Asia Regulatory Roundup: China Ends 2015 With Spate of Manufacturing Quality Actions (6 January 2016)

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

China Ends 2015 With Spate of Manufacturing Quality Actions

China Food and Drug Administration (CFDA) has closed out 2015 with a spate of actions relating to manufacturing quality. In the publications, CFDA detailed the implications of a new stance on quality management that prohibits some companies from continuing operations and revealed regulatory actions against specific facilities.

The update with the broadest reach relates to the changes to quality management, which came into force on 1 January. CFDA posted a clutch of documents about the deadline, the latest in a multi-year push to improve quality standards, to prepare local officials to enforce the new policy and forewarn manufacturers about its consequences. Manufacturers that lack certification under the new quality management requirements must stop operating.

CFDA is seeking the support of local authorities with the enforcement of the requirement. National officials called on their colleagues to step up both routine and unannounced inspections of facilities and withdraw the quality management certificates of companies that fall short of standards. CFDA wants officials to revoke the license to operate as a pharmaceutical business from any company that repeatedly fails to bring its operation in line with quality management requirements.

While advocating for local regulators to take tough actions against violators of the law and follow up to ensure they are not continuing to operate illegally, CFDA has included provisions to give leeway to companies that are trying to bring their operations up to standard. CFDA is giving companies that are heading in the right direction until the end of 2016. Responsibility for overseeing this process falls on local authorities, which are the focal point of certification under the newly decentralized model.

Other regulatory tasks will continue to be handled at a national level. Days before the spate of posts about the quality management deadline, CFDA posted an alert about the outcome of work done by one of its national groups, which handles drug testing. The testing lab noted concerns with liver extract capsules sold by multiple manufacturers, leading to the recall of products.

Quality Management, GMP, Sterile, Liver Extract, More (Chinese)

DCGI Initiates Clampdown on Online Medicine Sales

The Drugs Controller General of India (DCGI) has called for state regulators to step up oversight of online sales of medicines. DCGI issued the request for officials to keep a "strict vigil" after listening to the concerns people presented to a subcommittee that was set up to consider how to regulate online pharmacies.

Dr. S. Eswara Reddy, the Joint Drugs Controller of India, made the request in a circular distributed to state drug controllers. The letter asks state officials "to put a strict vigil on online sale of medicines and take action against those indulging in online sale of medicines in violation of the Drugs and Cosmetics Act and Rules thereunder." Initial media reports interpreted this statement as an outright, temporary ban on the online sale of medicines, but others have raised doubts about the intent.

The All India Organisation of Chemists and Druggists (AIOCD), one of the organizations that lobbied against the liberalization of online sales, is clear about the objective of the circular. "Though the ban is temporary, it is still a ban," Ramesh Chandra Gupta, president of the Hyderabad chapter of AIOCD, told The Times of India. "Local drug control authorities must react to quickly ensure it is properly implemented as several online pharmacy stores are still operating on the ground."

Others are less certain. Livemint reported there is no ban, a view that appears to be backed up by the text of the circular, which calls for regulators to act against firms that are violating the Drugs and Cosmetics Act. Surendra Mantena, chief operating officer of MedPlus Health Services, thinks his company is operating within the law. "Those who make a request for drugs through our portal have to show up at one of their nearest MedPlus stores with the doctor prescription," he told TOI.

Faced with such uncertainty, Apollo Pharmacy has taken the precaution of stopping online sales. The company will have to wait for clarity. Regulatory officials in the state of Telangana plan to wait a week before implementing an action plan. In the longer term, the focus is on the ruling of the subcommittee that was created to consider the topic. Early reports suggested the panel was in favor of allowing online drug sales, but these emerged prior to the DCGI circular.

CDSCO Notice, TOI, Livemint

CFDA Passes New Generic Naming Rules for Medical Devices

CFDA is to require medical devices to have generic Chinese-language names. The requirement, which is set to come into force in April, is being presented by CFDA in an attempt to improve the oversight of medical devices in China.

Officials have set rules with which the names must comply. The rules are, in part, a move to stop companies from using the name of a medical device to talk up its effectiveness. CFDA has specifically prohibited the use of marketing terminology, such as "health" and "beauty," as well as language that exaggerates the benefits of the device. The regulator is also keen to keep names short, suggesting the use of no more than three words to describe the characteristics of the device.

The publication of the rules late in 2015 brought to a close a 12-month period in which CFDA moved to revise multiple aspects of its regulation of medical devices. As well as the naming requirements, the industry is adapting to new regulatory stances on the reporting of adverse events, supervision of quality and handling of product registration.

CFDA Notice (Chinese)

Indian Pharmacopoeia Delays Deadline for Implementation of 2016 Addendum

The Indian Pharmacopoeia Commission (IPC) has pushed back the deadline for implementation of changes set out in its addendum for 2016. IPC has given the industry another three months to react to the changes, which must now be implemented by the end of March.

IP Addendum 2016 features more than 90 additions that, at the time of their publication, IPC said would "play a significant role in improving the quality of medicines." The list of additions includes two general chapters, three changes relating to vaccines and 14 updates to IPC's stance on herbal medicines. IPC also included texts about the recombinant human growth hormone somatropin and the colony stimulating factor pegfilgrastim.

The majority of the additions, 64 in total, relate to the monographs of chemicals. IPC had originally set an end-of-year deadline for the implementation of the deadline, but with just days to go, the pharmacopoeia's secretary-cum-scientific director, DCGI GN Singh, issued a statement pushing back the cutoff point by three months.

IPC Notice

Other News:

The Indian Department of Commerce has expressed the belief that its Drug Authentication and Verification Application (DAVA) will make it impossible to export fake drugs without being traced. Officials made the claim after DAVA, a track and trace system currently in pilot testing, won the Asia Pacific Council for Trade Facilitation and Electronic Business' trade facilitation award. Statement

CFDA has told Chinese medicine manufacturers that lack the ability to comply with herbal product extract requirements to stop production. The regulator brought new requirements into force at the start of the year as part of its 18-month drive to improve the standard of Chinese medicines. Last year was marked by the discovery of faults with the extraction of ginkgo. CFDA Notice (Chinese)