DRAP issued Guidelines for Public Health Programs (PHPs) to promote Pharmacovigilance activities and enhancing collaboration with National Pharmacovigilance Centre, DRAP.

Drug Regulatory Authority of Pakistan (DRAP) aims at providing a holistic system of Pharmacovigilance in the country. Public Health Programs are key stakeholders involved in the reporting, assessment and risk communication of various un-wanted effects arising after the use of drugs, vaccines and other therapeutic goods. Reporting of Adverse Events associated with the use of therapeutic goods exclusively being used by PHPs is essential to a pharmacovigilance system.

The key objectives of pharmacovigilance activities in public health programs are:-

  1. To improve public health and safety in relation to the use of therapeutic goods in PHPs;
  2. To detect problems related to the use of therapeutic goods and associated risk communication in a timely manner
  3. To encourage the safe, rational and more effective use of therapeutic goods.

This guideline will assist the Public Health Programs (PHPs) for enhancement of pharmacovigilance activities, and provide a guidance on communication channels among PHPs and Pharmacovigilance Centres for collaborative working to synergize activities within the National Pharmacovigilance system of Pakistan.

DRAP published the draft of this guidelines on its website on 23rd April, 2022 inviting the comments of stakeholders on the draft. After through consultation and careful consideration, fist edition of the guidelines on the pharmacovigilance activities in the public health programs are finalized. Nevertheless, anyone can still furnish his/her comments on the guidelines using our comments submissions methods for consideration in the future editions of the document.

Please click to view the document, GUIDELINES ON PHARMACOVIGILANCE FOR PUBLIC HEALTH PROGRAMMES

Decision 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 Restane Inhalational Solution Identified and Confiscated

Rapid Alert

DRAP Alert NoNoI/S/12-22-40
Action Date1st December 2022
Target Audience• Regulatory Field Force
• Healthcare Professionals- Anesthesiologist, Surgeons, Pharmacists, and Nurses
• Pharmacists and Chemists at Distribution, Institutional suppliers
• General Public
Problem StatementDuring the surveillance activities in different Hospitals of Punjab, Regulatory Field Force had drawn samples of this product for test/analysis. The Provincial Drugs Testing Laboratory, Faisalabad has declared the samples as spurious and adulterated.
The product detail is as under: –

Therapeutic Good Affected:-

SrProduct NameCompositionBatch #Manufactured by (as stated on label)Marketed by
(as label)
1
RESTANE Inhalation Solution 100ml
IsofluraneN0111B24
N0892A10

M/s Piramal Critical Care, Inc. Schelden Circle Bethlehem PA 18017, USA
Allied Distributors 103-K, Block-2 P.E.C.H.S, Karachi Pakistan.
Action InitiatedThe Regulatory Field Force has been directed to increase the surveillance activities at Health Facilities (Hospitals) in addition to markets and confiscate these batches of product. All Pharmacists and chemists working at Hospital distributions and Pharmacies should immediately check the stock and stop supplying these batches of 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 this products.
Advice for Healthcare Professionals-DRAP requests increased vigilance at hospitals and within the supply chains of institutions/pharmacies/healthcare facilities likely to be affected by this product. Anesthesiologists and the supporting staff involved in surgical procedures where anesthetics are involved should remain vigilant about the suspected batches of said 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-If you are intending to plan any surgeries where anesthetic procedures are involved, or you are an attendant to a such patient, you are requested to cross check the originality of this product with your healthcare professionals (e.g. physicians, surgeons, gynecologist, anesthesiologist, etc.) to ensure the originality of product.

Rapid Alert: Drug Product; Falsified Tablin 300mg Capsule identified in the market

Rapid Alert

Suspected Falsified Product

DRAP Alert NoNoI/S/10-22-36
Action Date24th November 2022
Target Audience1. 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 StatementDuring 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:-

SrProduct NameCompositionBatch #Manufactured by (as stated on label)
1TABLIN 300mg Capsule
Pregabalin 300mgBatch No. 699M/s Theramed Pharmaceuticals (Pvt) Ltd, Lahore.
Action InitiatedThe 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 NoNoI/S/10-22-35
Action Date30th November 2022
Target Audience1. 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 NoNoII/S/10-22-33
Action Date23rd November 2022
Target Audience1. 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.

