Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia.
After Hearing Industry Concerns, DCGI Forms Track-and-Trace Working Group
The Drug Controller General of India (DCGI) has formed a working group focused on the incoming track-and-trace requirements for leading pharmaceutical brands. DCGI Dr. Eswara Reddy ordered the creation of the working group after industry groups expressed concerns about the requirements.
India is moving toward the implementation of a track-and-trace mechanism for the top 300 drug brands sold in the country. The Drugs Technical Advisory Board recommended the creation of such a mechanism in May, prompting Reddy to call Novartis, Pfizer and other major drugmakers to a meeting late last month. Now, the Central Drugs Standard Control Organization (CDSCO) has shared minutes from the meeting.
The minutes show industry groups have multiple concerns about the track-and-trace requirements. Some of the concerns stem from the experience of complying with the 2D barcode requirements for drug exports. Manufacturers told Reddy challenges with parent-child linkage of the barcodes has led to hardships, leading them to argue for a simple approach to authentication.
Reddy also heard from micro, small and medium-sized enterprises affected by the track-and-trace plan. Limiting the requirement to the best-selling 300 brands means many of the organizations it will affect are large. However, some smaller companies will be affected. These companies want to receive a subsidy to ensure their thin operating margins are protected from the extra costs imposed by the requirement. Contract manufacturers also warned about the financial impact.
These issues will become particularly pressing if India expands the program beyond the initial list of brands and in doing so affects very small businesses. Some attendees at the meeting have doubts about the viability of expanding the program, but none of the discussions have deterred DCGI from pushing ahead with the restricted track-and-trace initiative.
Talks with manufacturers identified a central portal as the preferred way to manage the system, but the details remain undecided. DCGI has tasked a working group composed of representatives of trade groups and CDSCO with refining and formalizing the plan. The working group will submit a report in three to four months.
TGA to Strengthen Warnings About Risks of SGLT2 inhibitors
The Therapeutic Goods Administration (TGA) of Australia is working to strengthen the warning labels of sodium glucose co-transporter 2 (SGLT2) inhibitors. TGA targeted the diabetes drugs after learning of cases of diabetic ketoacidosis in patients undergoing surgery while taking the medicines.
TGA issued a warning about the link between SGLT2 inhibitors such as Bristol-Myers Squibb’s Farxiga and Boehringer Ingelheim’s Jardiance and the buildup of ketone bodies in the blood in 2015. That led to letters to healthcare professionals about the complication — which can lead to coma — and recommendations about how to prevent, spot and treat the condition.
Despite those actions, local reports of diabetic ketoacidosis have increased. Of TGA’s 219 reports of diabetic ketoacidosis linked to SGLT2 inhibitors, 57 date from December or later. TGA said the rate of reports began to tick up around 12 months ago.
The persistence of the reports has led TGA to propose additional actions. Working with sponsors, TGA plans to strengthen the warning labels carried by SGLT2 inhibitors. The warning will discuss the risk the drugs pose to patients who are undergoing surgical procedures requiring anesthesia or light sedation. Almost one-third of the 57 diabetic ketoacidosis reports received since December relate to patients who used SGLT2 inhibitors before or after a surgical or medical procedure.
Some of the reports are particularly worrying. TGA continues to hear of patients who are diagnosed with diabetic ketoacidosis and have normal blood glucose concentrations. These cases of euglycemic ketoacidosis can take longer to diagnose as a typical indicator of the condition — an elevated blood glucose level — is absent. Delays to diagnosis are associated with worse outcomes.
TGA has also received seven adverse event reports related to Type I diabetics who received SGLT2 inhibitors on an off-label basis.
India Delays Implementation of Oxytocin Rules
The Indian government has delayed the implementation of rules restricting the production and sale of oxytocin until the start of September. Officials proposed the legislation in April to counter misuse of the hormone by dairy farmers and originally planned to bring it into force this month.
With that initial target passing, India will continue under the old system for two months longer than anticipated. The delay pushes back the date on which India will start enforcing rules it thinks may finally bring the long-running problem of oxytocin misuse under control.
The incoming rules bar private companies from supplying oxytocin domestically. Publicly owned drug makers will continue to produce oxytocin for the domestic market, but only by selling it directly to registered hospitals, clinics and certain government bodies. Retail chemists will not be allowed to sell oxytocin. The rules require the barcoding of oxytocin to support the enforcement of the restrictions.
Government officials came up with the rules and the timeline for their implementation after discussing the problem of oxytocin misuse with manufacturers. Despite those preparations, the government has pushed back the initial deadline.
NPPA to Review India’s Ceiling Price for Knee Implants
The National Pharmaceutical Pricing Authority (NPPA) of India is reviewing the ceiling prices it put on knee implants 11 months ago. NPPA is seeking price data from manufacturers including Johnson & Johnson and Stryker to facilitate the reassessment.
India’s price watchdog wrote to 15 manufacturers of knee implants seeking information about their devices. NPPA wants to know whether the devices are made locally or outside India, the volume sold in the last fiscal year and financial figures for each step in the supply chain, from the import price or manufacturing cost as of 30 June through to the maximum retail price. NPPA wants these details for a range of products that are involved in knee implants, such as tibial and stem devices.
The price data could persuade NPPA to relax its price cap, although the limited precedent available suggests the agency is as likely to lower the ceiling. When NPPA reviewed the price of cardiac stents earlier this year, it slightly lowered the ceiling for drug-eluting stents and increased it for bare metal stents. Notably, NPPA rejected calls for the creation of a third higher pricing tier for the latest stents from multinational manufacturers.
NPPA is accepting responses from manufacturers of knee implants until 30 July.
has added video conferencing capabilities to its public relations office. The capabilities will enable entrepreneurs and startups with regulatory questions to access CDSCO without visiting its offices in person. CDSCO sees the service enabling more people to benefit from its recently created public relations office. CDSCO Notice
has reviewed the safety of two intragastric balloon systems after learning of deaths and serious injuries to patients in the United States
. The review identified 19 adverse events and three deaths linked to the systems in Australia since 2009. TGA is now working with manufacturers of the systems to ensure patients and healthcare professionals know the risks of the devices. TGA Notice
The government of India
has assigned analysts to serve as testing officers for different classes of medical devices. The move follows the designation of laboratories as sites for the testing of condoms, syringes and other types of medical technology. Gazette Notification