Asia Regulatory Roundup: India Tightens Stem Cell Guidelines (17 September 2017)

Posted 17 October 2017 By Nick Paul Taylor

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

India Tightens Stem Cell Guidelines to Curb ‘Rampant’ Unethical Therapeutic Practices

India has tightened its guidelines on the banking and therapeutic use of stem cells in response to “rampant unethical practices.” The updated guidelines strengthen mechanisms for the review and monitoring of stem cell clinical trials and prohibit commercial banking of most biological materials.

The guideline reiterates that stem cell use is investigational and as such can only be performed in clinical trials. The Indian Council of Medical Research (ICMR) adopted the same position in 2013. What has changed are the mechanisms in place to stop the circumnavigation of restrictions on the use of stem cell therapies.

ICMR’s guidelines states sponsors must gain approval from the Central Drugs Standard Control Organization (CDSCO) before starting clinical trials of stem cells. Trials can only take place at Institutional Committee for Stem Cell Research registered sites and under the oversight of medical professionals registered with the Medical Council Of India.

These rules apply to all stem cell trials. ICMR has also introduced tiered regulatory requirements tied to the level of manipulation performed on the stem cells. Cells that undergo genetic modifications are subject to different regulatory requirements than those that are used in a form close to their natural state.

The decision to restrict commercial banking of biological materials received immediate pushback from the industry. ICMR found no scientific evidence “to substantiate clinical benefits with the use of stem cells derived from cord tissue, placenta, tooth extract, adipose tissue, dental pulp, menstrual blood and olfactory ensheathing cells.” Given Indian companies’ offers to bank these materials, the institute is concerned about the “exploitation and commoditization of the resources.”

CDSCO only permits and licenses umbilical cord banking. ICMR wants the regulator to enforce this rule. Affected companies want the freedom to bank a range of materials. 

LifeCell, an Indian stem cell bank with a menstrual blood service, said the guidelines disregard global practices and are inconsistent with local regulatory decisions. Most importantly for LifeCell’s business, it thinks the guidelines misguidedly attack biological banks to curb therapeutic misuse.

On LifeCell’s website, “Lisa” says, “Stem cells saved my life, it could save yours, too.” Yet, in attacking the guidelines, the company argues that while stem cells are not ready for use as treatments, there is a need to bank biological materials for a future in which they are approved therapeutics

“It is imperative that the [government] should impose a strict ban on usage of these [mesenchymal stem cells]s for treatments today and ensure compliance but not restrict preservation for the future,” Mayur Abhaya, the CEO of LifeCell, said. “I’m sure the [Drug Controller General of India] would take a fair view to provide the opportunity to preserve these stem cells for future use considering the advancing opportunities in research and clinical trials.”

Publication of the final guideline comes three months after ICMR released a draft text for review.

Final Guidelines, LifeCell Statement

CFDA Moves Quickly to Implement Reforms to Clinical Trials, Approval Process

China Food and Drug Administration (CFDA) has quickly implemented the reforms proposed by the State Council. The agency issued a notice this week stating China will lift its restrictions on its involvement in multicenter Phase I studies.

CFDA posted its notice the day after the State Council put forward major reforms that will affect how drugs and devices are developed and approved for use in China. The CFDA notice contains no new proposals but is notable in that it means the State Council’s reforms are moving forward fast.

The CFDA notice marks the implementation of four proposals from the lengthy State Council text. These proposals cover many of the headline reforms, including the liberalization of rules about the involvement of Chinese sites in multicenter phase 1 trials.

CFDA’s rapid implementation of the changes — its notice came one day after that of the State Council — reflects the agency’s familiarity with the reforms and desire to reshape drug and device development and approval processes. Many of the reforms proposed by the State Council were based on changes put forward by CFDA in a draft policy document earlier this year.

CFDA Notice (Chinese)

Australia Commits to January Introduction of Black Triangle Drug Safety Scheme

Australia will introduce a black triangle adverse event reporting scheme in January. Mirroring the European Union’s scheme, the initiative will add inverted black triangles to the packaging of new medicines to encourage doctors and patients to report adverse events linked to these drugs.

The Therapeutic Goods Administration (TGA) first floated the idea of a 1 January 2018 start date for the black triangle scheme in a targeted consultation paper 11 months ago. However, that date was absent from a more recent consultation, raising doubts about when the program would go live. TGA has now dispelled those doubts by officially stating the scheme will start in January.

From January onward, most newly registered prescription medicines will join the scheme. The exceptions are biosimilars, generics and seasonal flu vaccines, all of which are supported by years of adverse event reports on their predecessors by the time they come to market.

The product information (PI) and consumer medicines information (CMI) sheets of products in the scheme will feature an inverted black triangle symbol and accompanying text. Manufacturers must put the symbol at the top of the first page of the PI and CMI. The accompanying text states the drug is subject to additional monitoring and doctors and patients should report side effects.

TGA’s decision to implement the scheme follows a consultation on the initiative and other aspects of its medicine monitoring plans. The industry broadly welcomed the black triangle, but sought clarification on a range of issues. TGA addressed some of these questions in a notice about the start of the scheme. Clarifications include confirmation drugs will carry the symbol for five years.

TGA Notice

NPPA Gives Hospitals 7 Days to Explain Failures to Comply With Device Price Rules

India’s price watchdog has warned more than 20 hospitals for failing to comply with its rules on orthopedic knee implants. The National Pharmaceutical Pricing Authority (NPPA) has given the hospitals a week to explain why they are yet to add knee implant prices to their websites.

NPPA’s August notice introducing the knee implant price ceiling tasked “every distributor, dealer and institution” with making their price lists easily accessible. In practice, NPPA wants hospitals to display the price they charge patients for each type of knee implant on the homepages of their websites. The price list should feature the device’s brand name, specifications and manufacturer.

The price watchdog gave hospitals three days to comply when it issued the notice in August. Almost two months later, at least 21 hospitals are yet to upload the information to their website homepages.

In response, NPPA has sent a letter to the hospitals, copying in the relevant state drug controllers. The letter gives the hospitals seven days to explain why they have failed to comply with the rule. It is unclear from the letter what, if anything, NPPA will do if the hospitals fail to respond.

NPPA Notice

Other News:

TGA has unveiled changes to the format of PI documents. The changes are intended to ensure important information is collated at the front of the document. TGA Notice

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Categories: Biologics and biotechnology, Drugs, Medical Devices, Regulatory strategy, Regulatory intelligence, News, Asia, CFDA, CDSCO, TGA

Tags: Asia Regulatory Roundup, stem cells, black triangle

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