Report on Availability Status and Supply Disruption of Eye Drops

The Drug Regulatory Authority of Pakistan (DRAP) has received information that certain brands of eye drops are short in supply in the market. The DRAP’s committee has conducted a quick survey of the market and found certain alternative brands available in the market. The main reason behind their short supply is the change of ownership globally from Allergan to AbbVie.

In this regard, Physicians are advised to consider prescribing the available alternative brands to their patients in light of the shortage. Patients should be informed about this during their consultations. Similarly, pharmacists should also communicate the availability of alternative brands to patients or caregivers.

Briefly, the availability status of eye drops reported short along with their alternative brands is presented in the table below:

Sr. No.Name of Drug ProductsManufacturer/ importerStatusReason / Stock positionAlternate brand available
 1Combigan Eye drops (Brimonidine and Timolol)  M/s Barrett HodgsonShort supplyGlobal merger/ acquisition (Change of ownership from Allergan to AbbVie)Brytim Eye Drops (Remington)
Imosol eye Drops (Schazoo)
 2Lumigan Eye drops (Bimatoprost)M/s Barrett HodgsonShort supplyGlobal merger/ acquisition (Change of ownership from Allergan to AbbVie)Allure Eye drops (Sante)
 3Alphagan Eye drops (Brimonidine tartrate)M/s Barrett HodgsonShort supplyGlobal merger/ acquisition (Change of ownership from Allergan to AbbVie)Brimodine Eye drops (Sante)
Brimod eye drops (Remington)
 4Cosopt eye drops (Dorzolamide and Timolol)M/s OBS PakistanShort SupplyStock of 30,000 packs is in transit.Co-Dorzol eye drops (Sante)
Co-Dorz eye drops (Ethical)

Schedule of Meetings of Clinical Studies Committee (CSC) for the Year 2024

The Clinical Studies Committee (CSC) of Drug Regulatory Authority of Pakistan (DRAP) is mandated under Bio Study Rules 2017 for the regulatory oversight of clinical trials and clinical studies related to therapeutic goods in the country. The CSC reviews and approves clinical study protocols, ensuring they adhere to ethical and scientific standards. It also monitors ongoing clinical trials to assess participant safety and efficacy, makes informed decisions regarding study design, and collaborates with researchers, sponsors, and other stakeholders to ensure quality clinical research and safety of the participants.

The Committee has decided that the CSC meetings will be convened after every 45 days and an annual CSC meeting schedule for 2024 (tentative) has been issued with the aims to enhance transparency, efficiency, and collaboration.

S. No.CSC MeetingProposed Dates
0149th CSC Meeting2nd week of May, 2024
0250th CSC Meeting4th week of June, 2024
0351st CSC Meeting2nd week of August, 2024
0452nd CSC Meeting4th week of September, 2024
0553rd CSC Meeting2nd week of November 2024
0654th CSC Meeting4th week of December, 2024

Change in Manufacturing Unit of M/s Sois Life Sciences to Site at G-77. S.I.T.E. Super Highway, Phase-II, Karachi.

The Enlistment Evaluation Committee (EEC) in 120th meeting has considered the request of M/s Sois Life Sciences for change in manufacturing facility for their products from A-84, SITE, Super Highway, Phase-I, Karachi to their manufacturing site situated at G-77, S.I.T.E, Super Highway, Phase-II, Karachi. The EEC acceded the request of the firm and revoked the Enlistment Certificate No 01304.

Henceforth, all the product of M/s Sios Sois Life Sciences will be manufactured G-77, S.I.T.E, Super Highway, Phase-II, Karachi viz-a-viz Enlistment No. 0090. Therefore, manufacturing of Alternative medicines and health products by M/s Sois Life Sciences at A-84, S.I.T.E, Super Highway, Phase-I is prohibited and punishable offence under Rule 11 of the SRO 412 (I) /2014 read with Schedule II and III of the DRAP Act, 2012. Accordingly Notifications have been issued for strict compliance.

Implementation of Post Registration Variation Guidelines for Pharmaceutical and Biological Products (2nd Edition)

The Drug Regulatory Authority of Pakistan (DRAP) has recently released the 2nd Edition of the Post Registration Variation Guidelines for pharmaceutical and biological drug products. These guidelines provide essential information for submitting post-registration variation applications by registration holders and marketing authorization holders of drug products. The guidelines distinguish between minor variations (MiV-N, MiV-PA) and major variations (MaV), with specific timelines for each type. Applicants are required to adhere to the prescribed “Form” and documentation requirements when submitting variation applications.

Stakeholder Nominations are invited to a Webinar on GMP for Blood Establishment

World Health Organization (WHO) has developed a Guidance on Good Manufacturing Practice (GMP) for Blood Establishment to ensure the safety and quality of blood products with the aim to strengthen the technical capacity of National Regulatory Authorities (NRAs) for implementing the appropriate control of blood products. This GMP webinar will explain GMP principles and concepts comprehensively.

