Year: 2025
Decisions of the 94th Meeting of the Medical Device Board (MDB)
Submission of Required Details for Implementation of 2-D Barcode & Serialization by 1st September 2025
Drug Regulatory Authority of Pakistan (DRAP) is in process of implementing 2-D Barcode along with serialization for pharmaceutical products. In this regard, the pharmaceutical industry is hereby directed to provide the required details in the attached form not later than 1st September, 2025.
S.R.O. 1587(I)/2025 DRAP has adopted Pharmaceutical Inspection Co-operation Scheme (PIC/S) guidelines
Directive for Submission of Antimicrobial Batch Production and Import Data in DRIS
Registration holders of Pharmaceutical Products for human and veterinary use (manufacturers and importers) are directed to submit antimicrobials batch production / Import data (finished formulations) for use within Pakistan regularly in DRIS. DRAP will be analyzing yearly data for regulatory purposes. The data is critical for use in implementing Antimicrobial Stewardship Policies to combat AMR in Pakistan.
Minutes of 93rd meeting of Medical Devices Board
96th Meeting of Medical Devices Board will be held on 22nd August 2025
RAPID ALERT – CRACKDOWN AGAINST FALSIFIED / SPURIOUS DRUG PRODUCTS
Rapid Alert
CRACKDOWN AGAINST UNLICENSED / UNAUTHORIZED MANUFACTURERS
| DRAP Alert No | No I/S/08-25-56 |
| Action Date | 20th August, 2025 |
| Target Audience | 1. Regulatory Field Force of DRAP and Provincial Drug Control departments. 2. Healthcare Professionals 3. Pharmacies and medical stores |
| Problem Statement | Drug testing Laboratories from Provinces have informed the Drug Regulatory Authority of Pakistan that the samples of below mentioned products have been declared ‘Spurious’. The details of reports are as under: |
The product identification details are as under: –
Therapeutic Good Affected:-
| S# | Product Name | Batch No. | Purported Manufacturer | Remarks |
| 1 | Brexin Tablet Each tablet contains: Piroxicam-β-Cyclodextrine (Lyophilized) e.q to Piroxicam……20mg | 1192087 | Purported to be manufactured underlicense of Chiesi Farmaceutici S.P.A., PARMA-ITALY Marketed by: Chiesi Pharmaceuticals Pvt. Ltd., Lahore. | Drug Testing Laboratory, Rawalpindi Punjab declared the purported drug product as ‘Spurious’ as defined under clause (i) of subsection (z-b) of Section 3 of the Drugs Act, 1976. |
| 2 | Tablet Zetro 500mg (Reg. # 053120) Each film coated tablet contains: Azithromycin (as dihydrate) ………………….500 mg | F18031 | Purported to be manufactured underM/s Getz Pharma (Private) Limited. Plot # 01, Sector 25, Korangi Industrial Area, Karachi (DML# 000933). | Drug Testing Laboratory, Rawalpindi declared the purported drug product as ‘Spurious’ as defined under clause (i) of sub-section (z-b) of Section 3 of the Drugs Act, 1976. |
| 3 | Tablet Augmentin 625mg Each film coated tablet contains: Amoxicillin (as trihydrate) …………… 500 mg. Clavulanic Acid (as potassium salt) …… 125mg. | 7F4W | Purported to be manufactured underM/s GlaxoSmithKline Pakistan Limited, F/268, S.I.T.E. Karachi (DML# 000233). | Drug Testing Laboratory, Multan declared the purported drug product as ‘Spurious’ as defined under clause (i) & (ii) of sub-section (z-b) of Section 3 of the Drugs Act, 1976. |
| 4 | Tablet TONOFLEX-P Each Film Coated Tablet Contains: Tramadol HCl …… 37.5 mg Paracetamol ……… 325 mg | KFM145 | Purported to be manufactured underM/s Sami Pharmaceuticals (Pvt.) Ltd. F-95, S.I.T.E. Karachi (DML# 000072). | Drug Testing Laboratory, Rawalpindi declared the purported drug product as ‘Spurious’ as defined under clause (i) & (ii) of sub-section (z-b) of Section 3 of the Drugs Act, 1976. |
