Decisions of 58th Meeting of Medical Device Board (Deficiency letter for Medical Devices Applications)
The Medical Device Board (MDB) of Drug Regulatory Authority of Pakistan in its 58th 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.
Stakeholders Comments are invited on Draft Guidelines for Post-Registration Variation of Drugs
DRAP has rolled out a draft for the second edition of its guidelines on procedure and data requirement for post registration variation of drugs. These Guidelines are intended to assist manufacturers and importers to incorporate variations in their product to account administrative changes, technical and scientific progress, or to improve or introduce additional safeguards. Registration / Marketing Authorization holders are responsible for the safety, efficacy, and quality of drug products that are placed on the market throughout their approved life cycle. These guidelines retain the essentials of the previously published guidelines and have been extended with new terminology of types of variations and documentation required to support a specific change.
This guideline is intended to provide information for submission of post-registration variation application by the registrations / marketing authorization holders of drug products. It includes categories of variations and the required documentation & procedures for submission of an application for a particular variation.
This guidance document is applicable to APIs and excipients manufactured by chemical synthesis or semi-synthetic processes and biological processes and the drug products containing such APIs & excipients.
These draft guidelines on post registration variation were uploaded on the official website of DRAP on 4th July, 2023, seeking comments and suggestions from stakeholders on the draft rules. Stakeholders can submit their comments and suggestions within 14 days of uploading this draft using prescribed format, (further information on comments submission is available on this link). Comments and suggestions can be forwarded via email to muneeb.cheema∂dra.gov.pk, copying at zeeshan.nazir∂dra.gov.pk, or can post at mailing address Director, Pharmaceutical Evaluation & Registration 4th floor TF Complex, 7th Mauve Area, G-9/4, Islamabad.
SRO.769(I)/2023 dated 23rd June, 2023: Fixation of Maximum Retail Price (MRP) of Drugs and Biologicals
Rapid Alert; H&OTC Product: Falsified and Unregistered N-Gaisk Plus Tablets by M/s Naz Homoeo Pharmacy
Rapid Alert
Falsified and Unregistered N-Gaisk Plus Tablets
| DRAP Alert No | No II/S/06-23-27 |
| Action Date | 19th June 2023 |
| Target Audience | 1. Regulatory Field Force 2. Pharmacists and Chemists at Distribution, Pharmacies, and Medical Stores 3. General Public |
| Problem Statement | Federal Inspector of Drugs Karachi took the sample of N-Gaisk Plus Tablets and sent it to Central Drug Laboratory, Karachi for test/analysis. Federal Government Analyst has declared the sample as Un-registered under the Drugs Act 1976 The product detail as under: – |
Therapeutic Goods Affected:-
| Sr | Product Name | Batch # | Manufactured by | Remarks |
|---|---|---|---|---|
| 1 | N-Gaisk Plus Tablets Registration No.: Nil Mfg. Date: Aug 2022 Exp. date: Aug 2028 | 004 | M/s. Naz Homoeo Pharmacy, Karachi | Diclofenac sodiumhas been identified on assay test (24.81mg) which is an allopathic drug and the sample is not registered with DRAP. Hence sample is declared as “Un-registered Drug Product” |
| Risk Statement: | The Claimed Product is Homoeopathic with some quantity of an allopathic ingredient Diclofenac Sodium which is an Anti-Inflammatory/Rheumatic drug used to treat Rheumatoid Arthritis and associated pains. As the product is unregistered this infers that the quality and safety attributes of the product are not accepted and approved by DRAP. Unregistered products containing Diclofenac Sodium may cause severe adverse reactions including Gastric bleeding and diarrhea. |
| Action Initiated | The Regulatory Field Force has been directed to increase surveillance throughout the supply chain to confiscate the 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 supplier of such products should be provided to the Regulatory field force (DRAP, Provincial Health Departments and States) to ensure the removal of this product. |
| 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 the above-mentioned products. -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 not use this product and shall contact their physician or healthcare provider if they have experienced any problem related to taking or using this drug product 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. |
