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Regulatory News | 05 May 2015 | By Nick Paul Taylor
Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia.
China has confirmed it will remove price caps from most medicines on 1 June 2015. The long-rumored move will shift the responsibility for negotiating prices to buyers, notably the hospitals that account for three-quarters of medicine purchases in China.
The buying power of hospital networks means the lifting of the caps is unlikely to trigger a jump in prices. However, the decision still marks a milestone in the transition of Chinese healthcare away from a centralized, government-led model and toward a system dictated by market forces. China began the transition in April 2014 when it removed price caps from certain products.
From 1 June, price caps will only apply to anesthetics and grade one psychiatric medicines. The gradual liberalization of the market is part of China’s attempt to stop the drug shortages and rising costs that have blighted the healthcare system in recent years.
The Maharashtra Food and Drug Administration (FDA) has begun an investigation into the sale of prescription medicines on Snapdeal, a major online retailer in India. If the investigation leads to a prosecution, an Indian court could hand out a five-year jail sentence to executives.
Snapdeal is a big player in the Indian e-commerce sector — a fundraising round last year valued the business at $1 billion — and its legal troubles have implications for the rest of the sector. Sites such as Amazon and Snapdeal are prohibited under Indian foreign investment rules from stocking products themselves, The Economic Times reports, so instead simply facilitate sales by third parties.
Maharashtra FDA alleges some retailers have used Snapdeal to sell emergency contraceptives, erectile dysfunction treatments and other prescription drugs. Last month, the regulator told Snapdeal to stop the sale of such products, but one week later a staffer was able to buy drugs through the site. The sale led Maharashtra FDA to open a legal investigation into Snapdeal’s CEO, directors and distributors.
Snapdeal argues it cannot be held responsible for what others sell on its site. The receptiveness of the legal system to this argument has implications for Amazon and the future of online medicine sales in India. Maharashtra FDA is also investigating other online retailers but is yet to start formal legal proceedings.
The Economic Times
The Australian Competition and Consumer Commission (ACCC) has authorized the adoption of a more stringent code covering the financial relationships between physicians and pharma firms. Companies must start reporting payments to physicians from October 2016.
By authorizing Medicines Australia to strengthen the code, ACCC has brought two years of debate to an end. The eventual compromise is acceptable to both sides of the argument, but is unlikely to stop consumer groups from lobbying for further changes. A member of the Consumers Health Forum of Australia (CHFA) has already criticized the cap on the reporting of food and drinks.
Companies do not need to report any meals they buy for doctors that cost less than $120, a stipulation that has caused criticisms and counter claims. CHFA views the cap as enabling pharma companies to gain significant unreported access to physicians through frequent meals. Physician groups are insulted by the accusation their prescribing habits can be swayed by lunches, though.
The Indian government has approved a materiovigilance program to keep track of adverse events related to medical devices. Data reported to the online portal will feed into analyses of the risks and benefits of medical devices, the Press Trust of India reports.
India is also setting up a technical committee to review data and make recommendations. The plan is part of the steadily advancing movement to separate the regulation of medical devices and drugs, in which the Association of Indian Medical Device Industry (AIMED) has played a significant role.
AIMED furthered another aspect of its plan this week by signing a memorandum of understanding with the Indian Medical Association (IMA). IMA will approve Indian-made medical devices that meet certain quality standards and promote their use in local hospitals, potentially furthering AIMED’s push to lessen the country’s reliance on imports.
Press Trust of India, PharmaBiz
Regulators in China and New Zealand have tightened oversight of medicines containing codeine. The changes recommended by New Zealand’s Medicines Adverse Reactions Committee (MARC) mirror those adopted recently in Europe.
MARC recommended the use of cough and cold medicines containing codeine be restricted to people aged 12 years and over. Europe’s Pharmacovigilance Risk Assessment Committee (PRAC) made the same recommendation in March. MARC also called for the use of bromhexine — which breaks up thick phlegm — to be limited to people aged six years and over. Europe also recently reviewed bromhexine, but it opted against placing an age restriction on medicines containing the ingredient.
China Food and Drug Administration (CFDA) has undertaken its own, wider-reaching revision of a policy on codeine. The new CFDA policy places more stringent requirements on manufacturers of codeine-containing medicines and limits the duration for which they can be prescribed.
Medsafe Notice, CFDA Policy (Chinese)
A task force has sent guidelines for the manufacturing and marketing of dietary supplements to the Food Safety and Standards Authority of India (FSSAI). The country currently lacks regulatory guidelines covering the approval and oversight of dietary supplements.
FSSAI formed the 17-person task force to address the regulatory gap and will now review the recommendations it has received, PharmaBiz reports. If the proposals come into force, companies wishing to manufacture and market dietary supplements will need to obtain a no-objection certificate before starting operations. The requirement is a step toward the raising of standards.
“There has been an increase in the incidents of misuse or improper manufacturing conditions. Considering the huge health risks it can pose to the consumers, it is high time to concentrate on having an ideal approval policy that will ensure proper compliance of manufacturing of all the products,” Dr. Hemant Koshia, a regulatory commissioner in Gujarat who was on the task force, said.
China’s State Administration for Industry and Commerce (SAIC) has probed Siemens healthcare unit for bribery and may mount investigations against other medical device manufacturers, an anonymous source told Reuters. The Siemens investigation reportedly involved 1,000 hospitals and accusations of “commercial bribery.” Reuters Editor's Note: Reuters has issued a correction to earlier reports that alleged Siemens was investigated for commercial bribery. Both Siemens and SAIC have denied that the company was investigated. Reuters, SAIC Press Release (Chinese)
The Indian commerce ministry has tried to reassure exporters that it will listen to and act on their concerns about incoming track and trace requirements. From July 1, the tertiary and secondary packaging of products manufactured from April 1 onward must feature barcodes before they can be exported. PharmaBiz
Australia’s Therapeutic Goods Administration (TGA) has set up a new business services site through which organizations can update their contact details and other information. TGA is also giving users the ability to print their own invoices and thinks other changes to the system will cut the incidence of accidental overpayments. TGA Notice
Karnataka Drugs and Pharmaceutical Manufacturers Association (KDPMA) has told the Drugs Controller General of India (DCGI) about the presence of unapproved fixed dose combinations (FDCs) in the supply chain. Government hospitals are allegedly among the buyers of the FDCs. KDPMA has asked DCGI to clear state authorities to approve the drugs. PharmaBiz
Tags: Asia Regulatory Roundup, Regulatory Roundup