The 7th Japan-India Symposium on Regulation of Medical Products held in New Delhi
December 12, 2024
The 7th Japan-India Symposium on Regulation of Medical Products was held in New Delhi, India on July 10, 2024. The symposium was organized by the Ministry of Health, Labour and Welfare (MHLW), the Pharmaceuticals and Medical Devices Agency (PMDA), and the Central Drugs Standards Control Organization (CDSCO) of the Indian Ministry of Health and Family Welfare. The symposium was organized by the Ministry of Health and Family Welfare of India and the Central Drugs Standards Control Organization (CDSCO). The symposium aims to improve the level of pharmaceutical regulations in Japan and India and to facilitate regulatory compliance by industry by sharing the latest trends in the regulation of pharmaceuticals, medical devices, and regenerative medicine products, as well as issues and proposals from industry, and by discussing international regulatory harmonization and cooperation. In the pharmaceuticals session, the PMDA presented quality control of APIs, the JPMA presented e-Labeling, and the CDSCO presented recent GMP revisions. The discussion was lively and included questions from the industry. Here is a report on the main topics related to pharmaceuticals.
Overall Photo
Introduction
The India Group of the Asia Subcommittee of the International Committee of the Pharmaceutical Manufacturers Association of Japan (PMAJ) consists of about 10 members and is working daily to resolve issues faced by Japanese companies in the region. The exemptions from clinical trials for drug registration and the quality assurance of APIs and formulations manufactured in India are prioritized issues because of their significant impact on the business of each company, and this symposium has been used as a forum for proactive problem-solving. This time, members of the India Group, the chairpersons and vice chairpersons of the Asia Subcommittee, the Secretariat of the Pharmaceutical Manufacturers Association of Japan (PMAJ), and the Executive Director arrived in India. The day before the symposium, we visited the New Delhi office of the OPPI and had a strategy meeting with local foreign companies to confirm a common understanding of the issues faced by the industry. We are grateful for the opportunity to solve the issues together with the OPPI members and Japanese regulators.
Due to the Corona disaster, we have not been able to hold face-to-face meetings for some time, but we were able to meet together in New Delhi and deepen our relationship by listening to the true opinions of local stakeholders in various parts of the country. Just prior to the symposium, Prime Minister Fumio Kishida (at the time of holding) held a summit meeting with Prime Minister Narendra Modi at the G7 Summit on June 15, and expressed his desire to "further diversify and deepen the relationship between the two countries. Based on the good relationship between the two countries, I am very grateful that this symposium provided an unshakable opportunity to further strengthen cooperation between the two countries in the area of medical products and to contribute to patients around the world through the creation of innovative pharmaceutical products. I sincerely hope that this symposium and the related dialogue on healthcare between Japan and India will continue in the future.
Opening Ceremony
After opening remarks from the regulatory authorities of both countries, Ms. Sachiko Nakagawa, Executive Director of the Pharmaceutical Manufacturers Association of Japan (PMAJ), delivered remarks on behalf of the Japanese pharmaceutical industry. She mentioned the protection of intellectual property and appropriate pricing to ensure that new innovations are created and continue to be created, and expressed her thoughts on achieving universal health coverage. In addition, lamplighting took place. Lamplighting has a special meaning to the participants, symbolizing knowledge, success, and good beginnings, while respecting traditional culture.
Lamplighting, a ritual deeply rooted in Indian culture
Regulatory Update
First, Dr. Ranga Chandrasekhar, Joint Drugs Controller of CDSCO, gave a presentation on quality control throughout the product life cycle from development to marketing. India has revised Schedule M (GMP outline) in December 2023, and will gradually introduce it in the future. Risk Management (PQR) and Quality Risk Management (QRM). The target group is categorized as large companies with sales over Rs. 2.5 billion and smaller SMEs, each with different implementation timelines. Since India has a large number of SMEs, CDSCO holds workshops on a regular basis to provide training to alert them to the issue. Joint inspections by the national and state governments have been introduced to eliminate differences, as interpretations may differ from state to state. Recent efforts to strengthen the regulatory system include more stringent quality testing of cough syrups for export, and he also mentioned ease of doing business by improving transparency, accountability, and speeding up approvals.
