Asia-Pacific Roundup: Pakistan’s DRAP seeks feedback on revised clinical trial guidelines

The Drug Regulatory Authority of Pakistan (DRAP) has released draft guidelines on the conduct of clinical trials for consultation. DRAP is planning to add sections on audits and inspections of clinical research service providers and the parallel processing of study and site filings.

Officials published the first edition of the document in May 2022. The draft second edition, which is based on International Council for Harmonisation and World Health Organization guidelines, retains the structure of the existing document but features multiple changes.

In one new section, DRAP outlines the process for applicants that want to seek authorization to run a study and use sites that are yet to receive approval. DRAP is proposing to allow such applicants to submit separate filings for studies and sites along with a request for parallel processing. Approval of the study will be subject to the authorization of the sites but otherwise the process is the same as for other filings.

Another new section covers licensing audits and inspections for contract research organizations and other clinical trial service providers. Audits or inspections may be run to “evaluate the suitability and acceptability of research related [facilities],” DRAP wrote. The draft points readers to four inspection checklists for facilities that may be the subjects of visits.

DRAP’s proposed changes to existing sections include descriptions of the key responsibilities of principal, co-principal, and site investigators, as well as major additions to its discussion of amendments and urgent safety measures.

The draft now states that sponsors and investigators should file amendments for new protocols or changes to existing protocols before implementing the changes. DRAP plans to encourage sponsors and investigators to collate minor amendments made in a short space of time into single filings. The draft features a table that divides potential revisions, such as changes to the primary endpoint and increases in the duration of the research, into major and minor amendments.

DRAP is also planning changes to the section on reports and final review. The agency has drafted a new subsection about the nomination of experts to review reports and the handling of investigational medicinal products (IMPs). DRAP has shared advice on IMP reconciliation, destruction, and storage. The agency consulted on the storage and destruction of other medicinal products late last year.

The clinical trial draft is open for comment until 22 February.

DRAP Notice, Draft Guidelines

Indian government details CDSCO actions to ensure the quality of medicines

The Indian government has defended its record on the quality and safety of medicines in response to questioning in Lok Sabha, the lower house of its parliament.

A politician in the ruling party asked whether the government has taken measures to implement World Health Organization standards and whether it proposes “to strengthen the monitoring mechanism of the pharmaceutical supply chains particularly of those small production units which evade the regulatory inspections to ensure the quality and safety of the medicines in the country.”

In response, a government representative cited changes to the Drugs Rules, 1945 that were published late last year. The changes related to good manufacturing practices and requirements of premises, plant, and equipment for pharmaceutical products. The representative noted that the changes will apply to large manufacturers after six months and smaller manufacturers after 12 months.

The response also covered the work of the Central Drugs Standard Control Organization and state drug units, which have “conducted risk-based inspections of 275 premises.” The inspections led to “more than 250 actions like issuance of show cause notices, stop production order, suspension, cancellation of licenses/product license.” The government shared more details of its actions in a press release.

Press Release

Malaysia’s NRPA triples foreign bioequivalence and ethics inspections, shares findings

Malaysia’s National Pharmaceutical Regulatory Agency (NPRA) performed three times more assessments of foreign bioequivalence and ethics sites last year than in 2022 as part of an expansion of its inspection activities.

In 2022, NPRA’s Bioequivalence and Ethics Committee (BEEC) planned seven overseas inspections. The figure jumped to 23 last year, although three of the inspections were postponed. Most, 12, of the 20 visits that BEEC completed were surveillance inspections. The inspection program took the committee to bioequivalence centers in India, Thailand, Taiwan, Jordan, and China.

During the 20 foreign and one local bioequivalence inspections, BEEC made 362 observations. Issues with the organization of clinical aspects of the sites were the most common problem, accounting for 36% of the observations. At 26%, bioanalytical organizational issues were the second most common problem.

Most, 284, observations were minor, but BEEC also identified 69 major issues and nine critical problems. The critical observations related to clinical and bioanalytical organization, as well as to study sample analysis.

In the ethics inspections, BEEC made 139 observations, 23 of which were major. Review procedures were the most common problem, accounting for more than one third of observations, but membership of the ethics committee was the top major issue.

NPRA Report

India’s NPPA addresses complaints about delays when using online portal

India’s National Pharmaceutical Pricing Authority (NPPA) has updated the IPDMS 2.0 portal in response to user complaints about the form submission process.

Users of the system, also known as the Integrated Pharmaceutical Database Management System, told NPPA that they experienced delays in the “delivery of the One Time Passwords (OTP), validity period etc., while submitting Forms on IPDMS 2.0 platform,” according to the drug price watchdog.

In response, NPPA carried out “a comprehensive review of the process for OTP related issues including delivery of OTP via SMS and Email, period of validity of OTP, single use etc.” with its technical service provider, India’s Centre for Development of Advanced Computing. The review led to updates “to ensure fast delivery of the OTP and its use for submission of intended form,” NPPA said.

The update is the latest in a series of actions taken to correct problems identified by users. NPPA acted on feedback from the Federation of Indian Chambers of Commerce and Industry last year and responded to 40 issues raised at a meeting with industry in 2022.

NPPA Notice

Indian pharmacopeia releases draft monograph revisions for public consultation

The Indian Pharmacopoeia Commission (IPC) has published proposed changes to more than 200 general chapters and monographs.

IPC, which is accepting feedback until 22 March, is asking manufacturers, regulatory and health authorities, researchers, and other stakeholders to comment on the planned changes. The organization also wants manufacturers to submit samples of their products to “ensure that the proposed revised monograph adequately controls the quality of the product(s) they manufacture.”

Almost 90 of the planned changes are “minor” amendments, IPC said, but other updates will have a bigger impact on manufacturers. Across the affected molecules, IPC is proposing to revise dissolution limits, upgrade assays and add processes for detecting new impurities.

IPC Notice

Other News:

The Indian government has rescinded a law that restricted the sale and distribution of the antiviral medications oseltamivir, also known as Tamiflu, and zanamivir. Officials imposed restrictions in 2009 and amended them in 2017. Now, the government, after holding a consultation, has rescinded the restrictions and added the ingredients to schedule H1. CDSCO Notice, More

Asia-Pacific Roundup: Pakistan’s DRAP seeks feedback on revised clinical trial guidelines

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