Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia.
High Court Hears Case Against Appointment of DRAP CEO
A legal challenge to the appointment of the CEO of the Drug Regulatory Authority of Pakistan (DRAP) has reached the Islamabad High Court. The court has given DRAP CEO Dr. Muhammad Aslam and other interested parties 15 days to respond, after which it will reconvene to hear the case.
Mirza Abdul Rehman, a former vice president of the Federation of Pakistan Chamber of Commerce and Industry, brought the action against the appointment, which he views as illegal. Rehman has multiple grievances, ranging from a belief that the job description and hiring process were crafted to favor Aslam to concerns about conflicts of interest, Daily Times reports. Aslam was working at Japanese pharma company Otsuka during the DRAP CEO recruitment process.
The court case is a distraction at a time when Aslam is trying to improve DRAP while also fighting fires that started before his appointment. Another problem surfaced this week when a health ministry official leaked details of DRAP’s rented offices to DAWN. DRAP is reportedly paying almost $1 million to renovate rented offices it will only occupy for 14 months. The regulator began renting the building in July to give it a base while a new headquarters is built, but is yet to transfer all its units to the site.
Officials at the National Assembly standing committee on national health servicesare reportedly unhappy with the outlay on the 30,000-square-foot rented building. The displeasure of the committee is one of several ways in which the relocation is a headache for Aslam. “I am also in a hurry to start the construction of the building because the prices of construction materials are escalating,” he said. – Nick Paul Taylor
Daily Times, The Nation, DAWN
What do Regulatory Pros Need to Know About Personalized Medicines and Companion Diagnostics in the EU?
The shift from “one-size-fits-all” medicinal products to more targeted and customized drugs is introducing new challenges for the people involved in the development and commercialization of such products.
One of those challenges: Knowing how to bring your personalized medicine product to market. Want to learn how? Attend this upcoming RAPS workshop and hear from experts and EMA regulators involved in the regulation of personalized medicine. Register by 11 May 2015 to attend this essential event. [Read More...]
NPPA Chief Ousted After Nine Months on the job
The chairman of India’s National Pharmaceutical Pricing Authority (NPPA) has been removed from his post just nine months after being appointed. During his brief reign, Injeti Srinivas clashed with the pharma and medical device industries repeatedly, a fact some think contributed to his downfall.
Srinivas tried to extend price controls beyond the list of essential medicines within one month of taking the NPPA post in June. In December, he turned his attention to medical devices. Neither move won him friends in the industry. “He was shunted out because he was really effective as NPPA chairperson and had become a thorn in the side of the drug companies with respect to price control,” Chinu Srinivasan, of nonprofit essential medicine manufacturer LOCOST, told The Times of India.
NPPA is now looking for a new leader while Srinivas has landed at the Sports Authority of India. The decision to move Srinivas on coincided with news that the government is to raise the price caps on 509 essential medicines by almost 4%, Press Trust of India reports. DG Shah, secretary general of the Indian Pharmaceutical Alliance, welcomed the inflation-linked price hike. – Nick Paul Taylor
The Times of India, Press Trust of India, FiercePharmaAsia
India Advances Plan to Regulate Medical Devices Separately from Drugs
A proposal to split the regulation of medical devices and drugs has moved a step closer to being heard in the Indian parliament. The Health Ministry signed off on the proposal this week, after which it sent the plan to other government departments for consultation.
If the ministry can get the other departments to buy into the proposal, it will be heard in Rajya Sabha. The plan is to create dedicated standards for medical devices. Officials at the Central Drugs Standard Control Organization (CDSCO) will enforce the standards for high-risk devices, while notified bodies will handle the regulation of medium-risk products, the Press Trust of India reports. Self-regulation is proposed for low-risk devices.
The proposal — which is advancing in conjunction with clinical trial reforms — is one of several ways in which medical device regulation in India could change in the coming years. PharmaBiz reports a task force set up by the Department of Pharmaceuticals is calling for a wide-reaching Medical Device Regulatory Act, while the government is trying to strengthen the sector by creating dedicated manufacturing parks. A list of essential medical devices, the prices of which would be controlled, is also planned. – Nick Paul Taylor
Press Trust of India, PharmaBiz, Press Release
New Barcode Requirements for Indian Drug Exports
In an effort to build its reputation for quality medicines, India will require barcodes on the cartons used to transport drug exports, The Economic Times reports. India already requires barcodes on the tertiary packaging that holds the cartons during transportation. By adding barcodes to the product cartons, which in turn contain the primary packages of a drug, the government hopes to distance legitimate exported product from counterfeit products that claim to be made in India.
Initially, the government had planned to add the barcodes to products' primary packaging as well. However, the local manufacturing industry argued that this would be burdensome and technically infeasible to accomplish.
While many larger companies in India already implement similar tracking measures, small and medium companies have been slower to adapt to the new requirements. – Michael Mezher
The Economic Times
Interview on Pharmacopeial Challenges in Japan, Harmonization
The United States Pharmacopeial Convention's Quality Matters blog interviewed Issei Takayama about Japan's challenges related to its pharmacopeia.
Takayama, who works as a technical officer at Japan's Pharmaceuticals and Medical Devices Agency (PMDA) and serves as Secretariat for the Japanese Pharmacopeia's (JP) Expert Committees, talks about the Pharmacopeial Discussion Group (PDG), an effort to harmonize pharmacopeial standards across the US, Europe and Japan. The three countries' pharmacopeias formed the PDG in 1989, with the goal of developing pharmacopeial standards and procedures that would yield the same results and decision in each jurisdiction.
