Welcome to our new website! If this is the first time you are logging in on the new site, you will need to reset your password. Please contact us at firstname.lastname@example.org if you need assistance.
Your membership opens the door to free learning resources on demand. Check out the Member Knowledge Center for free webcasts, publications and online courses.
Hear from leaders around the globe as they share insights about their experiences and lessons learned throughout their certification journey.
RAPS recognizes that the current situation in Ukraine impacts our members and customers on many levels. If you are directly impacted by the current situation in the region and are challenged to meet your deadlines or obligations to RAPS, please reach out to email@example.com so that we can defer those challenges. Your health and safety are paramount to us.
Posted 12 May 2015 | By Nick Paul Taylor
Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia.
The Drug Controller General of India (DCGI) is studying how other regulators handle online sales of prescription drugs in anticipation of drafting its own rules. DCGI initiated the project in the wake of a state regulator’s action against online retailer Snapdeal.
Discussions in the Indian media in the days after Maharashtra Food and Drug Administration (FDA) began legal proceedings against Snapdeal focused on the lack of regulations covering the online sale of medicines. Dr. BR Jagashetty, the former national advisor of drugs control, called for the rapid adoption of new rules and a licensing system. Jagashetty said the Central Drugs Standard Control Organization (CDSCO) should handle licenses and charge a “hefty fee,” PharmaBiz reports.
DCGI is still in the early stages of deciding how to regulate the sector but is committed to doing something. “There is an online distribution system in place which today is not approved legally and hence is unacceptable. There are currently provisions and safeguards under the Indian [law] to deal with prevalent malpractices but we are planning to explore other international regulatory bodies on how are they are tackling the challenges in online pharmacy,” DCGI Dr. GN Singh said.
State regulators, notably in Gujarat and Maharashtra, are currently leading the campaign against illegal online sales but want support from national bodies. Maharashtra FDA asked DCGI to step up its activities in the days after the action against Snapdeal.
PharmaBiz, More, Jagashetty
Trade groups representing doctors, drug manufacturers and pharmacists have accused the Drug Regulatory Authority of Pakistan (DRAP) of delaying the sale of low-cost hepatitis C drugs. The allegations center on the availability of generic versions of Gilead’s hepatitis C blockbuster Sovaldi.
Leaders of the Pakistan’s medical, pharmacy and pharmaceutical associations, plus representatives of other trade groups, told the press officials delayed the approval of hepatitis C drugs to give one company a monopoly. The company that was allowed to sell a version of Sovaldi reportedly has ties to a government minister. The Nation reports a bribe was involved and legal action was taken against companies that tried to enter the hepatitis C market.
Critics of DRAP often refer to the presence of a “mafia” within the organization. The decision to name someone from the private sector to lead DRAP was partly related to these concerns. A shortlist of four public sector candidates was dismissed, reportedly because the hiring committee found allegations of corruption against each of the officials.
A court in Australia has signed off on a compensation deal between Pfizer and people who reported suffering from addictions after taking Parkinson’s treatments Cabaser and Dostinex. Pfizer proposed the settlement in December to bring years of legal disputes to an end.
The people in line to receive a slice of the settlement — which reportedly amounts to millions of dollars — claim to have experienced severe addictions to gambling, food and sex after taking the drugs. At least one person said they gambled away their life savings, despite never having a problem before receiving the medication, The Guardian reports.
Patients began putting together a class action in 2008, two years after Pfizer sent precautionary warnings to doctors about possible side effects associated with Cabaser. The campaign resulted in Pfizer offering a settlement late last year, the approval of which this week should stop the 172-person class action suit that was due to start this year from reaching the court.
The Indian Comptroller and Auditor General (CAG) has found cases of pharma companies claiming tax benefits on illegal gifts to doctors. Some companies seemingly broke the rules twice, first by giving gifts to doctors and then claiming tax back on the illegal expenses, the Press Trust of India reports.
CAG identified the wrongdoing by combing through 2,868 assessment records covering pharma firms. Almost 10% of the reports were noncompliant with the rules. These cases involved taxes totaling $210 million. A subset of the cases took place in states where the law bars companies from giving gifts to doctors. Almost $9 million in taxes was affected by those 36 cases.
The findings suggest state-level efforts to restrict gifts to doctors and a national-level policy to ban the claiming of tax benefits on such expenses have failed to change the approaches of all companies. The Centre Board of Direct Taxes stated its position on expenses in 2012, while Indian states and the Medical Council of India have policies on providing gifts and hospitality to doctors.
Press Trust of India
China is investigating a former health official who supervised clinical trials, an anonymous source told Bloomberg. The probe reportedly relates to corruption and violations of Communist Party discipline that are alleged to have taken place during the official’s 10-year stint as clinical trial czar.
Wang Yu was director of China’s National Health and Family Commission’s bureau of medical administration until he retired last year. The role gave Yu responsibility for overseeing the clinical research of drugs and medical devices, plus a leading role in the creation of policies covering medical institutions. Details of the allegations are yet to emerge, but Bloomberg framed the case as part of President Xi Jinping’s two-year anti-corruption campaign.
The campaign has affected more than 100,000 government officials and major western companies, notably GlaxoSmithKline, which was fined $484 million last year for paying bribes. Media reports last week said Siemens and other medical equipment manufacturers are the latest targets for the anti-corruption campaigns, although the relevant government department denied it has initiated an investigation. Officials failed to respond to Bloomberg’s questions about Yu.
The Chinese state media has run a series of stories to downplay concerns the lifting of price caps will cause the cost of drugs to jump. As well as reminding people that the hospital bidding process is expected to keep costs down, the Chinese government is pushing local officials to monitor the market for signs of price manipulation. FiercePharmaAsia
China Food and Drug Administration (CFDA) has banned 30 companies from advertising health products. CFDA implemented the ban in response to the publication of “severely illegal” adverts for 33 products, including dietary supplements and medical equipment. The companies continued to run the adverts despite being warned by CFDA last year. Xinhua
Officials in China are working on new rules covering animal testing and pediatric medicines. A committee is working on guidelines for the use of drugs in children, while the Department of Laboratory Animal Science is aiming to post draft standards on animal testing by the end of 2015. FiercePharmaAsia, China Daily
China’s Supreme People’s Court has cleared the path for generic copies of the crystalline version of Pfizer’s Lipitor by ruling its patent is invalid. Citigroup found Pfizer held 80% of the market for drugs containing atorvastatin — the active ingredient in Lipitor — as recently as last year. However, it now faces more widespread generic competition. BioCentury
India’s Drugs Technical Advisory Board (DTAB) has rejected a proposal to increase the qualifications needed to become a government analyst. The board ruled the current requirements of being a medicine, science or pharmacy graduate with five years of drug testing experience are sufficient. PharmaBiz
Tags: Asia Regulatory Roundup, Regulatory Roundup