Asia Regulatory Roundup: CDSCO Reopens Clinical Trial Rules for Comment

Regulatory NewsRegulatory News | 21 November 2018 |  By 

Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia.
CDSCO Reopens Clinical Trial Rules for Comment After Supreme Court Order
The Central Drugs Standard Control Organization (CDSCO) is accepting further feedback on its clinical trial rules. CDSCO closed comments on the draft earlier this year, only for the Supreme Court to tell it to give people another chance to share their views.
India’s Supreme Court made the ruling against the Indian government in September after hearing a case brought by Swasthya Adhikar Manch, an activist group that has previously caused clinical trials of new drugs to come to a halt in the country. Swasthya Adhikar Manch’s history of activism shows it has an interest in how CDSCO regulates clinical trials, but the Supreme Court said none of the people who brought the case had filed objections to the draft when it opened for comment in February.
With the comment period having closed without input from all interested parties, the legal counsel for the Indian government agreed to invite objections to the draft. The Supreme Court also advised the legal counsel to hold a hearing with people who object to aspects of the draft “so that the rules can be finalized once and for all since it pertains to the health of the people of the country.”
In recent weeks, CDSCO has acted to comply with the commitments and recommendations made at the Supreme Court hearing. CDSCO tried to put the matter to bed by holding a meeting earlier this month at FDA Bhawan with people who objected to the rules. Despite that, some people, including the petitioners to the Supreme Court, asked CDSCO to schedule another date to provide them with an opportunity to present their views.
CDSCO responded to the request by asking interested parties to submit their views, objections and suggestions and attend a meeting later this week. The meeting will take place at FDA Bhawan on Thursday.
As CDSCO sees it, the temporary reopening of the comment period and meetings fulfill the promises that were made at the Supreme Court hearing. The meeting on Thursday should therefore move CDSCO a step closer to finalizing a document with significant implications for the future of clinical research in India.
Notable changes proposed in the draft include provisions to slash the time it takes for regulators to grant clearance to start clinical trials. The document forms part of a broader effort to make Indian regulations more amenable to industry.
CDSCO Notice, Court Order, PharmaBiz
Korean Securities Regulator Calls for Dismissal of Samsung BioLogics CEO
The Korean securities regulator has ruled that Samsung BioLogics “intentionally violated accounting rules.” After reaching the ruling, the agency recommended the dismissal of the CEO of the contract manufacturer and imposed a fine of KRW 8 billion ($7 million).
Samsung BioLogics has come under increasing pressure over the past six months as regulators have looked into accounting actions it took in 2015. As Korea’s Securities and Futures Commission (SFC) sees it, changes to the accounting treatment of a stake in a joint venture between Samsung BioLogics and Biogen amount to an intentional violation of the rules. The changes preceded a swing from loss to profit at Samsung BioLogics in the run up to the company’s initial public offering in 2016.
Management at Samsung BioLogics defended their actions when the financial regulator reached its preliminary decision earlier this year, with a vice president warning the company would file a lawsuit if it deemed the final ruling to be unacceptable. Samsung BioLogics maintained its innocence and committed to filing an administrative suit after receiving the latest ruling.
The ruling features multiple sanctions against Samsung BioLogics and other organizations involved in the situation. In addition to the CEO dismissal recommendation and fine, Samsung BioLogics has to contend with the suspension of trading in its stock. SFC asked the Korean stock exchange to consider whether Samsung BioLogics should be delisted. Samsung BioLogics’ auditors also face fines and bans from working with the contract manufacturer.
SFC Notice, Samsung Statement
China Tasks Regional Regulators With Accelerating Medical Device Approvals
China’s National Medical Products Administration (NMPA) has set out how it wants its local offices to accelerate medical device approvals and otherwise implement its reforms of the sector. The NMPA document covers changes to device licenses and their implications for regional regulatory officials.
Regional offices will play a central role in the move to a 14-day review time for certain medical device filings and other aspects of the reforms. In light of that important position, NMPA has tasked the offices with fully understanding the changes and told them to designate a person who will liaise with the medical device team at the national head office. NMPA expects to receive progress reports.  
The demands reflect the fact that the success of the reforms is tied to actions taken at a local level. To ensure a smooth implementation, NMPA wants regional offices to streamline their approach to the regulation of quality systems and approval materials.
NMPA’s reforms are part of a multi-year effort to change how medical devices are regulated in China. These efforts have sought to improve the quality of medical devices sold in China while cutting the time it takes for regulatory-compliant companies to get their products to market. Li Li, the deputy director of NMPA, recently visited the device evaluation center to assess progress toward these goals and lay out the future objectives of the division.
NMPA Notice, More (both Chinese)
India’s NPPA Changes Tetanus Vaccine Price After Multi-Year Dispute
India’s National Pharmaceutical Pricing Authority (NPPA) has changed the ceiling price of the tetanus vaccine. The price revision follows a dispute and legal tussle dating back to a correction NPPA made to an earlier statement in 2014.
When NPPA established a ceiling price for the tetanus vaccine in 2013, it placed restrictions on what manufacturers could charge “per pack” of product. The following year, NPPA issued a correction that changed the pricing unit from “per pack” to “per ml.” That correction led to a court case in which the petitioners argued “each pack could only mean 0.5 ml as the said quantity conforms to the industry norm.” The correction effectively cut the per pack ceiling price from Rs 10.29 ($0.14) to Rs 5.15.
Since then, the Delhi High Court and Indian Department of Pharmaceuticals (DoP) have both looked at the matter, and vaccine manufacturers Biological E and Serum Institute have objected to aspects of how NPPA has approached the pricing of their tetanus products.
The back and forth between the various organizations led to a DoP order in June which led to an NPPA notice about a new ceiling price. NPPA set the ceiling price of 0.5ml packs of tetanus vaccine at Rs 9.95. The ceiling price for 5ml packs is Rs 21.43. In doing so, NPPA reset the ceiling price at near the level manufacturers charged under the original per pack price.
NPPA Notice
Other News:
NMPA has issued a notice about standardizing the handling of drug export sales certificates. The Chinese agency wants to establish a unified drug export sales certification information management system. NMPA envisions regional offices uploading information about export sales certificates to the system. The statement also covers enforcement matters. NMPA Statement (Chinese)


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