Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia.
DCGI: ‘Everything Should be Online’
The Drug Controller General of India (DCGI) has called for all regulatory applications to take place online to cut the time it takes for companies to receive a decision. Indian regulators have already begun to increase their online presence, but DCGI GN Singh sees the transition going much further.
Singh explained his views on the benefits of digital-based regulation in an interview with Business Today. “Everything should be online. If you want a license, why should you come to me? You should apply online, adhere to the prescribed guidelines and get it in a time-bound period,” Singh said. The goal is to have online services with fixed timelines up and running within the next two years.
Indian regulators see such services as a way to make approval timelines more consistent while also preventing corruption. Both issues have dogged the regulatory system for years. “At both the central and state levels, there is a cadre of clerks always on the lookout for ways to make money,” the head of a pharmaceutical company said. “A small clearance takes months unless you pay money.”
The anticipated uptick in government investment could improve the situation. Singh expects to double the number of regulatory staff within two years. Growth will then slow slightly, resulting in the headcount doubling every three years. The rapid growth, while welcome, will put strain on India’s regulatory system in new ways, notably the logistical challenge of hiring and training so many people.
Singh wants to manage the situation by creating a university for regulatory affairs and patient safety. “I’m going to propose this to the government. We need to train people and keep improving their skills continuously,” he said. – Nick Paul Taylor
Business Today, Q&A
CFDA Collaborating with Alibaba on Electronic Regulation Platform
Alibaba Health has unveiled the results of a collaboration with China Food and Drug Administration (CFDA) on its recently launched website. The new offering is the China Drug Electronic Regulation Platform, a way for companies to keep CFDA informed of their details and drug transactions.
Marbridge Daily, a China-focused consultancy, picked up the news from a report on 36Kr.com. In a translation of the news, the consultancy reports CFDA has led the initiative with Alibaba handling the operation of the platform. CFDA wants manufacturers, wholesalers, retailers and medical establishments to register through Alibaba’s platform and scan barcodes to record drug transactions.
The CFDA-led initiative is one of four components of Alibaba’s nascent health website. Alibaba Health also features a data analysis service for manufacturers, a way to connect hospitals and patients and a mobile app for managing prescriptions. The mobile app underpins Alibaba’s recent deal with China Jo-Jo Drugstores, which is working with the e-commerce giant on online sales of prescription drugs. – Nick Paul Taylor
Indian Consumers to get Web Portal for Reporting Shortages, Grievances
India will soon be launching a web portal for consumers to report drug shortages and file complaints if they have been overcharged for treatments. The Times of India reports that the government promises to reply to complaints within two days, and that a mobile application is forthcoming.
The portal will contribute to the National Pharma Pricing Authority’s (NPPA) efforts to combat counterfeit and black-market drugs, and will help the agency to monitor the country’s fragmented pharmaceuticals landscape.
The system’s success will be heavily reliant on a new database for registered drugs that is scheduled to launch in May 2015. An official told The Times of India “The database is important to strengthen monitoring and redress of complaints. Unless we fix the back-end system, the scheme cannot be successful.” – Michael Mezher
The Times of India
Weigh-in on Trans-Pacific Partnership
The former lead negotiator for the Australia-US free trade agreement has come out against the Trans-Pacific Partnership (TPP). Dr. Ruth Lopert says the amount of regulatory data protection being sought by the US would increase costs for Australia’s Pharmaceutical Benefits Scheme (PBS).
Lopert warns that increasing regulatory data protection would have a negative effect on competition, especially in developing countries, and told The ABC “Australia as a good global citizen has an obligation to consider the interest of its neighbors in its negotiation – not just be concerned about Australian interests.”
Australia’s Trade Minister Andrew Robb has defended the trade talks, calling the negative press a “scare campaign.” Robb has said he would oppose increasing any extensions to regulatory data protection.
Malaysia’s Trade Minister has also expressed reservations about increasing regulatory data protection, saying, “Malaysia still has not agreed with any proposals relating to medicines.” – Michael Mezher
The ABC: Lopert Interview, Robb Interview, The Malaysia Insider
Report Claims Australia Slow to Reimburse New Medicines
A new report by Medicines Australia finds that Australia lags behind other developed countries in access to new medicines. The report looks at the number of newly registered medicines available for reimbursement in 20 members of the Organization for Economic Co-operation and Development (OECD).
The report finds only 39% of newly registered medicines were eligible for reimbursement in Australia between 2009 and 2014. On average, 54% of new medicines were eligible for reimbursement for all countries surveyed. Japan led the ranking, with 93% of medicines eligible for reimbursement.
The report also finds that Australia takes longer on average to list medicines for reimbursement. Australia took more than nine months to list 50% of newly registered medicines for reimbursement, while Japan, Germany, Austria, the UK and Switzerland provided reimbursement for more than 50% of newly registered medicines in less than three months. – Michael Mezher
Medicines Australia Report
WHO Calls on India to Invest in Medical Device Sector
The World Health Organization (WHO) representative to India has called for the country to end its history of underinvestment in the medical device sector. Dr. Nata Menabde made the comments on the day an Indian research institute was designated a WHO Collaborating Centre for Priority Medical Devices.
