The Medical Device Board (MDB) of Drug Regulatory Authority of Pakistan in its 53rd 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
Notification: Directions of Registration Board on Reference Product data submissions for conducting Pharmaceutical Equivalence and Comparative Dissolution Profile Studies
Registration Board of DRAP has issued a Guidance document for applicants on submission of application on form 5-F (CTD) for registration of pharmaceutical drug products for human use. Submission of data of pharmaceutical equivalence and Comparative Dissolution Profile (CDP) is required under section 3.2.P.2.2.1 (Formulation Development) of Form 5F (CTD).
In order to further harmonize the submission of such data and ensure data integrity, Registration Board in its 322nd meeting held on 8th & 10th November, 2022 decided as under:
“Firm shall submit the image/picture/snapshot of the innovator/reference/comparator pack against which Pharmaceutical equivalence / Comparative Dissolution Profile studies have been performed and shall reveal the details of brand name, manufacturer, batch# and expiry date of the innovator/reference/comparator product in the section 3.2.P.2.2.1 (Formulation development) of Form 5F.“
Accordingly, above decision of Registration Board is hereby notified and circulated for information and compliance by relevant stakeholders / applicants.
Notification: Directions of Registration Board on the Drug Substance (DS) for Product Development, R&D, and Stability Testing
The Registration Board of Drug Regulatory Authority of Pakistan grants registration to pharmaceutical and biologicals drug products for human and veterinary use. The Drugs (Licensing, Registering and Adverting), Rules, 1976 as amended requires that applicant shall submit applications for human use on Form 5F (CTD), along with submissions of product development, and stability studies, etc under the relevant modules.
For these studies, applicants firms have to procure the Drug Substance / Active Pharmaceutical Ingredient (API) from licensed pharmaceutical manufacturers only having valid Good Manufacturing Practices (GMP) Certifications and/or Drug Manufacturing Licenses form the relevant Regulatory Authority of the Country of origin.
The DRAP Authority, upon the request of Pharmaceutical Manufacturers Association has allowed the manufacturers to acquire Drug Substance / Active Pharmaceutical Ingredient (except controlled Drugs / Substance) from another Drug Manufacturing License (DML) holders which has already imported / procured from an authorized source, only for conducting product development and stability studies to submit application for registration to DRAP on Form 5F. However, all requirements of quality and traceability would be applicable in such cases and will be the responsibility of the manufacture/applicant. Further, the products so manufactured in NO case shall be allowed for commercial sale.
The directions of DRAP Authority and Registration Board is notified accordingly.
SRO 24(I)/2023. Maximum Retail Price (MRP) Fixation of twenty (20) Drugs dated 11th January, 2023
Deficiency Letters from EEC 111th and 112th meetings
Minutes of 323rd meeting of Registration Board held from 6th to 8th December, 2022
The Drug Registration Board convened its 323rd meeting from 6th to 8th December, 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.
Recall Alert: Drug Product; Paracet 1g/100mL Infusion by M/s Standpharm Pakistan Pvt Ltd, Lahore.
Recall Alert
| DRAP Alert No | NoI/S/01-23-43 |
| Action Date | 3rd January 2023 |
| Target Audience | 1. 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 | Paracet 1g/100mL Infusion, Active Ingredient(s): Paracetamol Company: M/s. Standpharm Pakistan Pvt Ltd, Lahore Batch No. CIJI70 Manufacturing Date: 20-09-2022 Expiry Date: 20-09-2024 |
| Problem / Issue | CDL Karachi has declared the batch No. CIJI70 of Paracet 1g/100ml Infusion manufactured by M/s. Standpharm Pakistan (Pvt.) Ltd., Lahore as substandard & adulterated drug product. |
| Action Initiated | -The manufacturing company has been 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. |
Stakeholders Comments are invited on the Draft Guidelines on Good Manufacturing Practices (GMP)
Although the Drugs (Licensing, Registering & Advertising) Rules, 1976 under the Drugs Act, 1976 provides detail requirements on Good Manufacturing Practices (GMP), however, DRAP intends to provide a compiled GMP guidance document stipulating Drug Regulatory Authority of Pakistan’s (DRAP) expectations on GMP from pharmaceutical & biological drugs manufacturers.
This document is intended to provide guidance regarding Good Manufacturing Practices (GMP) for the manufacturing of pharmaceutical & biological drug in accordance with the Drugs (Licensing, Registering & Advertising) Rules, 1976, under the Drugs Act, 1976, the good manufacturing practices aim at ensuring that:
- Products are consistently produced and controlled to the quality standards appropriate to their intended use
- Products are manufactured as required by the marketing authorization or product specification; and
- All those risks have been diminished that are inherent in any pharmaceutical / biological production operation, including contamination, cross contamination and mix ups (confusion) that cannot be detected completely through the testing of final products.
This draft guideline is uploaded on the official website of DRAP dated 5th January, 2023 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 ajmal.sohail∂dra.gov.pk, copying at hasan.afzaal∂dra.gov.pk , or can be posted at mailing address, Additional Director, Quality Assurance & Lab Testing, Drug Regulatory Authority of Pakistan, 3rd floor TF Complex, 7th Mauve Area, G-9/4, Islamabad.
Public Awareness: Availability of Drugs
DRAP works closely with the manufacturing companies to ensure the availability of essential drugs in the market. However, shortages of drugs is a global phenomena and it may occur due to various reasons including the discontinuation of certain products, supply interruptions of materials and manufacturing or quality concerns, etc. DRAP is continuously working to minimize the impact of shortages on general public.
For problem related to the drugs availability, DRAP can be reach out at its Toll- Free Number: 0800-03727, or through email at drugshortages∂dra.gov.pk within working hours from Monday to Friday 08:00 AM to 04:00 PM.
DRAP Newsletter: Volume 02-Quarter 01, 2023
The second volume of quarterly Newsletter of DRAP was issued on 1st January, 2023. This issue highlights the key initiatives and accomplishments of the outgoing year-2022, and welcomes the new year-2023 with reaffirmation to its commitments. DRAP is implementing its Strategic Plan 2022-25 with full zeal and devotion, to protect the public health through effective regulation for availability of safe, quality assured and efficacious therapeutic goods for the people of Pakistan.