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Regulatory Focus™ > News Articles > 2021 > 1 > Asia-Pacific Roundup: India approves AstraZeneca, Bharat Biotech COVID vaccines

Asia-Pacific Roundup: India approves AstraZeneca, Bharat Biotech COVID vaccines

Posted 05 January 2021 | By Nick Paul Taylor 

Asia-Pacific Roundup: India approves AstraZeneca, Bharat Biotech COVID vaccines

India has approved COVID-19 vaccines developed by AstraZeneca and Bharat Biotech for restricted emergency use. The clearances position India to embark on a campaign to vaccinate 300 million high-risk people and healthcare workers by early August.
The AstraZeneca and Bharat coronavirus vaccines, both of which are kept in standard refrigerators, will spearhead the vaccination campaign after getting the support of the Subject Expert Committee. Acting on the recommendation of the committee, the Central Drugs Standard Control Organization (CDSCO) approved the vaccines for restricted emergency use subject to certain regulatory conditions.
AstraZeneca’s Indian partner, Serum Institute of India, won approval for the adenovirus vector vaccine largely on the strength of data from sites in Brazil, South Africa and the UK. Serum Institute shared interim safety and immunogenicity data from a 1,600-subject study in India to show the applicability of the global results to its home market. The Indian clinical trial is continuing.
Watchdog All India Drug Action Network (AIDAN) sought clarification on points including the extent of the Indian data shared by Serum Institute and the regulatory conditions imposed on the vaccine but offered no opinion on whether CDSCO should have approved the product.
AIDAN was more outspoken about Bharat’s vaccine, stating it was “shocked” and “baffled” by the recommendation for approval. The divergent responses to the two approvals reflects differences in the amount of publicly available data on the vaccines. While the late-phase clinical trial data supporting approval of AstraZeneca’s vaccine was published in The Lancet, Bharat has only shared results from Phase I and 2 clinical trials featuring around 800 subjects in non-peer-reviewed preprints.
Efficacy data was not included in the CDSCO notice announcing approval of the Bharat vaccine, branded Covaxin. Rather, the statement briefly describes the safety and immunogenicity findings of early-phase trials and notes that the vaccine appears safe based on the 22,500 subjects vaccinated so far in the Phase 3.
CDSCO justified the decision ahead of Phase 3 data on the grounds that more vaccine options are needed “especially in case of infection by mutant strains.” AIDAN criticized the comment, arguing there is no scientific basis for the claim that the vaccine may work against new strains. CDSCO asked to see Phase 3 safety and efficacy data when Bharat sought emergency approval last month.
The decision to approve two vaccines could boost India’s chances of meeting its immunization goals. India has also moved to ensure the local availability of vaccines by preventing Serum Institute from exporting the vaccine, according to a report in AP. Serum Institute is contracted to produce 1 billion doses of the vaccine, making it a key part of the global response, but all its supplies will go to the Indian government for now. Global shipments could begin in March or April.
Press Release, AIDAN Response, AP
TGA finalizes imminent regulatory changes for custom-made medical devices
Australia’s Therapeutic Goods Administration (TGA) has finalized the regulations that will apply to 3D-printed products and other personalized medical devices starting 25 February. The finalization of the text follows several years of discussions that saw industry pushback against parts of the plan.
Medical Device Production Systems (MDPS), perhaps the most contentious part of TGA’s draft plans, are included in the final framework but will not take effect when the regulations come into force next month. Rather, TGA will include a definition of MDPS, which healthcare facilities use to make certain personalized devices, but hold off on applying it until the concept is refined.
TGA is working with the International Medical Device Regulators Forum and other groups to establish the procedures and processes needed to support the concept. The pause on MDPS implementation follows a 2019 consultation that drew criticism of the concept, in TGA’s view because its paper “was, perhaps, not sufficiently clear.”
By deferring the implementation of MDPS, TGA has enabled the rest of the proposals to advance. TGA said the framework will reduce the scope of the current definition of custom-made devices and change the exemption conditions, including by requiring annual reporting and enabling it to inspect production facilities.
TGA Notice
India establishes grace period for medical devices now regulated as drugs
India has granted a grace period to manufacturers and importers of certain medical devices that are now treated as drugs for regulatory purposes. The devices moved to the new regulatory regime on 1 January, but existing ways of working could remain valid for up to six months.
The grace period applies to existing producers and importers of nebulizers, blood pressure monitors, digital thermometers and glucometers that have applied for licenses under the Medical Device Rules, 2017. Companies in that situation can continue to provide their products for up to six months while the authorities review their applications.
CDSCO granted the industry the grace period after receiving a request to give companies another three to six months “because a lot of procedural work is to be done such as resolution of queries, audit of facilities by the regulators and notified bodies, as the case may be, testing of products at the requisite testing labs etc.”
CDSCO Notice
TGA shares guidance on the performance of face masks and respirators
TGA has shared guidance on choosing appropriate standards and meeting its performance testing requirements for surgical face masks and respirators. The release of the guidance follows the identification of common areas of noncompliance in a postmarket review conducted by TGA.
The guidance lists standards from ISO and other bodies that are applicable to the performance requirements of face masks and respirators, such as fluid resistance and breathability. Other sections of the text address the application of testing methods, sampling plans and postmarket oversight. TGA also provided a detailed overview of its requirements for fluid resistance testing.
TGA published the guidance shortly before releasing a notice about importing personal protective equipment (PPE). The second notice describes how PPE is regulated at the Australian border and offers advice for people who want to import products for personal or commercial use. Publication of the text follows a period in which PPE imports rose in response to the COVID-19 pandemic.
TGA Guidance, More
Malaysian NPRA updates guidance on conditional registration of new drugs
Malaysia’s National Pharmaceutical Regulatory Agency (NPRA) has revised its guidance on the conditional registration of new chemical entities and biologics.
The updated guidance hews closely to the first edition of the document that NPRA published in 2018. Many of the changes appear to be related to the COVID-19 pandemic. NPRA has clarified throughout the document that the conditional registration pathway applies to vaccines, as well as other types of new medicine.
Elsewhere, NPRA has added a link to a document on the approval of vaccines and other products in the context of disasters. NPRA issued the directive on fast-track conditional registrations during outbreaks, epidemics and pandemics last month.
The new guidance features some changes unrelated to COVID-19. NPRA has revised the wording of part of a conditional registration flowchart, while leaving the core process unchanged, and added a reference to the Drug Registration Guidance Document to a section on orphan medicines.
NPRA Guidance
Other News:
TGA has issued a safety advisory about the risk of infection with the Zostavax vaccine. TGA Notice


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