Asia-Pacific Roundup: Pakistan clarifies term ‘essential drugs and biologicals’ in update to pricing legislation

Pakistan has published changes to its drug pricing policy. The revisions cover the definition of the term “essential drugs and biologicals,” which officials have expanded to cover all strengths of a medicine.

Officials previously updated the definition in the Drug Pricing Policy, 2018 three years ago. At that time, Pakistan defined essential drugs and biologicals as products “included in the list of essential medicines as published by the World Health Organization (WHO) and notified by the Ministry of National Health Services, Regulations and Coordination and as updated or revised from time to time.”

Pakistan has largely retained that definition for the revised document but also added five conditions. The first condition states “all strengths of a particular dosage form of drug and biological shall be considered as essential, if any of the strength of that dosage form is present in notified WHO Model List of Essential Medicines (MLEM).”

The second condition lists eight groups of dosage forms such as “cream, ointment, gel, lotion and paste” and “intravenous, intramuscular, subcutaneous and other injectable forms.” Under the revised rules, all dosage forms in a group are considered to be interchangeable with each other “if any of the strength in one dosage form is present in WHO MLEM.”

In the third point, the Drug Regulatory Authority of Pakistan (DRAP) clarifies that “if any biological drugs is present in WHO MLEM, it shall be considered as essential irrespective” of its source, such as human, animal or microbial, and process or technology.

The fourth condition explains that if all the ingredients in combination formulations of vaccines or biologicals are “individually labeled and categorized as essential in WHO MLEM, the combination in all strengths shall be considered as essential.” The fifth condition states that when a product is named in WHO MLEM but unregistered in Pakistan alternatives “mentioned against that particular molecule shall be considered as essential in that dosage form.”

Through the changes, DRAP has potentially expanded the range of products that fall under the definition of essential by eliminating opportunities to exclude them from the list on grounds such as the fact they have a different strength than the medicine in WHO MLEM. The changes come as the weakening of the Pakistani Rupee against the US dollar drives up the cost of essential medicines in the country.

DRAP Notice

Indonesia’s BPOM conducts wave of internal audits of quality management systems

The Indonesian Food and Drug Authority (BPOM) has conducted a series of internal audits to assess the implementation of the International Organization for Standardization’s (ISO) requirements for quality management systems.

ISO 9001:2015 specifies requirements for QMS at organizations that need to show they can consistently provide products and services that meet customer and regulatory expectations, and that aim to enhance customer satisfaction. Over the past week, BPOM has disclosed internal audits of ISO 9001:2015 across its operations.

The audits took place at BPOM sites in the Indonesian cities of Denpasar, Serang, Kendari and Medan. The audit in Medan led to a disciplinary gathering at which the leadership outlined the follow-up steps identified after the assessment.

BPOM framed the audits to help increase the consistency of quality management. Under ISO 9001:2015, organizations are advised to conduct internal audits as frequently as is needed to improve processes.

BPOM Notice (Indonesian)

TGA fines Australian firm $44,000 over alleged unlawful advertising of medicinal cannabis

The Therapeutic Goods Administration (TGA) has fined Affinity Corp Australia AU$66,000 ($44,000) over alleged unlawful advertising of medicinal cannabis products.

TGA accused the company of promoting the use of unapproved prescription-only medicinal cannabis products, including its own products, and therefore breaching the ban on advertising prescription-only products to the public.

The fine is the latest in a series issued by TGA in relation to the promotion of medicinal cannabis. In the space of a month last year, TGA fined five medicinal cannabis AU$1.2 million over alleged promotions on their websites and social media platforms. TGA fined a health practitioner AU$12,320 for similar reasons in the same period.

TGA sent five infringement notices to Affinity Corp. The company has little presence online, but the LinkedIn page of a person who claims to own the business says that “through the development of CBD infused products I have been able to assist clients stuck in prescription medication addiction to live their best lives.” The individual is the proprietor of another business that creates “medicinal cannabis products from oils to balms.”

TGA Notice

Singapore’s HSA issues notice about fixing battery fault for Medtronic HeartWare devices

Singapore’s Health Sciences Authority (HSA) has alerted healthcare professionals about Medtronic’s battery replacement to mitigate a fault with its HeartWare ventricular assist device (HVAD) system.

Last year, HSA shared a letter that described a fault that could cause both batteries connected to the HVAD controller to malfunction and stop providing power, causing the pump to stop. The problem was related to a weld non-conformance within the batteries that can cause them to fail to deliver power, and an interaction between software and the circuit board that can cause electrical faults.

Now, HSA has shared details of Medtronic’s response to the problem. “Medtronic has implemented a change to the battery configuration mode to mitigate the battery electrical fault issue and will be replacing all affected batteries of the HVAD system,” HSA said.

The regulator released information about Medtronic’s actions alongside details of a software update from Boston Scientific. The update is designed to enable physicians to identify Emblem subcutaneous implantable cardioverter defibrillators that have hydrogen-induced accelerated battery depletion.

HSA Notice

Indian Pharmacopoeia Commission inks deal with Suriname to expand use of its standards

The Indian Pharmacopoeia Commission (IPC) has entered a memorandum of understanding with the Health Ministry of Suriname for Suriname to officially recognize the Indian Pharmacopoeia.

IPC has worked in recent years to expand the use of the Indian Pharmacopoeia by overseas regulatory agencies. Afghanistan became the first country to officially recognize the Indian standards late in 2019. Since then, the Indian Pharmacopoeia has reached agreements with Ghana, Nepal, Mauritius and now Suriname.

The vice-chairman of the Pharmaceuticals Export Promotion Council of India explained the benefits of increasing recognition of the Indian Pharmacopoeia last year, telling Pharmabiz that it will simplify drug exports because manufacturers can use the same standards that they apply to domestic production. The goal is to have Western countries, which are big buyers of India-made drugs, to recognize the standards,

IPC Notice

Other news:

DRAP has fixed the prices of four cardiac stents sold by companies including Boston Scientific. The action by the Pakistani regulatory agency comes weeks after it set the maximum prices of 15 other drug-eluting stents made by Abbott, Boston Scientific, Medtronic and other international medtech companies. The four new prices are toward the bottom end of the range set in the earlier notice. DRAP Notice

Indonesia’s BPOM has uncovered an online marketplace that has sold illegal drugs and food valued at more than IDR 18 billion ($1.2 million). BPOM Notice (Indonesian)

Asia-Pacific Roundup: Pakistan clarifies term ‘essential drugs and biologicals’ in update to pricing legislation

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