| 5 | Tablet EFASTON Each film coated tablet contains Dydrogesterone …… 10 mg | 41160 | Purported to be manufactured underM/s Lahore Chemical & Pharmaceutical Works (Private) Limited. 137- Ferozepur Road, Lahore (DML# 000064). | Drug Testing Laboratory Rawalpindi declared the purported drug product as ‘Spurious’ as defined under clause (i) & (ii) of sub-section (z-b) of Section 3 of the Drugs Act, 1976. |
| 6 | Capsule Gabica 300 mg Each Capsule contains: Pregabalin ……… 300 mg | 403C27 | Purported to be manufactured underM/s Getz Pharma (Private) Limited. 29-30/27 Korangi Industrial Area, Karachi (DML# 000284) (recovered from Peddler / Hawker) | Drug testing Laboratory Multan declared the purported drug product as ‘Spurious’ as defined under clause (i) & (ii) of sub-section (z-b) of Section 3 of the Drugs Act, 1976. |
| 7 | Imcomox Capsule Each Capsule Contains: Amoxycillin trihydrate eq. to Amoxycillin (U.S.P) …. 500mg | 08 | Purported to be manufactured underM/s IMCO Pharmaceutical Labs. 73- Industiral Estate, Hayatabad, Peshawar. (DML # 000317) | Drug Testing Laboratory, Faisalabad declared the purported drug product as ‘Spurious’ as defined under clause (i) & (ii) of sub-section (z-b) of Section 3 of the Drugs Act, 1976. |
| 8 | Omnidol NU Tablet Each uncoated tablet contains: Paracetamol …….500mg Caffeine …………….65 mg | 1220 | Purported to be manufactured underM/s Olive Laboratories. Plot No.52-S-6 National Industrial Zone Rawat Rawalpindi. (000524) | Drug Water and Food Testing Laboratory Gilgit Baltistan declared the purported drug product as under: – For assay of caffeine, ‘Spurious’ as defined under clause (i) of sub-section (z-b) of Section 3 of the Drugs Act, 1976 & For assay of Paracetamol, ‘Substandard’ as defined under sub-section (zz) of Section 3 of the Drugs Act, 1976. |
| 9 | CAPSULE CEFSPAN 400 mg Each capsule contains: Cefixime………400mg | F0580 | Purported to be manufactured underM/s Barrett Hodgson Pakistan (Pvt) Ltd. F/423 SITE Karachi. (000457) | Drug Testing Laboratory Rawalpindi declared the purported drug product as ‘Spurious’ as defined under clause (i) & (ii) of sub-section (z-b) of Section 3 of the Drugs Act, 1976. |
| 10 | CAPSULE ICON 100 mg Each capsule contains: Itraconazole pellets eq. To itraconazole 100 mg | 241694 | Purported to be manufactured underM/s Ferozsons Laboratories Ltd. Amangarh Nowshera (DML #000038) | Drug Testing Laboratory Rawalpindi declared the purported drug product as ‘Spurious’ as defined under clause (i) & (ii) of sub-section (z-b) of Section 3 of the Drugs Act, 1976. |
| 11 | Tablet NOVIDAT Each film coated tablet contains: Ciprofloxacin Hydrochloride eq. to Ciprofloxacin 500mg | FIM147 | Purported to be manufactured underM/s Sami Pharmaceuticals (Pvt) Ltd. F-95 Off Hub River Road, SITE Karachi. (DML # 000072) | Drug Testing Laboratory Rawalpindi declared the purported drug product as ‘Spurious’ as defined under clause (i) & (ii) of sub-section (z-b) of Section 3 of the Drugs Act, 1976. |
(Please find pictorial guidelines for identification of falsified products in the pdf version to be downloaded from link above)
| Risk Statement | All the above mentioned purported drug products are confirmed as falsified/spurious, as its packaging falsely claims that it was manufactured by a licensed pharmaceutical company—whereas it was not. Laboratory testing has revealed that the product contains no active pharmaceutical ingredient, resulting in complete lack of therapeutic effect. Such falsification poses a serious risk to public health, potentially leading to treatment failure, disease progression, and even life-threatening outcomes, particularly for patients relying on these medications for critical care. The public is strongly advised not to use these purported drug products and to report any suspicious or unverified medicines to DRAP immediately. |
