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Posted 07 February 2017 | By Nick Paul Taylor
Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia.
India has finalized its long-awaited medical device rules. The legislation is set to ease regulation of medical device manufacturing and development by freeing the industry from rules designed for the pharmaceutical sector.
Until now, a lack of dedicated regulations covering the majority of medical devices left the sector working under legislation tailored to the needs of the drug industry. The application of drug rules to medical devices led to unnecessarily burdensome regulations, the industry has long argued, and in doing so held back development of the domestic sector. By creating rules specifically for medical devices, Indian officials have sought to clear these barriers to growth.
Clinical trials are one subject tackled by the new rules. Applying drug regulation to devices forced the four-phase clinical trial process on developers of medical equipment, despite much of the rest of the world having a more streamlined pathway. The rules published this week move India to a two-phase clinical trial process, in which safety is assessed in a small number of patients before a larger pivotal efficacy study is initiated. Subjects injured in trials are eligible for compensation.
Officials have also rethought how medical device manufacturing is regulated. In creating rules for the production of medical devices, India has looked to the now-defunct Global Harmonization Task Force framework for guidance, Hindustan Times reports. Bringing manufacturing practices in India in line with international standards, rather than pushing drug regulations on the sector, is expected to provide a boost to India’s attempts to foster a local medical device production industry.
The government is outsourcing the task of auditing manufacturers of devices categorized as Class A and Class B, the local equivalent of Europe’s low to moderate risk Class I and Class IIa groupings. Notified bodies, which could be “any institute, organization or body corporate,” will audit producers of such devices to verify their conformance with the quality management system. The notified bodies will be accredited by the National Accreditation Body, which could itself be an outside firm or institute appointed by the government.
India is set to start enforcing the rules on 1 January. The industry has had multiple opportunities to review and comment on the text. The text published this week is a slightly modified version of a draft circulated by officials in October, which in turn was largely based on the original draft Indian officials released for consultation in June.
Device Rules, Hindustan Times
The Drug Regulatory Authority of Pakistan (DRAP) has released draft labeling requirements for alternative medicines for consultation. DRAP has created the rules to standardize the labeling of nutraceuticals, traditional therapies and other products classed as alternative medicines.
In the rules, DRAP defines a series of terms such as “adequate intake,” “classical unani medicines” and “specification monograph” before detailing the labeling requirements for different types of alternative medicines. The rules feature sections focused on the labeling of alternative medicines, nutraceuticals, homeopathic products and medicated cosmetics. There are overlaps between the requirements for each type of product, such as the need to list the name and address of the manufacturer, but each also features distinct requirements.
Specific requirements include a demand that the labels of alternative medicines and nutraceuticals print the proper name of the ingredients “in a more conspicuous manner than the trade name.” The labels of both types of product must also advise pregnant or breastfeeding women to talk to a healthcare professional before use, unless specifically exempted.
Labeling requirements unique to alternative medicines include the need to include a poison symbol if the formulation contains methylated spirits. DRAP has also detailed some requirements specific to certain products, such as those containing ginseng or ginkgo extract. Products containing ginseng must state they are contraindicated for use in pregnant women, and that the safety of long-term use has not been established.
The text includes a list of diseases DRAP views as incurable. The list includes cancer, diabetes, hypertension and impairment of sexual function. Manufacturers of alternative medicines are not allowed to claim their products treat these conditions.
DRAP sent a copy of the draft rules to trade groups late last month, but only published them online this week. The letter to trade associations asked for feedback to be submitted in the next two weeks.
Draft Rules, DRAP Notice
The Central Drugs Standard Control Organization (CDSCO) has established a process for making and handling grievances with the recommendations of Subject Expert Committees (SECs). CDSCO’s process sets timelines for the handling of complaints.
Officials are giving people with grievances seven days from the release of SEC meeting minutes to file a complaint with the Drug Controller General of India (DCGI). Once the complaint is received, DCGI Dr. GN Singh will allocate the case to a committee headed up by the relevant joint drugs controller. The committee will include the relevant deputy drugs controller of India (DDCI) and two other DDCIs.
Complainants can expect to hear the recommendation of the committee within seven days. The timelines for making and processing grievances are intended to ensure cases are resolved swiftly, something that was not guaranteed under the previous, less formalized process.
In the past, when an organization was unhappy with an SEC recommendation, it approached various authorities seeking a solution to its grievance, CDSCO wrote in a notice to explain the new process. The new pathway provides companies with a channel to make complaints.
The Taiwan Food and Drug Administration (TFDA) has released a draft revision to the clinical trial informed consent form for consultation. Officials at the Ministry of Health and Welfare have updated the form to incorporate the views of the industry, government and other groups.
Taiwan first introduced the form in 1996 to standardize the protection of the rights of people who participate in clinical trials. Now, it has deemed the form in need of updating and turned to the Taiwan Association of Institutional Review Boards, industry experts and members of the government for feedback on how to improve the text.
The result is a draft form that features new instructions to help trial participants fill in the form. Officials have also added examples and made other changes to the text. The Ministry of Health and Welfare is accepting feedback on the draft for 30 days.
TFDA Notice, Draft Form (both Chinese)
The Therapeutic Goods Administration (TGA) of Australia has approved nitrostat tablets from Pfizer in an attempt to prevent a shortage while Arrow Pharmaceuticals deals with a formulation problem. Last year, TGA said disintegration problems with Arrow’s product would likely necessitate a recall, but it wanted to hold off until alternative supplies were sourced. The recall is yet to happen because supplies from Pfizer cannot meet demand. TGA Notice
DCGI Singh has issued more notices about the need to rationally use antibiotics to cut the risk of resistance developing. The regulatory leader sent letters this week to five medical and pharmacy trade groups asking them to raise awareness among their members of the need to use antibiotics rationally. DCGI began the recent push following the death of a patient from multidrug-resistant bacteria. DCGI Letter, More
Tags: India medical device regulations, DRAP, TFDA