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Regulatory News | 28 July 2015 | By Nick Paul Taylor
Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia.
China Food and Drug Administration (CFDA) has given drugmakers until 25 August to self-audit and authenticate clinical trial data they have included in regulatory filings. The action is intended to root out drugs that are seeking approval on the strength of forged data, a status some think applies to as many as half of all applications in China.
By making drugmakers audit their data and get legal representatives to vouch for their authenticity, CFDA is effectively conducting an arm’s-length vetting of the quality of filings in its backlog. Each company seeking CFDA approval must go over various aspects of its filings, such as the consistency of databases and original records, to show CFDA the data is legitimate. Companies also have the option to withdraw their applications ahead of the deadline.
If some observers are correct, the action could lead to a major shakeup of the list of drugs seeking CFDA approval. “Many applications were based on forged medical charts and exaggerated effectiveness. It’s conservative to say 50% of applications were based on forged data,” Shi Lichen, director of the Dingchen Medical Consultancy, told South China Morning Post. Such applicants now face a choice: Withdraw their filings or try to trick CFDA.
The regulator plans to work with local authorities to inspect applicants and verify the legitimacy of claims about the reliability of their data. Any company found to have destroyed evidence faces a ban on registering drugs of up to three years, while clinical trial sites proven to have forged data risk having their licenses revoked. The action could help CFDA to reduce its backlog of applications and save its reviewers from wasting their time on fraudulent submissions.
South China Morning Post, CFDA Notice (Chinese)
The Indian government has tasked diplomats with restoring the reputation of the nation’s validation procedures in Europe, The Financial Express reports. Officials initiated the diplomatic campaign to limit the fallout from the GVK Biosciences scandal, but some fear it will actually make things worse.
Prime Minister Narendra Modi’s government has taken an unusually public and active role in the GVK affair, going as far as to threaten to take the case to the World Trade Organization. The situation appeared to have calmed down, but with the date of the ban on GVK-tested drugs nearing, the government has turned to backchannels to present its case. Officials have reportedly tasked diplomats with arguing the case should not be “blown out of proportion” by “vested interests.”
The “vested interests” in question are innovative Western pharma companies, which India has long suspected are running a campaign against its generic drug industry. India is trying to protect local companies and the image of its regulatory capabilities, but some have doubts about the approach. Anonymous drug industry sources told the newspaper the GVK affair is a routine regulatory issue and diplomatic interventions could prove to be counterproductive.
The Financial Express
Shandong Freda Pharmaceutical Group has secured regulatory clearance to sell products directly to consumers, China Daily reports. The approval means five state-owned businesses now have clearance to make direct sales, which is a growing part of China’s evolving drug distribution mix.
In total, more than 50 companies have gained direct sales clearance in China since legislation was brought in to allow the model in 2006. Shandong Freda will use the status to sell its products directly and through its proprietary stores. For now, Shandong Freda is limiting the role of the Internet to the facilitation of real-world purchases, a model known as “online to offline” or O2O for short, but the e-commerce sector is becoming increasingly hard to ignore.
While the industry is still waiting for CFDA to allow online sales of prescription drugs, the sector is booming despite its current limitations. State news agency Xinhua profiled the industry this week and talked up the prospect of CFDA signing off on a law to allow prescription medicines to be sold online. “When that happens, we estimate sales will increase two-fold,” Wu Yonghao, secretary-general of Drugs & Health Committee of Internet Society of China, said.
China Daily, FiercePharmaAsia, Xinhua
An advisory committee to the Drug Controller General of India (DCGI) has tentatively recommended the phasing out of gelatin in capsules. The recommendation, which is yet to be formalized, would lead to drug manufacturers switching from gelatin to cellulose or starch.
Members of the scientific committee considered the question after the Bureau of Indian Standards (BIS) established best practices for non-gelatin capsules. The initial decision of the committee adds to the momentum behind the move away from gelatin, which is underpinned by creation of the BIS standards, Indians’ aversion to the substance on religious grounds and the United States Food and Drug Administration’s historic concerns about the quality of bovine extracts used in the excipient.
Despite these tailwinds, a move away from gelatin in favor of cellulose or starch is likely to take time. “The committee will now go back and look at the available evidence to make its technical recommendations. We expect a report in a couple of months, but we cannot adopt the BIS standards in toto. We have to update the Indian Pharmacopoeia Commission,” an anonymous source told The Indian Express.
The Indian Express
DCGI has taken another step toward the establishment of rules for online pharmacies in India. The latest advance is the creation of a subcommittee staffed by the chiefs of regional regulators and other top officials to discuss how best to approach the topic.
The commissioner of Maharashtra Food & Drugs Administration is to lead the subcommittee, giving the state that has driven online pharmacies to the top of the regulatory agenda a starring role in the field’s future. Maharashtra made online sales a hot topic by raiding the offices of Snapdeal. The raid and accompanying legal actions pushed DCGI to reassess the regulatory environment and decide that it is ill suited to the world of online retail.
Exactly how oversight will be changed to adapt to the Internet is unclear, with some groups lobbying against changes that would enable more online trade while others campaign for the opening up of the market. The burden of helping DCGI decide how to proceed in this polarized environment will now fall on the subcommittee. “The subcommittee has been asked to view in detail the online pharmacy sale of medicines,” Karnataka Drugs Controller Raghurama Bhandary told PharmaBiz.
Officials at the Indian Ministry of Health have asked their colleagues in the commerce department to grant a compulsory license for dasatinib, the chronic myeloid leukemia drug sold by Bristol-Myers Squibb as Sprycel. In 2012, a government agency allowed Natco Pharma to make and sell a lower-priced copy of Bayer’s Nexavar. Press Trust of India
The Indian government is reviewing the Drug Prices Control Order, 2013, the legislation that covers the capping of the costs of certain medicines. Officials said the aim is to make the law work better for patients and the industry. Earlier this month, the Supreme Court described India’s current model of drug pricing as “absurd” and “irrational.” Press Trust of India
Tags: Asia Regulatory Roundup, Regulatory Roundup