| Action Initiated | The Regulatory Field Force has been directed to conduct surveillance activities to confiscate the abovementioned Un-Registered/falsified product. All Pharmacists, chemists, and other healthcare professionals working at distributions, pharmacies, healthcare facilities, and other aspects of the supply chain system should immediately check the stock, and information related to the suppliers of such products should be provided to the Regulatory field force (DRAP, Provincial Drug Control Departments) to ensure the removal of these product from the circulation. |
| Advice for Healthcare Professionals | DRAP requests healthcare professionals to have increased vigilance within the supply chains of institutions/pharmacies/healthcare facilities likely to be affected by above mentioned product. Any adverse events or quality problems experienced with the use of these products should be reported to National or Provincial pharmacovigilance centers using Adverse Event Reporting Form or online through this link. Further information on reporting problems to DRAP is available on this link. |
| Advice for Consumers | Consumers should not use these products and should contact their physician or healthcare provider(s) if they have experienced any problem related to taking or using the above mentioned products and should report the incident to the Drug Regulatory Authority of Pakistan / National Pharmacovigilance Centre. All therapeutic goods must be obtained from 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 PRODUCTS DECLARED SUBSTANDARD BY CENTRAL DRUGS LABORATORY, KARACHI.
Recall Alert
| DRAP Alert No | No II/S/08-25-55 |
| Action Date | 18 August, 2025. |
| Target Audience | – National Regulatory Field Force. – Pharmacists and Chemists in Distribution, Pharmacies and Medical Stores – Healthcare Professionals – Physicians, Pharmacists, and Nurses at hospitals and clinics – General Public |
| Problem / Issue | Central Drugs Laboratory Karachi informed the Drug Regulatory Authority of Pakistan that the samples of below mentioned drug products have been declared as ‘Substandard’. |
Therapeutic Goods (s) Affected: –
| S# | Product Name | Batch No. | Manufacturers | Remarks |
| 1. | Famila 28F Tablets Each Tablet contains: Levonorgestrel…0.15mg Ethinyl Estradiol…0.03mg Ferrous Iron….24.37mg (Reg. No. 023941) | K185 | M/s. ZAFA Pharmaceutical Laboratories (Pvt.) Ltd. A-46 SITE North Karachi (DML#000490) | ‘Substandard’ on the basis of tests of content uniformity (Levonorgestrel, Ethinyl Estradiol) and Assay(Levonorgestrel). |
| 2. | Famila 28F Tablets Each Tablet contains: Levonorgestrel…..0.15mg Ethinyl Estradiol…0.03mg Ferrous Iron….24.37mg (Reg. No. 023941) | K189 | M/s. ZAFA Pharmaceutical Laboratories (Pvt.) Ltd. A-46 SITE North Karachi (DML#000490) | ‘Substandard’ on the basis of tests of content uniformity (Levonorgestrel, Ethinyl Estradiol) and Assay (Levonorgestrel). |
| 3. | Famila 28F Tablets Each Tablet contains: Levonorgestrel……0.15mg Ethinyl Estradiol…0.03mg Ferrous Iron….24.37mg (Reg. No. 023941) | K187 | M/s. ZAFA Pharmaceutical Laboratories (Pvt.) Ltd. A-46 SITE North Karachi (DML#000490) | ‘Substandard’ on the basis of tests of content uniformity (Levonorgestrel, Ethinyl Estradiol), Weight variation of Ferrous Iron and Assay (Levonorgestrel & Ethinyl Estradiol). |
| 4. | Famila 28F Tablets Each Tablet contains: Levonorgestrel……0.15mg Ethinyl Estradiol…0.03mg Ferrous Iron….24.37mg (Reg. No. 023941) | K192 | M/s. ZAFA Pharmaceutical Laboratories (Pvt.) Ltd. A-46 SITE North Karachi (DML#000490) | ‘Substandard’ on the basis of tests of content uniformity (Levonorgestrel, Ethinyl Estradiol), and Assay (Levonorgestrel & Ethinyl Estradiol). |
| 5. | Famila 28F Tablets Each Tablet contains: Levonorgestrel……0.15mg Ethinyl Estradiol…0.03mg Ferrous Iron….24.37mg (Reg. No. 023941) | K194 | M/s. ZAFA Pharmaceutical Laboratories (Pvt.) Ltd. A-46 SITE North Karachi (DML#000490) | ‘Substandard’ on the basis of tests of content uniformity (Levonorgestrel, Ethinyl Estradiol), and Assay (Levonorgestrel). |
