S/10-22-28 |
| Action Date | 25th October, 2022 |
| 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, Clinics and Healthcare Institutions 4. General Public |
| Problem Statement | During the market surveillance activities in different areas of Karachi, Provincial Drug Inspectors from Karachi have identified the suspected samples of products and sent for analysis to Drug Testing Laboratories. The Provincial Drugs Testing Laboratory, Sindh, Karachi has declared the samples of following products as spurious. The stated manufacturers on the labels of these products has informed that they have not manufactured these batches. Details are as under: – |
| Sr | Product Name | Batch # | PURPORTED TO BE MANUFACTURED BY |
|---|---|---|---|
| 1 | Cap Rulling 40mg | 4RU083 | M/s. High-Q Pharma Karachi. |
| 2 | Cap Eskeem 40mg | 4EK086 | -do- |
| 3 | Cap Mixel 400mg | 4MX120 | -do- |
| 4 | Tab Dicloran 50mg | 002H | M/s. Sami Pharma Karachi |
| 5 | Inj Meronem IV 1g | 4A21D282 4A21H02 4B21K26 | M/s. ACS Doblar & packed by Ms. Pfizer Pakistan Ltd. |
| 6 | Inj. Tanzo 2.25g | PN20148 | M/s. Bosch Pharma Karachi |
| 7 | Inj. PENRO 500mg | PO210047 | -do- |
| 8 | Tab. Ciproxin 500mg | BAA058 | M/s. Bayer Pakistan Ltd Karachi |
| 9 | Cap Azomax 250 | PMSA | M/s. GlaxoSmithKline Ltd. |
| 10 | Tab. Relief Extra Finished (Packed strips) | Not mentioned | M/s. Combitic Global Caplet, India |
| Action Initiated | The Regulatory Field Force has been directed to increase the market surveillance and confiscate these batches of above-mentioned products. All Pharmacists and chemists working at distributions and Pharmacies should immediately check the stock and stop supplying these batches of products. The remining stock should be quarantine 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 above-mentioned batches of products. |
| 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 stop using these products bearing the affected batch number(s) and shall contact to their physician or healthcare provider if they have experienced any problems that may be related to taking or using any these drug products, and report the incident to Drug Regulatory Authority of Pakistan / National Pharmacovigilance Centre. -All therapeutic goods must be obtained from the 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. |
Drug Impurity Alert ! Compulsory Testing of Solvents Glycerin, Propylene Glycol & Sorbitol used in Oral Preparations for Presence of any Toxic Impurities (e.g. Diethylene Glycol (DEG) & Ethylene Glycol (EG).
Drug Safety Alert
| Date: | 21st of October 2022. |
| Target Audience: | • Regulatory Field Force • Manufacturers of Glycerin containing formulations to control level of Diethylene glycol and Ethylene glycol • Healthcare Professionals- Physicians, Pharmacists, and Nurses • General Public |
| Problem or Issue: | Glycerin, Sorbitol & Propylene glycol are widely used in therapeutic goods as solvents. However, recently there has been report in international media related to the adulteration of these materials with highly toxic Diethylene Glycol (DEG) and Ethylene Glycol(EG). These impurities, DEG and EG are poisonous and may lead to severe health injury or death, as recently reported in Gambia, and also being associated with the incident happened in Indonesia due to consumption of syrups containing glycerin. These reports warrant an emergent need of extraordinary measures and vigilant monitoring of these possible contaminants. |
| Potential Hazards linked to DEG and EG: | Toxic effects can include abdominal pain, diarrhea, inability to pass urine, headache, altered mental state, vomiting and acute kidney injury which may lead to death especially in children |
| Advice for healthcare professionals: | DRAP requests increased vigilance within the supply chains of institutions/pharmacies/healthcare facilities to detect any substandard / falsified product in the market. Adverse reactions or quality problems experienced with the use of any product shall be reported to the National Pharmacovigilance Centre(NPC), DRAP using Adverse Event Reporting Form or online through this link. Further information of reporting problems to DRAP is available on this link. |
| Advice for Manufacturer’s and Importers of Products containing Glycerin Solvent: | Perform test/analysis of for presence of any toxic impurity/contaminants specially when used in oral dosage forms such as syrups/suspensions etc. It is legal responsibility of all manufacturers of therapeutic goods to ensure before marketing that all the manufactured therapeutic goods are safe for consumption. Therefore, it is required that all manufacturers using these solvents must perform proper testing to detect DEG and EG contamination |
| Advice for General Public: | All therapeutic goods must be obtained from the licensed pharmacies, and other authorized retail outlets. The authenticity and condition of products should be carefully checked. Seek advice from your pharmacists or other healthcare professional in case of any doubt. |
| Guidelines for reporting Adverse Drug Reactions (ADRs): | Both healthcare professionals and patients are requested to report any adverse events they have experienced to National Pharmacovigilance Centre, Drug Regulatory Authority of Pakistan through DRAP Med Vigilance E-reporting system or at npc∂dra.gov.pk. Similarly, adverse events can also be reported through Med Safety Mobile Application that is available for download from the App store (For iOS devices) and Google Play (For Android devices). |
| References: |
DRAP has issued alerting note to all relevant stakeholders for taking effective measures in this regard.