Drug Safety Alert: Risk of Kidney Injury and Death due to Hydroxyethyl-Starch Solutions for Infusion.

Drug Safety Alert

Update from Pharmacovigilance Risk Assessment Expert Committee (PRAEC) of Pakistan

Date:29th of November, 2022
Target Audience:• Manufacturers and importers of hydroxyethyl-starch solutions for infusion.
• Healthcare Professionals; and
• Patients, consumers or caregivers.
Background:The Pharmacovigilance Risk Assessment Committee (PRAC) of the European Medicine Agency (EMA) on 11th February, 2022 recommended that the market authorization of hydroxyethyl-starch (HES) solutions for infusion should be suspended across the European Union. These solutions for infusion products are indicated as an addition to other treatments for plasma volume replacement following acute (sudden) blood loss.
The safety of these solutions for infusion was reviewed in 2013, and a number of restrictions and measures to minimise the risk of kidney injury and death in certain patients (those critically ill, with burn injuries or with sepsis, a bacterial infection in the blood) were put in place at that time.

Likewise, as a result of a third review conducted in 2018, the use of HES solutions for infusion was further restricted to only accredited hospitals, and healthcare professionals prescribing or administering the medicines had to be trained in their appropriate use. In addition, further warnings were introduced to remind healthcare professionals that these medicines must not be used in patients with sepsis or kidney impairment or in other vulnerable patients such as the critically ill in order to ensure these solutions for infusion were not used in patients who were at increased risk of harm. Market authorization holders of HES solutions for infusion were also requested to conduct a drug utilization study to check that the restrictions were adhered to in clinical practice.

The PRAC of the EMA accordingly reviewed the results of the study, which show that HES solutions for infusion are still being used outside the recommendations included in the product information and concluded that the further restrictions introduced in 2018 have not sufficiently ensured that the medicines are used safely and that HES solutions were continually used in certain groups of patients in whom serious harm has been demonstrated. In view of the serious risks that certain patient populations were still exposed to, the PRAC recommended the suspension of the marketing authorizations for HES solutions for infusion in the European Union. Accordingly, the European Commission on 24th May, 2022 issued a legal decision confirming the suspension of the market authorization of HES solution for infusion.
Therapeutic Good(s) Affected:Name: Hydroxyethyl-Starch solutions for infusion.

These solutions for infusion products are indicated as an addition to other treatments for plasma volume replacement following acute (sudden) blood loss.
Action in PakistanAccordingly, the case of the risk of kidney injury and death due to hydroxyethyl-starch solutions for infusion was discussed in the 1st meeting of the Pharmacovigilance Risk Assessment Expert Committee (PRAEC) of the National Pharmacovigilance Centre (NPC), Division of Pharmacy Services, Drug Regulatory Authority of Pakistan (DRAP). The PRAEC-DRAP after detailed deliberation and discussion and as per Rule 10 (1) (h) (v) of Pharmacovigilance Rules, 2022 (reliance mechanism) decided to recommend to the Registration Board of the DRAP to suspend the registration of Hydroxyethyl-Starch (HES) solutions in Pakistan subject to the availability of alternative treatment options.
Advice for healthcare professionals:Healthcare professionals are informed that the National Pharmacovigilance Centre, DRAP is working with the Registration Board and manufacturers/importers of hydroxyethyl-starch solutions for infusion to suspend the registration of these solutions in Pakistan. Therefore, healthcare professionals are reminded that there are alternative solutions for infusion available in the Pakistani market for the treatment of plasma volume replacement following acute (sudden) blood loss and the same must be considered as the treatment in these conditions.
Advice for patients:Patients are informed that the National Pharmacovigilance Centre, DRAP is working with the Registration Board and manufacturers/importers of hydroxyethyl-starch solutions for infusion to suspend the registration of these solutions in Pakistan. Therefore, talk with your doctor before initiation of treatment with those solutions as alternative treatment options are available in the market.
Guidelines for reporting Adverse Drug Reactions (ADRs):Both healthcare professionals and patients are requested to report any suspected Adverse Drug Reaction (ADR) to National Pharmacovigilance Centre, Drug Regulatory Authority of Pakistan through Med Vigilance E-Reporting system available on DRAP website.
Similarly, ADRs can also be reported through MedSafety App that is available for download from App store (for iOS devices) and Google Play (for Android devices).
References:Minutes of 1st meeting of Pharmacovigilance Risk Assessment Expert Committee.
European Medicine Agency update regarding hydroxyethyl-starch solutions for infusion recommended for suspension from the market.

