HOTC – Drug Regulatory Authority of Pakistan

Rapid Alert: Urgent Recall of Suspected Products for Contamination of DEG / EG

Asad Ullah Product Recalls, Recall Alerts, Safety Info February 21, 2023February 22, 2023Alert, DRAP, HOTC, Pharnacovigilance, QA & LT, QualityDefects, RapidAlert, Recall

Rapid Alert

Urgent Recall of Suspected Product for contamination of DEG / EG

DRAP Alert No	N^oI/S/02-23-8
Action Date	20^th February 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, Clinics and Healthcare Institutions 4. General Public
Problem Statement	Medical Control Agency, Gambia has issued a Safety Alert Ref: – MCA/AD/23/MJK(029) dated 13th February,2023 for KOF Relief Syrup bearing Batch# L394, manufactured by M/s Davis Pharmaceutical Laboratories, Islamabad-Pakistan due to presence of Ethylene Glycol (EG) at unacceptable levels. DRAP Inspectorate has initiated the investigation based on this information, and decided to recall all the suspected products manufactured by the firm using the same source of excipient i.e Glycerin and Propylene Glycol (PG). The details of suspected contaminated products are as under: –

Therapeutic Goods Affected:-

Sr	Product Name	Composition	Batch #	Manufactured by (as stated on label)
1	Bromgen Syp 100mL (Reg. Export Only)	Bromhexine HCl	L392	M/s Davis Pharmaceutical Laboratories, Islamabad-Pakistan
2	Kof Relief Syp 100mL (Reg, Export Only)	Chlorpheniramine Maleate Ammonium Chloride Sodium Citrate Menthol Green Banana Flavour	L394	-do-
3	Macofen Syp 100mL (Reg, Export Only)	Ibuprofen	L395	-do-
4	Vomitil Suspension 120mL (Reg, Export Only)	Domperidone	L400, L408, L414,	-do-
5	Asperfin Syp 60mL	Ketotifen	L401	-do
6	Davis Tonic Syrup (250mL, 120ml)	Vitamin B12 Vitamin B1 HCl Vitamin B2 Vitamin B6 Vitamin B3 Folic Acid Vitamin B5 Sodium Glycerophosphate Manganese Sulphate Ferric Ammonium Citrate	CS07, CS20, CS21, CS23, CS30, CS31, CS42, CS70, CS71, CS159	-do-
7	Zinc Syp 60mL	Zinc Sulphate Monohydrate	CS06, CS36, CS37, CS38, CS39, CS45, CS46, CS47, CS48, CS60, CS75, CS76, CS80, CS81, CS83, CS92, CS93	-do-

Action Initiated	The manufacturing company has been directed to immediately recall the suspected batches of these products from the market. All Pharmacists and chemists working at distributions and Pharmacies should immediately check their stocks and stop supplying these batches of products. The remaining stock should be quarantine and return to the supplier / company. 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 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 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.

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Lists of Applications for Provisional Enlistment of Alternative Medicines and Health Products

Ijaz Mustafa Alternative Medicines, General February 14, 2023February 15, 2023HOTC

Following is the provisional list of applications are received for provisional enlistment of products with the Division of Health & OTC, Drug Regulatory Authority of Pakistan, Islamabad under provisions of SRO 412 (I)/2014 dated 27-5-2014. Applicant firm are requested to furnish comments with respect to submitted applications within 30 days of the uploading of this list, if any. The comments received within 30 days of the publication of this list will be given due consideration, after which a final list will be uploaded on the website. Comments received after due date shall not be entertained. The processing of these applications under provisions of above said SRO will be dealt on First Come First Serve basis as per sequence of date mentioned against each application

These lists are prepared according to types of products and categories of applicant’ firms, as under:-

2021_-_Date_wise_Provisional_List_of_Application_for_Provisional_Enlistment_of_Homeopathic_products Download

2021_-_Date_wise_Provisional_List_of_Applications_for_Provisional_Enlistment_of_Herbal_Unani_products Download

2021_-_Date_wise_Provisional_List_of_Applications_for_Provisional_Enlistment_of_Nutraceutical_products_Download

110th Meeting of Enlistment Evaluation Committee (EEC); Notice for Submission of Deficient Information / Documents

Asad Ullah Enlistment Evaluation Committee September 30, 2022September 30, 2022HOTC

The 110th meeting of Enlistment Evaluation Committee (EEC), Division of Health and OTC, DRAP was held on 3rd August, 2022. The detailed of applications which required further information and documentation is attached hereunder for information by all stakeholders.

