Progress and Pitfalls Part II - A Worldview of Regulatory Progress

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Regulations

Part 1 of this article discussed the history of medical and drug regulations and regulatory agencies in the United States, Britain, and the European Union, read it here. 

Part 2 continues, moving to three of Asia’s top medical markets, including China, Japan, and India.

CHINA

Inciting Incident

China’s regulatory history is long, with safety directives for medicines dating back to between 800 and 200 BCE. No inciting incident sheds light on why the early rules were promulgated. Impressive, given the comparatively recent 19th century kick-off of UK and US regulations.

Regulatory Response

Titled the Inner Canon of the Yellow Emperor (also Huangdi Neijing), this series of medical and health teachings includes a compilation of medicinal substances, purposes, and categorization into toxic and non-toxic categories. Other newer references followed, such as Shennong’s Classic of Materia Medica (25-220 CE). Shennong’s presented a lower, middle, and upper grading system of “365 medicinals” with the lowest grade considered toxic, to be used at the lowest possible dose only for emergent care (trading out as soon as initial improvement, or failure to improve, occurred). These writings and others included detailed collocation and processes to be followed. Despite their archaic origins, the records remain a cornerstone of modern Chinese medical doctrine today.

First Regulatory Agency

It would not be until 1950 that industrial modernization and regulatory oversight appeared when the People’s Republic of China Food and Drug Administration (CFDA) was formed. The division reported to the State Council of the PRC, setting rules and policies for food, drugs, medical devices, and cosmetics.

China’s regulatory journey was complicated by the State Council’s strict control of all drugs. In 1978, reforms set regulators and the drug industry onto a more development-oriented path. While it was progress, quality and safety challenges ensued. In the face of ongoing constraints from centralized control, China introduced an independent regulatory structure. The move increased motivation for regulators to monitor quality and safety to a degree.

Current Regulatory Agency

In 2018, the CFDA was renamed the National Medical Products Administration (NMPA). The revamped body kept its existing responsibilities, while opening pathways for foreign clinical trial data approved by NMPA standards. Other changes included a revised review and approval process which assigned responsibility for pre- and post-market approval activities for drugs and devices.

What About Packaging?

As their growth in the medical sector continues at an exponential rate, Chinese regulators have kept their administrative eye off packaging during the decades of change. Global ISO and ASTM standards have remained as reference points as the NMPA continued to prepare its own standards. In June 2022, new drafts were released by the Chinese Pharmacopoeia Commission. The drafts updated 46 drug packaging standards with public comments taken through September 1, 2022. The standards are slated to be finalized in the Chinese Pharmacopoeia 2025 Edition.

Other recent packaging updates include two new NMPA drug traceability standards for drugs manufactured for the China market. These include standards on how domestic and imported data must be presented in response to patient queries. An addition to the GS1/EMDC product identifier standard, the Drug Traceability Code must be called out to set it apart from other barcodes.

JAPAN

Inciting Incident

Japan’s earliest mention indicating the medicinal/pharmaceuticals industry appears to be 33 joint seal documents dated in 1658 from 33 “medicinal products retailers” in Doshomachi, Osaka. Those parties would today be pharma company representatives and had been conducting their business prior to the submission of the letters. The letters called for the regulation to protect against sales of “fake drugs.” The sealed nature of these complaints was a nod to their importance.

Regulatory Response

The direct outcome of the letters is unknown, but nearly 50 years passed before records show formal regulatory action related to “fake drugs.”

First Regulatory Agency

In 1722, the ruling shogunate, Tokugawa, opened drug testing facilities called Wayakushu Aratamekaisho in five cities, to stop “fake drugs” from reaching the markets. This served as the first formal regulating agency. Following WW2, Japan created the Enterprise Reorganization Act (1946) and Pharmaceutical Affairs Law (1948). Due to infrastructure damage, the restoration of companies as modern facilities in a new world took time. This allowed pharmaceutical leaders and governmental officials to work together to enhance the 1948 Pharmaceutical Affairs Law, finally enacting the law in 1960. Japan joined the international Global Harmonisation Task Force (GHTF) in 1993 as a partner in the organization’s goal to unite medical device regulators and industry.