Drug Safety Alert: Increased Risk of Cardiovascular Events with Co-administration and Interaction Between Hydroxychloroquine or Chloroquine, and Macrolide Antibiotics

Drug Safety Alert

Update from Pharmacovigilance Risk Assessment Expert Committee (PRAEC) of Pakistan

Date:29th of November, 2022
Target Audience:• Manufacturers and importers of hydroxychloroquine or chloroquine, and systemic macrolide antibiotics;
• Healthcare professionals; and
• Patients, consumers or caregivers.
Background:The MHRA on 15th February, 2022 announced that the product information for hydroxychloroquine, chloroquine and macrolide antibiotics (azithromycin, erythromycin or clarithromycin) will be revised to include the increased risk of cardiovascular events and cardiovascular mortality if hydroxychloroquine or chloroquine is taken with a macrolide-antibiotic. A review was conducted by the Pharmacovigilance Expert Advisory Group of the Commission on Human Medicines following the results of a retrospective observational study which shows that co-administration of azithromycin with hydroxychloroquine in patients with rheumatoid arthritis is associated with an increased risk of cardiovascular events (including angina or chest pain and heart failure) and cardiovascular mortality.

It was recommended in the review that the product information for hydroxychloroquine and systemic azithromycin medicines should be amended to include new warnings and advice on these risks. Owing to the similar safety profiles, the risks with concurrent use of hydroxychloroquine and azithromycin were considered to apply to the concurrent use of hydroxychloroquine and other systemic macrolide antibiotics (clarithromycin or erythromycin) and to the use of chloroquine with systemic macrolide antibiotics. Therefore, the review recommended that similar warnings should also be added to the product information for chloroquine and for systemic clarithromycin or erythromycin. However, these warnings were not being introduced for topical macrolide products (which are indicated for conjunctivitis or acne).

The MHRA also reminded the healthcare professionals that the product information for hydroxychloroquine and chloroquine already contains warnings about cases of cardiomyopathy resulting in cardiac failure, in some cases with fatal outcomes. It was also informed that evidence suggests both hydroxychloroquine and chloroquine can prolong the QT interval, especially in overdose or when used in combination with other medicines with the potential to induce cardiac arrhythmias. Likewise, warnings are also in place across the product information for azithromycin, clarithromycin, and erythromycin to use caution in patients with a history of QT interval prolongation or in patients receiving a medicine known to cause QT prolongation. Although the mechanism of the observed effects was not examined in detail by the study, it was proposed that events could have been caused by cumulative effects of hydroxychloroquine and azithromycin on the QT interval, potentiating arrhythmias and cardiac death, or through other additive cardiotoxic effects more generally.
Therapeutic Good(s) Affected:Name of Drugs: (i)Hydroxychloroquine,
(ii) Chloroquine; and
(iii) Systemic macrolide antibiotics (not topical).