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109th Meeting of Enlistment Evaluation Committee (EEC); Notice for Submission of Deficient Information / Documents

Asad Ullah Enlistment Evaluation Committee September 30, 2022September 30, 2022HOTC

The 109th meeting of Enlistment Evaluation Committee (EEC), Division of Health and OTC, DRAP was held on 5th July, 2022. The detailed of applications which required further information and documentation is attached hereunder for information by all stakeholders.

Deficiency-letter-of-109th-meeting-of-EEC Download

Submission of Deficient Information / Documents (Enlistment Evaluation Committee (EEC) 92nd meeting held on 30th July, 2021)

Murtaza Awan Alternative Medicines October 21, 2021December 29, 2021HOTC

The applications of following applicants were placed before the Enlistment Evaluation Committee (EEC) in its 92^nd meeting held on 30^th July, 2021 and the same have been deferred being deficient of the information / documents as specified in column (3) of the Table below which may be furnished within 20 days of uploading of this letter on official website of DRAP along with soft data as per Annexed Format at the end of this letter/document.

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Submission of Deficient Information / Documents (Enlistment Evaluation Committee (EEC) 91st meeting held on 13th July, 2021)

Murtaza Awan Alternative Medicines October 21, 2021December 29, 2021HOTC

The applications of following applicants were placed before the Enlistment Evaluation Committee (EEC) in its 91^st meeting held on 13^th July, 2021 and the same have been deferred being deficient of the information / documents as specified in column (3) of the Table below which may be furnished within 20 days of uploading of this letter on official website of DRAP along with soft data as per Annexed Format at the end of this letter/document.

Deficiency-letter-of-all-deferred-products-in-91st-meeting-of-EEC-held-on-13-07-2021 Download

Date Wise FIFO List of Applications For Provisional Enlistment Of Products Applied By Herbal/Unani Firms (FIFO List 2020)

Murtaza Awan Alternative Medicines October 13, 2021December 29, 2021HOTC

List of Applications For Provisional Enlistment Of Products Applied By Herbal/Unani Firms.

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Date Wise FIFO List of Applications For Provisional Enlistment Of Products Applied By Nutraceutical Firms And Firms Having Herbal/Unani Sections Along With Nutraceutical Sections (FIFO List 2020)

Murtaza Awan Alternative Medicines October 13, 2021December 29, 2021HOTC

“In continuation to the previous FIFO list uploaded on official website of Drug Regulatory Authority of Pakistan on 29th June, 2021 and after incorporating the responses submitted by the firms within the stipulated time, following is the list of applications received for provisional enlistment of products with the Division of Health & OTC Products, Drug Regulatory Authority of Pakistan, Islamabad under provisions of SRO 412 (I)/2014 dated 27-5-2014. The processing of these applications under provisions of above said SRO will be dealt on First Come First Serve basis as per sequence of R&I date mentioned against each application.

Please note that formulations of all products of respective companies must be forwarded in MS Word & MS Excel Formats (Soft Copy) annexed at the end of this document (Annexure-I) to the official e-mail “hotcdivision∂gmail.com” of Health & OTC Division with the title “M/s…………. FIFO List 2020” within 15 days positively. Soft Formulations should be provided as per data given in Form-3 already submitted with dossier in hard form. Any discrepancy found in the submitted data in soft and hard shall be liable to rejection of the product application.

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Date Wise FIFO List Of Applications For Provisional Enlistment Of Products Applied By Homeopathic Firms (FIFO List 2020)

Murtaza Awan Alternative Medicines October 13, 2021December 29, 2021HOTC

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Submission of deficient information / documents (Enlistment Evaluation Committee (EEC) 90th meeting held on 17th June, 2021)

Murtaza Awan Alternative Medicines October 8, 2021December 29, 2021HOTC

The applications of following applicants were placed before the Enlistment Evaluation Committee (EEC) in its 90^th meeting held on 17th June, 2021 and the same have been deferred being deficient of the information / documents as specified in column (3) of the Table below which may be furnished within 20 days of uploading of this letter on official website of DRAP along with soft data as per Annexed Format at the end of this letter/document.

Deficiency-letter-of-all-deferred-products-in-90th-meeting-of-EEC-held-on-17-06-2021 Download

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