The Drug Registration Board convened its 317th meeting on 16th- 17th May, 2022 in the Committee Room of Drug Regulatory Authority of Pakistan, G-9/4, Islamabad. The minutes of meeting are hereby circulated for information of all stakeholders.
Month: June 2022
Minutes of 286th Meeting of Central Licensing Board held on 11th May 2022
DRAP notified Pharmacovigilance Risk Assessment Expert Committee (PRAEC) under the Pharmacovigilance Rules, 2022
Proposed amendments in the Rules : DRAP invites comments from stakeholders and public on the draft amendments in the Drugs (Licensing, Registering and Advertising) Rules, 1976;
The Drug Regulatory Authority of Pakistan (DRAP) has issued a proposal to amend the current version of the Drugs (Licensing, Registering and Advertising) Rules, 1976. The proposed amendments relates to the minimum area requirement for establishment of a pharmaceutical manufacturing units and adoption of Pharmaceutical Inspection Cooperation / Scheme (PIC/S) Guidelines for Good Manufacturing Practices (GMP), in order to further align more closely with the international standards and best practices, as practiced by many other regulatory authorities around the world.
The DRAP proposes to do so primarily by incorporating the provisos to enable manufactures and regulators to follow principles set by the Pharmaceutical Inspection Cooperation / Scheme (PIC/S) to maintain the quality standards at an acceptable level. PIC/s guidelines provide comprehensive guidance for both industry and regulators on various aspects of Good Manufacturing Practices.
DRAP has the mandate to issue guidelines and to monitor enforcement of licensing of manufacture of therapeutic goods and to implement internationally recognized standards under Section 7(c)(i) & (ix) of the DRAP Act, 2012. Control of environmental conditions for pharmaceutical industry is essential to manufacture quality products. and implementation of Good Manufacturing Practices (GMP) guidelines is critical to ensure the proper design, monitoring, and control of the manufacturing processes and facilities.
Stakeholders can submit their comments within 14 (fourteen) days of the publication of this Notification in the official Gazette of Pakistan using prescribed format, via email to aamar.latif∂dra.gov.pk, or can be posted at mailing address, Deputy Director, Division of Legal Affairs, Drug Regulatory Authority of Pakistan, 1st floor, TF Complex, 7th Mauve Area, G-9/4, Islamabad. Further information on comments submission can be accessed on this link.
SRO 778 (I)/2022 dated 10th June, 2022
National Pharmacovigilance Centre, DRAP intends to seek comments of Stakeholders on “Draft Guidelines on High Alert Medication Management”
DRAP envisions advancement in the healthcare system of Pakistan by working at par with international standards, and best regulatory practices through effective management and regulation of therapeutic goods. The National Pharmacovigilance Centre (NPC) at DRAP prepares and issues guidelines from time to time for different activities relating to Pharmacovigilance and promotion of pharmacy services to cater to the needs of different stakeholders.
NPC, DRAP has recently published a revised list of High Alert Medication on the official website and is currently developing a Guidelines on High Alert Medication Management.
This document is intended for the guidance and support of hospitals and healthcare professionals (HCP) for safe prescribing, dispensing, administration and monitoring of high alert medication (HAM) and applies to all healthcare settings and healthcare professionals involved in handling and usage of HAM. The outlined and recommended strategies are intended to educate HCPs, prevent risks associated with HAM, implement safety checks and encourage reporting of Adverse Events /Adverse Drug Reactions.
This draft guideline is uploaded on the official website of DRAP dated 16th June, 2022, for seeking comments and suggestions from stakeholders on the draft document. Stakeholders can submit their comments and suggestions within 15 days of uploading this document using prescribed format, (further information on comments submission can be accessed on this link). Comments and suggestions can be forwarded via email to npc∂dra.gov.pk, copying at aqsa.hashmi∂dra.gov.pk , or can be posted at mailing address, Director, Division of Pharmacy Services, Drug Regulatory Authority of Pakistan, 3rd floor, TF Complex, 7th Mauve Area, G-9/4, Islamabad.