Drug Regulatory Authority of Pakistan (DRAP) invites healthcare professionals and stakeholders working in the blood establishments to attend/participate in the World Health Organization (WHO) webinar on “Good Manufacturing Practice (GMP) for Blood Establishment from 7 to 10 May 2024.

     

Combating Substandard and Falsified Products : Public Alert Reporting

Islamabad, 4th April, 2024 —  The Drug Regulatory Authority of Pakistan (DRAP) is aiming for effective communication and public awareness on combating Substandard and Falsified (SF) products to protect public health; hence the frequency of public alerts is likely to increase, and media communication of key messages represents an important mediator of the behaviour of individuals in response to public health countermeasures. Since culpability is commonly used as a tool to influence public behaviour, it is important to keep the public informed while avoiding panic due to misinformation/disinformation,

In a recent event, DRAP issued an alert No I/S/03-24-15 regarding the presence of falsified Risek 40mg injections in the market. This alert was intended to caution healthcare providers and the public about the presence of counterfeit products in the market and to procure the product from authorized sources only. Unfortunately, some misinterpretations of the alert have led to widespread misinformation.

DRAP is committed to ensuring the safety and well-being of the public and calls for responsible reporting. We are working diligently to remove the falsified products from the market and to hold those responsible, accountable.

Switching Over to Pakistan Single Window (PSW) for Drug Import License and Import Release of Donations Medicines

The Drug Regulatory Authority of Pakistan has switched over submission, processing and release order of Drug Import License and Import release of donation medicines on Pakistan Single Window (PSW).

Drug Import License (DIL)

All Drug Manufacturing License (DML) holder companies are enabled o submit applications for all type of Drug Import License form March 05, 2024 through PSW System..

Import of Donations

All registered International Non-Governmental Organizations (INGOs), Donor Partners, Local NGOs/Hospitals, and Government Projects involved in donated drugs are required to submit applications for import clearance on through PSW System from February 29, 2024

Guidelines on Risk Based Sampling and Testing of Drugs; Comments invited on draft Document

At the Drug Regulatory Authority of Pakistan (DRAP), our commitment to public health and safety drives our actions. We recognize that ensuring the quality and efficacy of pharmaceutical products is paramount. To achieve this, we emphasize risk-based sampling and testing strategies for assuring Safety and Quality of therapeutic goods to safeguard public health.

These Guidelines reflect a structured approach on regulatory oversight by allocating resources efficiently by prioritizing sampling collection, testing, and surveillance based on risk levels. This ensures that critical aspects of drug quality receive the attention at first and enable focusing regulatory efforts to high-risk areas. The draft guidelines are prepared based on the recommendation of ICH Q9 (Quality Risk Management), WHO working document QAS/15.630, and USP-PQM guidance document for implementing risk-based post-marketing quality surveillance in low and middle-income countries.

DRAP invites all interested parties and relevant stakeholders to provide their comments and inputs on the draft guideline. Stakeholders can submit their comments and suggestions within 15 days of uploading this document using prescribed format, (further information on comments submission can access on this link. Comments and suggestions can be forwarded via email to mehwish.tanveerdra.gov.pk with a copy to mahvash.ansaridra.gov.pk or can be posted at the following mailing address: Assistant Director (QC-II), Quality Assurance & Laboratory Testing, Drug Regulatory Authority of Pakistan, 3rd floor, TF Complex, 7th Mauve Area, G-9/4, Islamabad.

DRAP appreciates your participation and contribution to this consultation process.

Important Notice to INGOs, NGOs, Hospitals and Government Programs/Departments Importers of Donated Drugs in Pakistan

The Drug Regulatory Authority of Pakistan (DRAP) and the Pakistan Single Window (PSW) have implemented an automated clearance system for the importation of donated drugs in Pakistan. This system aims to optimize and expedite the efficiency of the pharmaceutical supply chain in Pakistan and ensure a seamless and transparent delivery of donated drugs.

PSW Subscription Required for Donated Drugs Importation in Pakistan

To participate in this system, all registered International Non-Governmental Organizations (INGOs), Donor Partners, Local NGOs/Hospitals, and Government Projects involved in donated drugs importation need to acquire their PSW Subscription promptly.

The PSW Subscription is a pivotal step in ensuring a smooth and sustainable pharmaceutical supply chain in Pakistan. Your subscription significantly contributes to the optimization of drug distribution, allowing us to collectively make a more substantial impact on public health.

How to Subscribe in 6 Easy Steps:

  • Visit the PSW website to access detailed instructions, user manuals, and demo videos.
  • Follow the straightforward subscription process and complete your subscription efficiently.
  • If you have any questions or require assistance during the subscription process, contact the PSW Support team at 021-111-111-779 or reach out via email at supportpsw.gov.pk.