Recall Alert: Drug Product; Sterile Water for Injection (Batch # 440) By M/s. Karachi Pharmaceutical Laboratories, Karachi
Recall Alert
| DRAP Alert No | NoI/S/10-22-29 |
| Action Date | 20th October, 2022 |
| Target Audience | 1. Pharmacists and Chemists at Distribution, Pharmacies and Medical Stores 2. Healthcare Professionals- Physicians, Pharmacists, and Nurses at hospitals, Clinics and Healthcare Providing Institutions 3. General Public |
| Product(s) Affected | Sterile Water for Injection, Company: M/s. Karachi Pharmaceutical Laboratories, Karachi Batch No. 440 Manufacturing Date: June-2022, Expiry Date: June-2025 |
| Problem Statement | The Central Drug Laboratory Karachi has analyzed the sample of Sterile Water for Injection (Registration No. 012570) bearing Batch No. 440, and declared it as Substandard. The company has been directed to recall the affected batch of product from the market. |
| Action to be taken | -All Pharmacists and chemists working at distributions and Pharmacies are required to immediately return the stock of above mentioned batch of product to the company. -Distributors and pharmacies are advised to be vigilant and report any suspected batch of product(s) in the supply chain to the DRAP using online form, or through phone at +92 51 910 73 17, or Email at gsms∂dra.gov.pk. -Regulatory field force of all federating units (DRAP, Provincial Health Departments and States) have also increased surveillance in the market to ensure the effective recall of defective product(s). |
| Advice for Healthcare Professionals | -DRAP requests increased vigilance within the supply chains of healthcare institutions and hospital pharmacies. -Adverse reactions or quality problems experienced with the use of 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) 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. All drug products must be obtained from authorized licensed sources/outlets. Their authenticity and condition should be carefully checked. Seek advice from a healthcare professional in case of any doubt. |
Usage of online account for DRAP E-services(Pharma industry)
Notification: Applications for Registrations of Pharmaceutical drugs submitted on Form 5/5D requiring submission of Product Stability Data
Registration Board in 320th meeting held on 29th – 31st August 2022 has issued a direction with regards to the applications received on Form 5 / 5-D for registration of pharmaceutical drugs, which requires submission of stability study data for further processing. The list of such applications is available on official website of DRAP (link).
The decision of Registration Board is notified and attached hereunder for information and compliance by all relevant stakeholders.
SRO 1888(I)/2022 : Notification of Clinical Studies Committee under Bio-Study Rules, 2017
WHO Global Alert on Contaminated Pediatrics Cough Syrups Identified In Gambia-West Africa
Drug Safety Alert
Update from WHO Global Surveillance and Monitoring System
| Date: | 12th of October 2022. |
| Target Audience: | • Healthcare Professionals- Physicians, Pharmacists, and Nurses. • Manufacturers and Importers of Glycerin containing formulations to control level of Diethylene glycol and Ethylene glycol • General Public |
| Problem or Issue: | World Health Organization (WHO) has issued Medical Product Alert No. N°6/2022 dated 05th October 2022 which refers to four substandard products, identified in Gambia. These four products are Promethazine Oral Solution, Kofexmalin Baby Cough Syrup, Makoff Baby Cough Syrup and Magrip N Cold Syrup. Laboratory analysis of samples of each of the four products confirm that they contain unacceptable amounts of diethylene glycol and ethylene glycol as contaminants. DRAP has never authorized sale of any products from Maiden Pharmaceuticals Limited (Haryana, India) and these four products referred in WHO medical product alert are neither registered nor available on Pakistan market, however these may have been carried for personal use while visiting other countries. Please do not use any of these products as these are substandard products and their use may result in serious injury. |
| Potential Hazards linked to DEG and EG: | Toxic effects can include abdominal pain, diarrhea, inability to pass urine, headache, altered mental state, vomiting and acute kidney injury which may lead to death especially in children |
| Advice for healthcare professionals: | DRAP requests increased vigilance within the supply chains of institutions/pharmacies/healthcare facilities to detect any substandard / falsified product in the market. Adverse reactions or quality problems experienced with the use of any product shall be reported to the National Pharmacovigilance Centre(NPC), DRAP using Adverse Event Reporting Form or online through this link. Further information of reporting problems to DRAP is available on this link. |
| Advice for Manufacturer’s and Importers of Products containing Glycerin Solvent: | Unacceptable amounts of Diethylene glycol (DEG) and Ethylene glycol (EG) as contaminants may lead to severe injury or death. You are therefore advised to strictly follow the pharmacopoeia guidelines for excipients and ensure testing of all those products where diethylene glycol and ethylene glycol can appear as impurity, to ensure specifications limits are being comply for all those products where glycerin is used especially cough syrups and other oral products. |
| Advice for General Public: | All therapeutic goods must be obtained from the licensed pharmacies, and other authorized retail outlets. The authenticity and condition of products should be carefully checked. Seek advice from your pharmacists or other healthcare professional in case of any doubt. |
| Guidelines for reporting Adverse Drug Reactions (ADRs): | Both healthcare professionals and patients are requested to report any adverse events they have experienced to the National Pharmacovigilance Centre, Drug Regulatory Authority of Pakistan through DRAP Med Vigilance E-reporting system or at npc∂dra.gov.pk. Similarly, adverse events can also be reported through Med Safety Mobile Application that is available for download from the App store (For iOS devices) and Google Play (For Android devices). |
| References: | Medical Product Alert No. N°6/2022 |