Current Regulatory Agency

Modern Japan’s pharmaceutical and medical device regulations are managed (and developed) by the Ministry of Health, Labour and Welfare (MHLW). Since its inception in 2004, the implementation of policies is administered by the Pharmaceuticals and Medical Devices Agency (PMDA). The PMDA appoints regulators to act at the local government level. The PMDA branch, as the regulatory body, has persevered through multiple challenges. Using the trials as “lessons learned” has greatly improved processes and success. The PMDA has also made it a practice to share their experiences and assist other countries navigating regulatory practices. Many amendments over the years have advanced Japan’s commitment to quality, purity, and patient safety for the development of drugs and medical devices.

What About Packaging?

One of the most recent amendments to Japan’s packaging regulations for drugs and medical devices (2021) abolishes paper packaging inserts and information resources. The amended act requires electronic records that can be browsed. For OTC drugs and direct-to-consumer products, paper materials remain the requirement.

In June 2021, ISO released updated guidance in response to Japan’s proposal for a standard addressing “the isolator systems necessary for manufacturing pharmaceuticals…” The resulting standard, ISO 13408-6:2021 sets forth isolator system requirements for both drugs and medical devices, particularly focused on products that are not suited to traditional (heat) sterilization methods. The standard also includes design and validation, oversight and control, and employee training.

INDIA

Inciting Incident

In 1857, the British government assumed governance over India with the dissolution of the East India Company. The transition and influx of government officials led to discussions with the Indian Medical Service (IMS), a branch of the military for various forms of medical officers. Specifically, high mortality rates among the ranks (69 per 1000) due to illness and infection were noted. Poor sanitary healthcare practices came under scrutiny, planting the seeds for medical advancements and regulatory action.

Regulatory Response

By 1863, British India’s Commission of Public Health was formed, actively working to squelch epidemic threats to the public. One of the greatest challenges was that India presented an unfamiliar roster of endemic disease, such as leprosy, malaria, and bubonic plague. In response, the British appointed Sanitation Commissioners through the IMS.

While limited in authority, these regional officers were responsible for administering vaccinations against smallpox. They were also charged with setting up and maintaining vital statistics records of area populations and medical/vaccination records.

First Regulatory Agency

For more than half a century, it was a bumpy ride, followed by World Wars 1 and 2 which ultimately led to India’s independence on August 15, 1947. Ostensibly, India’s door for modern pharma and medical device industries cracked open in 1940, with its passage of the Drugs and Cosmetics Act of 1940. Among the rules it set forth (and many subsequent amendments), the Act established the Central Drugs Standard Control Organisation (CDSCO) as its regulatory agency.

 Current Regulatory Agency

The CDSCO remains in place as the regulatory authority for India’s drug and medical device approval processes. The Drug Controller General of India (DCGI) is an office within the CDSCO that approves licensing of many medicines.

India’s newest medical device industry regulations are detailed under the Medical Device Rules of 2017, as amended GSR 777(E) 10-2022. The overhauled rules are the latest update to India’s 1940 Drugs and Cosmetics Act.

While significant progress has been made since the 1940 Act established India’s medical product industries, much work remains to be done to harmonize practices at Indian state and “zone” levels.

What About Packaging?

India’s medical products industry is less than 80 years old. As such, the speed of evolution of the global drug and medical device marketplace has surpassed India’s ability to keep pace. As such, if medical device and terminal sterile barrier packaging standards have challenged global industry frontrunners, how much more would it elude India?

Packaging, or more directly, labeling requirements for India’s pharmaceuticals are stated in Drug and Cosmetic Rules (D. & CRs) 1945, Section 96, 97. Labeling requirements for medical device manufacturers are found in the same D & CRs, Section 109A.

That said, there is little available information regarding formal monitoring of packaging/labeling compliance for either pharmaceutical or medical device products licensed through the CDSCO.

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