Asia Regulatory Roundup: After Legal Fight, India Bans 328 Fixed-Dose Combinations
Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia.After Legal Fight, India Bans 328 Fixed-Dose Combinations
India has banned 328 fixed-dose combinations (FDCs) with immediate effect, furthering its two-year fight to get the products off the market. The FDC ban follows a ruling that there is no therapeutic justification for the combinations.
Officials first targeted FDCs in March 2016. At that time, the Indian government tried to ban 344 it perceived to be irrational. Another five FDCs were added to the list of prohibited products following a report by a committee. However, Pfizer and other manufacturers affected by the ban fought back, leading to a lengthy legal tussle. The Delhi High Court overturned the ban late in 2016. On appeal, the Supreme Court tasked the Drugs Technical Advisory Board (DTAB) with ruling on the FDCs.
DTAB returned its decision at the end of July. The board found “no therapeutic justification for the ingredients contained” in 328 of the FDCs. As these FDCs “may involve risk to human beings,” DTAB recommended banning their production, sale and distribution. Weeks later, the government has acted on DTAB’s report, banning 328 FDCs and placing restrictions on a further six products.
Government officials issued the bans in a series of notifications in the Gazette of India. In parallel, the Drug Controller General of India (DCGI) Eswara Reddy told staffers at the Central Drugs Standard Control Organization (CDSCO) to ensure manufacturers in their jurisdictions stop producing FDCs on the list of banned products.
The DTAB ruling and subsequent government action represent major steps toward the removal of the FDCs from the market. However, the government is yet to completely finish off the work it began in 2016. Following the latest attempt to ban the FDCs, Wockhardt went to the Delhi High Court to fight back against the government. The status of FDCs first manufactured before 1988 remains unresolved, too.
CDSCO Notice, Gazette Notification, The Economic Times, NDTV
TGA Starts Opioid Reviews After Consultation About Curbing Misuse
Australia’s Therapeutic Goods Administration (TGA) has started reviewing whether regulatory actions related to pack sizes and indications can curb misuse of powerful opioids. TGA began the reviews after seeking feedback on whether it should use its regulatory powers to help prevent the excessive and inappropriate use of opioids.
The consultation, which started in January, and a subsequent workshop to discuss points raised in the 98 submissions, have led TGA to take a closer look at four ways it may be able to address opioid use. TGA is now reviewing the pack sizes, indications, label warnings and educational activities related to strong schedule 8 opioids. In reviewing the topics, TGA will assess whether patients are receiving the right drugs, in the right amounts, supported by appropriate warnings and education.
TGA is concerned that patients who are prescribed opioids for short-term use after leaving the hospital are receiving more doses than they need. In other cases, the agency is questioning whether patients with certain conditions need strong opioids such as fentanyl at all. One aspect of TGA’s agenda is focused on raising awareness of opioid alternatives. When patients do need to take strong opioids, TGA wants to ensure they know about the risks of addiction and overdose.
Officials zeroed in on these areas after the consultation suggested they may strike the right balance between restricting and maintaining access to opioids. Many respondents to the consultation raised concerns about the potential to cause harm by taking regulatory actions intended to curb misuse.
Trade group Medicines Australia warned a one-size-fits-all approach to the regulation of schedule 8 opioids would hurt the sector. Equally, TGA’s proposals prompted cautious reactions from groups representing healthcare professionals. The Royal Australasian College of Physicians (RACP) warned that some of the proposed regulatory changes have “important implications regarding the clinical management of these patients.” RACP has “significant concerns” that the Australian healthcare system is unable to manage the changes “without many patients experiencing harm.”
TGA Notice
China Faults Clinical Trials of Medtronic, Siemens Devices in Compliance Review
The China National Drug Administration (CNDA) has identified compliance problems at clinical trials of medical devices developed by Medtronic and Siemens. Chinese officials found the failings through an early application of its revised approach to the regulation of device development and registration.
Under its new approach to medical devices, CNDA reviewed the compliance of some medical device clinical trials in July. The review identified failings at nine clinical trials, including assessments of a drug-coated balloon catheter in development at Medtronic and an assay from Siemens. CNDA also found shortcomings at seven clinical trials involving Chinese companies.
The review of the trial of Medtronic’s balloon catheter found fault with work done by the central laboratory. In assessing the trial of Siemens’ assay, CNDA identified problems related to blinding and unblinding.
CNDA’s assessments of the clinical trials form part of a broader effort to ensure devices produced and sold in China are safe, effective and of a suitably high quality. The agency and its predecessor have made a raft of changes to the regulation of medical devices in recent years to move the country toward that goal.
CNDA Notice (Chinese)
TGA Reports Drop in GMP Clearance Backlog Following Process Improvements
TGA has reported a decrease in the number of compliance verification good manufacturing practice (GMP) clearance applications awaiting processing. The drop follows process improvements intended to help TGA get on top of problems created by its growing workload.
At the start of June 2017, prior to the enactment of the improvements, TGA needed to process 1,327 compliance verification clearance applications. On 3 September, 11 months after adopting the new process, TGA had 799 applications. The workload is still resulting in delays to processing times, but TGA sees the reduction as evidence it is on the right track.
The reduction to the backlog was underpinned by a drop in the number of applications related to non-sterile active pharmaceutical ingredients (API) awaiting processing at TGA. The 58% drop in the number of non-sterile API filings accounted for almost three-quarters of the total reduction.
TGA achieved the reductions despite the number of new GMP clearance applications remaining high by historical standards. Last year, TGA received 5,327 applications. That is down on the 5,600 filings TGA received in the 2015 fiscal year but well above historical levels. Faced with the workload, TGA is processing clearance applications in order of GMP expiry dates.
TGA Notice
Other News:
The Drug Regulatory Authority of Pakistan (DRAP) has issued a warning after learning manufacturers have raw materials from “unknown sources.” DRAP wants manufacturers in possession of these raw materials to destroy them. After one month, DRAP will send inspectors to check the sources of APIs procured by manufacturers. DRAP Notice
India has asked patients affected by hip implants made by DePuy Medical to contact the central and state level committees set up to determine what compensation they should receive. The request is the latest step in the Indian government’s attempts to assess the harm caused by implants from the Johnson & Johnson subsidiary. CDSCO Notice
TGA has published a report about its international engagement strategy for the coming fiscal year. The report details how TGA hopes to improve the regulatory system through the use of reports from comparable overseas agencies. TGA Report