Asia-Pacific Roundup: India’s CDSCO posts draft legislation on manufacturing change approvals, notifications

India’s Central Drugs Standard Control Organization (CDSCO) has introduced draft legislation describing the requirements for informing authorities of manufacturing changes.

The proposed revisions to the Drugs Rules, 1945 apply to “any change in manufacturing process, or excipients, or packaging, or shelf life, or specifications, or testing, or documentation, etc.” Manufacturers will need to inform the licensing authority of such changes, although the specifics will depend on the nature of the revisions.

CDSCO has proposed grouping changes with substantial potential to have an adverse impact on the identity, strength, quality, purity, or potency of a drug product. Under the draft legislation, CDSCO will categorize such revisions as major quality changes. Manufacturers need to obtain prior approval from the licensing authority to make such Level I changes.

Companies will also need to obtain prior approval before making changes with a moderate potential to have an adverse impact on the identity, strength, quality, purity, or potency of a drug product. CDSCO plans to categorize such revisions as Level II changes.

Manufacturers can implement most minor quality changes with minimal potential to have an adverse impact on the identity, strength, quality, purity, or potency of a drug product without obtaining approval. Changes in the shelf life of the drug substance and drug product are exceptions to the rules on minor, Level III changes.

CDSCO said companies should tell the licensing authority of any change in the manufacturing process, excipients, packaging, shelf life, specifications, testing, or documentation in writing within 30 days. Other sections of the proposed legislation state manufacturers need prior approval for moderate and major changes and should submit minor changes annually in the first quarter of the calendar year.

CDSCO Notice

WHO names Singapore’s HSA as first agency to achieve highest tier of medtech regulation

Singapore’s Health Sciences Authority (HSA) has become the first regulatory agency to achieve the top level of regulatory performance for medical devices under the World Health Organization’s (WHO) global benchmarking framework.

HSA reached maturity level 4 (ML4). WHO awarded the status after using its Global Benchmarking Tool Plus for medical devices to assess HSA. The assessment showed HSA “operates at an advanced level of performance with mechanisms for continuous improvement, and consistently ensures the safety, quality, and performance of medical devices throughout their life cycle,” WHO said.

Yukiko Nakatani, WHO assistant director-general for health systems, access, and data, said HSA’s ML4 achievement shows the impact of sustained investment in regulatory capacity and provides a reference point for other countries working to strengthen their systems. Globally, 32% of regulatory authorities can fully ensure medicines, vaccines, and other health products meet required standards, according to WHO.

In 2022, HSA was the first agency to achieve ML4 for a medicines regulatory system. WHO recognized HSA as a Stringent Regulatory Authority for high-risk in vitro diagnostics (IVDs) in 2023. The recognition means HSA-registered IVDs qualify for the expedited assessment pathway under WHO’s prequalification program.

HSA disclosed its ML4 status for medical devices at the International Medical Device Regulators Forum (IMDRF), which Singapore hosted last week. The agency used the event to reveal plans to apply for full membership of the Medical Device Single Audit Program (MDSAP) in the second half of the year. HSA is currently an official observer. Full MDSAP membership would allow HSA to play a bigger role in the body.

The agency also used the IMDRF meeting to formalize its regulatory reliance program with Malaysia's Medical Device Authority and sign a safety memorandum of understanding with Uzbekistan’s Ministry of Health Centre for Pharmaceutical Products Safety. Uzbekistan has a medicine reliance pathway tied to ML4 agencies and will explore setting up a similar mechanism for medical devices with HSA.

WHO Statement, HSA Notice, More

Reports of GLP-1 promotion spur CDSCO to clarify ban on direct and indirect drug marketing

Alleged promotion of GLP-1 receptor agonists has led CDSCO to clarify that direct and indirect marketing of prescription-only medicines is banned in India.

CDSCO said certain pharmaceutical companies may be engaging in direct or indirect promotion of GLP-1 medicines, which are used to treat diabetes, overweight, and obesity. The alleged promotional activities include disease awareness campaigns and digital media outreach. CDSCO responded by clarifying the rules on disease awareness campaigns that serve as surrogate adverts for prescription-only medicines.

“Any promotional activity carried out under the pretext of disease awareness, influencer engagement, corporate campaigns, or similar activities that create brand recall/product visibility of the prescription product, shall also be treated as violations,” CDSCO said.

The ban covers any direct or indirect promotional activity in print, electronic, digital, social media, or any other public platform that is intended to promote the product to the general public. CDSCO said it views indirect adverts seriously and will treat them as an irrational or misleading marketing practice.

Novo Nordisk sells its injectable GLP-1 drug semaglutide as Ozempic for diabetes and Wegovy for obesity in India. Eli Lilly won approval for its rival diabetes treatment Mounjaro last year. A key semaglutide patent expires in India this week. Multiple companies have outlined plans to launch generic copies of the drug.

CDSCO Notice

New Zealand’s Medsafe seeks feedback on raising vitamin D limit for general sale medicines

The New Zealand Medicines and Medical Devices Safety Authority (Medsafe) is holding a consultation on plans to double the amount of vitamin D permitted in general sale medicines.

Currently, patients need a prescription to access medicines containing more than 25 micrograms (mcg) per daily dose in New Zealand. Medsafe has proposed increasing the threshold to 50 mcg. The Medicines Classification Committee rejected a request to raise the limit to 75 mcg last year, concluding that while vitamin D deficiency is an issue in New Zealand, the change would exacerbate existing problems.

Medsafe commissioned independent advice from an expert who concluded the limit should be raised to 50 mcg. The conclusion reflected evidence that adverse events are rare and relatively mild at 50 mcg and that raising the limit to 75 mcg is excessive and less safe.

Officials want feedback on whether people agree that the benefits of increasing the limit to 50 mcg outweigh the risks and that the downsides outweigh the upsides at 75 mcg. Medsafe also asked whether people see significant risks to consumers self-selecting products containing a daily dose of 50 mcg.

The consultation closes on 2 April.

Medsafe Consultation

Other News:

India’s Drugs Technical Advisory Board (DTAB) has recommended changes to the rules on submitting periodic safety update reports. Currently, companies file reports every six months for two years and then switch to annual submissions. DTAB has recommended changing the schedule for vaccines and modified- or sustained-release drugs. The schedule for other drugs will stay the same. Meeting Minutes

The Philippine Food and Drug Administration (FDA) has clarified a notice about moving to its eServices system. Companies must use eServices, not ePortal, for all initial applications. The agency said stopping accepting ePortal filings will facilitate the switch to eServices. FDA is still using ePortal for renewals, reapplications, and amendments related to products initially approved through ePortal. FDA Notice

CDSCO has stopped accepting offline license submissions for recombinant DNA products. The Indian regulator now requires applicants to use its Online National Drug Licensing System. CDSCO Notice

Asia-Pacific Roundup: India’s CDSCO posts draft legislation on manufacturing change approvals, notifications

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