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Regulatory News | 21 June 2016 | 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 released a guide to the implementation of its revised vaccine procurement and distribution regulations. The updated policy calls for vigilant record keeping by organizations in the supply chain and stronger regulatory oversight of each step in the process to stop a recurrence of the vaccine distribution scandal that rocked the country earlier this year.
Faced with growing public skepticism toward the safety and efficacy of vaccines and political pressure to fix the shortcomings that allowed such doubts to grow, CFDA moved quickly to adopt new policies. The resulting documents, which were first unveiled in April and expanded on this week, address many of failings that enabled the improperly stored vaccine ring to prosper unnoticed for years, from the channels through which products are procured to the steps that are taken to ensure they are kept under the right conditions from the moment they leave the factory.
Cold chain considerations are the focal point of one of the seven sections in CFDA’s guide to adopting the new policies. The regulator is asking vaccine manufacturers and distributors to ensure products are stored and shipped at the appropriate temperature and humidity. Organizations are expected to create vaccine traceability systems and keep original, complete and accurate data on storage and shipping conditions to demonstrate their compliance with requirements. The onus for ensuring this is the case falls partly on vaccine buyers, who are expected to demand to see temperature data.
In the event that an organization is unable to provide shipping and storage data, either in a paper or electronic format, the buyer should back out of the deal and inform regulators immediately. CFDA is planning to bolster its own activities and capabilities so it can follow up on tips from informants and generally oversee the supply chain. Regular assessments of compliance with supply chain regulations and surprise inspections are planned. The regulator intends to make the results of its tests available publicly.
CFDA wants to see its local departments establish full-time teams of inspectors to carry out the work. The capacity-building program is intended to both equip local offices to keep tabs on a larger portion of the supply chain and enhance the vaccine-related skills possessed by members of the teams. In parallel, health planning departments are set to improve their own capabilities, specifically by setting up information technology systems to support the management of procurement, cold chain oversight and the sharing of data between regions.
CFDA Guide (Chinese)
Drug Controller General of India (DCGI) Dr. GN Singh has told producers of fixed-dose combinations (FDCs) to submit protocols for Phase IV clinical trials. The letter is the latest step in a long-running attempt by Singh and his colleagues to get manufacturers of certain FDCs to demonstrate the safety and efficacy of their products.
Regulatory attempts to get FDC manufacturers to generate safety and efficacy data date back to at least the start of 2013. At that time, national regulators told state licensing authorities in India to give certain manufacturers of FDCs 18 months to prove the safety and efficacy of their products. The data requests were targeted at companies that brought FDCs to market without first gaining due approval from the DCGI office. That process led the Central Drugs Standard Control Organization (CDSCO), in consultation with an expert committee, to demand the submission of Phase IV clinical trial protocols.
Running Phase IV trials would allow FDC manufacturers to leverage real-world use of their products to show they are safe and effective, but few companies have complied with the request for protocols. “A considerable time has already been given to these firms, however, it has been noted that most of these companies are yet to submit Phase IV clinical trial protocol,” Singh wrote. “Applicants who have not yet submitted Phase IV trial protocol shall submit the same immediately.” The letter contains no details of what will happen to companies that fail to comply with the request.
The original and latest request for Phase IV protocols bookend a period in which CDSCO initiated a ban on 344 FDCs, an action that the regulator said was motivated by a lack of safety and efficacy data on the affected products. FDC manufacturers, including Abbott Laboratories and Pfizer, have spoken out against the ban, leading to a legal challenge that is yet to be resolved. The initiation of Phase IV trials to generate the safety and efficacy data demanded by Singh could help to end the dispute.
The National Pharmaceutical Pricing Authority (NPPA) of India has threatened to take legal action against companies that are yet to register their products on the Integrated Pharmaceutical Database Management System. Drugmakers were originally asked to register before the end of October 2014, but NPPA has repeatedly moved back the deadline to assuage industry concerns.
NPPA set up IPDMS, also known as the pharma data bank, to enable it to move all of the submissions it receives to an online platform. That process has proven to be difficult in practice. In the NPPA letter threatening legal action against companies that are still yet to comply with its request, the Indian price watchdog lists all of the deadlines that have come and gone over the past 20 months. NPPA has extended the deadline on nine separate occasions and issued additional notices demanding firms sign up immediately. The agency has also held seven meetings to discuss the matter with industry.
Despite this long-running campaign to address concerns with the platform, NPPA is yet to win over some of the industry. “Many companies have not submitted the forms as required under DPCO, 2013 in IPDMS,” NPPA Director Roshni Sohni wrote in the letter. Sohni has responded by starting to issue show cause notices to companies that are yet to file mandatory returns or have failed to register their products altogether. These notices require the companies to explain why they have failed to comply with the requirements.
What happens next depends on how the targeted companies respond. NPPA has said it will use the powers conveyed to it through the Drug Price Control Order, 2013 and Essential Commodities Act to prosecute the companies if necessary. The agency has sent notices to “top 10 firms” that are yet to register their products, NPPA Chairman Bhupendra Singh told the Press Trust of India. Singh plans to issue notices to other companies in the future.
NPPA Notice, The Press Trust of India
An online pharmacy trade group is pressuring the Indian government to clarify its guidelines on the sale of medicines over the internet. The Indian Internet Pharmacy Association (IPA) claims the current situation is preventing legitimate players from developing their operations and that the sector has been subject to “excessive and aggressive regulatory action.” Press Release
Tags: vaccine distribution in China, FDC manufacturers in India, NPPA