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

Asad Ullah Licensing and Inspections, News & Updates, Notifications, Regulatory Updates November 24, 2022November 28, 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.latif∂dra.gov.pk , copying at ajmal.shoail∂dra.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.

Draft-Therapeutic-Goods-Federal-Inspectors-Laboratories-and-Federal-Government-Analysts-Rules-2022 Download

DRAP invited Comments from Stakeholders on the Draft Therapeutic Goods (Advertisement) Rules, 2022

Ijaz Mustafa Advertisements, Drugs, Notifications, Publications November 22, 2022November 23, 2022

Drug Regulatory Authority of Pakistan Act, 2012 under section 7 (c)(iii) and (x) mandated the DRAP for the regulation of Advertisements, enforcement and monitoring of advertisement rules and ban on false advertisement. Schedule II- B of the DRAP Act, 2012 prohibits the advertisements of any therapeutic goods except in accordance with the prescribed conditions.

The current changing trend of advertisement and promotional activities by pharmaceutical companies and the requirement of extension of scope from drugs to therapeutic goods has led to the development of these draft rules. These draft rules contain provisions almost similar to the ones given in Rule 31 of the Drugs (Licensing, Registering & Advertising) Rules 1976, included but not limited to; amended Schedule with the list of drugs permissible for advertisement as earlier consulted with stakeholders, Schedule with diseases for which advertisement is prohibited, schedule with the details on advertisement or promotional material keeping in consideration the ethical criteria; Forms for submitting applications of advertisement approval, Formats for granting approval for advertisement and schedule with details on advertisement or promotional material keeping in consideration the ethical criteria.
These draft Therapeutic Goods (Advertisement) Rules, 2022 were uploaded on the official website of DRAP dated 21^st 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 can be accessed on this link). Comments and suggestions can be forwarded via email to aamar.latif∂dra.gov.pk , copying at aqsa.hashmi∂dra.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.

Click here to View/Download the draft Therapeutic Goods (Advertisement) Rules, 2022

Draft-Therapeutic-Goods-Advertisement-Rules-2022 Download

Notification – SRO 1995(I)/2022 MRP of Paracetamol

Yasir Mahmood Notifications, SROs November 4, 2022November 4, 2022Notifications

MRP-of-Paracetamol-03.11.2022 Download

Notification: Applications for Registrations of Pharmaceutical drugs submitted on Form 5/5D requiring submission of Product Stability Data

Asad Ullah Drugs, Notifications, Regulatory Updates October 17, 2022October 17, 2022Notifications, PER

Registration Board in 320th meeting held on 29th – 31st August 2022 has issued a direction with regards to the applications received on Form 5 / 5-D for registration of pharmaceutical drugs, which requires submission of stability study data for further processing. The list of such applications is available on official website of DRAP (link).

The decision of Registration Board is notified and attached hereunder for information and compliance by all relevant stakeholders.

Notification-Form-5 Download

SRO 1888(I)/2022 : Notification of Clinical Studies Committee under Bio-Study Rules, 2017

Ijaz Mustafa Clinical Trials, Notifications October 13, 2022October 13, 2022

SRO-1888-of-2022-Clinical-Studies-Committee Download

Notification: Expert members of the Medical Device Board (MDB)

Ijaz Mustafa Medical Devices, Notifications September 15, 2022September 16, 2022

Notification_of_MDB_Members Download

National Essential Medicine Lists

Asad Ullah Notifications, Pharmacovigilance, Publications July 22, 2022December 21, 2023Notifications, Pharmacy Services, Pharnacovigilance

Availability of essential medicines is one of the essential building blocks of healthcare system. Essential medicines are those which satisfy the primary healthcare need of the population. These are intended to be available within the context of functioning of health system at all times, in adequate amounts, in the appropriate dosage form with assured quality, and at a price that the individual and community can afford.

Careful selection of a limited range of essential medicines of high quality can provide better management towards judicious use of health resources.

National standard treatment guidelines navigate selection of essential medicine with the expectation to ensure their availability with reference to proper use of medicine within the healthcare system while reducing its cost.

National Essential Medicine List NEML is a critical document which provides and supports quality of health services across the country. The list is based on disease prevalence, evidence on efficacy and safety, and comparative cost-effectiveness and parameters adapted by W.H.O in its latest edition of Model List of Essential Medicines.

Health sector in general and Pharmaceutical sector in particular is expected to seriously consider adopting this list as a way forward to guide Provincial Governments in Medicine & Pharmaceutical sector policies, the determinants of medicines access and availability. The Provincial Governments can play a pivotal role to encourage procurement and supply chain management policies based on essential medicine concepts to promote rational use of scarce public resources. Drug Regulatory Authority is committed to make all efforts to improve patient care through availability of cost efficacious, safe & quality medicines availability in the country.