Asia-Pacific Roundup: India seeks feedback on harmonization plan

The Department of Pharmaceuticals (DoP) is holding a consultation into plans to align India’s regulatory standards with international best practices to encourage the development of novel medicines.

Officials in India have identified pharmaceutical research and development (R&D) to grow the industry and improve healthcare in the country. “As the country aspires to secure its place as a global leader in healthcare, it is imperative to have a comprehensive policy framework that can effectively address the multifaceted challenges plaguing the pharmaceutical sector,” according to the draft National Pharmaceuticals Policy 2023.

The draft policy touches on several areas, such as funding and capacity building, but regulation is central to the plan. Earlier documents identified a need for India’s regulations to evolve, adding elements that encourage R&D to the current focus on patient safety.

One section of the draft covers harmonization and the creation of “conducive regulations including price regulation and transparency with focus on quality.” The “imperative of regulatory harmonization” is at the core of the policy, explaining that “strategic move ... [can] create an environment that fosters innovation, ensures affordability, and prioritizes transparency within the pharmaceutical sector and complements the work of National R&D Policy.”

Aligning India's regulatory standards with international best practices is a way to balance innovation with safety, reducing compliance burdens and “ensuring that pharmaceutical companies can seamlessly adhere to global standards.” In the DoP’s view, “harmonization not only streamlines the research and development process but also enhances the credibility of Indian pharmaceutical products on the global stage.”

The policy identifies internal regulatory processes that the DoP wants to improve. The DoP sees a need to simplify the licensing system to “avoid duplication of efforts and to ensure better coordination among different regulatory [authorities],” as well as to “enhance ease of doing research and business and further to balance patient safety with product innovation measures.” Mandatory track and trace is one proposed action.

Another set of proposals deals with drug pricing in India. The DoP wants “to strike a balance that encourages fair pricing without stifling innovation.” By monitoring and regulating prices, the department aims to “reduce the financial burden on patients while maintaining a conducive environment for pharmaceutical companies to thrive.” The goal is to establish “a rational and transparent drug pricing mechanism” that balances “industry sustainability with affordability for patients.”

The desire to balance the interests of industry and patients is reflected in a plan to set up “mechanisms that prevent price manipulation and arbitrary increases.” The DoP sees the approach as bringing “stability to the market” and thereby increasing investor confidence, while also “safeguarding the interests of consumers.”

“Regulatory harmonization, price regulation and transparency are not just administrative processes but tools to ensure that patients have access to high-quality medicines and healthcare services when they need them the most. It fosters an ecosystem where Indian pharmaceutical companies can compete on the international stage, not just in terms of cost-effectiveness but also in terms of quality, innovation, and ethical practices,” the policy states.

The DoP is accepting feedback on the draft until 30 November.

Draft Policy

CDSCO seeks provider to build new digital drugs regulatory system

The Central Drugs Standard Control Organization (CDSCO) has shared details of its plans to improve the digital regulatory system in India. CDSCO outlined problems with the current system and its aspirations to fix them in a document designed to help find a software services provider to partner on the project.

In the 74-page document, CDSCO outlines its plans to develop a “unified digital ecosystem.” The new approach, which CDSCO calls the Digital Drugs Regulatory System (DDRS), is intended to ensure the quality of medicines sold in India and exported around the world.

“Once operational, all existing portals will be discontinued, and DDRS will serve as a single window, single sign on and unified portal for all regulatory activities. This platform is envisioned to serve as a new approach to [the] regulatory system. The system needs to be developed using a platform design approach, open-source technology stack and open standards,” CDSCO wrote.

The proposed platform differs from the current system. As CDSCO explains in the document, the Centre for Development of Advanced Computing, India has developed platforms to move regulatory processes online but the software has limitations. The platforms “have been mostly developed and implemented in silos over the years” and “are hosted and operated from individual domain names and have minimal integration with each other.” As such, “a single window experience” is impossible using the platforms.

Officials added that the “performance of these platforms has been found to be slow and inconsistent during peak load demands by the users.” The shortcomings of “in-built checks and balances” necessitate “manual verification of electronic data submitted by the applicants at various stages in duplicating efforts many times among officers.”

CDSCO is accepting expressions of interest from software service providers until 30 November.

CDSCO Notice

Singapore, Republic of Korea named WHO-Listed Authorities for ‘advanced level of performance’

The World Health Organization (WHO) has named the drug regulators in Singapore and the Republic of Korea as two of the first three authorities to comply with all of its indicators and requirements.

WHO established the indicators and requirements as part of its push to create a set of WHO-Listed Authorities (WLAs). WLAs are regulatory authorities or regional regulatory systems that comply with all the indicators and requirements and, as such, are recognized as trusted organizations that deliver rulings that other bodies can use to inform their own decisions.

Yukiko Nakatani, assistant director-general for access to medicines and health products at WHO, said the WLA program is intended to promote “confidence, trust and further reliance on authorities that have attained this global recognition, through the transparent and evidence-based pathway for designating and listing of WLAs.” Switzerland is the third WLA.

Other authorities will retain responsibility for deciding whether to use the WLA list. However, while noting that the decision “depends on the specific context of its intended use,” WHO expects users of the list to benefit from “a robust, transparent, evidence-based, global system for recognizing regulatory excellence serve the interests of a variety of stakeholders that are committed to promoting access to safe, effective and quality medical products.”

WHO Statement, HSA Notice

TGA extends oral cefalexin substitution as antibiotic shortage drags on

Australia’s Therapeutic Goods Administration (TGA) has extended the serious scarcity substitution instrument (SSSI) for oral anibiotic cefalexin.

TGA extended the SSSI, which was due to expire at the end of October, until 30 April 2024 after learning that supply disruption could continue over the coming months. The shortage began in December 2022 and, while it now only applies to syrups and suspensions, it continues to require regulatory flexibility to ensure patients can access medicines.

The SSSI allows pharmacists to substitute an alternative cefalexin syrup or suspension strength when the prescribed product is unavailable or dispense capsules if the prescribed product is unavailable and the patient can swallow.

TGA Notice

Asia-Pacific Roundup: India seeks feedback on harmonization plan

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