Suspected Falsified Alert; Drug Products; Suspected Anti-D Immunoglobulin Injection in the market

Rapid Alert

DRAP Alert NoNoI/S/10-22-29
Action Date28th October 2022
Target Audience1. 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 StatementDRAP received a complaint regarding the presence of following suspected product in the market. This product is not imported and marketed by the authorized registration holder and neither DRAP has issued import clearance for this product. National Control Laboratory for Biological has also not issued any lot release to this product.
SrProduct NameCompositionBatch #Manufactured by (as stated on label)
101 IMMUNORHO 300µg (1.500iu)
(PFS; Pre-filled syringe)
Human anti-D immunoglobulinM05W25212M/s. KEDRION BIOPHARMA.
Action InitiatedThe Regulatory Field Force has been directed to increase the market surveillance and confiscate this product. All Pharmacists and chemists working at distributions and Pharmacies should immediately check the stock and stop supplying this product. The remaining 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 suspected 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 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 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.
Pictures of Suspected falsified product

Regulatory Update / Advisory; Recall of Targocid 200mg powder for solution for injection/infusion or oral solution in UK

Date:   31st October, 2022

Target Audience: –  

  • Healthcare Professionals- Physicians, Pharmacists, and Nurses.
  • General Public

Problem or Issue: –

Sanofi UK has initiated an urgent recall of two batches of Targocid 200mg powder for solution for injection/infusion or oral solution (Batch Number 0J25D1 and Batch Number 0J25D2). Reason for recall is the out of specifications results obtained for bacterial endotoxins in the retained samples.

However, both of these batches were not imported or marketed in Pakistan by the authorized registration holder company, hence, Pakistan’s market will not be affected by this recall operation.

Nonetheless, DRAP has directed registration holder company to test the retaining samples of other batches which are supplied in Pakistan to ensure that problem is not extended beyond the identified two batches.  

Advice for healthcare professional: –

Healthcare professionals should be aware of the clinical symptoms related to the potential risk to patient health; a high temperature (fever) or low body temperature, chills and shivering, cold, clammy and pale or mottled skin, a fast heartbeat, fast breathing, severe breathlessness, severe muscle pain, feeling dizzy or faint, a change in mental state – such as confusion or disorientation, loss of consciousness, slurred speech, nausea and vomiting and/or diarrhea.

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.  Further information on how to report a problem to DRAP is available on this link.

Advice for general public: –

Since, these affected batches have not been imported or supplied in Pakistan by the marketing authorization holder, no recall is initiated for this product in Pakistan. These these batches were supplied and being recalled in the UK market only. However, if any person has carried these affected batches for their personal use they are advised not to consume it, and consult their healthcare provider immediately.

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.

Suspected Falsified Alert; Drug Products; Regulatory Field Force reported the presence of suspected falsified products in market

Suspected Falsified Alert

DRAP Alert NoNoI/S/10-22-28
Action Date25th October, 2022
Target Audience1. 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 StatementDuring 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: –
SrProduct NameBatch #PURPORTED TO BE MANUFACTURED BY
1Cap Rulling 40mg4RU083M/s. High-Q Pharma Karachi.
2Cap Eskeem 40mg4EK086-do-
3Cap Mixel 400mg4MX120-do-
4Tab Dicloran 50mg002HM/s. Sami Pharma Karachi
5Inj Meronem IV 1g4A21D282
4A21H02
4B21K26
M/s. ACS Doblar & packed by Ms. Pfizer Pakistan Ltd.
6Inj. Tanzo 2.25gPN20148M/s. Bosch Pharma Karachi
7Inj. PENRO 500mgPO210047-do-
8Tab. Ciproxin 500mgBAA058M/s. Bayer Pakistan Ltd Karachi
9Cap Azomax 250PMSAM/s. GlaxoSmithKline Ltd.
10Tab. Relief Extra Finished
(Packed strips)
Not mentionedM/s. Combitic Global Caplet, India
Action InitiatedThe 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 NoNoI/S/10-22-29
Action Date20th October, 2022
Target Audience1. 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 StatementThe 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.

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.