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Asia Regulatory Roundup: India Proposes Rules on Manipulated Cell- and Tissue-Based Therapies

Posted 11 April 2018 | By Nick Paul Taylor 

Asia Regulatory Roundup: India Proposes Rules on Manipulated Cell- and Tissue-Based Therapies

Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia.

India Proposes Rules on Manipulated Cell- and Tissue-Based Therapies

India has released draft rules covering the manipulation of human cells and tissues for therapeutic purposes. The rules define the types and levels of cell and tissue manipulation that will result in the material being classifed as a therapeutic cell-based product for regulatory purposes.

National Guidelines for Stem Cell Research published late last year by the Indian Council of Medical Research and Department of Biotechnology base the level of regulatory oversight applied to products on the extent to which cells or tissues are manipulated. Cells that undergo basic processing steps such as isolation and washing are classified as minimally manipulated and subject to less oversight than stem cells that are genetically modified before being administered to patients.

The publication created a framework for oversight of the development and use of cell therapies. However, the current Drugs and Cosmetics Rules of 1945 make no mention of these considerations. Cell therapies are absent from the list of products classified as drugs under the rules.

Draft rules published this week would change that. The plan is to add a new clause defining cell- and stem-cell-based products as drugs that have “been derived from processed cells including cell or tissue which has been processed by means of substantial or more than minimal manipulation with the objective of propagation and/or differentiation of a cell or tissue, cell activation and production of a cell-line.”

The draft proposal echoes the language used in last year’s guidelines. Any ex-vivo alteration of a cell population expected to alter function, such as T-cell depletion, is classified as substantial manipulation under the draft rules. Cells that undergo such manipulation will be treated as drugs for regulatory purposes.

To avoid this level of oversight, healthcare professionals and researchers must meet India’s definition of minimal manipulation. Processing steps such as isolation, washing and centrifugation are acceptable. The definition of minimal manipulation is based on that established in last year’s guidelines.

Indian officials are accepting feedback on the draft rules for 45 days.

Draft Rules

More Resources Enable TGA to Increase Number, Timeliness of Inspections

The Therapeutic Goods Administration (TGA) of Australia increased its manufacturing site inspection activities in the second half of last year. TGA assessed 30% more local manufacturers than over the corresponding period in 2016 as the effect of its greater inspection resources began to take effect.

From July to December 2016, TGA inspected 74 Australian manufacturers. Last year, the number came in just shy of 100. TGA attributed the sharp rise to the availability of more resources and a switch to shorter inspections. The period also saw an increase in the proportion of Australian manufacturers inspected within three months of application. Ninety-two percent of sponsors received such a timely inspection in the second half of 2017.

TGA’s attempts to process applications faster have yet to translate into improvements across its whole operation. The proportion of re-inspections performed within six months of the due date remains at around 70%. Similarly, the processing times for overseas manufacturers remained static. TGA is still performing around half of initial inspections within six months and 60% of re-inspections within six months of the due date. The agency kept at these levels while inspecting 63% more foreign sites.

The medical device inspection unit reported bigger shifts in the proportion of quality management system audits it carried out within allotted times. However, as the unit performs relatively few audits, the figures are prone to greater variance.

TGA Report

CDSCO Registers First Notified Bodies Amid Reports of Slow Progress

India’s Central Drugs Standard Control Organization (CDSCO) has registered its first two notified bodies. News of the registrations comes amid reports that disappointment with the fee structure among potential applicants has slowed uptake.

CDSCO established the notified body program to facilitate the audit of manufacturing facilities under the medical device rules that came into force at the start of the year. The program started to gain traction this week when the Indian units of multinational inspection, testing and certification businesses, Intertek and TUV Rheinland, became the first to be registered by CDSCO.

Intertek and TUV’s early involvement suggests multinational organizations see India’s notified body program is an opportunity worth pursuing. However, Pharmabiz reports some industry insiders think the fee structure is too tight.

“The proposed fee structure is much less than the compensation practices prevailing in the industry. It will be difficult to get competent firms as notified bodies if the government refuses to loosen purse strings,” an official from one quality certification company told the Indian trade publication.

India is offering notified bodices around $300 per man day for site and product assessment audits. A further $185 in travel expenses per auditor is available.

Perceptions that the sums are too meagre to make working as a notified body in India viable could have major implications for the medical device rules. India needs enough certified notified bodies to oversee the medical device manufacturing sector, which the government hopes to see grow as a result of its “Make in India” initiative and other programs. A shortfall in notified bodies could stymie efforts to grow the sector while raising standards.

CDSCO Notice, Pharmabiz

Japan’s PMDA Posts Draft Views on Continuous Manufacturing

The Japanese Pharmaceuticals and Medical Devices Agency (PMDA) has published draft views on the use of continuous manufacturing. PMDA sees efficiency benefits to the adoption of the approach and has shared advice to help manufacturers realize this and other improvements.

Traditionally, pharmaceutical manufacturers have used batch processing. This approach features a series of distinct steps, between which activity stops. In contrast, continuous manufacturing is an uninterrupted process that converts raw materials into finished products. Regulators, including the US Food and Drug Administration, have argued continuous manufacturing is faster, more reliable and safer, contributing to a gradual increase in adoption.

Now, PMDA is doing its bit to move things along. The draft document published by the agency lays out how to design a control strategy, validate process performance and perform stability tests that enable the adoption of continuous manufacturing.

Publication of the document marks the culmination of nearly two years of work by Yoshihiro Matsuda and other PMDA scientists involved in the agency’s Innovative Manufacturing Technology Working Group. Over that time, PMDA officials have met with their counterparts in the US and Europe and discussed continuous manufacturing with industry and academia. The result is a text intended to further PMDA’s policy of encouraging companies to introduce innovative production technologies.

PMDA Draft

Other News:

The website of China’s new regulatory umbrella group has gone live. Visitors to the China Food and Drug Administration (CFDA) site are now redirected to the landing page for the State Administration for Market Regulation (SAMR). The new SAMR website links out to the old CFDA homepage. China’s President Xi Jinping framed the creation of SAMR as part of an attempt to bring more investment to the country in a speech this week. SAMR Site (Chinese), Xinhua

CFDA is recruiting 40 people to work at its drug evaluation unit. Around half of the new hires will work directly or indirectly on drug reviews. The remaining 19 people will take up general management positions. CFDA Notice (Chinese)

TGA is surveying consumers and healthcare professionals about their experiences of its adverse event reporting system. TGA Notice

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