WHO awarded the designation to the National Health Systems Resource Centre (NHSRC), making it the first Collaborating Centre in Southeast Asia and strengthening its technical ties to the facility. While the event marked a boost for the industry, Menabde took the opportunity to take India to task over its “underinvested and heavily import driven” medical device sector.
The Ministry of Health and Family Welfare published the comments in a press release, in which the health secretary outlined how he plans to improve the situation. Regulation and investment in associated infrastructure will play a role. “It is critical to have the specifications in place for the medical devices. There is also need for dedicated medical devices testing laboratories to ensure the safety and efficacy of these devices,” health secretary Shri B P Sharma said. – Nick Paul Taylor
Press Release, Press Trust of India
Pakistani Pharmacy Takes on Drug Quality and Supply Chain Issues
The Express Tribune profiled the Karachi-based Pharmacie Plus, which says it is taking measures into its own hands to combat spurious medicines and other drug safety issues. Hamza Usman, director of Pharmacie Plus, said his company buys directly from approved suppliers to avoid counterfeit products and pays special attention to how its products are stored and handled. Usman says his company has also started to add barcodes – which are not provided by manufacturers – to its products so it can trace products back to their source in case there is an issue. – Michael Mezher
The Express Tribune
Ranking Biopharma Potential in Asia
Genetic Engineering & Biotech News has ranked eight countries in Asia (plus Australia) for their potential as biopharmaceuticals development clusters. As with other industries, the biopharmaceuticals industry has looked to Asia to cut manufacturing costs. The article points out that growth in the domestic biopharmaceuticals industry is attracting the attention of foreign firms.
The article ranks the countries based on research and development spending, number of patents, number of companies and jobs in the industry. The ranking places China at the top, followed by Japan, India, South Korea, Taiwan, Australia, Malaysia and Singapore, respectively. – Michael Mezher
Genetic Engineering & Biotech News
Chinese consumers reportedly stocked up on over-the-counter drugs while visiting Japan for their New Year celebrations. The trend was spotted in an analysis of posts on social media and is thought to be linked to consumer worries about the quality of medicines sold in China. Drugs sold in Japan are perceived to be safer and represent better value. Wall Street Journal
The Association of Indian Medical Device Industry (AIMED) has partnered with the Quality Council of India (QCI) and the National Accreditation Board for Certification Bodies (NABCB) to create a voluntary quality certification scheme for medical devices. The initiative is intended to cover gaps in mandatory regulations and raise the standard of medical device production in India. PharmaBiz
CFDA has begun investigating chocolate manufacturers. Preliminary findings show some companies have non-compliance issues relating to labeling and other matters. CFDA is continuing to probe the companies while also working to tighten oversight of the industry as a whole. More stringent supervision of adherence to hygiene standards is among the planned changes. CFDA Notice (Chinese)
DCGI has approved copies of Gilead Sciences’ hepatitis C blockbuster Sovaldi from Hetero Drugs and Natco Pharma. Both companies have non-exclusive licenses from Gilead to manufacture and sell hepatitis C drugs. Gilead’s developing world strategy faced renewed criticism this week, notably over how it is trying to stop drugs being diverted to rich countries. Business Standard, Reuters
India’s National Pharmaceutical Pricing Authority (NPPA) has called for drug manufacturers to pass on the savings from a tax break to consumers. The industry will now pay 6% excise duty, down from 6.18% before the government rethought its approach to a particular levy. NPPA wants to see the drop reflected in immediate changes to maximum retail prices. Press Trust of India
Representatives of the US Food and Drug Administration (FDA) have met with their counterparts at the Central Drugs Standard Control Organization (CDSCO) to discuss how they can work together in India. FDA reportedly used the meeting to clarify its regulatory expectations to CDSCO and the four state bodies that attended. Training, joint inspections and data sharing were discussed. PharmaBiz
CFDA has named another 11 websites as part of its ongoing campaign to stop the illegal and misleading promotion of products online. The list includes two websites that carry the GlaxoSmithKline logo but appear to have no affiliation to the company. Both websites promote Alkeran, a treatment for multiple myeloma sold by GlaxoSmithKline. CFDA Notice (Chinese)
Gujarat Food & Drugs Control Administration (FDCA) has sought the help of NPPA to address a severe shortage of human albumin. NPPA has responded by contacting manufacturers, but some think its actions caused the problem in the first place. Prices of albumin are now capped, a situation that some claim has prompted companies to stop manufacturing the product. PharmaBiz
CFDA has approved particle therapy equipment from Siemens, marking the first time such a device has received regulatory clearance in China. The equipment is installed at a hospital in Shanghai where it will be used for the treatment of solid tumors and some benign diseases. Regulators will continue to monitor the safety of the device under a post-marketing surveillance program. CFDA Notice (Chinese)
Australia’s Pharmaceutical Benefits Advisory Committee (PBAC) has mounted a defense against calls by the industry to accelerate the approval and reimbursement of cancer drugs. PBAC said the proposed changes would “greatly increase the cost to the community...without any commensurate gain in health outcomes.” PharmaTimes
The Washington PostprofilesLebanon’s Health Minister Wael Abu Faour, who has made headlines in the country for his efforts to raise food safety standards and reduce prescription drug costs in the country.
India may delay new labeling requirements that would have cigarette manufacturers cover 85% of their products’ packages with graphic images designed to discourage smoking, The Times of India reports.