Next, Mr. Daisuke Tanaka, Director of PMDA's International Affairs Department, shared the latest initiatives: PMDA has shortened the review period by 2022 compared to 2006, and is eliminating drug loss to achieve a rapid and stable supply of drugs. Drug losses are particularly high for rare diseases and pediatric drugs. In order to solve this problem, the regulatory framework is being studied from the viewpoints of development promotion, clinical trials, post-marketing surveillance, quality, and information dissemination. The report also covers topics including the need for Phase I trials in Japan, PMDA's future plans for start-ups and ventures, overseas collaboration sites, drug inspection agreements and the Pharmaceutical Inspection Cooperative Scheme (PIC/S) office, and Japan's 2024 NHI price revision, and discusses a wide range of initiatives to improve access to medicines from multiple perspectives. The session also covered topics including the Pharmaceutical Inspection Convention and the Pharmaceutical Inspection Cooperative Scheme (PIC/S) Office, and Japan's 2024 NHI price revision.
During this session, the Pharmaceutical Manufacturers Association of Japan (PMAJ) asked the CDSCO, "We have heard that you are planning to issue guidance on Ph4 trial exemptions, but we would like to know if you have any updates. You also talked about clarification of clinical trial requirements today; do you have any guidance you can confirm?" I asked. In response, CDSCO replied, "For clinical trials, it is based on the 2019 New Drugs and Clinical Trials Regulations. If the product has already been approved in another country, there are cases where exemptions may be granted depending on the requirements, albeit on a conditional basis. He added that this guideline is being revised and prepared for the list of reference countries, including Japan.
As a later note, as of August 7, 2024, the CDSCO published an Order on the CDSCO website regarding the countries and categories of exemptions from clinical trials, exempting five categories of drugs from clinical trials in India if they are approved in six locations (the United States, the United Kingdom, Japan, Australia, Canada, and the European Union). The five categories are: orphan drugs, gene and cell therapy products, new drugs used in pandemic situations, new drugs used for special defense purposes, and new drugs that represent a significant advance over the current standard of care.
Pharmaceutical Session
Mr. Kenichi Mikami, Director of PMDA's Drug Quality Control Department, shared the latest topics related to the quality control system for pharmaceutical products in Japan, including the results of PMDA's on-site inspections. He introduced GMP-related regulations in Japan, types and scope of GMP conformity investigations, risk-based decision-making cycle of inspections, and comparison of conventional investigation systems by product category. Sh. Arvind Kukrety, Deputy Drugs Controller, CDSCO, then shared the revised GMP requirements for active pharmaceutical ingredients, including drug regulations and their framework, standards and the Indian Pharmacopoeia, and approval and licensing requirements after approval. The Indian Pharmacopoeia Board assures quality and safety and sets all necessary standards for testing and analysis of pharmaceutical products. Standard products in India must be obtained from this Pharmacopoeia Board and must comply with the requirements
The Pharmaceutical Cooperative also identified regulatory harmonization of this pharmacopoeia as a priority and asked the CDSCO the following questions.
（I have a question regarding the availability of standard products of the Indian Pharmacopoeia. We are facing a situation where there is no Japanese distributor that handles standard products. We have asked several Japanese distributors, but none of them carry the standard products and will not do so in the future. We purchase directly from the Indian Pharmacopoeia Board, but this direct purchase is not smooth. What is your opinion on the situation where the unavailability of standard products is a barrier to inclusion in the Indian Pharmacopoeia and the difficulty in conducting tests in compliance with the Indian Pharmacopoeia? We would like to know if you have any ideas to improve the situation, such as strengthening the procurement of standard products or expanding the number of distributors.
CDCSO responded as follows
(CDSCO) There are various standards, but most of them cover generics. We are making efforts to be able to refer to pharmacopoeias from other countries, but it is difficult. There has been little awareness of the situation for out-of-country companies, where standard products exist but procurement is not possible. We would like to understand this issue and share it with the Pharmacopoeia Committee to solve the problem of procurement of standard products.
Indian group members pose questions to the CDSCO and urge
to resolve the issues.
Supplementary comments in this regard were made by a local Japanese company's pharmaceutical representative to promote understanding of the CDSCO.