Suspension of Drug Registration: Famotidine Liquid Suspension in the Strengths of 10mg/5mL and 40mg/mL
Drug Safety Alert
Update from Registration Board of Drugs
| Date: | 15th of June 2022. |
| Target Audience: | • Provincial Drugs Control Units and Provincial Pharmacovigilance Centres. • Manufacturer/registration holders of Famotidine 10mg/5ml and 40mg/5ml Liquid Suspension; • Healthcare Professionals; and • Patients, consumers or caregivers. |
| Problem or Issue: | The Registration Board of Drug Regulatory Authority of Pakistan (DRAP) in its 317th meeting held on 16-17th of May 2022 in light of discussions, benefit-risk analysis and public health impact suspended all drug registrations of Famotidine 10mg/5ml and 40mg/5ml Liquid Suspension under Section 7(11)(d) read with Section 42 of the Drugs Act, 1976 in the larger public interest, with immediate effect as these products were neither approved by any Reference Regulatory Authorities nor efficacy data is available with any registration holder. These products will stay suspended for a period of one (01) year; or till the time its efficacy is well established through indigenous clinical trials in accordance with the Bio Study Rules, 2017; or if it is approved by the Reference Regulatory Authorities, whichever is earlier. Likewise, Registration holders were directed to suspend the manufacturing and import of these drug products immediately and to withdraw available stocks from the market in the larger public interest. The decision applies to all registration holders of Famotidine 10mg/5ml and 40mg/5ml Liquid Suspension except those who have obtained interim relief from the Hon’ble Lahore High Court, Lahore or who have registration of Famotidine 40mg/5ml Dry Suspension. |
| Background: | The Registration Board in its 250th meeting held on 10th July, 2015 had decided that Famotidine 10mg/5ml Suspension is not registered in any reference regulatory agencies and the internationally available formulation is a dry powder for suspension in the strength of 40 mg/ 5 ml and asked applicants to revise their formulation as per innovator (new registration application With complete fee) within six months if the manufacturing facility is approved by Central Licensing Board. However, DRAP’s Authority in its 70th meeting held on 05th Sep 2019 decided that “For formulations containing “drugs” which were previously registered by the Registration Board and have proof of availability and prescription of last 10 years but are not available in the Reference Regulatory Authorities shall continue to be considered/ registered as drugs until and unless withdrawn on Safety, Efficacy and Quality reasons”. Accordingly, Registration Board in its 296th meeting held 8th-10th Sep, 2020 decided that “since all such formulations which are not approved by the Reference Regulatory Authorities; the safety and efficacy profile cannot be established in the absence of a well-established system for reporting of adverse events, so a reference shall be forwarded to DRAP’s Authority with the request to review the decision taken in its 70th meeting held on 05-09-2019. In this regard, PE&R Division shall prepare a comprehensive document/agenda for consideration of Authority”. It was also decided that “For all those formulations which are registered/ applied in strengths, different from those approved by reference regulatory authorities, the registration holders/ applicants shall standardize their formulations (by submitting registration application with requisite fee, provided that the firm did not have same registration) in line with those approved by reference regulatory authorities. Meanwhile, the policy of reliance on reference regulatory authorities was approved by the Authority in its 73rd meeting held on 06-11-2019. Subsequently, the registration board in its 313th meetings, dated 16-18th Nov, 2021 decided to issue show-cause notices to registration holders/ manufacturers under Section 7 (11)(d) of the Drug Act, 1976 and opportunity of personal hearings. The decision of the Registration Board was endorsed by Authority in its 128th meeting of Authority held on 14th Dec 2021 and decided that “Drug formulations/strengths which were previously registered by the Registration Board but are not available in any Reference Regulatory Authorities, shall be reviewed and disposed-off keeping in view of safety and efficacy evidence/data in the Reference Regulatory Authorities”. In line with the decision taken by the Board in its 313th meeting, show-cause/personal hearing notices were issued to registration holders for hearing before the Registration Board on 1st February, 2022 at 2:30 pm. However, due to prevailing cases of COVID-19, personal hearings were postponed. Many of registration holders of Famotidine 10mg/5ml and 40mg/5ml Liquid Suspension challenged the Show Cause Notices issued for cancellation of their drugs stating violation of the decision taken in the 70th Meeting of the DRAP Authority held on the 05-09-2019. However, the