Asia-Pacific Roundup: Indian Pharmacopoeia joins global discussion group pilot

Regulatory NewsRegulatory News | 13 September 2022 |  By 

The international Pharmacopoeial Discussion Group (PDG) has accepted the Indian commission into a one-year pilot that is intended to expand its membership beyond the European Union, Japan and the US.
 
Almost one year ago, PDG revealed it was preparing a pilot to integrate additional world pharmacopeias. PDG is currently made up of the European Pharmacopoeia, the Japanese Pharmacopoeia and the United States Pharmacopeia, with the World Health Organization acting as an observer. Together, the groups have harmonized and maintained 29 general chapters, plus 46 excipient monographs, since PDG began operations in 1989. The expansion pilot is intended to drive global pharmacopoeial convergence.
 
PDG reviewed applications to join the pilot expansion against criteria that required pharmacopeias to have approaches and policies equivalent to the existing members, apply selected International Council for Harmonisation quality guidelines such as Q2, Q3C and Q3D as principles for standard development and implement all harmonized general chapters and monographs.
 
Only one of the applicants met all the PDG criteria. The acceptance of the Indian Pharmacopoeia Commission’s (IPC) application will see the body join the pilot expansion in October, positioning it to serve as a proving ground for PDG’s plans to grow beyond the EU, Japan and the US.
 
While PDG rejected all the other applications, it plans to “remain in touch” with the unsuccessful pharmacopeias regarding “collaborative opportunities in the future with the aim of achieving greater convergence of global pharmacopoeial standards.” The collaborative opportunities include continuing to share PDG publications, such as draft texts for public consultation and final sign-off texts, with non-PDG pharmacopeias “in order to support convergence of these texts beyond the PDG.”
 
There may also be further opportunities to join the expanded PDG in the future. The established PDG members “will use the lessons learned from the one-year expansion pilot to further refine the group’s working methods and, at the end of the pilot, will identify any changes necessary to ensure that PDG continues to perform efficiently, prior to a broader rollout.”
 
PMDA Notice
 
Indian committee finds Sanofi failed to run study as per approved clinical trial protocol
 
India’s vaccine Subject Expert Committee (SEC) has accused Sanofi of failing to conduct a study of its hexavalent vaccine “as per approved clinical trial protocol.” The committee concluded the “clinical study report is not acceptable as presented.”
 
Sanofi arranged the meeting to discuss the next steps for its hexavalent vaccine, which is designed to provide protection against diphtheria, tetanus, pertussis, hepatitis B, Haemophilus influenzae type b and poliomyelitis. At the meeting, Sanofi presented the Phase III clinical trial report alongside a proposal to seek permission for administration of an intramuscular booster dose in infants aged 12 to 24 months.
 
“After detailed deliberation the committee noted that [the] firm has not conducted the study as per approved clinical trial protocol and the committee recommended that [the] clinical study report is not acceptable as presented,” SEC wrote in its minutes from the meeting.
 
The setback comes around 18 months after SEC recommended that Sanofi was given permission to manufacture and market the vaccine, “subject to the condition that [the] firm should continue the ongoing study on booster dose and submit safety and efficacy data as and when available.” At the 2021 meeting, the committee also advised that Sanofi’s clinical trial sites may be audited for compliance with good clinical practice requirements.
 
Meeting Minutes
 
TGA approves Australia’s first combination self-tests for COVID-19 and influenza
 
The Therapeutic Goods Administration (TGA) has approved Australia’s first combination self-tests for COVID-19 and influenza. TouchBio and Fanttest received the approvals after presenting clinical and analytical data.
 
Combination tests that differentiate between COVID-19 and influenza could be useful at times when both pathogens are circulating, given that infection with either can result in similar symptoms. TGA said that, for many consumers, “distinguishing between COVID-19 and influenza is important in managing their infections.”
 
TGA expects the suppliers to make the tests available to buy from pharmacies, supermarkets or online. The TouchBio COVID-19 and Flu A/B Rapid Antigen Combo Test is now available for pre-order for shipping at the end of September. The standard price direct from TouchBio is AU$27 ($18.50), although the company is currently offering the test for AU$24.30.
 
Like suppliers of other COVID-19 self-tests, the sponsors must provide instructions for use and telephone support. TGA is requiring the sponsors to provide it with ongoing quality and performance information, including reports of any problems with the use of the tests, such as users who experience false positives or false negatives, and evidence that they can detect emerging COVID-19 variants.
 
TGA Notice
 
Pakistan’s DRAP adopts action plan to strengthen cooperation with other regulators
 
The Drug Regulatory Authority of Pakistan (DRAP) has adopted a medicine regulation action plan drafted by the Organization of Islamic Cooperation (OIC). More than 40 OIC members adopted the plan, which calls for increased cooperation, development of human resources and harmonization initiatives.
 
OIC lists multiple Asian countries, including Bangladesh, Malaysia and Pakistan, among its members. Last week, the heads of national medicine regulatory agencies in the member states, including the DRAP CEO Asim Rauf, met in Turkey, leading to the adoption of an action plan for 2022 to 2024 that is intended to promote access to safe, effective and quality medicines and vaccines.
 
The action plan includes eight objectives related to topics including cooperation, human resources and the creation and strengthening of regional and sub-regional harmonization and networking among OIC countries.
 
Attendees also adopted the Istanbul Declaration, which recognizes the challenges posed by the COVID-19 pandemic and the disparity among OIC members. The disparity relates, in part, to the lack of sufficient medicine manufacturing capacities in some countries.
 
DRAP Notice, OIC Notice
 
India assigns non-sterile, hand-held medical devices to risk categories for MDR, 2017
 
India’s Central Drugs Standard Control Organization (CDSCO) has assigned risk categories to non-sterile and invasive surgical instruments used for procedures such as cutting, drilling and sawing. The release of the list advances the implementation of the Medical Devices Rules, 2017.
 
The list covers “non-sterile, nonpowered, hand-held or hand-manipulated surgical instruments for general use intended to be used in various general surgical procedures.” That term captures four types of medical device, namely those used for: cutting and dissecting; clamping and occluding; retracting and exposing; and grasping and holding.
 
CDSCO has assigned all four groups of surgical instruments to risk category A. Class A is the lowest risk category in India. The low risk of the surgical instruments partly reflects the fact they are intended for transient use, a term CDSCO defines as continuous use for less than 60 minutes.
 
CDSCO Notice
 
Other News:
 
The Philippine Food and Drug Administration (FDA) has limited parking in its compound to senior citizens and people with a permanent disability. FDA said a lack of space and “the increase of schedule of daily release of authorizations” led it to impose the restrictions on parking, which are intended to support the effective and efficient delivery of public services. FDA Notice
 
TGA has published a safety advisory about high levels of lead and other heavy metals in the ayurvedic medicine named Penisole. Taking the medicine could result in lead poisoning. TGA Notice

 

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