SRO 207(I)/2023 dated 21st Feb, 2023: Fixation of Maximum Retail Price (MRP) of Drugs
Proposed Amendments in the Rules: Stakeholders Comments are invited on Draft Amendments in the Drugs (Research) Rules, 1978
The Drug Regulatory Authority of Pakistan (DRAP) has issued a proposal to amend the current version of the Drugs (Research) Rules, 1978. These draft amendments are herby notified seeking comments from stakeholders.
Stakeholders can submit their comments within 14 (fourteen) days of the publication of this Notification using prescribed format, via email to aamar.latif∂dra.gov.pk, or can be posted at mailing address, Additional Director, Division of Legal Affairs, Drug Regulatory Authority of Pakistan, 1st floor, TF Complex, 7th Mauve Area, G-9/4, Islamabad. Further information on comments submission can be accessed on this link.
Rapid Alert: Urgent Recall of Suspected Products for Contamination of DEG / EG
Rapid Alert
Urgent Recall of Suspected Product for contamination of DEG / EG
| DRAP Alert No | NoI/S/02-23-8 |
| Action Date | 20th 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. |
Recall Alert: Drug Product; Capex 500mg Tablet (Batch# 2040006) by M/s. Rotex Pharma, Islamabad
Recall Alert
| DRAP Alert No | NoI/S/04-23-23 |
| Action Date | 16th February 2023 |
| Target Audience | 1. Pharmacists and Chemists at Distributions, Pharmacies and Medical Stores 2. Healthcare Professionals- Physicians, Pharmacists, and Nurses at Hospitals, Clinics and Healthcare Providing Institutions 3. General Public |
| Product(s) Affected | Capex 500mg Tab Composition: Capacetiabine Manufactured by: M/s. Rotex Pharma, Islamabad Batch No. 2040006 |
| Problem / Issue | DRAP received a complaint that a drug product Capex 500mg Tab contains a hair punch within the tablet, which shows adulterated quality which may compromise the quality of drugs. |
| Action Initiated | -The manufacturing company/registration holder has been directed to immediately recall the defected batch of product from the market. -All Pharmacists and chemists working at distributions and Pharmacies should immediately check their stocks and stop supplying this product batch. 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 increase vigilance within the supply chains of healthcare institutions and hospital pharmacies to identify and return the defective batch(es) of this product to the importer/company. -Adverse reactions or quality problems experienced with 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(s) if they have experienced any problem that may be related to taking or using this product. -All drug 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. |
Proposed Amendments in the Rules: Stakeholders Comments are invited on Draft Amendments in the Drugs (Licensing, Registering & Advertising) Rules 1976 and the Medical Device Rules, 2017
The Drug Regulatory Authority of Pakistan (DRAP) has issued a proposal to amend the current version of the Drugs (Licensing, Registering and Advertising) Rules, 1976 and the Medical Device Rules, 2017. These draft amendments are herby notified seeking comments from stakeholder.
Stakeholders can submit their comments within 14 (fourteen) days of the publication of this Notification using prescribed format, via email to aamar.latif∂dra.gov.pk, or can be posted at mailing address, Additional Director, Division of Legal Affairs, Drug Regulatory Authority of Pakistan, 1st floor, TF Complex, 7th Mauve Area, G-9/4, Islamabad. Further information on comments submission can be accessed on this link.
Invitation to bid (Supply of lab chemicals, glassware, consumable items etc. for National Control Laboratory for Biologicals (NCLB), Islamabad during the FY 2022-23)
Lists of Applications for Provisional Enlistment of Alternative Medicines and Health Products
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_productsDownload
Cancellation of Enlistment Certificates (Form-6 and Form-7) of two alternative products manufacturers’ for non-compliance to minimum regulatory requirements.
Enlistment Evaluation Committee (EEC) has cancelled the provisional enlistment certificates of two (02) alternative products manufacturing companies for non compliance to minimum manufacturing requirement as per applicable rules. The Committee also cancelled / revoked all the product enlistment certificates issued on the name of these two firms. The cancellation letters have been issued by the Division of Health & OTC to the all concerned authorities.
DRAP issued Consolidated Guidance Document on Good Manufacturing Practices for Manufacturing Sites of Drugs.
To ensures the quality of drugs and compliance with its Current Good Manufacturing Practice (cGMP), DRAP monitor the manufacturers to ensure compliance to minimum requirements for the methods, facilities, and controls used in manufacturing, processing, and packing of a drug product. These Good Manufacturing Practices are intended to make sure that a product is safe for use, and meet the prescribed standard of quality.
Although the Drugs (Licensing, Registering & Advertising) Rules, 1976 under the Drugs Act, 1976 provides detail requirements on Good Manufacturing Practices (GMP), however, DRAP intended to provide a compiled GMP guidance document stipulating Drug Regulatory Authority of Pakistan’s (DRAP) expectations on GMP from pharmaceutical & biological drugs manufacturers.
This Guideline is intended to provide guidance regarding the Good Manufacturing Practices (GMP) for the manufacturing of pharmaceutical & biological drug in accordance with the Drugs (Licensing, Registering & Advertising) Rules, 1976, under the Drugs Act, 1976, the good manufacturing practices aim at ensuring that:
- Products are consistently produced and controlled to the quality standards appropriate to their intended use
- Products are manufactured as required by the marketing authorization or product specification; and
- All those risks have been diminished that are inherent in any pharmaceutical / biological production operation, including contamination, cross contamination and mix ups (confusion) that cannot be detected completely through the testing of final products.
This document will help industry and Regulators to conform the requirement of GMP for production, verification, and validation of manufactured products and ensure that they are effective and safe.