decision taken in the 70th Meeting of the DRAP Authority has been reviewed in the 128th Meeting held on 14-12-2021, whereby the Registration Board was allowed to review and dispose of the registration of drugs keeping in view their safety and efficacy. The Registration Board in its 315th meeting held on 1st Feb 2022 noted the information and advised to provide the opportunity of a personal hearing in the next meeting of the Registration Board. Lastly, the Registration Board in its 317 meetings held on 16-17th May, 2022 gave an opportunity of a personal hearing and after reviewing the discussion of personal hearing, risk-benefit analysis and public health impact suspended all drug registrations of Famotidine 10mg/5ml and 40mg/5ml Liquid Suspension under Section 7(11)(d) read with Section 42 of the Drugs Act, 1976 in the larger public interest, with immediate effect, for 1 year or earlier subject to some conditions, as Famotidine Suspensions in strength/ dosage form other than 40mg/5ml Powder for Oral Suspension are neither approved by any Reference Regulatory Authorities nor efficacy data is available with any registration holder. |
| Therapeutic Goods Affected: | Famotidine 10mg/5ml & 40mg/5ml Liquid Suspension (not Famotidine 40mg/5ml Dry Suspension) Famotidine is used in gastric and duodenal ulcers, Zollinger-Ellison Syndrom, Gastro-Eesophgeal disease, heart burns, and indigestion. Whereas, in children, it is used for peptic ulcers and gastro oesophagal disease. |
| Advice for healthcare professionals: | Healthcare professionals are informed that the Registration Board of Drug Regulatory Authority of Pakistan (DRAP) in its 317th meeting held on 16-17th of May 2022 in light of discussions, benefit-risk analysis and public health impact suspended all drug registrations of Famotidine 10mg/5ml and 40mg/5ml Liquid Suspensions under Section 7(11)(d) read with Section 42 of the Drugs Act, 1976 in the larger public interest, with immediate effect as these products were neither approved by any Reference Regulatory Authorities nor efficacy data is available with any registration holder. Healthcare professionals may stop prescribing Famotidine 10mg/5ml and 40mg/5ml Liquid Suspension to patients. Famotidine 40mg/5ml Dry Suspension or other treatment options available in the market may be prescribed. |
| Advice for patients: | Patients and consumers are informed that the Registration Board of Drug Regulatory Authority of Pakistan (DRAP) in its 317th meeting held on 16-17th of May 2022 in light of discussions, benefit-risk analysis and public health impact suspended all drug registrations of Famotidine 10mg/5ml and 40mg/5ml Liquid Suspension under Section 7(11)(d) read with Section 42 of the Drugs Act, 1976, therefore, patients who are using the above-mentioned Famotidine suspensions may consult/speak with their healthcare professionals to shift/change their treatment to Famotidine 40mg/5ml Dry Suspension or other treatment options available in the market. |
| Guidelines for reporting Adverse Drug Reactions (ADRs): | Both healthcare professionals and patients are requested to report any adverse events they have experienced with their previous treatment with Famotidine 10mg/5ml and 40mg/5ml Liquid Suspension or even with Famotidine 40mg/5ml Dry Suspension to the National Pharmacovigilance Centre, Drug Regulatory Authority of Pakistan through DRAP Med Vigilance E-reporting system or at npc∂dra.gov.pk. Similarly, adverse events can also be reported through Med Safety Mobile Application that is available for download from the App store (For iOS devices) and Google Play (For Android devices). |
| References: | Partial Minutes of 317th Meeting of Registration Board. |
Suspension of Drug Registration: Tablets of Diclofenac Potassium in Strengths of 75mg and 100mg
Drug Safety Alert
Update from Registration Board of Drugs
| Date: | 15th of June 2022. |
| Target Audience: | • Provincial Drugs Control Units and Provincial Pharmacovigilance Centres. • Manufacturers and Importers of Diclofenac Potassium 75mg and 100mg; • Healthcare Professionals; and • Patients, consumers or caregivers. |
| Problem or Issue: | The Registration Board of Drug Regulatory Authority of Pakistan (DRAP) in its 317th meeting held on 16-17th of May 2022 in light of discussions, risk-benefit analysis and public health impact, suspend all drug registrations of Diclofenac Potassium 75mg and 100mg under Section 7 (11) (d) read with Section 42 of the Drugs Act, 1976 due to the reason that these formulations are neither approved by any Reference Regulatory Authority nor any safety and efficacy data regarding these products is available with any registration holder. These formulations will stay suspended for a period of one (01) year; or if safety and efficacy is well established through indigenous clinical trials in accordance with the Bio Study Rules, 2017; or if it is approved by the Reference Regulatory Authorities, whichever is earlier. Likewise, Registration holders were directed to suspend the manufacturing and import of these drug products immediately and to withdraw available stocks from the market in the larger public interest. The decision applies to all registration holders of Diclofenac Potassium 75mg and 100mg except those who have obtained interim relief from the Hon’ble Lahore High Court, Lahore. |
