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 11 August 2015 | By Nick Paul Taylor
Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia.
The Indian government has deferred free trade talks with the European Union in response to the ban on drugs tested by GVK Biosciences. Talks were due to resume this month after a two-year hiatus, but the European Medicines Agency's (EMA) decision to ban 700 drugs tested by GVK has prompted India to withdraw, the Press Trust of India reports.
Officials in the Indian government have taken an active role in the argument over how EMA has handled the GVK affair, notably by threatening to involve the World Trade Organization and calling on diplomats to lobby their contacts. With none of these threats and actions altering EMA's decision, the Indian government has deferred the resumption of free trade talks. The Commerce and Industry Ministry said the decision reflects how "disappointed and concerned" it is by the EMA action.
A lot is at stake. Annual trade between India and the European Union is nearing $100 billion, but the effort to establish a pact to encourage more commerce has faltered. Negotiators first sat down in 2007 but it is now two years since they last met. A failure to finalize free trade terms could harm companies on both sides of the negotiations, but the Indian Pharmaceutical Alliance has come out in support of the government's action, calling it "bold and befitting."
The pullback by India raises doubts about whether the deal will ever come to fruition. European Union Trade Commissioner Cecilia Malmström said this week that a "stock-taking meeting" between the two sides is the next step, EurActiv reports. The meeting, which is penciled in for September, is intended to establish whether there is enough "ambition" to warrant restarting negotiations over the trade deal.
Press Trust of India, The Economic Times, EurActiv
Indian tax officials have conducted a dawn raid on 30 commercial and residential premises relating to Claris Lifesciences. The state-wide operation is the latest step in a probe by income tax officers into the financial activities of the Indian manufacturer of sterile injectables.
Around 150 officials were involved in the raids, which started at 6:30 a.m. and targeted properties used by Claris Lifesciences, its promoters and sister companies, the Press Trust of India reports. The premises searched in the raid included residential properties, factories and offices. Exact details of what the officials were looking for are yet to emerge, but the probe into the company reportedly relates to suspected tax evasion and black money transactions.
The raids turned up evidence to further the case. "Officials have found incriminating documents which had bogus transactions carried out by the company. These documents have revealed fake purchases and expenses. The officials have also collected data from all the computer hard disks of the company," an anonymous source told The Times of India. The Bombay Stock Exchange is now seeking clarification about the case. Shares in Claris Lifesciences fell 10% in the days after the raids.
As well as the aforementioned documents, tax officials seized bank lockers and jewelry. The search has also uncovered Rs 7.25 crore ($1.1 million) in cash, at least some of which officials say was held by senior management at Claris Lifesciences. Around 10 bank lockers are still being searched and the seized hard disks are with the tax department's cyber forensics lab for analysis.
Press Trust of India, The Times of India
The growth in China of all bar one of the world's top biopharma companies has slumped. In recent years, companies have enjoyed mid-teen growth rates but government-driven changes to prices and the broader healthcare ecosystem have contributed to a significant slowdown.
AstraZeneca was the only big pharma company to buck the trend in the second quarter, Reuters reports, with all of its peers seeing their growth rates slip into single digits. Observers are pinning the sector-wide slump on reforms initiated by the Chinese government to control its healthcare budget, some of which have changed the regulatory and commercial landscape in which Western biopharma companies are operating.
"I think there's a conscious effort to slow it down a bit," Joe Jimenez, CEO of Novartis, said in July after posting quarterly results. "Then on top of that, you have what's happening from an economy standpoint in the stated shift towards what they're calling sustainable economic growth, which is leading to lower overall growth rates." The question now is when, if at all, Chinese officials will release the handbrake and let the healthcare market grow up to its forecasted $185 billion by 2018.
The Drug Controller General of India (DCGI) Dr. GN Singh has asked regional officials to send lists of veterinary drugs, including details such as their manufacturers, dates of approvals and indications. Singh has initiated the program in an attempt to build a comprehensive list of drugs used in India.
As it stands, India lacks a complete, centralized list of animal medicines, a situation veterinarians think is leading to the misuse of drugs. Such misuse can result in overdoses and the development of resistance, events that harm both animals and humans. "Indiscriminate usage by non-registered and untrained practitioners is leading to frequent cases of drug resistance and treatment failure," Dr. Avinash Srivastava of Wellcon Animal Health told India Today.
More than 200 veterinary drugs are approved in India. Some veterinarians prescribe products from beyond this list, though, including drugs intended for humans such as diclofenac, a nonsteroidal anti-inflammatory drug that has been cited as the cause of the decline in the population of vultures in India.
The Indian government is once again considering tweaking its approach to drug pricing as it tries to ensure certain drugs are available to even its poorest citizens. If the plan goes ahead, India will make 50 drugs for cancer, AIDS and other diseasesavailable for cheaper than they can be sourced today.
Ananth Kumar, the minister of chemicals and fertilizers, is assessing the proposal as a way to make drugs available to everyone in the country, regardless of income. The plan would bring cheap drugs to a large proportion of the Indian population. Kumar said around 1 billion people in India — out of a population of 1.3 billion — need "extra health security," the Press Trust of India reports. As well as cancer and AIDS drugs, Kumar is looking at treatments for diabetes, hypertension and the flu.
"These 50 to 55 medicines are very essential and we need a bracket of such 50 to 55 medicines which should be provided at cheaper rates and are of good quality. Therefore the government is looking into this and exploring this," Kumar said. India already controls the prices of hundreds of products through its National List of Essential Medicines. The new scheme would go beyond this by offering the medicines viewed as being the most essential for even less.
Whether such policies are effective is a topic of debate.
Press Trust of India
The Indian commerce ministry is considering simplifying the process of exporting drugs from the country. PharmaBiz
Tags: Asia Regulatory Roundup, Regulatory Roundup
Regulatory Focus newsletters
All the biggest regulatory news and happenings.