Hydroxychloroquine is indicated for the treatment of rheumatoid arthritis, systemic lupus erythematosus, and dermatological conditions aggravated by sunlight. Chloroquine is indicated for malaria prophylaxis or treatment and other indications. Macrolide antibiotics such as erythromycin, clarithromycin and azithromycin are used to manage and treat various bacterial infections like pneumonia, sinusitis, pharyngitis and tonsillitis etc.
Action in PakistanAccordingly, the case of risk of cardiovascular events with co-administration and interaction between hydroxychloroquine or chloroquine, and macrolide antibiotics was discussed in the 1st meeting of the Pharmacovigilance Risk Assessment Expert Committee (PRAEC) of the National Pharmacovigilance Centre (NPC), Division of Pharmacy Services, Drug Regulatory Authority of Pakistan (DRAP). The PRAEC-DRAP after discussion decided as per Rule 10 (1) (h) (iv) and (vi) of Pharmacovigilance Rules, 2022 (reliance mechanism) to update prescribing information (warning and interaction sections) of hydroxychloroquine, chloroquine and macrolide antibiotics (azithromycin, erythromycin or clarithromycin excluding topical macrolides) about the potential interaction of increased risk of cardiovascular events and cardiovascular mortality if hydroxychloroquine or chloroquine is taken with a macrolide-antibiotic.
Advice for healthcare professionals:Healthcare professionals are informed that an observational study has shown that co-administration of azithromycin with hydroxychloroquine in patients with rheumatoid arthritis is associated with an increased risk of cardiovascular events (including angina or chest pain and heart failure) and cardiovascular mortality. Therefore, carefully consider the benefits and risks before prescribing systemic azithromycin or other systemic macrolide antibiotics (erythromycin or clarithromycin) to patients being treated with hydroxychloroquine or chloroquine. If there is a clinical need to prescribe systemic macrolide antibiotics with hydroxychloroquine or chloroquine, use caution in patients with risk factors for cardiac events.
Advice for patients:Patients are informed that some antibiotics (known as macrolides) taken by mouth or given as an injection at the same as hydroxychloroquine or chloroquine have been associated with an increased risk of side effects that affect the heart. Seek urgent medical help if you have any signs of problems with your heart (for example, palpitation, fainting, chest pain, or unexplained breathlessness).
Guidelines for reporting Adverse Drug Reactions (ADRs):Both healthcare professionals and patients are requested to report any suspected Adverse Drug Reaction (ADR) to National Pharmacovigilance Centre, Drug Regulatory Authority of Pakistan through Med Vigilance E-Reporting system available on DRAP website.
Similarly, ADRs can also be reported through MedSafety App that is available for download from App store (for iOS devices) and Google Play (for Android devices).
References:Minutes of 1st meeting of Pharmacovigilance Risk Assessment Expert Committee.
MHRA update regarding Hydroxychloroquine, chloroquine: increased risk of cardiovascular events when used with macrolide antibiotics; reminder of psychiatric reactions.

Drug Safety Alert: Risk of Major Congenital Malformations with Pregabalin

Drug Safety Alert

Update from Pharmacovigilance Risk Assessment Expert Committee (PRAEC) of Pakistan

Date:29th of November, 2022
Target Audience:• Manufacturers and importers of Pregabalin;
• Healthcare Professionals; and
• Patients, consumers or caregivers.
Background:The Medicine and Healthcare Products Regulatory Agency (MHRA) of the United Kingdom on 19th April, 2022 announced that the product information for pregabalin will be updated to include information from a new study which has suggested pregabalin may slightly increase the risk of major congenital malformations if used in pregnancy. The MHRA reviewed the results of a Nordic observational study that consisted of 2,700 pregnancies exposed to pregabalin in the first trimester, alongside a recent European review which had the same conclusions. The study showed a higher prevalence of major congenital malformations in the babies (live or stillborn) exposed to pregabalin in the first trimester of pregnancy compared with those not exposed to pregabalin or any other antiepileptic drug.
The review concluded that pregabalin’s use during the first trimester of pregnancy may cause a slight increase in the risk of major congenital malformations in the unborn child. Furthermore, the Health Products Regulatory Authority (HPRA) of Ireland back in February 2022 also recommended that product information of Pregabalin along with other anti-epileptic drugs be updated based on the evidence of risks associated with in-utero exposure to these drugs. The product information of pregabalin continues to advise that effective contraception should be used during treatment and that use in pregnancy should be avoided unless it is necessary.
Therapeutic Good(s) Affected:Name of Drug: Pregabalin

