Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia.
Prevalence of Substandard Drugs in India’s Supply Chain Prompts Regulatory Proposals
The Indian Ministry of Health has recommended increasing regulatory oversight of government facilities after a survey found 10% of drugs in the state supply chain are substandard. That figure is seven percentage points higher than at retail outlets, raising concerns the government is failing to safely procure and distribute medicines.
Officials identified the difference in the proportion of substandard drugs in retail and government supply chains by testing 47,954 samples from around the country between 2014 and 2016. Fake drugs were similarly rare in both supply chains — 0.0245% for retail, 0.023% for government — but the figures for not of standard quality (NSQ) medicines diverge sharply.
The overall proportion of NSQ drugs in government supply chains is estimated at 10%, compared to 3% in the retail sector. These figures mask significant variation between states and product types. In Sikkim, a state bordering Bhutan, China and Nepal in northern India, one-third of samples were deemed NSQ. The NSQ rate in Sikkim and other states was particularly high for parenterals. More than half of parenterals tested in Sikkim were NSQ, compared to 9% of oral dosage forms.
These differences between government and retail and oral and parenterals were seen, to greater and lesser extents, across the country. The trends caught the attention of the Ministry of Health.
“There is something amiss in the existing procurement processes, especially in states where the NSQ is much higher than the national average. Further, lack of uniform levels of enforcement may be leading to difference in the extent of NSQ in retail outlets and government supply chain in different states,” the report states.
To improve the situation, officials want the Central Drugs Standard Control Organization (CDSCO) and state regulators to jointly inspect government warehouses and pharmacies at least once a year to ensure they are equipped to store medicines. The inspections should assess the installation and maintenance of temperature and humidity control capabilities. When combined with a review of government procurement policies, officials hope the more rigorous regulatory regime will improve quality in state supply chains.
The report also includes a breakdown of the samples tested by company. The data include some eye-catching numbers. In Maharashtra, 26 of the 46 Pfizer medicines sampled from the retail supply chain were declared NSQ. Only a few companies, such as Acme Diet Care, were linked to state-level NSQ numbers worse than Pfizer. The finding contrasts with results elsewhere. Only one of the 221 Pfizer medicines tested in the rest of the country was ruled NSQ, and overall substandard drugs were no more common in Maharashtra than the rest of India.
TGA Proposes Risk-Based Framework for Regulation of Complementary Medicines
The Therapeutic Goods Administration (TGA) of Australia has started a consultation on reform of the regulatory framework for complementary medicines. TGA is seeking feedback on its plans to adopt a risk-based framework and a list of indications the lowest-risk medicines can target.
Officials set out the create a three-tier risk-based framework on the recommendation of the expert panel convened by the government to review drug and device regulation in Australia. Adoption of a three-tier system will necessitate the creation of a third pathway for approval. Today, medicines either undergo a full TGA evaluation or are listed on the basis of self-declarations of compliance. The review panel felt a third pathway was needed to bridge the gap between these options.
TGA is proposing the intermediate pathway be used by developers of products that are deemed low risk, in part because they only contain certain permitted active ingredients, but are aimed at “intermediate level indications.”
“Intermediate level indications will include references to prevention or alleviation of non-serious forms of a disease, condition, ailment, defect or injury. Incorrect use might, for example, lead to a delay in seeking medical treatment and adverse consequences for the consumer. Allowing such medicines to be supplied without being individually assessed for efficacy would undermine the TGA’s risk-based regulatory framework,” TGA wrote in its consultation document.
To mitigate these risks, TGA plans to rely on a mix of sponsor self-assessment and regulatory premarket assessment of efficacy to assess medicines following the intermediate pathway.
Before the pathway can go live, TGA needs to determine which indications are eligible for the current, fully self-certified approach and which will fall into the intermediate category. Today, companies following the self-certified pathway can enter any indications using a free-text field in the electronic listing facility. This freedom has resulted in “significant rates” of ineligible indications being entered, according to TGA.
To address the problem, TGA is working on a list of low-risk indications, such as those covering general health maintenance and prevention of dietary deficiency. TGA is seeking feedback on the best way to build and structure the list.
India Applies Price Controls to Cardiac Stents, Triggering Reports of Recalls, Shortages
India has capped the price of bare metal and drug-eluting coronary stents. The action follows years of planning amid reports of profiteering by players along the supply chain, but it has nonetheless sparked reports of industry criticism and artificially created shortages.
The National Pharmaceutical Pricing Authority (NPPA) of India has set the ceiling price of bare metal and drug-eluting stents at Rs 7,260 ($108) and s Rs 29,600 ($442) before local taxes and VAT, respectively. Prior to the adoption of the cost control, bare metal stents typically cost six times that amount. NPPA attributed the prices previously paid by patients for cardiac stents to markups by distributors and hospitals of up to 200% and 650%, respectively.
Capping the prices of stents should stop such profiteering, but in the near term it is also creating some disruption. Reports emerged of manufacturers recalling stents in the days after news of the cap was confirmed. The recalls were ostensibly to allow relabeling of the stents, an action NPPA has since said is unnecessary. Some people see the recalls as an attempt to create an artificial shortage, an accusation NPPA is taking seriously enough to mention in a memo to the industry.
In the longer term, the bigger concern is whether the price cap will stifle innovation. NPPA claims the price is high enough to enable stent manufacturers to turn a profit. However, the industry has questioned whether the prices are high enough to justify investment in the development of new, innovative stents.
NPPA Order, More
CFDA Finds Fault with Roche Medical Device Quality Management Practices
China Food and Drug Administration (CFDA) has found fault with Roche’s medical device quality management practices. The regulator issued a notice about Roche’s diagnostics operation as part of a flurry of warnings to medical device manufacturers.
CFDA’s notice about Roche refers to the temperature limit stipulations of a supplier quality agreement. Officials plan to review Roche’s response to the findings of the surprise inspection at a meeting next month.
Roche was one of tens of medical device companies warned by CFDA following surprise visits by inspectors. The criticism of the Swiss company was mild compared to that aimed at some local companies. CFDA ordered some of the targeted businesses to suspend operations until their failings are fixed.
The activity builds on CFDA’s attempts to raise medical device quality standards.
CFDA Notice (Chinese)