Rapid Alert; H&OTC Product: Falsified and Unregistered Sugar XL Capsules by M/s Naz Homoeo Pharmacy
Rapid Alert
Falsified and Unregistered Sugar XL Capsules
| DRAP Alert No | No II/S/06-23-26 |
| Action Date | 19th June 2023 |
| Target Audience | 1. Regulatory Field Force 2. Pharmacists and Chemists at Distribution, Pharmacies, and Medical Stores 3. General Public |
| Problem Statement | Federal Inspector of Drugs Karachi took the sample of Sugar XL capsules and sent it to Central Drug Laboratory, Karachi for test/analysis. Federal Government Analyst has declared the sample as Unregistered under the Drugs Act 1976. The product detail as under: – |
Therapeutic Goods Affected:-
| Sr | Product Name | Batch # | Manufactured by | Remarks |
|---|---|---|---|---|
| 1 | Sugar XL Capsules Registration No.: Nil Mfg. Date: Nil Exp. date: use within 5 years | Nil | M/s. Naz Homoeo Pharmacy, Karachi | Glibenclamide has been identified on an assay test (3.34mg) which is an allopathic drug and the sample is not registered with DRAP. Hence the sample is declared as “Un-registered Drug Product.” |
| Risk Statement: | The Claimed Product is Homoeopathic with some quantity of an allopathic ingredient Glibenclamide which is an oral hypoglycemic drug used to treat type 2 diabetes. As the product is unregistered this infers that the quality and safety attributes of the product are not accepted and approved by DRAP. Unregistered products containing Glibenclamide may cause adverse reactions including variation in blood glucose level which may lead to hypoglycemic conditions and the patient may get faint. |
| Action Initiated | The Regulatory Field Force has been directed to increase surveillance throughout the supply chain to confiscate the 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 supplier of such products should be provided to the Regulatory field force (DRAP, Provincial Health Departments and States) to ensure the removal of this product. |
| 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 the above-mentioned products. -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 not use this product and shall contact their physician or healthcare provider if they have experienced any problem related to taking or using this drug product 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. |
Rapid Alert: Drug Product; Falsified Defitelio Infusion identified in the WHO Regions of Europe and the Eastern Mediterranean
Rapid Alert
WHO Medical Product Alert N°3/2023 On Falsified DEFITELIO (defibrotide sodium)
| DRAP Alert No | No I/S/06-23-25 |
| Action Date | 19th June 2023 |
| Target Audience | 1. Regulatory Field Force 2. Healthcare Professionals- Physicians, Pharmacists, and Nurses at hospitals and clinics, etc. 3. Pharmacists and Chemists at Distribution, Pharmacies, and Medical Stores 4. Patients, Caregivers, and General Public. |
| Problem Statement | WHO issued Medical Product Alert No. 3/2023 on falsified batch No. 19G19A, Expiry Date 01/2025, of DEFITELIO identified in the United Arab Emirates and publically reported by the national regulatory authority (in November 2022). The falsified batch was also identified in Kyrgyzstan (in March 2023). They have been identified in UK/Ireland packaging and US packaging. This falsified product is not registered in Pakistan. The genuine manufacturer of DEFITELIO has confirmed that the products referenced in WHO alert are falsified. Lab analysis of a sample of falsified products found it did not contain any of the stated active ingredients. The genuine manufacturer has also advised that: i. Stated batch number 19G19A is not a genuine DEFITELIO batch number ii. Expiry dates are falsified iii. Falsified US pack with batch 19G19A / Exp. 01/2025- the vial inside the pack has a different batch number- M06B466E which is not a genuine batch number. |
| Therapeutic Goods Affected:- | DEFITELIO 80 mg/ml Concentrate for Infusion Active Ingredient: (Defibrotide Sodium) Registration No.: Nil Batch No. Outer carton Batch: 19G19A Exp. date: 01/2025 and Inner vial Batch: M06B466E Purported Manufacturer (as per label) M/s. Gentium SRl For further information please click for details of the affected products. |
| Risk Statement | DEFITELIO (Defibrotide sodium) is an antithrombotic agent used to treat severe venous-occlusive disease (VOD) in adult and pediatric patients undergoing hematopoietic (blood) stem cell transplantation. · Use of falsified products will compromise the treatment of disease and may intensify the existing condition. · It may lead to life-threatening reactions due to intravenous administration as safety, sterility and quality of product are unknown. |
