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Regulatory News | 09 June 2015 | By Nick Paul Taylor
Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia.
A pair of surveys by Deloitte and EY has shown the Indian pharma industry is still grappling with the problem of regulatory compliance. More than half of respondents to the Deloitte survey said their compliance teams lack the training to handle regulatory responsibilities, yet a similar number of people have made investment in their compliance strategy a low priority.
The belief among 55% of the respondents in the survey of 33 organizations that Indian companies lack the training and skills to meet their responsibilities is, in part, a result of industry growth and the evolution of regulatory policies outstripping the development of compliance teams. However, there is no indication of a widespread willingness among Indian companies to spend their way out of the problem, with 48% of respondents saying compliance is not an investment priority.
A revision of business practices and outlook is needed if the industry is to address the discrepancy between companies’ need to invest in compliance and their willingness to do so. “The attitude of Indian manufacturers is more output oriented than quality driven,” Ajaz Hussain, a former US Food and Drug Administration (FDA) staffer, told The Economic Times. Deloitte said the lack of zero-tolerance attitudes to noncompliance and a shortage of talent are ongoing issues.
While the survey data suggest many companies are unwilling to invest in compliance, internal and external forces may force them to change. Whistleblowers are a common starting point for both internal and regulatory investigations. More than three quarters of firms rely on whistleblowers to detect fraud and noncompliance. EY warns that companies that fail to establish whistleblowing systems increase the likelihood of disgruntled employees voicing their concerns to regulators.
Business Today, The Economic Times, The Press Trust of India, More
The Indian government has proposed bringing medical devices under price controls and setting up an autonomous body to oversee the sector. Government officials laid out the plans in a draft policy document, bringing an end to months of speculation.
If the policy comes into force as planned, India will create an autonomous National Medical Devices Authority (NMDA) operating beneath the Department of Pharmaceuticals (DoP) and may set up a medtech-focused wing of the National Pharmaceuticals Pricing Authority (NPPA). Medical devices could also be given their own section in the Essential Commodities Act or controlled using a dedicated policy and Medical Devices Price Control Order.
The plan is vague for now, but the topic of affordability is at the forefront of the government’s thinking. Industry officials have six weeks to submit feedback on the draft policy, which also calls for the creation of NMDA to establish best practices, remove trade barriers and support the use of risk-assessment methods. NMDA will also have the power to ask the government to tweak its policies to help local medical device manufacturers.
Procurement processes that favor locally-made devices, zero duty on the importation of raw materials and long-term tax breaks are all mooted in the draft policy document.
The Times of India, Draft Policy
The Competition Commission of India (CCI) has fined GlaxoSmithKline and Sanofi after Bio-Med alleged the big pharma companies had created a meningitis vaccine cartel. CCI fined Glaxo $9.4 million and told Sanofi to pay $470,000.
Officials at CCI began probing Glaxo and Sanofi after hearing reports that the Indian government facilitated the creation of a meningitis vaccine cartel by raising the turnover companies needed to compete for contracts. This practice of year-on-year increases in the turnover barrier is alleged to have taken place between 2008 and 2012, after which Glaxo and Sanofi reportedly moved to maximize the profitability of their newly strengthened competitive positions.
“It was found that upon the disqualification of the Informant in 2012 due to modifications of eligibility conditions, both companies colluded to divide the entire tendered quantities and to earn supernormal profits by quoting significantly higher prices,” CCI wrote. CCI has ordered Glaxo and Sanofi to stop engaging in the practice, which in its opinion is a violation of the competition act. The companies have 60 days to pay their fines.
Glaxo has denied it was involved with anti-competitive activities and is considering appealing the ruling.
The Economic Times, More
Australia’s Therapeutic Goods Administration (TGA) has recommended against requiring routine blood monitoring of people taking Boehringer Ingelheim’s Pradaxa. The recommendation, which also applies to other new oral anticoagulants, follows allegations that Boehringer withheld data on the benefits of monitoring from regulators.
TGA made the recommendation after finding no evidence that routine plasma monitoring is likely to add significantly to physicians’ ability to assess the risk of bleeding. The regulator already tells physicians to assess renal impairment, age, concomitant medications and comorbidities alongside the clinical parameters of each anticoagulant when assessing dosing and bleeding risk. As it stands, TGA sees little value in adding routine plasma monitoring to the mix.
The regulator began assessing the topic following an investigation by the journal BMJ that alleged Boehringer had failed to share evidence of the benefits of routine monitoring. Boehringer has since accused BMJ of publishing “numerous misleading statements,” arguing that the mechanism of action of Pradaxa means assessing renal function is of more significance than monitoring plasma concentrations. TGA’s decision also applies to Eliquis and Xarelto.
Gujarat Food and Drug Control Administration (FDCA) has said its program to test 12,000 medical devices a year has identified substandard products. The state regulator initiated the policy to stop the importation of substandard medical devices, but has also found locally-made products that fall short of the expected standards.
Over the few years the policy has been in place, Gujarat FDCA has found evidence to confirm its initial suspicion that some people use India as a dumping ground for substandard medical devices made and initially sold overseas. However, the problem is broader than that, with substandard devices identified by the state regulator originating from many countries, including India. Such findings have led to regulatory actions.
“Based on the random sampling and testing, we have taken actions like suspension and cancellation of manufacturing licenses in certain cases in the state of Gujarat,” Gujarat FDCA Commissioner Dr HG Koshia told PharmaBiz. The government is responding to the problem. In the draft medical device policy released this week, it proposes placing higher taxes on imports of second-hand devices that are more than five years old to make dumping prohibitively expensive.
PharmaBiz, Draft Policy
The Indian Patent Office has rejected an application covering Abraxane, the blockbuster breast cancer drug sold by Celgene. Natco Pharma has opposed the patenting of the drug for years and is now closer to being able to launch a generic copy. TOI
China Food and Drug Administration (CFDA) has taken action against another group of websites it suspects are selling counterfeit drugs. The eight websites are the latest to be named in an ongoing drive to stop the spread of misinformation and fake drugs online. CFDA Notice (Chinese)
India’s DoP is considering stopping pharmacies from selling dietary supplements. The minister of state for Chemicals and Fertilisers advanced the idea, which would restrict pharmacies to selling pharmaceutical items such as medicines and syrups. PTI
Tags: Asia Regulatory Roundup, Regulatory Roundup