| 6. | Famila 28F Tablets Each Tablet contains: Levonorgestrel……0.15mg Ethinyl Estradiol…0.03mg Ferrous Iron….24.37mg (Reg. No. 023941) | K195 | M/s. ZAFA Pharmaceutical Laboratories (Pvt.) Ltd. A-46 SITE North Karachi (DML#000490) | ‘Substandard’ on the basis of tests of content uniformity (Levonorgestrel, Ethinyl Estradiol), and Assay (Levonorgestrel). |
| 7. | Imcomox 125mg/5ml Suspension Each 5ml of reconstituted suspension contains: Amoxicillin (as Trihydrate) ………………….125mg (Reg. No. 013756) | 029 | M/s. Imco Pharmaceutical Lab. 73/A Industrial Estate Jamrud Road, Peshawar (DML#000317) | ‘Substandard’ on the basis of Assay (Amoxicillin trihydrate). |
| 8. | Imcodal Oral Suspension Each 5ml of Suspension contains: Metronidazole Benzoate.. 64mg Ethinyl Furazolidone….25mg (Reg. No. 013363) | 013 | M/s. Imco Pharmaceutical Lab. 73/A Industrial Estate Jamrud Road, Peshawar (DML#000317) | ‘Substandard’ on the basis of Assay (Furazolidone). |
| Risk Statement: | Famila 28F: The affected batches of Famila 28F Tablets due to content uniformity, assay failures of hormonal ingredients, and weight variation in the iron component, may lead to reduced contraceptive efficacy, hormonal imbalance, and inconsistent iron supplementation, increasing the risk of complications, particularly in vulnerable groups such as Young Women, Perimenopausal Women, Women with history of Anemia, Patients with Comorbidities. Imcomox: Laboratory testing has confirmed that the amoxicillin content in this drug product is below the approved specification range, making it subpotent. Such reduced strength may cause treatment failure, particularly in infants and young children, the primary users of this medicine. The recall is being undertaken to prevent potential health risks and safeguard public safety. Imcodal: Laboratory testing has confirmed that the furazolidone content in this suspension is below the approved specification range, indicating subpotency. Inadequate active ingredient may lead to ineffective treatment of gastrointestinal infections, particularly in children, who are the primary recipients of this medicine. This recall is being carried out to prevent treatment failure and protect public health. |
| Action Initiated | – The regulatory field force of DRAP and Provincial Drug Control departments has been directed to immediately conduct market surveys for detection and removal of these products from the market. – All pharmacists and chemists working at distributors and pharmacies should immediately check their stocks and stop supplying these products. The remaining stocks 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 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 these 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. |
RAPID ALERT – CRACKDOWN AGAINST UNLICENSED/UNAUTHORIZED MANUFACTURERS
Rapid Alert
CRACKDOWN AGAINST UNLICENSED / UNAUTHORIZED MANUFACTURERS
| DRAP Alert No | No I/S/08-25-54 |
| Action Date | 11th August, 2025 |
| Target Audience | 1. Regulatory Field Force of DRAP and Provincial Drug Control departments. 2. Healthcare Professionals 3. Pharmacies and medical stores |
| Problem Statement | The Drug Regulatory Authority of Pakistan (DRAP) has received information from the Drug, Water and Food Testing Laboratory, Gilgit-Baltistan, indicating that the following purported drug products have been declared ‘spurious’ upon analysis and reportedly manufactured by entities not licensed or authorized by DRAP. The relevant laboratory findings and product details are as under: |
The product identification details are as under: –
Therapeutic Good Affected:-
| S# | Product Name | Batch No. | Purported Manufacturer | Remarks |
| 1 | Missron Tablet Each Tablet contains Dydrogesterone ……. 10mg | 48022 | M/s Fegga Pharmaceutical, F-21/H.P.T.C., S.I.T.E., KARACHI. | Drug Water and Food Testing Laboratory Gilgit Baltistan declared the purported drug product as ‘Spurious’ as defined under clause (i) & (ii) of sub-section (z-b) of Section 3 of the Drugs Act, 1976. |
