Recall Alert: Drug Product; Recall of Contaminated Liquid Preparations
Recall Alert
| DRAP Alert No | No I/S/01-24-05 |
| Action Date | 30th January 2024 |
| Target Audience | · Pharmacists and Chemists at Distribution, Pharmacies and Medical Stores · Healthcare Professionals- Physicians, Pharmacists, and Nurses at hospital and clinics etc. · General Public |
| Problem / Issue | Government Analyst DTL Bahawalpur and DTL Rawalpindi have informed that following products are found to be of “sub-standard” quality due to presence of Ethylene Glycol (EG) impurity at unacceptable levels. Details of affected products is provided in table below. |
Therapeutic Good(s) Affected: –
| Product Names | Composition | Batch No | Manufacturer | Test Results |
|---|---|---|---|---|
| Asthanil 60ml Syp | Ketotifen 1mg/5ml | 03-23 | M/s. Siza International (Pvt.) Ltd 18-Km Ferozpur Road, Lahore. | Ethylene Glycol: 2.896% Does not comply |
| Virol Syrup | Ribavirin 5mg/5ml | 35080 | M/s. Raazee Therapeutics (Pvt.) Ltd., 48-Km Lahore-Kasur Road, Lahore. | Ethylene Glycol: 3.31% Does not comply |
| Torax DM Syrup | Dextromethorphan HBr 12.5mg & Diphenhydramine HCl 12.5mg | 110-23 | M/s. Siza International (Pvt.) Ltd., 18-Km Ferozpur Road, Lahore. | Ethylene Glycol: 2.14% Does not comply |
| Texcol EX Syrup | Acefylline Piperazine 45mg, Diphenhydramine HCl 8mg | 63833 | M/s. Raazee Therapeutics (Pvt.) Ltd., 48-Km Lahore-Kasur Road, Lahore. | Ethylene Glycol: 0.985% Does not comply |
| Texcol DM Syrup | Dextromethorphan HBr 10mg/5ml | 09953 | M/s. Raazee Therapeutics (Pvt.) Ltd., 48-Km Lahore-Kasur Road, Lahore. | Ethylene Glycol: 1.19% Does not comply |
| Allerphene Syrup | Chloepheniramine Maleate 2mg/5ml | 3002 | M/s. PDH Pharmaceuticals (Pvt.) Ltd., 19-Km Ferozpur Road, Lahore. | Ethylene Glycol: 1.417% Does not comply |
| Speczine Syrup | Promethazine HCl 5mg/5ml | 276 | M/s. Spectrum Laboratories (Pvt.) Ltd., 8-Km Raiwind Road, Lahore. | Ethylene Glycol: 2.43% Does not comply |
| Bronyl syrup | Nutraceutical cough preparation | BL-013 | M/s. Florex Pharma Pvt Ltd, 25-Km Lahore-Jaranwala Road, Sheikhupura-Lahore. | Ethylene Glycol: 0.12% Does not comply |
| Action Initiated | -All pharmacists and chemist working at distributions and pharmacies should immediately check their stocks and stop supplying mentioned products. The remaining stocks should be quarantined and returned to the supplier/company. Regulatory field force of all federating units (DRAP and Provincial Health Departments) should also increase surveillance in the market to ensure the effective recall of defective products(s). -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 to enhance vigilance within the supply chains of institutions/pharmacies/healthcare facilities likely to be affected by this defective batch of the product. -Adverse reactions or quality problems experienced with this product may be reported to the National Pharmacovigilance Centre(NPC), DRAP using the 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). They shall contact their physician or healthcare provider(s) if they have experienced any problem that may be related to using this product. -All therapeutic 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. |
Warning To Therapeutic Goods Manufactures on DEG/EG Impurities in Raw Materials: A Serious Threat to Therapeutic Goods Quality and Safety
The Drug Regulatory Authority of Pakistan (DRAP) has issued a warning to the therapeutic goods industry about the use of raw material contaminated with diethylene glycol (DEG) and ethylene glycol (EG) impurities, which can pose serious health risks to consumers.
What is the issue?
The Central Drugs Laboratory Karachi has declared another sample of raw material i.e. propylene glycol (PG) as substandard sent for test/analysis due to unacceptable levels of ethylene glycol.
Propylene glycol, sorbitol and glycerin are used as solvents in the manufacturing of oral liquid preparations in the pharmaceutical and alternative medicines industry. When used in oral liquid preparations, these solvents can lead to serious health risks due to DEG and EG toxicity. When ingested, DEG and EG are metabolized into toxic metabolites that can affect the central nervous system, heart, and can cause kidney damage, which can be fatal.
