Asia Regulatory Roundup: India Calls for Local Trials Ahead of Dengue Vaccine Launch (10 May 2016)

Regulatory NewsRegulatory News | 10 May 2016 |  By 

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

Indian Committee Rejects Sanofi’s Request for Dengue Vaccine Trial Waiver

A top-ranking Indian health committee has rejected Sanofi’s request to bring its dengue vaccine to market without data from locally run Phase III trials. The ruling by the health apex committee follows positive responses from two other panels, which felt the waiving the requirement for a local Phase III trial was justified by the threat posed by the virus.

Members of the apex committee reviewed the same data and broader health situation as the subject expert committee and technical committee — the two lower-ranking health panels — but reached a different conclusion. “The apex committee noted that clinical trial cited as evidence in the present case is not sufficient to waive conduct of clinical trial in the country,” the highest-ranking panel wrote in its summary of a meeting held last month. Sanofi had hoped data from an Indian Phase II trial and a Phase III study run in Asian and Latin American countries would prove sufficient.

Despite the setback, Sanofi is still working to find a fast-tracked route to market in India, a country that suffered a record number of dengue cases and deaths in 2015. “Given the urgency of dengue in India, we are optimistic that we can work with the Indian regulatory authorities to find the best regulatory solution that allows us to increase the clinical data on our dengue vaccine in the Indian population, without delaying access,” a Sanofi spokesperson told The Economic Times. Exactly what this solution might look like is unclear. 

Prior to the apex committee ruling, the expectation had been that Indian regulators would rely on a Phase IV study to satisfy their demands for data on the safety and efficacy of the vaccine in the local population. The divergence from this previously proposed path forward is part of a larger disconnect between the apex committee and the subject expert committee. In response, the apex committee is proposing workshops for members of the other committee that are designed to address some of its primary concerns.

“The committee observed that the experts of the [subject expert committee] need to be appraised about the regulatory requirements relating to the clinical trials for compliance of the provisions for securing uniformity in the recommendations of various expert committees,” the apex committee wrote in its notes from the meeting.

Meeting Minutes Part One, Part Two, The Economic Times

China Orders Wholesalers to Self-Audit Legality of Their Operations

China Food and Drug Administration (CFDA) has ordered wholesalers to self-audit their operations and report any violations. The request is an attempt by CFDA to accelerate the identification of fake suppliers and forged trade ledgers in the wake of the improperly stored vaccine scandal.

CFDA has made improved regulatory oversight of pharmaceutical wholesalers a priority in the wake of the vaccine situation, which led to the detention of more than 200 people and negatively affected the careers of around 350 officials. The government and regulatory agency have proposed a slew of actions in the wake of the event, but the success of the initiatives will depend on their ability to make the industry comply. This week’s call for wholesalers to examine their own operations and confess to any failings they find is part of this process.

The request is reminiscent of CFDA’s initiative to weed out substandard regulatory filings by telling applicants to self-audit their data. That scheme successfully got some companies to admit that their applications fell short of the standard expected by CFDA, resulting in their removal from the backlog of filings awaiting review at the regulator. CFDA is looking for the drug wholesaler self-audit program to achieve similar goals, specifically by helping officials to identify illegal practices such as the forgery of trade ledgers at organizations in China’s vast distribution network.

To encourage companies to own up to their failings, CFDA is promising to be more lenient with firms that report any illegal activities they identify during their self-audit programs. CFDA wants companies to send detailed overviews of how they plan to address their failings. Lighter or otherwise mitigated punishments are promised for companies that take an open, proactive approach to improving their operations. In contrast, CFDA intends to reserve its toughest punishments for companies that fail to report illegal activities and continue to flout the law.

Companies that fail to submit reports listing any violations they find and details of how they intend to rectify the shortcomings face having their operational permits revoked. CFDA has also promised to enact strict and severe punishments against organizations within which it discovers unreported illegal activities. The proposed punishments extend to actions against individuals.

CFDA Notice (Chinese), Xinhua

CFDA Approves Virtual Doctor Drug Prescription and Dispensary Service

CFDA has approved a virtual doctor and drug dispensary pilot project run by China Jo-Jo Drugstores. Having received the regulatory green light, China Jo-Jo plans to install virtual doctor clinics at six of its retail pharmacies, enabling patients to undergo consultations and be prescribed medicines without meeting the physician in person.

China Jo-Jo has partnered with a Chinese hospital network and medical technology vendor to set up the platform, which will connect patients to physicians via video conferencing. Each pharmacy will also house diagnostic equipment to support the remote consultation. Once a physician has decided on the appropriate treatment, the patient will be able to pick up their prescription from the in-store dispensary service.

The platform is designed to serve patients in two distinct ways. “Access to doctors in China has been difficult historically in many rural areas of China. Not only does our program rectify this problem, relieving hospitals of patient overflow; we are also able to save consumers between 10% and 30% in prescriptions costs as compared to the exact same service rendered at area hospitals,” China Jo-Jo CEO Lei Liu said.

By setting up the platform, China Jo-Jo has opened up another route through which patients can gain access to medicines while it waits for regulators to give their approval to online sales of prescription drugs. Plans to open up the online market have been discussed seriously for more than a year, but progress has proven to be slower than forecast. China Jo-Jo is one of several organizations that have invested in online capabilities ahead of the anticipated liberalization of the regulations.   

Press Release

Other News:

The Central Drugs Standard Control Organization (CDSCO) has asked drug and cosmetics companies for feedback on how it can it can improve the process of obtaining approvals and clearances. CDSCO put out the request for comments to help with a Ministry of Health and Family analysis of the ways in which it can improve the experience of doing business with Indian regulators. CDSCO Notice

CDSCO has extended the use of its Sugam online portal to cover the import and registration of medical devices. Having extended the portal, CDSCO wants medical device companies that made hard copy filings from December to March to re-submit online. The extension comes six months after CDSCO first introduced the portal for use by drug companies. CDSCO Notice

Jiangxi Food and Drug Administration (FDA) has initiated a scheme designed to improve drug quality management. The strategy is designed to improve practices at companies and the regulatory teams tasked with overseeing them. Jiangxi FDA wants to see companies strengthen their quality teams. At the same time, FDA is calling for its teams and their peers to strengthen territorial supervision. FDA Notice (Chinese) 

CDSCO has asked to be kept better informed of the outcomes of inspections of bioavailability and bioequivalence service providers by foreign regulators. At a meeting with an Indian contract research trade group, CDSCO said it expects to receive details of any observations made and actions taken by overseas authorities within 15 days. Meeting Minutes 


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