| 2 | Quttefol OD tablets Each film coated tablet contains L-Methyl-Folate (Folic Acid) …………………… 800 mcg Vitamin B12 …….1000 mcg | QL-001 | M/s Adcok Pharmaceuticals Factory 3-km Defense Road Off-Raiwind Road, Lahore | Drug Water and Food Testing Laboratory Gilgit Baltistan declared the purported drug product as under: – For assay of Vitamin B12, ‘Spurious’ as defined under clause (i) of sub-section (z-b) of Section 3 of the Drugs Act, 1976 & For assay of Folic Acid, ‘Substandard’ as defined under sub-section (zz) of Section 3 of the Drugs Act, 1976. |
| 3 | Depasrone Tablets Each Tablet contains Dydrogesterone ……. 10mg | 2406 | M/s Alpine Laboratories, Plot A-41, S.I.T.E., Karachi | Drug Water and Food Testing Laboratory Gilgit Baltistan declared the purported drug product as ‘Spurious’ as defined under clause (i) & (ii) of sub-section (z-b) of Section 3 of the Drugs Act, 1976. |
| 4 | Dropha Tablets Each Tablet contains Dydrogesterone ……. 10mg | DRP-0004 | M/s Himax Pharmaceutical, Plot # 445, Korangi Industrial Area, Karachi | Drug Water and Food Testing Laboratory Gilgit Baltistan declared the purported drug product as ‘Spurious’ as defined under clause (i) & (ii) of sub-section (z-b) of Section 3 of the Drugs Act, 1976. |
| Risk Statement | All the above-mentioned purported drug products have been confirmed as falsified/spurious, as they are manufactured by entities that are neither licensed nor authorized by the Drug Regulatory Authority of Pakistan (DRAP). These products are being illegally manufactured and marketed without regulatory oversight, rendering their quality, safety, and efficacy highly doubtful. Laboratory testing has revealed the absence of active pharmaceutical ingredients in some samples, indicating a complete lack of therapeutic value. The circulation and use of such unregulated products pose a serious risk to public health, including treatment failure, disease progression, and potential life-threatening consequences. The public is strongly advised to avoid the use of these unregistered drug products and report any suspicious or unauthorized medicines to DRAP through its official reporting channels. |
| Action Initiated | The Regulatory Field Force has been directed to conduct surveillance activities to confiscate the abovementioned Un-Registered/falsified product. All Pharmacists, chemists, and other healthcare professionals working at distributions, pharmacies, healthcare facilities, and other aspects of the supply chain system should immediately check the stock, and information related to the suppliers of such products should be provided to the Regulatory field force (DRAP, Provincial Drug Control Departments) to ensure the removal of these product from the circulation. |
| Advice for Healthcare Professionals | DRAP requests healthcare professionals to have increased vigilance within the supply chains of institutions/pharmacies/healthcare facilities likely to be affected by above mentioned product. Any adverse events or quality problems experienced with the use of these products should be reported to National or Provincial pharmacovigilance centers using Adverse Event Reporting Form or online through this link. Further information on reporting problems to DRAP is available on this link. |
| Advice for Consumers | Consumers should not use these products and should contact their physician or healthcare provider(s) if they have experienced any problem related to taking or using the above mentioned products and should report the incident to the Drug Regulatory Authority of Pakistan / National Pharmacovigilance Centre. All therapeutic goods must be obtained from 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. |