| Background: | The Registration Board in its 258th meeting held on 25th and 26th April, 2016 had decided that Diclofenac Potassium is not registered in any reference country in doses more than 50mg, thus decided to issue show-cause notices to manufacturers of Diclofenac Potassium (75 and 100mg) for de-registration of these products. Subsequently, the registration board in its 288th meeting, dated 14-15th Feb 2019, decided that all registration holders of Diclofenac Potassium 75mg & 100mg shall be called for personal hearings. However, DRAP’s Authority in its 70th meeting heldon 05th Sep 2019 decided that “For formulations containing “drugs” which were previously registered by the Registration Board and have proof of availability and prescription of last 10 years but are not available in the Reference Regulatory Authorities shall continue to be considered/ registered as drugs until and unless withdrawn on Safety, Efficacy and Quality reasons”. Accordingly, Registration Board in its 296th meeting held on 8-10th Sep, 2020 decided that “Since, all such formulations which are not approved by the Reference Regulatory Authorities; the safety and efficacy profile cannot be established in the absence of a well-established system for reporting of adverse events, so a reference shall be forwarded to DRAP’s Authority with the request to review the decision taken in its 70th meeting held on 05-09-2019. In this regard, PE&R Division shall prepare a comprehensive document/agenda for consideration of Authority, keeping in view the practices adopted by RRA for all such formulations.” Meanwhile, the policy of reliance on reference regulatory authorities was approved by the Authority in its 73rd meeting held on 06-11-2019. Subsequently, the registration board in its 313th meetings, dated 16-18th Nov, 2021 decided to issue show causes to registration holders/ manufacturers under Section 7 (11)(d) of the Drug Act, 1976 and opportunity of personal hearings. The decision of the Registration Board was endorsed by Authority in its 128th meeting of Authority held on 14th Dec 2021 and decided that “Drug formulations/strengths which were previously registered by the Registration Board but are not available in any Reference Regulatory Authorities, shall be reviewed and disposed-off keeping in view of safety and efficacy evidence/data in the Reference Regulatory Authorities.” Many of registration holders of Diclofenac Potassium 75mg and 100mg challenged the Show Cause Notices issued for cancellation of their drugs stating violation of the decision taken in 70th Meeting of the DRAP Authority held on the 05-09-2019. However, the decision taken in the 70th Meeting of the DRAP Authority has been reviewed in the 128th Meeting held on 14-12-2021, whereby the Registration Board was allowed to review and dispose of the registration of drugs keeping in view their safety and efficacy. The Registration Board in its 315th meeting held on 1st Feb 2022 noted the information and advised to provide the opportunity of a personal hearing in the next meeting of the Registration Board. Meanwhile, the Pharmaceutical Evaluation and Registration Division of the DRAP reviewed all the available facts and finding along with the product monograph of diclofenac potassium in stringent regulatory authorities which depicts that the daily dose of diclofenac potassium is from 75- to 200mg in divided doses, whereas the maximum strength of available diclofenac potassium tablet is 50mg. The Division also prepared two questions that were communicated for guidance to various RRA’s including USFDA, Health Canada, MHRA UK, Sweden, TGA Australia and BNF. Lastly, the registration board in its meeting 317th meeting dated 16th to 17th May, 2022 after giving personal hearings to registration holders of diclofenac potassium 75-100mg, discussion during the meeting, risk-benefit analysis and public health impact of the Diclofenac Potassium 75mg and 100mg, decided to suspend drug registrations of Diclofenac Potassium 75mg and 100mg under Section 7 (11) (d) read with Section 42 of the Drugs Act, 1976 in the larger public interest for 1 year or earlier subject to some conditions. |
| Therapeutic Goods Affected: | Diclofenac Potassium 75MG and 100MG (Not 50mg or below) Diclofenac potassium is used in divided doses for treatment of pain or primary dysmenorrhea; relief of osteoarthritis, relief of rheumatoid arthritis etc. It is approved by various reference regulatory authorities in 12.5mg, 25mg and 50mg tablet strengths. A daily dose of diclofenac potassium is from 75-200mg in divided doses, whereas the maximum strength of available diclofenac potassium tablet is 50mg. However, in Pakistan, as per the PER Division, it was also approved in the strength of 75 and 100mg. |
