Asia Regulatory Roundup: India Seeks Feedback on Medical Device Safety and Performance Principles (25 July 2017)

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India Seeks Feedback on Essential Principles for Medical Device Safety and Performance

India has released draft guidance on the safety and performance of medical devices. The text gives companies flexibility in how they meet the design and manufacturing requirements officials see as essential to the safe, effective functioning of medical devices.

Officials at the Ministry of Health have selected seven essential principles that apply to all types of medical device and a longer list of requirements that only apply to certain classes of product. The onus is on manufacturers to select which of the requirements — which are split between in vitro diagnostics and other types of device — apply to their products and explain their reasoning for ignoring the others.

The wording of the principles, particularly the seven seen as essential for all medical devices, is broad enough to provide direction to manufacturers without imposing specific ways of working on them. This is illustrated by the third of the essential principles.

"Medical devices should achieve the performance intended by the manufacturer and be designed, manufactured and packaged in such a way that, during normal conditions of use, they are suitable for their intended purpose," the draft guidance states. The other six essential principles are similarly broad in scope and open for interpretation by the companies tasked with meeting them.

That flexibility extends to the more specific requirements that apply to certain types of medical device. For example, the guidance opts against enforcing particular testing practices on manufacturers with devices that incorporate biological materials. Instead, the text calls for companies to cut the risk of infection "as far as reasonably practicable" by choosing appropriate sources, donors and substances and using whatever mix of validated inactivation, conservation, test and control procedures works for them.

The model applied to the risk of biological materials, in which the goal is outlined and possible strategies suggested, recurs throughout the guidance in sections on labeling, software, radiation, drug-device combinations and anything else that may affect safety and performance. This way, the government sets out the broad characteristics it wants medical devices sold in India to possess without dictating exactly how companies must reshape their operations to meet its expectations.

Officials drafted the binding guidance to meet a provision of the Medical Devices Rules, 2017. The Drug Controller General of India (DCGI) is now accepting feedback on the draft ahead of the rules coming into force at the start of next year.

Draft Guidance

Drugmakers Tentatively Back TGA Work-Sharing Plan, Bring up Concerns with Aligning Timelines

Drugmakers including GlaxoSmithKline and Novartis have provided tentative support for Australia's plan to assess drug approval applications in collaboration with overseas regulators. Yet outstanding questions about topics including how the Therapeutic Goods Administration (TGA) will synchronize its evaluation timeline with those of its collaborators mean the jury is still out on the proposal.

TGA outlined its plans to work more closely with comparable overseas regulators (CORs) last year after being pushed to do so by an independent regulatory review panel. The proposal included a section on work sharing. Adoption of this model would see sponsors file for approval at TGA and another regulator simultaneously, after which the agencies would each take responsibility for parts of the submission. After reviewing a module, TGA would share it with its collaborator, cutting the time each agency commits to the filing and potentially shortening the review duration.

Those potential outcomes won the proposal the broad support of many of the large biopharma companies that responded to the call for feedback. However, as some of the companies see it, some major obstacles need working through before the model is adopted.

"Bayer requests the TGA to provide further clarity on how the work-sharing cooperation process will work as the evaluation process timeline differs between agencies and therefore robust communication channels and processes need to be developed before the process starts," the German conglomerate wrote in its feedback. GSK, Johnson & Johnson and Shire also mentioned the topic in their submissions.

TGA received more wholehearted industry support for the topics that were the primary focus of the consultation. The agency set out to learn whether its proposed two-step process for identifying opportunities for collaboration and criteria for choosing CORs are suitable. Many companies wrote in support of the process and selection criteria.

The question, as raised in the feedback, is whether TGA can establish a framework that facilitates effective collaborations with other regulators. This would address the timeline synchronization question and others raised by the industry, such as how TGA will access unredacted reports from CORs.

TGA will now work through the feedback before publishing the final COR criteria and other details later this year.

Industry Feedback

India Names and Shames Pfizer, Other Drugmakers over Prevalence of Substandard Products

India has published a list of companies that manufactured products found to be substandard in its National Drug Survey. The list includes Pfizer, Dr Reddy's Laboratories and 64 other companies that manufactured five or more products ruled to be not of standard quality (NSQ).

Pfizer is the biggest drugmaker on the list. Testers found 25 drug samples taken from the Western company were substandard. That put Pfizer 11th on the list of companies with the most NSQ products. Dr Reddy's was 36th with nine NSQ drugs. Pfizer's presence stems in part from its size, although an earlier analysis of the same data linked it to a more than 50% NSQ rate in one state.

The companies above Pfizer on the list are all local manufacturers. Unicure topped the list with 61 NSQ samples tested. Halewood Laboratories and Scott-Edil Pharmacia took the second and third spots with 48 and 45 NSQ samples, respectively.

Officials at the Ministry of Health decided to publish the list months after the full findings of the survey went online. The government published the report in February, before deciding to single out the companies responsible for the most NSQ drugs at a meeting last month.

CDSCO Notice

India Seeks Feedback on Updated Guidelines for Stem Cell Research

India has released guidelines for stem cell research for consultation. The update seeks to bring the guidelines in line with advances since the document was last amended in 2013.

Topics assessed by the Indian Council of Medical Research (ICMR) and Department of Biotechnology in the latest version include germline editing using technologies such as CRISPR-Cas9. The document restricts the germline editing of stem cells and human embryos to in vitro studies. Use of genome modified human embryos for developmental propagation is prohibited.

The document also touches on increases in the availability of pluripotent stem cells since the last update. With stem cells more readily available from a variety of sources for use in clinical trials, the authors of the text think it is important to establish procedures covering their use and handling. The latest version seeks to address this need and contribute to a curbing of the inappropriate use of stem cells.

"Indiscriminate use of stem cells without establishing efficacy for therapy and before obtaining adequate data on their safety has created unprecedented difficulties to therapeutic profligacy with vulnerable patients getting exploited," the draft guidance states.

The ICMR is concerned inappropriate use of stem cells is putting patients' health at risk and being used to financially exploit vulnerable people.

Draft Guidelines, PharmaBiz