The second volume of quarterly Newsletter of DRAP was issued on 1st January, 2023. This issue highlights the key initiatives and accomplishments of the outgoing year-2022, and welcomes the new year-2023 with reaffirmation to its commitments. DRAP is implementing its Strategic Plan 2022-25 with full zeal and devotion, to protect the public health through effective regulation for availability of safe, quality assured and efficacious therapeutic goods for the people of Pakistan.
News & Updates
Testing of Diethylene Glycol (DEG) & Ethylene Glycol (EG) at Central Drug Laboratory, Karachi
The Central Drug Testing Laboratory (CDL), Karachi, is providing facilities for testing of solvents (Glycerin, Propylene Glycol, and Sorbitol) used in oral preparations for the presence of any toxic impurities (e.g., Diethylene Glycol (DEG) and Ethylene Glycol (EG)) to the manufacturers and importers of pharmaceutical products. DRAP has already issued advisories and directions via letter F. No. 6-30/2022-QA dated October 21, 2022 and December 13, 2022 to the stakeholders for compliance.
Central Drug Laboratory has issued following guidance steps for manufacturers and importers for availing these facilities.
Sampling:
- Sampling should be made on the basis of √n + 1
- A composite of the quantity drawn should be made
- Divide this composite in three equal parts (approximately 30ml in each bottle)
Fee:
- Fee voucher to be generated on DRAP’s fee portal fee.dra.gov.pk by completing following steps:-
- a. Create Login / Enter Your Login Details
b. Click on Generate Fee
c. Select Division = Central Drugs Laboratory
d. Select Payment Head = Central Drugs Testing laboratory
e. Fee = Gas Chromatography
f. Enter Details - Fee for each batch is Rs.23000/-
Document Required:
- Sampling Information Sheet.
- Certificate of Analysis by Manufacturer.
- Testing Request Letter.
- Copy of voucher paid in any branch of Allied bank.
Testing Time:
- The samples will be tested on the FIFO basis.
Dispatch of Samples
- Three bottles as mentioned under sampling per batch shall be sent to CDL along with the
documents mentioned above. - The firm is responsible to maintain the conditions of samples during transportation.
- Sample should be dispatch on following Address:-
Director, Central Drugs Laboratory
4-B, SMCHS, Block B, Karachi
For any further assistance, Please contact to
Director, Central Drugs Laboratory, 4-B, SMCHS, Block B, Karachi or call at 021-34392159
Tender document / terms & conditions for hiring of janitorial services for DRAP head office & NCLB, Islamabad
Revocation/Cancellation of Form-6 (Provisional Certificate for Enlistment as manufacturer/importer) & Form-7(Provisional Certificate for Enlistment of products)
Decisions of 52nd Meeting of Medical Device Board (Deficiency letters Local/Import)
The Medical Device Board (MDB) of Drug Regulatory Authority of Pakistan in its 52nd meeting has deferred the following applications of registration of medical devices due to various deficiencies / shortcomings in the applications dossiers. These applicants are requested to furnish the requisite information / documentations as directed by the Medical Device Board. The detail is provided in the below attachment
Holding of Khuli E-Kachehri
Decisions of 51st Meeting of Medical Device Board (Deficiency letters Local/Import)
The Medical Device Board (MDB) of Drug Regulatory Authority of Pakistan in its 51st meeting has deferred the following applications of registration of medical devices due to various deficiencies / shortcomings in the applications dossiers. These applicants are requested to furnish the requisite information / documentations as directed by the Medical Device Board. The detail is provided in the below attachment.
Rapid Alert: Drug Product; Falsified Tablin 300mg Capsule identified in the market
Rapid Alert
Suspected Falsified Product
| DRAP Alert No | NoI/S/10-22-36 |
| Action Date | 24th November 2022 |
| 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 | During the market surveillance activities in different areas of District Sheikhupura Punjab, Regulatory Field Force has identified the suspected sample for product and sent for analysis to laboratory. The Provincial Drugs Testing Laboratory, has declared the samples as “spurious”. The stated manufacturers on the label has informed that they have not manufactured this batch number of product. Product detail is as under:- |
Therapeutic Good Affected:-
| Sr | Product Name | Composition | Batch # | Manufactured by (as stated on label) |
|---|---|---|---|---|
| 1 | TABLIN 300mg Capsule | Pregabalin 300mg | Batch No. 699 | M/s Theramed Pharmaceuticals (Pvt) Ltd, Lahore. |
| Action Initiated | The Regulatory Field Force has been directed to increase the market surveillance and confiscate this batch of the 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 product. -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. -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. |
Recall Alert: Drug Product; Ponstan Forte 500mg Tablets (Batch # 2050533) by M/s Pfizer Pakistan Ltd, Karachi.
Recall Alert
| DRAP Alert No | NoI/S/10-22-35 |
| Action Date | 30th November 2022 |
| 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 | Ponstan Forte 500mg Tablets, Active Ingredient(s): Mefenamic Acid Company: M/s. Pfizer Pakistan Ltd, Karachi Batch No. 2050533 Manufacturing Date: 09-2020 Expiry Date: 08-2025 |
| Problem / Issue | The Drug Testing Laboratory, Baluchistan has analyzed the sample of batch No. 2050533 of Ponstan Forte 500mg Tablets manufactured by M/s. Pfizer Pakistan Ltd Karachi, Pakistan and declared it as “Substandard” based on the analysis. |
| Action Initiated | -The company is 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. |
Recall Alert: Drug Product; Diamicron 80mg Tablets (Batch#1740) by M/s. Servier Research & Pharmaceuticals Pakistan (Pvt) Ltd Lahore.
Recall Alert
| DRAP Alert No | NoII/S/10-22-33 |
| Action Date | 23rd November 2022 |
| 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 | Diamicron 80mg Tablets, Active Ingredient(s): Gliclazide Company: M/s. Servier Research & Pharmaceuticals Pakistan (Pvt) Ltd Lahore. Batch No. 1740 Manufacturing Date: 04-2022 Expiry Date: 04-2025 |
| Problem / Issue | Central Drug Laboratory, Karachi has analyzed the samples of Diamicron 80mg Tablets manufactured by M/s Servier Research & Pharmaceuticals Pakistan (Pvt) Ltd Lahore and declared the batch No. 1740 as “substandard” based on the analysis report. |
| Action Initiated | -The company is 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. |