Takayama admits that the JP has had challenges with resources and capacity, which he says have left the country with fewer reference standards than the US. Additionally, as the JP works mostly with Japanese companies, it is difficult to obtain reference materials for impurity standards. – Michael Mezher
Investigating Counterfeit Drugs in Asia
Al Jazeera takes an in-depth look at the counterfeit medicines trade in Asia. A reporter, working undercover, describes the scene in a Bangkok marketplace where spurious drugs were being sold alongside knockoff handbags and perfume.
An investigator for Pfizer told reporters that one of the drivers behind the influx of counterfeit drugs is the profit they carry, claiming they can be more profitable than heroin.
One woman profiled in the story, left quadriplegic from a car accident, describes her experience taking what she believed to be counterfeit drugs to treat her muscle spasms when she could no longer afford the genuine product. She told Al Jazeera, "At first I thought it's cheap and effective … I felt tightness in my chest, my blood pressure shot up." A representative of the Philippines Pharmacists Association told Al Jazeera that people are turning to the drugs without necessarily knowing they might be fake or substandard. – Michael Mezher
TGA Pushes Back Reforms Until After Expert Review
Australia’s Therapeutic Goods Administration (TGA) has delayed the implementation of five planned reforms covering drug advertising, medical devices and other topics. TGA had planned to adopt the new policies in the 2014-2015 fiscal year, but the start of a government review has forced a change.
The delays are the result of overlaps between recommendations made in the 2011 “TGA reforms: A blueprint for TGA's future” — which the regulator has spent the past few years implementing — and the topics covered by the Expert Review of Medicines and Medical Devices Regulation. Government officials committed to the review in October in a move that has forced TGA to put some of its reforms on hold.
In the latest update on the adoption of the blueprint recommendations, TGA reports it has pushed back the deadlines for five initiatives that clash with the review. The reforms include plans to publish medical device information on the TGA website, make the regulation of advertising more transparent and stop manufacturers of complementary medicines making inappropriate claims. The drug and medical device component of the review was due to be submitted by the end of March. – Nick Paul Taylor
Medical Device Developments in Malaysia
The Malaysian Medical Device Authority (MDA) unveiled a temporary fast-track registration process for medical devices that have been previously registered in the US, EU, Canada, Japan or Australia, Emergo Group reports. Additionally, all Class A (lowest risk) devices will qualify for fast-track registration. Qualifying devices may skip certification by the Conformity Assessment Board (CAB) for up to five years. Companies will still have to engage with the CAB within the first three years and certify their products before the end of the five-year period. Companies may apply for registration in this manner until 30 June 2015.
MDA has also released a draft guidance detailing the requirements for medical device post-market surveillance audits. The audits will either be routine surveillance, or "for cause," in response to adverse event reports or at the behest of other regulatory authorities. Companies may be cited for major and/or minor non-compliance issues, depending on the severity and/or outcome of any violation. – Michael Mezher
Emergo Group – Fast-Track, Post-Market Surveillance Audit
Stomach Medicine Recall in Taiwan
The Taiwan Food and Drug Administration (TFDA) has ordered the recall of 23 stomach medicines over concerns that manufacturers did not use pharmaceutical-grade ingredients in the products, the Taipei Times reports. The agency said that 13 of the 27 companies it inspected over a three-day period could not verify whether food- or pharmaceutical-grade ingredients were used to make the products.
In Taiwan, companies are required to use pharmaceutical-grade magnesium carbonate and calcium carbonate in health supplements or medicines. The TFDA kicked off its recent spate of inspections after receiving reports that companies were using substandard magnesium and calcium ingredients.
The companies will be fined for the violations and have and have until Wednesday to pull them from shelves in the country. – Michael Mezher
A delay in the release of funding has forced Gujarat Food & Drugs Control Administration (FDCA) to push back the opening of its drug testing facility. The construction of the laboratory is complete, but FDCA needs money to fit it out with testing equipment. Bureaucracy is reportedly holding up the release of the cash. FDCA’s food testing site opened its doors this week. PharmaBiz
China has committed to driving down drug prices in its latest five-year plan for healthcare. The government plans to pursue the price-cutting agenda in parallel to an attempt to sever the link between drug profits and doctors’ incomes. An early attempt to implement aspects of the strategy came unstuck earlier this month when dialysis patients protested. China Medical News
Seunghee Kim has become the first woman to lead South Korea’s Ministry of Food and Drug Safety.Kim began working for the ministry in 1988, since when she has risen through the ranks to occupy positions including head of the National Institute of Food and Safety Evaluation and most recently vice minister. FiercePharmaAsia
American Enterprise Institute Adjunct Scholar Roger Bate has accused the World Health Organization (WHO) of kowtowing to India in its report on substandard and counterfeit medicines. “One can see the hands of the usual suspects in this interim report, notably India. The Indian government ... doesn’t want anything that will undermine the rapid growth of its generic drug industry,” Bate wrote. S4S Blog
China Food and Drug Administration (CFDA) has taken steps to strengthen the supervision of raw milk drinks. The regulator wants to ensure all sellers of raw milk drinks are fully licensed and have suitable process controls in place. CFDA Notice (Chinese)
New Zealand’s Medsafe has put guaifenesin on its medicines monitoring scheme after the Centre for Adverse Reactions Monitoring received reports of tinnitus and hearing loss. Guaifenesin is used in cough treatments sold in New Zealand by Johnson & Johnson, Pfizer and others. Medsafe Notice