Asia-Pacific Roundup: Pakistan’s DRAP gains powers to invest research fund in regulatory infrastructure

The Ministry of National Health Services is granting Pakistan’s drug regulator the power to use a central research fund to operate and upgrade a wider range of buildings and other pieces of infrastructure.

In the Drugs (Research) Rules, 1978, the Ministry outlines various ways the Drug Regulatory Authority of Pakistan (DRAP) can spend a central research fund, which DRAP collects and maintains. The earlier version of the rules focused on the use of the fund for research, scholarships and drug development, and evaluation. One line of the old rules covered the use of the fund to upgrade and establish drug research and testing laboratories.

The Ministry’s update splits the possible uses of the fund into two subsections. The first subsection briefly sets out the potential to use the money for basic and operational research. The second subsection lists the types of infrastructure DRAP can operate and maintain using the fund.

DRAP can spend the money on “its laboratories, pharmacovigilance centers, antimicrobial consumption surveillance cell, drug information and poison control center [and] unit for reference standards as per pharmacopeia monograph.” The regulator can use the money to facilitate upgrades to provincial drug testing laboratories and pharmacovigilance centers.

Investments in “databases and data centers” are the other authorized uses of the fund. The data-focused uses of the fund include the “digitization of record thereof in respect of therapeutic goods and related activities for international accreditations.”

The Ministry made the changes as part of a broader update of the research rules. The update includes additional definitions, the simplification of the section on categories of drug research, the addition of a reference to International Conference on Harmonisation good clinical practice guidelines and the revision of a section on the committee of experts on drug research.

Previously, the committee was made up of leaders from bodies such as the Pakistan Medical Research Council, professors of pharmacy from each province of the country and one expert in biotechnology. The updated rules require the committee to mainly be made up of five professors or scientists of pharmacy, pharmacology, biotechnology, chemistry, or medicine. The chair can co-opt any expert to be a member. A DRAP director will convene the meetings and nominees of two trade groups will act as observers.

DRAP Notice

Indian authorities seek feedback on draft adverse event reporting form for IVDs

Indian authorities have released a draft form for reporting adverse events linked to in vitro diagnostics (IVDs) for consultation.

The Indian Pharmacopoeia Commission (IPC) and Central Drugs Standard Control Organisation (CDSCO) created the draft form in collaboration with associations of IVD manufacturers. The form is intended to help stakeholders including manufacturers, importers and healthcare professionals to capture adverse events related to IVDs.

IPC is seeking feedback on the form until 5 March. The draft, which could change based on the feedback, features sections for collecting the date and type of report, the detail of the organization or person filing the information and the type of IVD linked to the adverse event.

Another section is focused on the adverse event itself. People completing the form must list the type of adverse event, such as a malfunction or false positive, and the location where it happened. The section also includes a question about the severity of the event. If the event was serious, the submitter must say whether it resulted in death, disability or various other severe outcomes.

The form includes a section for information on the patient and a description of any investigations and corrective actions initiated in response to the adverse event. Stakeholders completing the form need to attach certain documents to their submissions.

IPC and CDSCO created the form to support the Materiovigilance Programme of India. The organizations launched the initiative in 2015. Medical device adverse event reporting became mandatory when the Medical Device Rules, 2017 took effect in 2018. A reporting form for medical devices is already available.

IPC Notice

GSK Pakistan recalls anxiety drug over nitrosamine impurity, stops production

GSK Pakistan is recalling 36 batches of the oral anxiety medicine Motival because it found a nitrosamine impurity.

The company told DRAP, Pakistan’s drug regulatory agency, that it initiated the voluntary recall in response to the discovery of N-nitroso nortriptyline in the affected batches. The tricyclic antidepressant nortriptyline is one of two active ingredients in Motival tablets. Since 2018, mutagenic, genotoxic and potentially carcinogenic nitrosamines have been detected in a range of drug products.

Concerns about the presence of nitrosamines have spread to nortriptyline and amitriptyline, another tricyclic antidepressant, in recent years. Regulatory agencies in places including Hong Kong and Singapore have overseen recalls triggered by the discovery of N-nitroso nortriptyline since 2023. The nitrosamine can form when a tertiary amino group interacts with a nitrite group.

DRAP told its field force and provincial drug control departments to find and remove affected Motival batches from the market. The agency also asked distributors and pharmacies to immediately check their stocks and stop supplying the products. GSK Pakistan told DRAP it has stopped manufacturing and releasing Motival tablets.

DRAP Notice

Hong Kong approves Hutchmed lung cancer drug under ‘1+’ fast-track mechanism

Hutchmed has won approval for two doses of Orpathys in Hong Kong. The company received approval for the tablets in non-small cell lung cancer under Hong Kong’s recently expanded “1+” mechanism.

The government implemented the mechanism in November 2023 to make it easier for companies to bring treatments for life-threatening or severely debilitating diseases to market in Hong Kong. Under the program, companies can seek authorization for eligible drugs in Hong Kong after receiving approval from one reference regulatory agency. Hong Kong previously required companies to have two prior approvals.

Officials extended the scheme to cover all new chemical or biological entities, new indications, vaccines and advanced therapy products in November. Hutchmed received approval for Orpathys in Hong Kong one month after China’s National Medical Products Administration granted full approval to the lung cancer drug. Orpathys received conditional approval in China in 2021.

The Orpathys approval is the second “1+” lung cancer authorization in quick succession. Amgen won approval for its DLL3 targeting bispecific Imdelltra in small cell lung cancer under the mechanism late last year.

Press Release, 1+ Approvals

Indian Pharmacopoeia starts consultation into planned monograph name changes

IPC is seeking feedback on plans to change monograph titles to align the Indian Pharmacopoeia with current regulatory practices.

The organization is proposing to add “for” to the titles of monographs of dry powder oral suspensions and powder form injection products. The 2022 pharmacopeia uses titles such as “amoxycillin oral suspension” and “aciclovir intravenous infusion.” Those titles would become “amoxycillin for oral suspension” and “aciclovir for intravenous infusion” under the proposed changes.

IPC said the shift in the terminology will “ensure better clarity among stakeholders for enhanced regulatory compliance.” The change will align India with established international standards, IPC said, and ensure that the monographs clearly indicate the intended use of the finished formulations. The goal is to establish “a more straightforward approach of monograph classification.”

The organization sees the change benefiting manufacturers, regulatory bodies and other stakeholders. IPC is seeking feedback with a view to making the change in the 2026 edition of its pharmacopeia.

IPC Notice

Asia-Pacific Roundup: Pakistan’s DRAP gains powers to invest research fund in regulatory infrastructure

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