In the past two years, there have been international reports related to the adulteration of these raw materials with DEG and EG causing kidney damage and death of children in Gambia, Uzbekistan, and Indonesia. Industrial grade DEG and EG are used for various applications (solvents, antifreeze agent) in other industries.
Earlier, several cases of substandard raw materials including PG and finished goods contaminated with DEG and EG have been reported from various part where investigations have suggested that the main problem lies with the integrity of supply chain of raw material which appears to be compromised. Consequently, action has been initiated against the culprits involved.
What are the actions taken by DRAP?
Despite repeated warnings and instructions, many therapeutic goods manufacturers have neglected to verify the quality and safety of their raw materials from authorized vendors. The Central Drug Laboratory, Karachi is currently analyzing both raw materials and finished products for EG and DEG contamination, following the pharmacopoeial standards and WHO guidelines for testing of EG and DEG in oral liquid preparations. To ensure the quality and safety of their products, manufacturers should test their raw materials for EG and DEG contamination before using them in their production processes to prohibit potential influx of contaminated products in the market.
In view of the criticality of the matter and potential for untold human tragedy, the therapeutic goods industry is once again warned to screen raw materials (propylene glycol, glycerin and sorbitol) for contamination with EG and DEG before using these materials in the manufacturing of oral liquid preparations. Additionally, all finished products must be analyzed for EG and DEG contamination before their release into the market. DRAP also issued directives to nutraceutical and alternative medicine companies to ensure compliance and safeguard public health from contaminated products. Additionally, the industry is diected to recall any finished products that were manufactured using the contaminated lot/batch of propylene glycol, hold the affected batches of finished products and ensure testing of finished products for EG and DEG contamination before releasing them into the supply chain.
DRAP urge pharma industry to take measures to prevent utilization of contaminated raw material in the manufacturing of liquid preparation including following:-
- Implement a supplier qualification and verify the compliance of the suppliers with the relevant standards and regulations.
- Verify traceability and authenticity of the raw material using unique identifiers such as barcodes or RFID tags to track their movement and origin throughout the supply chain.
- Conduct regular risk assessments and monitor the performance of the suppliers, and take corrective actions if any issues are detected.
- Educate and train the staff and the suppliers on the importance of preventing EG and DEG contamination, and the potential consequences of using contaminated solvents.
- Verify the features that indicate the authenticity of the product, such as holograms, serial numbers, watermarks, or special packaging. The products should also be checked for any signs of poor printing, misspellings, inconsistent logos, tamper-evident seals or sturdy wrapping materials.
DRAP is committed to ensure the safety and quality of therapeutic goods in Pakistan, and protecting the public from substandard and falsified products.
Minutes of 294th Meeting of Central Licensing Board held on 27th December 2023
Acceptance of IAEA technical reports on radiopharmaceuticals as regulatory reference
Minutes of 334th meeting of Registration Board held on 25th January, 2024
The Drug Registration Board convened 334th meeting on January 25, 2024 in the Committee Room of the Drug Regulatory Authority of Pakistan, G-9/4, Islamabad. The minutes of the meeting are hereby circulated for the information of all stakeholders.
Registration Board Direction; Procedure for Capacity Assessment of the Contract Acceptor
Registration Board in its 333rd meeting held on 19th – 20th December, 2023 discussed the subject mentioned case and decided as under: –
1. Inspection of contract accepter for manufacturing / testing capacity assessment shall be conducted for all those contract manufacturers, who has not been inspected for such purpose with in the last 3 years. The panel shall verify capacity assessment of all those sections, which are approved by the Licensing Division.
2. Capacity assessment of newly applied facility (Section) shall not be carried out, if any section of that manufacturing facility has already been assessed within last three years.
3. Following shall be prerequisites for submission of application for contract manufacturing under Rule 20(A) of Contract Manufacturing Policy.
a. Affidavit on stamp paper (Showing name, designation, CNIC Number of contract giver) stating installed capacity of the contract accepter for contract manufacturing. This affidavit shall only be signed by the CEO / MD of the firm. i.e. contract accepter.
b. Copy of DML of both firms. i.e. contract giver and contract accepter along with Section (s) approval from Licensing Division.
c. Valid GMP certificate or GMP inspection report of the contract accepter, conducted within last three years.
d. Copy of legalized contract between contract giver and contract accepter on stamp paper presenting the capacities of the contract accepter for the manufacturing sections for whom the products have been applied, and
4. Affidavits submitted by the contract accepter, showing manufacturing / testing capacity, will be verified in the subsequent inspections conducted for GMP / renewal of DML and will be reported accordingly. Chairman, Registration Board may constitute panel of experts to verify capacity assessment, if required.