| Advice for healthcare professionals: | Healthcare professionals are informed that the Registration Board of Drug Regulatory Authority of Pakistan (DRAP) in its 317th meeting held on 16-17th of May 2022 in light of discussions, risk-benefit analysis and public health impact suspended all drug registrations of Diclofenac Potassium 75mg and 100mg under Section 7 (11) (d) read with Section 42 of the Drugs Act, 1976 due to the reason that these formulations are neither approved by any Reference Regulatory Authority nor any safety and efficacy data regarding these products is available. Healthcare professionals may stop prescribing diclofenac potassium having a strength of 75mg and 100mg to patients. Diclofenac Potassium in the strength of 50mg may be prescribed to the patient instead of Diclofenac Potassium of 75mg and 100mg. |
| Advice for patients: | Patients and consumers are informed that the Registration Board of Drug Regulatory Authority of Pakistan (DRAP) in its 317th meeting held on 16-17th of May 2022 in light of discussions, risk-benefit analysis and public health impact suspended all drug registrations of Diclofenac Potassium 75mg and 100mg, therefore, those patients who are using diclofenac potassium in the aforementioned strengths may consult/ speak with their healthcare professionals to shift/change their treatment to standard strength of 50mg of diclofenac potassium or other treatment options available in the market. |
| Guidelines for reporting Adverse Drug Reactions (ADRs): | Both healthcare professionals and patients are requested to report any adverse events they have experienced with Diclofenac Potassium (75mg, 100mg or even 50mg & below) to the National Pharmacovigilance Centre, Drug Regulatory Authority of Pakistan through DRAP Med Vigilance E-reporting system or at npc∂dra.gov.pk Similarly, adverse events can also be reported through Med Safety Mobile Application that is available for download from the App store (For iOS devices) and Google Play (For Android devices). |
| References: | Partial Minutes of 317th Meeting of Registration Board. |
Recall Alert: Drug Product; Water for Injection (Batch #M21421) by M/s. Vision Pharmaceuticals (Pvt.) Ltd., Islamabad.
Recall Alert
| DRAP Alert No | N0 I/S/06-22-16 |
| Action Date | 14th June, 2022 |
| Target Audience | 1. Pharmacists and Chemists at Distribution, Pharmacies and Medical Stores 2. Healthcare Professionals- Physicians, Pharmacists, and Nurses at hospitals, clinics and healthcare institutions 3. General Public |
| Product(s) Affected | Water for Injection, Company: M/s. Vision Pharmaceuticals (Pvt.) Ltd., Islamabad Drug Registration No. 081230 Batch No. M21421, Manufacturing Date: December-2021, Expiry Date: November-2024 |
| Problem Statement | The Central Drug Laboratory Karachi has analyzed the Water for injection bearing Batch No. M21421 4A20B27 and declared it as Substandard. The company has been directed to recall the affected batch of product from the market including pharmacies as well as the distribution setups operating in the country. |
| Action to be taken | All Pharmacists and chemists working at distributions and Pharmacies are required to immediately return the stock of above mentioned batch of the product(s) to the firm. Distributors and pharmacies are advised to be vigilant and report any suspected batch of the product(s) in the supply chain to the DRAP 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) have also increased surveillance in the market to ensure the effective recall of defective product. |
| Advice for Healthcare Professionals | DRAP requests increased vigilance within the supply chains of healthcare institutions and hospital pharmacies. If anyone has used this counterfeit product, or if anyone suffers from an adverse reaction/event after having used this product, it is advised to seek immediate medical attention from a qualified healthcare professional, and to report the incident to National Pharmacovigilance Centre, DRAP using this link. All drug products must be obtained from authorized licensed sources. Their authenticity and condition should be carefully checked. Seek advice from a healthcare professional in case of any doubt. |
Decisions of 47th meeting of Medical Device Board Meeting; Deficiency letter
The Medical Device Board (MDB) of Drug Regulatory Authority of Pakistan in its 47th meeting has deferred the 271 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, in the below attachment.
DRAP Organizes one-day Training Workshop of its officers on Key Performance Indicators (KPIs) of various Regulatory Functions
DRAP, in collaboration with Health Partner Organization United States Pharmacopeia, Promoting Quality of Medicines Plus, organizes a training workshop for regulatory staff to strengthen implementation of Strategic plan through regulatory functions KPI based performance measurement system.