Pregabalin is indicated for the treatment of peripheral and central neuropathic pain in adults, as adjunctive therapy in adults with partial seizures with or without secondary generalization, and for generalized anxiety disorder in adults.
Action in PakistanAccordingly, the case of the risk of major congenital malformations with Pregabalin was discussed in the 1st meeting of the Pharmacovigilance Risk Assessment Expert Committee (PRAEC) of the National Pharmacovigilance Centre (NPC), Division of Pharmacy Services, Drug Regulatory Authority of Pakistan (DRAP). The PRAEC after detailed deliberation and discussion decided as per Rule 10 (1) (h) (iv) and (vi) of Pharmacovigilance Rules, 2022 (reliance mechanism) to update prescribing information of Pregabalin to include information from a new study that pregabalin may slightly increase the risk of major congenital malformations if used in pregnancy and include advise on effective contraception during treatment in pregnancy.
Advice for healthcare professionals:A new study has demonstrated that pregabalin may slightly increase the risk of major congenital malformations if used in first trimester of pregnancy. Therefore, healthcare professionals should provide counselling to the patients on potential risks to an unborn baby with pregabalin and also on the need to use effective contraception during the treatment. Healthcare professionals are also advised to continue to avoid the use of pregabalin during pregnancy unless clearly necessary and only if the benefit to the patient clearly outweigh the potential risk to the fetus. In case where the benefit outweighs the risk, and it is clearly necessary that pregabalin has to used during the pregnancy, then the lowest effective dose should be used.
Advice for patients:Patients are advised to talk to their doctors before initiation of treatment with Pregabalin and discuss the benefit-risk of the medicine, particularly related to their case. Patients are also advised to talk with their healthcare professionals and use an appropriate contraception method during the treatment with Pregabalin to avoid pregnancy.
Guidelines for reporting Adverse Drug Reactions (ADRs):Both healthcare professionals and patients are requested to report any suspected Adverse Drug Reaction (ADR) to National Pharmacovigilance Centre, Drug Regulatory Authority of Pakistan through Med Vigilance E-Reporting system available on DRAP website.
Similarly, ADRs can also be reported through MedSafety App that is available for download from App store (for iOS devices) and Google Play (for Android devices).
References:Minutes of 1st meeting of Pharmacovigilance Risk Assessment Expert Committee.
Pregabalin (Lyrica): findings of safety study on risks during pregnancy of MHRA.

Rapid Alert: Drug Product; Falsified Xanax 0.5mg Tablets identified in the market

Rapid Alert

Suspected Falsified Product

DRAP Alert NoNoI/S/11-22-37
Action Date28th November 2022
Target Audience1. 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 StatementDuring the market surveillance activities in different areas of Ferozewala District Sheikhupura Punjab, Regulatory Field Force has identified the suspected sample of Xanax 0.5mg Tablets and sent for analysis. The Provincial Drugs Testing Laboratory, has declared the samples as “spurious” based on the analysis report. Details of the falsified product is as under: –

Therapeutic Good(s) Affected:-

SrProduct NameCompositionBatch #Manufactured by (as stated on label)
1Xanax 0.5mg TabletAlprazolam 0.5mgFM7597M/s Pfizer Pakistan Ltd,
B-2, S.I.T.E, Karachi.
Action InitiatedThe 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 this falsified product.
Advice for Healthcare Professionals-DRAP requests increased vigilance within the supply chains of institutions/pharmacies/healthcare facilities likely to be affected by this defective batch of above-mentioned product(s).

-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 reporting problems 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 only 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.

DRAP finalized guidelines on Post Registration Variations of Pharmaceutical and Biological Drug Products

DRAP has finalized its guidelines on procedure and data requirement for post registration variation of pharmaceutical and biological drug products. This document will 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.

These Guidelines will assist both Regulators and Industry on the regulation of variation / changes to the original registrations / Market Authorization of products in terms of procedures and criteria for the appropriate categorization, reporting of changes and subsequent approval as required. Data requirements are listed out to evaluate the impact of the proposed / intended change on the quality, safety and efficacy of the locally manufactured / imported finished pharmaceutical and biological drug products intended for human and veterinary use.

Registration holders of Pharmaceutical / Biological drug products for human and veterinary use are responsible for the safety, efficacy and quality of a finished pharmaceutical / biological drug product that is placed on the market throughout its approved life cycle. These guidelines are intended to provide supportive information for submission of post registration variation application by the registrations / marketing authorization holders of the finished drug products to implement a change. These guidelines will:-

  1. Facilitate the interpretation of the relevant regulations and decisions of Registration Board regarding post registration variations of registered drug products.
  2. Assist applicants to determine type of variation applies in each case with the classification entailing prior approval or intimation to DRAP.
  3. Provide guidance as per applicable SOPs on the conditions and other data requirements to support variance application.

The draft guidelines on data requirements for post registration variation were prepared three years ago and was available on the DRAP’ s website. Stakeholders have submitted their comments on the draft document and accordingly guidelines have been finalized after careful consideration of stakeholder’s comments.

For more information on Regulatory Guidelines published by DRAP, please navigate to Publications tabs on our website.