| Action Initiated | The Regulatory Field Force has been directed to increase the surveillance activities at Health facilities (Hospitals) in addition to markets and confiscate the batch of products if available. All Pharmacists and chemists working at distributions and Pharmacies should immediately check the stock and stop supplying this batch product. The remaining stock should be quarantined 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 these 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 the above-mentioned products. -Pharmacists and procurement officers present at healthcare facilities are requested to remain vigilant and inform patients of procuring medical products only from authorized channels. -Adverse reactions or quality problems experienced with the use of these products 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 | To ensure authenticity, consumers should always obtain medical products from authorized licensed pharmacies /outlets. The authenticity of these products should be carefully checked and If the consumer has any doubt, advice must be sought from your pharmacist. In case a consumer has experienced any problem related to taking or using these drug product(s), they should cease the use of the product in question immediately and contact their Physician or Pharmacist and should also report the incident to the Drug Regulatory Authority of Pakistan. |
Rapid Alert; Drug Product: Falsified Ciproxin 500mg Tablets identified in the Market
Rapid Alert
Falsified Ciproxin 500mg Tablets
| DRAP Alert No | No II/S/06-23-28 |
| Action Date | 19th June 2023 |
| Target Audience | 1. Regulatory Field Force 2. Pharmacists and Chemists at Distribution, Pharmacies and, Medical Stores 3. General Public |
| Problem Statement | Provincial Drug Control team has seized suspected falsified Ciproxin 500mg Tablets during the market surveillance activities in the District Kasur, Punjab. The Manufacturing Authorization holder company i.e. M/s Bayer Pakistan (Pvt) Ltd, Karachi has stated that based on the physical verification of security features, the products seized are not genuine, and thus it is a spurious/falsified products. The product detail as mentioned on the label is as under: – |
Therapeutic Goods Affected:-
| Sr | Product Name | Composition as per label | Batch # | Manufactured by (as stated on label) |
|---|---|---|---|---|
| 1 | Ciproxin 500mg Tablets Mfg.Date: 12-21 Exp.Date: 11-26 | Ciprofloxacin | BAA928 | M/s.Novartis Pharma (Pakistan) Ltd, Karachi For Bayer Pakistan (Pvt) Ltd, Lahore |
| Risk Statement: | Consequences of use of Spurious/ Falsified Drugs includes but not limited to followings: -Falsified/Spurious drugs may contain toxic and narcotic/psychotropic ingredients in unacceptable doses which may be life threating. -These are manufactured under unhygienic condition without the proper inspection and approval, which are highly injurious to human health. -Poor-quality medicines compromise the treatment of diseases and may intensified the existing condition. |
| Action Initiated | The Regulatory Field Force has been directed to increase surveillance throughout the supply chain to confiscate the 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 supplier of such products should be provided to the Regulatory field force (DRAP, Provincial Health Departments and States) to ensure the removal of this product. |
| 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 not use this product and shall contact their physician or healthcare provider if they have experienced any problem related to taking or using this drug product 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. |
Notification: Applications for Registration of Multiple Strength and Volume Drugs (Pharmaceutical) on Form-5F
Drug Regulatory Authority of Pakistan, on the recommendations of the Registration Board has issued guidance for submitting applications for registration of pharmaceutical product with multiple strengths and different fill volumes. The Notification issued in this regard is as under:-
Notification: Application on Form-5F (CTD) for Extension in the Contract Manufacturing Permission of Drugs.
Drug Regulatory Authority of Pakistan on the recommendation of the Registration Board has revised the data requirement for submitting applications for extension in the contract manufacturing permission of the drugs for those product where CTD dossiers has already been submitted and approved by the Registration Board. The Notification issued in this regard is as under:-