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Rapid Alert: Unregistered and Falsified RBST Injection Confiscated

Asad Ullah Recall Alerts
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Rapid Alert

DRAP Alert NoNo I/S/10-24-40
Action Date24th October 2024
Target Audience·         National Regulatory Field Force.
·         Distribution, Pharmacies and Medical Stores
·         Healthcare Professionals – Veterinarians, Chemists
·         Farmers/Consumers 
Problem StatementFederal Inspector of Drugs, Karachi alongwith FIA conducted a raid at premises of M/s Bismillah Medical Store, District Malir, Karachi and the following unregistered products/Stock was seized from the premises as per Form-2 under Section 18(1) of Drugs Act, 1976.
Product nameBatch/Lot No.Manufacturer Name
(as per label) 		Mfg. dateExp. date
Boostin Injection
(Recombinant Bovine Somatropin)

Reg. No. Nil		BSS22100M/s LG Chem, Korea.   30-05-202329-05-2026
Threat to Public HealthRecombinant Bovine Somatotropin hormone is banned in the country due to serious side effects on health of animals and impact on those consuming milk and meat of such animals. The product is also banned in Europe, Canada, Australia etc.
Action InitiatedThe Regulatory Field Force has been directed to increase the surveillance activities in market to confiscate the product. All pharmacists and chemist working at distributions and pharmacies are once again directed to not procure / supply unregistered drugs. The stocks of any suspected should be quarantined and supplier’s information should be provided to the Regulatory field force in order to ensure the removal of this product. Regulatory action will be taken against the persons involved in manufacturing/ storage /distribution/sale and use of any unregistered product
Advice for VeterinarianDRAP requests increased vigilance within the supply chains of institutions/pharmacies/healthcare facilities likely to be affected by this product. Further information of reporting problems to DRAP is available on this link
Advice for Farmers/ConsumerFarmers/Consumers should not use this product. They shall contact their physician or healthcare provider(s) if the animal experienced any problem that may be related to using this product.

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; Recall of 04 Substandard Batches from the Market

Asad Ullah Recall Alerts

Recall Alert

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DRAP Alert NoNo I/S/10-24-39
Action Date25th October 2024.
Target Audience– National Regulatory Field Force.
– Pharmacists and Chemists at Distribution, Pharmacies and Medical Stores
– Healthcare Professionals- Physicians, Pharmacists, and Nurses at hospitals and clinics
– General Public
Problem / Issue The Directorate of Drugs Control (DDC) Punjab has informed DRAP that samples of the following products have been identified as contaminated with DEG/EG impurities based on analysis conducted by the Drug Testing Laboratories Punjab.
The Details of affected product batches are tabulated below:-

Therapeutic Good(s) Affected: –

S#Product NameCompositionBatch No.Manufactured byTest Results  
01Zonid Suspension 120ml Reg# 022579Metronidazole 200mg/5mlZ266M/s. Bloom Pharmaceuticals (Pvt.) Ltd., Hattar.Contains Ethylene Glycol Above Permissible limits  
02Hedazol Suspension 60ml Reg# 046146Metronidazole 200mg/5ml7037M/s. Heal Pharmaceuticals (Pvt.) Ltd., Peshawar.-do-
03Vometol Suspension 120ml Reg# 094719Domperidone 5mg/5ml1347M/s. Roryan Pharmceutical Industries (Pvt.) Ltd., Peshawar.-do-
04Tritadin Syrup 60ml Reg# 096413Loratadine 1mg/ml005M/s. Trillium Pharmaceuticals (Pvt.) Ltd., Faisalabad.-do-
Action Initiated–The manufacturers have been directed to immediately recall the defective batches of their products from the market. All pharmacists and chemists working at distributions and pharmacies should immediately check their stocks and stop supplying these batches of the abovementioned product. The remaining stock 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, by phone at +92 51 9255969, or by Email at gsms∂dra.gov.pk.

-The regulatory field force of all federating units (DRAP, Provincial Health Departments, and States) has also increased market surveillance to ensure the effective recall of defective product(s).
Advice for Healthcare ProfessionalsDRAP 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 products 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.

    Provincial Workshop – Implementation of IDPs for Cross-Cutting Regulatory Functions to Strengthen National Regulatory System of Pakistan held on 21-22 October, 2024 at Lahore

    Asad Ullah Events
    Provincial Workshop – Implementation of IDPs for Cross-Cutting Regulatory Functions to Strengthen National Regulatory System of Pakistan held on 21-22 October, 2024 at Lahore

    Lahore – October 21-22, 2024: The Drug Regulatory Authority of Pakistan (DRAP), in collaboration with the World Health Organization (WHO) Pakistan, hosted a provincial workshop on the implementation of Institutional Developmental Plans (IDPs) aimed at strengthening the National Regulatory System of Pakistan based on WHO recommendations.

    Mr. Nadeem Mahbub, Federal Secretary of the Ministry of National Health Services, Regulation & Coordination, and Ms. Ellen Mpangananji Thom, Officer Incharge, WHO Office in Pakistan participated in this workshop.

    Mr. Asim Rauf, CEO DRAP briefed the participants on the roadmap for strengthening the regulatory system of Pakistan.

    This interprovincial coordination workshop was attended by key officials, including the Director General of Provincial Drug Control Administrations, the Chief Inspector of Drugs from all federating units, Directors of National Quality Control Laboratories (CDL and DTLs), officers from provincial regulatory institutions, and teams from DRAP working on the implementation of the Institutional Developmental Plans (IDPs) based on the WHO Global Benchmarking Tool for National Regulatory Authorities.

    This 02-day workshop provided the opportunities to strengthen the regulatory framework in all federating units by developing collaborative working procedures in various areas including pharmacovigilance, Market Surveillance, Licensing, Inspection, Laboratory Testing and Quality Management System.

    Minutes of 340th meeting of Registration Board held on 1st – 2nd October, 2024

    Asad Ullah Meeting Minutes, Registration Board

    The Drug Registration Board convened 340th meeting on October 1 – 2, 2024, in the Committee Room of the Drug Regulatory Authority of Pakistan, Prime Minister National Health Complex, Park Road, Islamabad. The minutes of the meeting are hereby circulated for the information of all stakeholders.

    Minutes of 340th meeting of Registration Board (1)Download

    Submission of Replies against Deferred Form-5/5A Applications of Human Drugs

    Ijaz Mustafa General

    In its 339th Meeting, convened from August 6-8, 2024, the Registration Board has issued a directive that all applicants should submit clarifications or replies for their deferred Form-5/5A applications by December 31, 2024. It is imperative to note that any submissions received after this deadline will not be considered, and will be be classified as disposed of, necessitating the submission of a new application on Form 5F.

    This initiative is designed to enhance the efficiency of the registration process and ensure strict adherence to current regulatory standards. This directive is in accordance with the implementation of the Form 5F (CTD) format for drug registration, effective March 31, 2019, which requires that all applications be evaluated based on the updated Form 5F data guidelines.

    submission-of-replyDownload

    Caution Regarding Fake Emails Impersonating DRAP Officials

    Yasir Mahmood General ,

    It has come to our attention that some individuals are receiving fraudulent emails impersonating officials of the Drug Regulatory Authority of Pakistan (DRAP). Please be advised that all official DRAP correspondence comes from email addresses ending with @dra.gov.pk.

    Stakeholders and the public are urged to remain vigilant and verify the authenticity of any communication. If in doubt, kindly contact DRAP through official channels.

    Thank you for your attention to this matter.

    Drug Regulatory Authority of Pakistan