Asia Regulatory Roundup: Packaging Problems in India, China Confronts Ebola (15 October 2014)
Welcome to our Asia Regulatory Roundup, a new feature exclusively for RAPS members. Each week our roundup will provide you with the latest, most important regulatory news affecting Asia and the companies operating therein.
Industry Hits Back Against India’s Plan to Ban PET Packaging
Some Indian pharmaceutical packaging companies are criticizing the Indian government’s plan to ban the use of polyethylene terephthalate (PET) as the primary packaging material of liquid oral formulations. The aim of the ban is to protect children, the elderly and pregnant women from health risks some people think are associated with PET.
The Indian government has given manufacturers six months to adopt alternative packaging materials, but gave no justification for its decision in its brief notice to alert the industry. PET has been criticized over safety concerns in India — where several public interest litigations have been filed — and other countries. However, Indian packaging manufacturers have rejected these concerns as unwarranted.
“The reality is that PET has passed all migration tests. It adheres to every global regulatory norm. Backed by such stringent compliances, PET was certified for use in drugs and foods covering biscuits to beverages,” Rajat Kedia, director at Indian packaging company Manjushree Technopack, told PharmaBiz.
A 2011 report by the European Food Safety Authority (EFSA) into the use of PET as a food packaging material backs up Kedia’s view. EFSA concluded PET is not a safety concern, a view that is shared by publishers of research papers on the material and other regulators. PET has been used as a food and drug packaging material in India since 1982.
After 32 years of PET use, manufacturers have doubts about the ability of the industry to switch to alternative materials within six months. Kedia and others are pressuring the government to reverse its ruling.
CFDA Seen as Potential Bottleneck for Ebola Drug Development
Sihuan Pharmaceutical has entered the race to develop a treatment for Ebola by acquiring an asset for RMB 10 million ($1.6 million), but observers think regulations and other China-specific issues could slow its progress.
The drug, JK-05, was discovered by the Chinese Academy of Military Medical Sciences, which will now work with Sihuan Pharmaceutical on its development. JK-05 has been tested in mice, but is yet to be given to people or non-human primates. The goal now is to get China Food and Drug Administration (CFDA) clearance for clinical trials and then give the drug to Chinese nationals working in Africa.
Reaching a point at which the drug is used in the field could take time. “Under typical circumstances, simply getting the drug into clinical trials and through registration — even if fast-tracked by CFDA and even if it aims only at Chinese local approval — would normally take a minimum of five years,” George Baeder, a consultant on the Chinese pharmaceuticals market, told the Financial Times.
The caveat is that these are not typical circumstances. According to Reuters, China may want to be among the first countries to provide an Ebola treatment to Africa to further tighten its relationship with countries on the continent. If the government decides to prioritize development of an Ebola drug, the normal CFDA timelines could be shortened, but the lack of live virus in the country would still pose difficulties.
Sihuan Pharmaceutical is optimistic it can speed the drug through development, though. “We believe that we can file to CFDA before the end of the year. They are looking at this very seriously ... and we could get on the ‘green light’ track,” Sihuan Pharmaceutical’s chairman Che Fengsheng said on an investor call attended by Reuters.
State FDA Calls for India to Adopt Price Controls for Medical Devices
The future of medical device regulation in India is continuing to generate debate. The Maharashtra Food and Drug Administration (FDA) is the latest to offer its opinion, telling national authorities they should adopt price controls for five classes of medical devices.
PharmaBiz reports Maharashtra FDA wants to see price controls applied to neuro coils, cochlear implants, cardiac stents, ortho implants and bone cement to ensure patients can afford the devices. The state regulator has advocated price controls since running a study that found patients are paying three times the import cost for medical devices. Stents reportedly cost twice as much as in Europe.
Maharashtra FDA has now taken its case to the Drug Controller General of India (DCGI) and National Pharmaceutical Pricing Authority (NPPA). The state regulator is recommending the five classes of medical devices be added to Drug Price Control Order (DPCO), a move that would give the government more power to dictate how much people pay for the products.
Aspects of medical device regulations that are already being reassessed also provoked further reaction this week. Proposed labeling rules have been criticized for containing loopholes and the Association of Indian Medical Device Industry (AIMED) fears a reference to international pharmacopoeia standards is confusing.
CDSCO to Sample 15 Classes of Drugs in Quality Tests Within Three Months
The Central Drugs Standard Control Organization (CDSCO) is to start sampling antibiotics and 14 other categories of drugs for its spurious medicine survey. CDSCO is running the survey to assess the prevalence of counterfeit and substandard drugs in India.
Collection of basic data by the National Sample Survey Organization (NSSO) is already nearing completion, PharmaBiz reports, after which samples will be taken and tested. The sample collection phase of the project is expected to be completed within three months. Samples will be taken from hospitals and pharmacies across India.
When CDSCO ran a similar survey in 2009, the prevalence of spurious drugs was calculated to be 0.046%. The Associated Chambers of Commerce and Industry of India (ASSOCHAM) and Indian Ministry Health have both quoted significantly larger figures than 0.046% in the past.
CFDA Begins Clampdown on Substandard Cosmetics
CFDA has asked local authorities to increase oversight of cosmetics manufacturers and traders after finding substandard products on sale in the country. Sampling by CFDA uncovered eight problematic products, many of which contained mercury.
The sampling prompted CFDA to issue a notice to local authorities requesting they strengthen their practices for enforcing cosmetic quality controls. Inspections of cosmetics production facilities, monitoring of traders and reporting of illegal activities to the police are all on the agenda. Consumers are also being encouraged to report any substandard products they see on sale.
Of the eight substandard samples tested by CFDA, some are suspected to be counterfeits, while others are thought to originate from unlicensed producers. The results of the investigation into the quality of cosmetics come weeks after CFDA reported on its much larger probe into the sale of substandard herbal products in China.
CFDA Notice (Chinese)
Other News:
The row over drug price controls in India is far from over. Weeks after NPPA withdrew its controversial plan to cap the prices of 108 drugs, the Supreme Court has agreed to hear a petition challenging the decision, the Economic Times reports. A final Department of Pharmaceuticals’ policy on the pricing of patented drugs is also yet to be released. Economic Times I PharmaBiz
China is to assess its drug review and approval process. The plan is to chip away at the backlog and prevent it from building up again by increasing headcount and taking other actions. Staffing shortages have previously been cited as a major reason for the backlog, especially as the filing of dozens of submissions to make generic copies of the same drug has given CFDA a big workload. CFDA Notice (Chinese)