Author: Asad Ullah
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.
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.
Notification: Directions of Registration Board on Labeling Requirements of Drug Products to Comply Pharmacopeial Specifications for Dissolution Testing
Registration Board in its 323rd meeting observed that various USP monographs for drug products prescribe more than one dissolution tests and that the pharmacopoeia in such cases recommends that “When more than one Dissolution Test is given, the labeling states the Dissolution Test used only if Test 1 is not used.”
Keeping in the USP labeling requirements narrated above and to comply to the Pharmacopeial specifications, the Board decided as under:
“The manufacturer shall mention the dissolution test Number on the secondary packing / unit carton of product for dissolution tests No 2,3 or 4 as per requirement of USP otherwise it would be presumed that dissolution test No.1 shall be performed on the finished product.”
Accordingly, the decision of Registration Board is circulated for information and compliance by relevant stakeholders / manufacturers.
DRAP and WHO collaborated to hold a “Two-Day Consultative Meeting on WHO AWaRe Classification of Antimicrobials in the National Essential Medicine List (NEML) of Pakistan”
Access, Watch, and Reserve (AWaRe) classification was introduced by the World Health Organization in 2017 for strengthening antibiotic stewardship and controlling antimicrobial resistance at the national level. This also includes in WHO GPW 13 indicators of antibiotic use. AWaRe is a relatively “easy” tool that offers more than overall antibiotic use or more conventional classifications.
WHO country office, in Pakistan, has been facilitating the development of Pakistan’s first “Evidence-based AWaRE classification of essential antibiotics” online active engagement of stakeholders. In the past two years, national experts in the field and consultants were engaged on multiple occasions through online and face-to-face meetings to develop the needful tools, formulate a comprehensive desk review, and collect the indigenous AMR data with support of NIH. The first consultative meeting of the process was held on 29th April 2021 and was attended by more than twenty participants from federal, and provincial levels with representation from both public and private sector.
Drug Regulatory Authority of Pakistan in collaboration with Ministry of National Health Services, Regulation and Coordination convened the final consultative meeting for development of the AWaRe classification of antibiotics for Pakistan. The meeting participants included the representatives from the M/o NHSR&C, DRAP, World Health Organization, National Institute of Health, Healthcare Commissions and National AMR surveillance program leads at federal and provincial levels, and the AMR sentinel sites. Leading national experts from the field of microbiology, infectious diseases, and other specialties including pharmacists, nurses, academicians, and public health professionals and epidemiologists were invited to ensure maximum contribution from the stakeholders.
The developed list will act as a guiding principle for designing institutional antibiotic policies and act as a stepping stone to achieve control of the growing antimicrobial resistance in the country.
Recall Alert: Drug Product; Awahaem Tablets (Batch # 2781 by M/s. Usawa Pharmaceuticals, Rialpur.
Recall Alert
| DRAP Alert No | NoI/S/01-23-04 |
| Action Date | 23rd January 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 | Awahaem Tablets Active Ingredient(s): Elemental Iron 100mg & Folic Acid 0.35mg Company: Ms. Usawa Pharmaceuticals (Pvt.) Ltd., Risalpur Batch No. 2781 Manufacturing Date: 06-2022 Expiry Date: 06-2024 |
| Problem / Issue | CDL Karachi has declared the batch No. 2781 of Awahaem Tablets, manufactured by M/s. Usawa Pharmaceuticals (Pvt.) Ltd., Risalpur as substandard drug product. |
| Action Initiated | -The manufacturing company has been directed to immediately recall the defected batch of product from the market. -All Pharmacists and chemists working at distributions and Pharmacies are required to immediately return the stock of above-mentioned batch of product to the supplier / importer / 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) 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 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(s) if they have had experienced any problem that may be related to taking or using this product. -All drug products must be obtained from the authorized licensed pharmacies /outlets. Their authenticity and condition should be carefully checked. If you have any doubt, please seek advice from your pharmacist. |