Asia Regulatory Roundup: India Releases Draft Drug Clinical Trial Rules for Consultation

Posted 13 February 2018 | By Nick Paul Taylor 

Asia Regulatory Roundup: India Releases Draft Drug Clinical Trial Rules for Consultation

Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia.
TGA Floats Changes to GMP Fees to Correct Historic Undercharging
The Therapeutic Goods Administration (TGA) is planning to revise its good manufacturing practice (GMP) fees to correct historic undercharging. A Deloitte report found TGA’s fees failed to cover $3.4 million of its costs last year, prompting the consultancy and Australian regulator to put three options  to the industry.
Deloitte’s report zeroes in on the mismatch between the number of hours TGA spends on inspections and the fees it charges for the work as the biggest contributor to the undercharging trend. Currently, TGA’s annual charge implies a fixed allowance of inspection hours for which it does not bill. These are known as “free” hours but, as Deloitte points out in the report, it costs TGA money to do the work. The model also falsely inflates the size of the annual fee.
The report proposes three ways to address these problems. Deloitte’s favored approach is to end the practice of “free” inspection hours and merge the current low and high licenses into a single annual charge. This will shift the burden of paying for inspections from everyone who has a license to the companies TGA visits. In doing so, Deloitte believes TGA can recover its inspection costs, charge the right rate for annual licenses and incentivize manufacturers to improve compliance.
Those incentives stem from the move to a direct fee-for-service model of inspection payments. The model means highly compliant manufacturers that require infrequent, short inspections will pay less than companies that struggle to follow the rules. That could incentivize companies to improve. The effect is magnified by plans to raise the hourly inspection rate for Australian manufacturers by 47% or more, depending on which option advances.
Deloitte built the incentive and related steps to recover inspection costs into two of its three options. The consultant’s favored option goes further by also raising the fee for GMP clearance applications, cutting the fee for GMP licence filings and introducing a new domestic variation application fee. This approach is intended to spread costs across more fees and stop some companies from subsidizing others. Manufacturers should get what they pay for.
The report strongly leans toward the two options that get closest to these goals, but it also features another, simpler approach. Under that model, TGA would increase all its fees and charges by 17.4%. Everything else would stay the same. The approach would address the undercharging but not fix the inequities in the current fee structure. The option also fails to incentivize manufacturers to improve their compliance. 
TGA is accepting feedback on the proposals until 5 March.
Deloitte Paper, TGA Statement
India Releases Draft Drug Clinical Trial Rules for Consultation
India has released draft drug clinical trial rules for consultation. The 128-page document covers the full spectrum of clinical trial activities, from ethics committees and manufacturing permissions to inspections and injury compensation.
Publication of the draft rules marks an important step in India’s attempts to codify its approach to clinical trials. The text sets out definitions for many of the key clinical trial terms before detailing the rules that will apply to drug developers and other stakeholders at each step in the process. Indian officials have also included forms that companies will use to apply for permission to perform certain actions, such as the manufacture of unapproved active ingredients.
The draft rules further India’s attempts to recover from the regulatory problems that throttled its clinical trial sector. A decade ago, analysts tipped India to become a major contributor of patients to global clinical trials but a local media backlash and subsequent regulatory actions sent the sector into a prolonged slump.
Recently, the Central Drugs Standard Control Organization (CDSCO) has sought to cut the time it takes to approve clinical trials and otherwise make the process more predictable and transparent. These actions have made India a better place to run trials, but problems including a lack of standardization of research application reviews have continued to hold back the sector. The draft rules seek to address some of these issues.
The draft is open to comment for 45 days.
Draft Rules
DCGI Orders Ports to Release Insulin Imports to Avoid Shortage
The Drug Controller General of India (DCGI) has ordered Indian port facilities to release shipments of insulin. Port officials held the formulations pending analytical tests, but delays at the laboratory have stopped supplies from entering the country.
DCGI Dr. GN Singh raised the issue with the ports after talking to the Organisation of Pharmaceutical Producers of India (OPPI). The trade group told Singh the port offices are sending every shipment of insulin to be tested at the National Institute of Biologicals (NIB). Delays at NIB have disrupted the supply of insulin, prompting OPPI to warn of a possible shortage.
In response, Singh has ordered immediate and long-term fixes to the problem. The first step is for port offices to release all consignments of imported insulin. Singh ordered the consignments’ release after learning from NIB that all insulin imports tested by NIB over the past three years have met their quality standards.
The longer-term action is intended to stop the bottleneck from reoccurring. Singh’s notice directed port officials to use risk-based criteria for sampling and testing biologicals. DCGI wants ports to follow these criteria, rather than simply send every insulin formulation for testing.  
CFDA Publishes 2018 Roadmap for Regulatory Rulemaking
The China Food and Drug Administration (CFDA) has released its legislative program for 2018. CFDA’s roadmap for the year features almost 40 new or revised laws, regulations and guidance documents.
Most of the activity relates to guidance documents. Revisions to texts covering the registration of medical devices and in vitro diagnostics are due later this year, as are new and updated texts about a range of big topics facing CFDA’s drug department. The drug department’s roadmap includes revisions to good clinical practices and registration, plus the development of documents on pharma inspections and data practices.
On the legal front, China is looking at its drug administration law and pharmaceutical patent regime. CFDA is also working on changes to three groups of regulations, including the document covering the supervision of medical devices.
CFDA Notice (Chinese)
Other News:
CDSCO has created an internal unit focused on homeopathic and traditional Indian medicines. The department will be led by two deputy drugs controllers, one focused on homeopathy, the other on the Indian medical system known as ayurveda. Two assistant drugs controllers will oversee siddha and unani, the other two practices in the department’s purview. The unit also has seven drugs inspectors. CDSCO Notice
Roche’s Alecensa has become the first medicine registered under TGA’s priority review pathway. The regulatory nod clears Alecensa for use in patients with anaplastic lymphoma kinase-positive, locally advanced or metastatic non-small cell lung cancer in Australia. TGA awarded priority review status to the ALK inhibitor in August, making it the first drug to secure the new designation. TGA Notice
The National Pharmaceutical Pricing Authority (NPPA) has revised its caps on the prices of cardiac stents. India’s NPPA has further lowered what companies can charge for drug-eluting stents but raised the cap on bare metal products. Notably, the agency has resisted industry calls to create a new, higher-tier category for premium stents. NPPA Post

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