Stakeholders are invited to submit their comments on Draft Guidance on Establishment of Pharmaceutical Unit and Post License Changes (2nd edition)

The Drug Regulatory Authority of Pakistan (DRAP) is inviting stakeholder comments on the revised guidance document: “Establishment of Pharmaceutical Unit and Post License Changes”. This document aims to simplify and clarify the regulatory procedures for applicants and firms seeking to acquire, renew, or modify their Drug Manufacturing Licenses (DMLs).

Features of Revised Edition of the Guidance Document

This document provides a clear and concise overview of the entire licensing process, from initial application to post-license modifications.

The guidance document outlines the steps involved in obtaining a DML, including site selection, application forms, fee payment, and inspections. This aims to make the process more efficient and transparent for applicants.

Who Benefits

Applicants: This guideline serves as a valuable resource for pharmaceutical companies, entrepreneurs, and individuals seeking to establish or expand their drug manufacturing operations in Pakistan.

Firms: Existing DML holders can utilize this document to understand their responsibilities and procedures for post-license changes and renewals.

Investors: The streamlined process outlined in the guideline can create a more attractive investment climate for the pharmaceutical industry in Pakistan.

To access the full DRAP guidance document, please Click on “Establishment of Pharmaceutical Unit and Post License Changes”.

The revised guidelines are open for public comments until March 7, 2024. DRAP invites all the relevant stakeholders, such as pharmaceutical companies and civil society organizations, to review the revised guidelines and provide their feedback and suggestions. Stakeholders can submit their comments and suggestions using prescribed format (click here to visit how to submit comments) via email to dir.licdra.gov.pk or can be posted at mailing address, Director, Division of Drug Licensing, Drug Regulatory Authority of Pakistan, PM health Complex, Park Road, Islamabad.

DRAP appreciates the cooperation and contribution of all the stakeholders in the development and improvement of the guidelines on conduct of clinical trials in Pakistan. DRAP hopes that the revised guidelines will facilitate and promote the conduct of high-quality, ethical, and reliable clinical trials in Pakistan, and ultimately benefit the public health and well-being of the people of Pakistan.

DRAP invites Comments on Draft Guideline for Storage and Destruction of Substandard-Falsified (SF )and recalled Therapeutic Goods

The Drug Regulatory Authority of Pakistan (DRAP) has drafted a guideline on the storage and destruction of recalled therapeutic goods, which are medicines, medical devices, and health products that do not meet the quality standards or are deliberately misrepresented. The guideline aims to provide a framework for the safe and effective management of such goods, from their identification and reporting to their disposal and documentation.

The draft guideline covers the following aspects:

  • The roles and responsibilities of different stakeholders, such as manufacturers, importers, distributors, health care providers, and regulators, in handling substandard and falsified as well as recalled therapeutic goods.
  • The criteria for selecting suitable storage facilities and methods for defective therapeutic goods.
  • The methods for destroying in an environmentally sound manner.
  • The records and reports that need to be maintained and submitted.

The draft guideline is available on the DRAP website on 27th October, 2023 for public consultation. DRAP invites comments and feedback from all stakeholders, including the pharmaceutical industry, health professionals, civil society organizations, and the general public. Stakeholders can submit their comments and suggestions within 15 days of uploading this document using prescribed format. For further guidelines on how to submit comments visit DRAP website or click here. Comments and suggestions can be forwarded via email to ajmal.sohaildra.gov.pk, copying at sanaullah.babardra.gov.pk, or can be posted at mailing address, Director, Quality Assurance & Lab Testing, Drug Regulatory Authority of Pakistan, 3rd floor TF Complex, 7th Mauve Area, G-9/4, Islamabad.

DRAP appreciates the cooperation and participation of all stakeholders in ensuring the quality, safety, and efficacy of therapeutic goods in Pakistan.

Training on Pakistan Single Window for DRAP Module

Pakistan Single Window-PSW is working on the automation of trade-related business processes of the Drug Regulatory Authority of Pakistan (DRAP). The existing business processes of issuance of License, Permits, Certificates and Others (LPCOs) by DRAP has been mapped in consultation with DRAP._

In this context, Pakistan Single Window-PSW would like to invite you for a hybrid Training Session for the Drug Regulatory Authority of Pakistan-DRAP Module. In this session our Domain and System Experts will provide you the walkthrough of filling Entity Registration, License Registration (DML), Product Registration and SECP Verification.

