Asia-Pacific Roundup: DRAP outlines pharma implications of Pakistan’s hazardous waste policy

The Drug Regulatory Authority of Pakistan (DRAP) has shared information about how national guidelines on the environmentally sound management of solid and hazardous waste will affect the pharmaceutical industry.

Pakistan’s Ministry of Climate Change released the National Hazardous Waste Management Policy, 2022, last year as part of its work to help the country meet its obligations under an international convention and achieve United Nations Sustainable Development Goals. The policy covers actions to control the movement of hazardous waste across borders, the management of contaminated sites and more.

“Pharmaceutical industry being a potential source of generating hazardous material as [a] byproduct of its manufacturing, research and development processes,” according to a notice on the DRAP website. “These involve handling of various chemical compounds which may be toxic, reactive, flammable or otherwise hazardous to human health and environment. Therefore, proper management of hazardous waste in [the] pharmaceutical industry is crucial to protect human health and [the] environment.”

The policy names pharmaceutical manufacturing as a major industry in Pakistan. In the section of the policy that refers to pharma, the Ministry of Climate Change wrote that “industrial pollution is a major problem in Pakistan,” adding that “the minimal response of industry to hazardous waste is mainly due to the poor performance of the sector, lack of information about new technologies and high investments required for changing the processes coupled with weak regulatory mechanism.”

According to the policy, “industries dispose of their effluents into nearby streams, rivers, lakes and agricultural fields, which on the one hand cause diseases and on the other degrade the overall water quality.” A recent paper called Pakistan “one of the most water-polluted” countries in South Asia.

While that paper found multiple reasons why drinking water in Pakistan is contaminated with microbial and toxic metals, a 2022 study about pharmaceutical pollution of the world’s rivers showed medicines are a particular problem for the country. The team behind the global study saw the highest mean cumulative concentration of active pharmaceutical ingredients (API) in Lahore, Pakistan.

DRAP Notice

Singapore’s HSA outlines response to API proposal, responds to frequent questions

Singapore’s Health Sciences Authority (HSA) has responded to questions raised during the recent public consultation into upcoming changes to the regulation of APIs. HSA released draft legislation for consultation in July.

The consultation attracted 59 comments from 16 parties, all bar one of which was a representative of the pharma industry. The top three types of feedback were requests for clarification on the licensing and regulatory requirements, the duties of licensees, and the transition approach, application process and fees.

HAS created a frequently asked question document based on the feedback. The FAQ defines “active ingredients,” reflecting the fact that 14% of the comments requested clarity on that term. Further, the agency answered four questions about the licensing and regulatory requirements, explaining that the new regulations will free API manufacturers and importers from the need to hold a Form A Poisons License (FAPL). The FAPL will, however, remain applicable to some veterinary products and diagnostic reagents. The section also explains the rules for APIs in clinical trials and the storage of active ingredients.

In a section on the duties of licensees, HSA explains that “in general,” the responsible person should be a qualified pharmacist. The authority plans to publish guidelines on the duties of responsible persons. HSA also used the section to clarify that manufacturers need to notify it when they plan to recall an API.

HSA Notice

DRAP details actions to improve pharmacovigilance reporting amid ongoing lack of centers

DRAP has outlined the steps it is taking to strengthen pharmacovigilance activities, reacting to slow uptake of new rules adopted in April 2022. Officials discussed the current situation at a recent meeting of the Pharmacovigilance Risk Assessment Expert Committee.

Almost 18 months after DRAP adopted rules on reporting adverse events, only Punjab and Islamabad had established their pharmacovigilance centers. The World Health Organization has developed plans for the establishment of “vibrant pharmacovigilance centers.”

A representative of Khyber, a region of Pakistan, said a planned pharmacovigilance center is awaiting approval, and 15 to 20 people are lined up to work on the program. Plans in Sindh are less advanced, with a representative noting a lack of “dedicated human resources and infrastructure” and a need for “capacity building and the provision of logins.”

Attendees heard that the Uppsala Monitoring Centre accepted a request for the provision of unlimited dedicated VigiFlow logins to healthcare professionals at regional and sub-regional centers at the hospital level. Officials want to strengthen human resources before starting to provide the logins.

DRAP Notice

Medsafe allows OTC sales of low-dose cannabidiol

The New Zealand Medicines and Medical Devices Safety Authority (Medsafe) has reclassified low-dose cannabidiol (CBD) to allow people to access the medicine without a prescription.

Medsafe previously classified CBD, a cannabinoid that has little-to-no psychoactive effects, as a prescription-only medicine. In December 2020, Australia’s Therapeutic Goods Administration reclassified low doses of the molecule to allow pharmacists to supply the medicine under certain circumstances. The Medsafe decision harmonizes the classification of low-dose CBD in Australia and New Zealand.

As it stands, no medicines containing low doses of CBD are approved for use in New Zealand. However, the CBD industry has “previously signaled that a change in classification may allow greater opportunities for research into the clinical efficacy and safety,” Medsafe said. The research could lead to approvals, and Medsafe said it welcomes applications for medicines containing low doses of CBD.

Medsafe Notice

TGA calls for cautious off-label use of baclofen after spasm drug is implicated in two deaths

Australia’s Therapeutic Goods Administration has asked physicians to use caution when prescribing the muscle spasm drug baclofen off-label.

The drug is indicated in the suppression of muscle spasms in patients with multiple sclerosis and certain spinal lesions. However, baclofen is also used off-label to treat conditions including musculoskeletal pain, gastroesophageal reflux disease and alcohol-use disorder. The drug is associated with complications and can be abused.

TGA called for caution when prescribing baclofen off-label after “recent coronial inquiries into two deaths have highlighted the need for health professionals to be alert to the well-documented risk of overdose with baclofen.” The risk of intentional and unintentional overdose is “particularly pronounced” when the drug is used off-label at higher doses for alcohol-use disorder.

TGA Notice

Asia-Pacific Roundup: DRAP outlines pharma implications of Pakistan’s hazardous waste policy

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