Asia-Pacific Roundup: Indian medtech industry pushes back against reform bill

The Association of Indian Medical Devices Industry (AiMeD) has raised multiple concerns with a bill that will repeal the Drugs and Cosmetics Act, 1940. With the legislation reportedly days away from being put before leaders of the Indian government, according to local news reports, AiMeD is pushing for major changes to the proposals.

Officials released a draft version of the New Drugs, Medical Devices and Cosmetics Bill, 2023 for consultation last year, receiving 9,000 comments.

“A good law needs to be reasonable and implementable,” AiMeD wrote in threaded comments on the social media platform X (formerly Twitter). “If [the] majority of regulated [companies] are breaking an unreasonable law, what use is that law? We seek minimum government and maximum governance.” Rajiv Nath, forum coordinator at AiMeD, added that the bill was “made by drug specialists without involving medical devices regulatory specialists.”

On X, AiMeD shared a list of concerns with the bill. The trade group objects to the excessive threat of imprisonment for noncompliance, a failure to address patient safety over the complete device life cycle and the legalization of “pseudo manufacturing.”

Some of AiMeD’s problems with the bill are tied to the application of rules and processes designed for the pharma industry to the medtech sector. The trade group said five of the eight proposed chapters are the same as the legislation on drugs and called out the use of the “antiquated” concept of pharma-type central testing labs and the “misplaced” use of terms such as “spurious” for medical devices.

AiMeD compared the Indian proposal unfavorably to the regulatory frameworks in place overseas. The trade group noted how “progressive countries seek third-party certificate compliance and administrative measures effectively” and called for India to benchmark its approach against regulations from the World Health Organization and other countries.

AiMeD Proposals

Online retail platforms sidestep India’s attempts to stop non-compliant medicine trade

Online retailers have denied responsibility for the sale of medicines online in India, telling the Central Drugs Standard Control Organization (CDSCO) that they are only operating as intermediaries.

The exchanges were triggered by events that date back to February but were brought to the fore last week after a politician questioned the Indian government. Responding to a query about the violation of “regulatory norms,” the government said CDSCO sent show-cause notices to “various firms” engaged in online drug sales early this year, but the action had a limited impact.

“The firms have mostly responded by stating that they are only providing an online platform for facilitating the sale of pharmaceutical products to customers and the platform[s] operate solely as intermediaries, connecting the users and the licensed pharmacies,” the government wrote.

As the government noted in its response, it published draft rules for incorporating provisions about the sale and distribution of medicines online in 2018. The draft proposal, which would amend the Drugs and Cosmetics Rules, 1945, contain provisions for registering and inspecting e-pharmacies, a procedure for the distribution or sale of drugs online, and a ban on advertising drugs through e-pharmacies.

Press Release

Indian committee rejects J&J’s attempt to bypass local Phase 3 for autoimmune drug

An Indian expert committee has rejected Johnson & Johnson’s request to waive the requirement to run a local clinical trial of its autoimmune treatment guselkumab.

The drug, which is sold as Tremfya, is approved in markets including the US to treat plaque psoriasis and psoriatic arthritis. In March, J&J sought a local clinical trial waiver for guselkumab for the psoriatic arthritis indication, pointing to the data generated to support approvals outside of India to make its case. The expert committee asked J&J to present safety data in Asian patients.

Last week, J&J returned with the requested data. The drugmaker “presented safety data from the Phase 4 trial of other countries including Asian patients and ethnicity-wise data from the clinical trials conducted globally,” according to the expert committee.

However, the committee “noted that there is no clinical data available on population of the Indian subcontinent,” leading it to recommend that J&J run a Phase 3 trial in India. J&J will need to submit a clinical trial protocol for review if it chooses to follow the committee’s recommendation. The decision sets back J&J’s efforts to support the growth of a drug that generated $1.3 billion in the first half of 2023, according to a company statement.

Meeting Minutes

Japan’s PMDA updates information on consultations to give companies guidance, advice

Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) has updated its advice about consultations with industry. PMDA consults to give guidance and advice on clinical trials of drugs, medical devices, and cellular and tissue-based products, as well as on data for regulatory submissions.

Previously, PDMA offered limited information about its consultations, explaining the sort of guidance it can provide and discussing a specific R&D service it launched in 2011 for supporting early-stage projects. The updated website covers the same general information and revised details of the early-stage program, now rebranded as Regulatory Science Consultations.

As PMDA explains on the updated website, it now offers three types of consultations for early-stage projects. The regulatory agency is offering: a general consultation that provides an introduction to topics such as the pharmaceutical regulatory system; a pre-consultation meeting to clarify discussion points; and a full scientific discussion.

PMDA is not charging to provide general information or for holding pre-consultation meetings, but a fee does apply to the full consultations. The agency will reduce its fee for participating in a full scientific discussion, which can last up to two hours, by 90% if the applicant meets certain criteria related to the size and financial situation of the organization.

PMDA

Indonesian regulatory agency partners on strategy for cell and tissue-based products

The Indonesian Food and Drug Authority (BPOM) is working with other stakeholders to create a strategy that supports the development and use of medicinal products based on cells and tissues.

BPOM advanced the initiative at a cross-sectoral forum. The project has brought BPOM together with educational institutions, hospitals, stem cell production facilities and medical professional associations to identify the challenges facing the sector and discuss ways to improve the situation.

The Indonesian government has recognized the need to work with academic institutions and businesses to support the growth of the sector. Specifically, officials want to provide regulatory control over cell and tissue product research, development and production to support the registration of new therapies with BPOM and their use by the public.

BPOM Notice (Indonesian)

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Australia’s Therapeutic Goods Administration (TGA) has issued an alert about a shortage of Sanofi’s epilepsy drug Sabril. TGA Notice

Asia-Pacific Roundup: Indian medtech industry pushes back against reform bill

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