The meeting is scheduled for Friday, 25th August 2023 from 03:30 PM till 04:30 PM. Manufacturers/DML holders working in Karachi are requested to join us physically at Main Conference Room, Fifth Floor, Bahria Complex-1, M.T Khan Road, Karachi.

Interested members are requested to register themselves by clicking below:
Registration Link: https://us06web.zoom.us/webinar/register/WN_42ArK1qtS1Sf9Xm2bcTi9g

Relevant members of Pharma Industry and associations are encouraged to get themselves register for this session for better understanding of new module. Pease note, only registered members will be allowed to attend this training session.

DRAP issued Consolidated Notification for Regulatory Fees

Drug Regulatory Authority of Pakistan (DRAP) issued a consolidated notification of Regulatory fess for various functions and services. This notification is issued under the section (1) of section 20 of the Drug Regulatory Authority of Pakistan Act, 2012 (XX.I of 2012) read with sub-rule (3) of rule 4 of the Drug Regulatory Authority of Pakistan (Fee and Levy) Rules, 2022, and in supersession of all such previous Notifications. The Drug Regulatory Authority of Pakistan with the approval of the Policy Board has specified these regulatory fees. The Notification is provided as under: –

DRAP issued Consolidated Guidance Document on Good Manufacturing Practices for Manufacturing Sites of Drugs.

To ensures the quality of drugs and compliance with its Current Good Manufacturing Practice (cGMP), DRAP monitor the manufacturers to ensure compliance to minimum requirements for the methods, facilities, and controls used in manufacturing, processing, and packing of a drug product.  These Good Manufacturing Practices are intended to make sure that a product is safe for use, and meet the prescribed standard of quality.

Although the Drugs (Licensing, Registering & Advertising) Rules, 1976 under the Drugs Act, 1976 provides detail requirements on Good Manufacturing Practices (GMP), however, DRAP intended to provide a compiled GMP guidance document stipulating Drug Regulatory Authority of Pakistan’s (DRAP) expectations on GMP from pharmaceutical & biological drugs manufacturers.

This Guideline is intended to provide guidance regarding the 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:

  1. Products are consistently produced and controlled to the quality standards appropriate to their intended use
  2. Products are manufactured as required by the marketing authorization or product specification; and
  3. 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 document will help industry and Regulators to conform the requirement of GMP for production, verification, and validation of manufactured products and ensure that they are effective and safe.

Stakeholder Comments are invited on the Draft Therapeutic Goods (Federal Inspectors, Laboratories and Federal Government Analysts) Rules, 2022

Drug Regulatory Authority of Pakistan Act, 2012 provides the legal mandate to inspect and enforce GXPs through out the supply chain of therapeutic Goods. Inspection of establishments is an essential regulatory function, to monitor the regulatory compliance to ensure that operations at these establishments are carried out in accordance with approved standards, conditions, guidelines and legislations. The scope of the Inspections applies to different Good Practices (GXPs) including Good Manufacturing Practices (GMPs), Good Distribution Practices(GDPs) and Good Clinical Practices (GCPs), etc.

DRAP Act 2012, under its Schedule-V provides the legal provisions for appointment, powers and procedures for working of Inspectors. These draft rules are intended to replace the existing Drugs (Federal Inspectors, Federal Drug Laboratory and Federal Government Analyst) Rules, 1976 and are aimed at converting Inspection activities to be based on a risk management approach, capable of revealing weaknesses and deficiencies in the production, quality control, storage or distribution of therapeutic goods, as well as to devise a uniform procedures for taking regulatory actions and handling of products with suspected quality defects or identified as substandard and falsified.

These draft Therapeutic Goods (Federal Inspectors, Laboratories and Federal Government Analysts) Rules, 2022 were uploaded on the official website of DRAP dated 24th November, 2022, 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 aamar.latifdra.gov.pk , copying at ajmal.shoaildra.gov.pk , or can be posted at mailing address, Additional Director, Division of Legal Affairs, Drug Regulatory Authority of Pakistan, 1st floor, TF Complex, 7th Mauve Area, G-9/4, Islamabad.

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.latifdra.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