5. The capacity verification report will be valid for 3 years.
Recall Alert: Drug Product; INCIP 200mg Infusion (Batch # CPV-85) by Inventor Pharma Pvt Ltd, Karachi
Recall Alert
| DRAP Alert No | No I/S/01-24-03 |
| Action Date | 16th January, 2024 |
| Target Audience | · Pharmacists and Chemists at Distribution, Pharmacies and Medical Stores · Healthcare Professionals- Physicians, Pharmacists, and Nurses at hospital and clinics etc. · General Public |
| Problem / Issue | Federal Government Analyst, CDL Karachi has declared the Batch No. CPV-085 of product “INCIP Infusion” as of Substandard quality. |
Therapeutic Good(s) Affected: –
| Product Names | Composition | Batch No | Manufacturer |
|---|---|---|---|
| INCIP 200mg Infusion Reg.No 088363 | Ciprofloxacin | Batch No. CPV-85 Mfg. Date: 09-23 Exp. Date: 09-25 | M/s Inventor Pharma (Pvt) Ltd, Karachi |
| Risk Statement: | The impact of the use of substandard infusion on the basis of visible particulate matter may introduce contaminants into the bloodstream that lead to adverse reactions or sepsis. |
| Action Initiated | -The manufacturer has been directed to immediately recall the defective batch of product from the market. All pharmacists and chemists working at distributions and pharmacies should immediately check their stocks and stop supplying this batch of product. The remaining stock should be quarantined and returned to the supplier/ company. The regulatory field force of all federating units (DRAP and Provincial Health Departments) has increase surveillance in the market to ensure the effective recall of defective products(s). -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 to enhance vigilance within the supply chains of institutions/pharmacies/healthcare facilities likely to be affected by this defective batch of the product. -Adverse reactions or quality problems experienced with this product may be reported to the National Pharmacovigilance Centre(NPC), DRAP using the 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). They shall contact their physician or healthcare provider(s) if they have experienced any problem that may be related to using this product. -All therapeutic 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. |
Minutes of 333rd meeting of Registration Board held on 19-20th December, 2023
The Drug Registration Board convened 333rd meeting on 19th-20th December 2023 in the Committee Room of the Drug Regulatory Authority of Pakistan, G-9/4, Islamabad. The minutes of the meeting are hereby circulated for the information of all stakeholders.
Guidelines on Standards for Establishment of Hospital Pharmacies is now open for comments.
Drug Regulatory Authority of Pakistan is seeking feedback on proposed guidelines for hospital pharmacies. These standards aim to ensure consistent, high-quality pharmacy services across all hospitals, ultimately benefiting patients and the healthcare system as a whole.
The guidelines cover four key areas:
- Hospital Pharmacy Operations which include aspects like organizational structure, staffing, resources, policies, and procedures for managing medications from procurement and storage to dispensing and monitoring.
- Medicine Use Management where the focus is on optimizing medication use within the hospital. This involves procedures for medication reconciliation, identifying potential issues, and implementing strategies to improve medication effectiveness and avoid medication-related harm.
- Quality Improvement with the believe in continuous improvement! These guidelines outline practices for assessing the effectiveness of hospital pharmacy services, identifying areas for improvement, and implementing corrective actions.
- Human Resources Development for ensuring a competent and skilled pharmacy workforce is crucial. The guidelines address training and development programs for all pharmacy personnel, from pharmacists to technicians.
DRAP invites you to review the proposed guidelines and share your thoughts and suggestions. Your input will be invaluable in shaping the final document and ensuring it reflects the needs and expectations of patients, healthcare professionals, and the community.
These guidelines were uploaded on the official website of DRAP on 12th of January, 2024 for seeking comments and suggestions from stakeholders on the draft document. Stakeholders can submit their comments and suggestions within 15 days of uploading this document using prescribed format. For further guidelines on how to submit comments visit DRAP website or click here. Comments and suggestions can be forwarded via email to dir.ps∂dra.gov.pk, copying aqsa.hashmi∂dra.gov.pk, or can be posted at mailing address, Director, Division of Pharmacy Services, Drug Regulatory Authority of Pakistan, 3rd floor TF Complex, 7th Mauve Area, G-9/4, Islamabad.