(Local representative): We are having trouble with procurement. In particular, the process is not rational and procurement is not possible. There is a current situation where everything has to be communicated by e-mail, etc. Communication within India is possible online, but it is difficult for manufacturers outside of India.
CDSCO told us that there was no one from the Pharmacopoeia Committee on the spot, so they would check again. Subsequently, at a meeting between the regulatory authorities the day after the symposium, PMDA again confirmed this issue with CDSCO and encouraged them to resolve it.
Furthermore, in August, the month following the symposium, we received word from the local authorities that an online portal for pharmacopoeias had opened in India. This portal also allows for the purchase of standard products, which we hope will lead to smooth procurement.
Rie Matsui, APAC e-labeling EWG Leader from the Pharmaceutical Manufacturers Association of Japan (PMAJ), then took the podium to give a presentation from an industry perspective on the implementation of e-labeling in Japan and Asia. e-labeling is a formal document that provides information about a drug product based on the conditions of drug approval. The requirements for e-labeling vary from country to country, and include paper and electronic media, as well as for patients and healthcare professionals. The paper product inserts that are included with the product are intended for different countries. In the EU, the information is intended for patients, while in the U.S. and Japan, the information is intended for health care professionals. In many Asian countries, most labeling is only for healthcare professionals, and only about 30% of countries have labeling for patients. The definition of e-labeling differs from country to country and region to region, but there are five main advantages The symposium will conclude with a presentation by CDSCO.
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Latest product information online
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QR codes and GS1 codes allow medical professionals and patients to access reliable information
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Paper media can be eliminated
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Can be structured based on standards, etc.
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Interoperable with other medical systems, etc.
As part of the industry efforts made when e-labeling was introduced in Japan, an industry group together with MHLW/PMDA conducted an awareness campaign to educate medical professionals. Comparing e-labeling initiatives in the Asian region, Japan's efforts are more advanced, but seven markets in the Asian region have recently issued e-labeling guidance. In addition, this e-labeling initiative is designed primarily for healthcare professionals, not for patients. The creation of structured e-labeling based on electronic standards will enable interoperability with personal health records and electronic prescriptions, provide personalized drug information, and offer other benefits, and discussions are underway in India to establish standards for its introduction in the healthcare sector. Discussions are underway in India to establish standards for the introduction of this technology in the medical field.
In response to this presentation, a question was raised from the floor. The question was raised from the floor: "Will e-labeling be applied to all medical products (vaccines, biopharmaceuticals, etc.)? What kind of regulation is it subject to? Is it for export or domestic use, and will companies be held responsible?
In response, Mr. Matsui said, "E-labeling applies to prescriptions and vaccines, but not to OTC products. So far, pharmaceutical companies have been able to comply with regulations and have not experienced any regulatory action." He responded.
Rie Matsui, a speaker from industry at the e-labeling session
Closing Remarks
Mr. Ranga from CDSCO took the stage at the end of the symposium to deliver closing remarks.
Mr. Ranga referred to the Memorandum of Cooperation (MOC) signed in 2015 between the Ministry of Health, Labour and Welfare of Japan and the Central Drugs Standards Control Organization, Ministry of Health and Family Welfare, Government of the Republic of India on a framework for dialogue and cooperation on medical product regulation, which has been He noted that this MOC is one of the most functional MOCs India has ever signed and that both India and Japan have been actively working and engaging on common goals. He expressed gratitude for Japan's continued support for capacity building in India, saying that this endeavor not only informs best practices, but also supports the industry and promotes industry compliance, which, if achieved, will be a great success. He also expressed India's desire to become a highly innovative supplier of medicines and to create innovation in the world. It seems that the goal of the Indian authorities is to be recognized as a highly reliable base, including in manufacturing.
Both countries need to cooperate with each other to continuously create high-quality, highly innovative innovations in the future, deepen their relationship, and continue multifaceted discussions through industry-government-academia collaboration. I sincerely hope that this good relationship will continue to be a beacon of light in medical care at all times, delivering medicines promptly to patients around the world who are waiting for new medicines.
(Chika Kuwahara, Leader, India Group, Asia Division, International Committee)