Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia.
India Shares Draft Legislation on Regulation of Online Medicine Sales
India has released draft legislation covering online pharmacies. The text sets out how organizations can receive clearance to operate as e-pharmacies and the rules they must follow to maintain their authorizations.
The question of how to facilitate a safe online trade in medicines has occupied Indian legislators and regulators for several years without either group establishing rules for the nascent field. Despite the absence of clear rules, some platforms have moved into the online medicine trade, leading to clashes between state regulatory agencies and companies including Snapdeal.
Several years after those clashes began, Indian legislators have published a draft document covering the online trade in medicines. The document states companies must be registered to sell medicines online. Indian authorities will grant registrations to companies that comply with provisions of the Information Technology Act, 2000, maintain patient privacy and feature details of their credentials on their online sales portals. India plans to charge Rs 50,000 ($690) to review submissions.
Unsuccessful applicants will hear from Indian authorities within 30 days of making their filings. In some cases, the authorities will ask applicants to address minor shortcomings before granting them a registration. Authorizations will last for three years, but e-pharmacies will need to show continued compliance during inspections every two years to maintain their clearances.
Officials are accepting feedback on the proposals for 45 days.
CNDA Investigation Finds China’s Vaccine Manufacturers Comply With GMPs
The China National Drug Administration (CNDA) has reported the findings of its investigation into the quality of the country’s vaccine manufacturing plants. CNDA found no evidence of failings that could affect safety and quality during its inspections of China’s 38 active vaccine producers.
Vaccine quality was thrust into the spotlight earlier this year when evidence of substandard practices at Changchun Changsheng Biotechnology emerged. Those findings raised concerns about the quality and safety of vaccines manufactured by other companies, prompting CNDA to assess practices across the sector.
CNDA’s summary of the results of the investigation suggest Changchun Changsheng is an outlier. Seven of the 45 vaccine producers targeted by CNDA are no longer active. CNDA’s inspectors found the other 38 firms all followed good manufacturing practices (GMPs) and had relatively complete quality management systems. The findings suggest all vaccines currently sold in China meet GMPs.
Chinese authorities still plan to tighten oversight of the sector, though. The planned actions are intended to improve quality management and traceability and otherwise cut the risk of a situation like the Changchun Changsheng scandal from happening again.
Ahead of Rebranding, India Calls for Suggestions of New Names for CDSCO
India is going ahead with plans to rename the Central Drugs Standard Control Organization (CDSCO). Eswara Reddy revealed the decision in a notice that asked people to propose new names and logos for the regulatory agency.
The prospect of rebranding CDSCO has gathered pace in recent years, culminating in a report by expert committee chief RA Mashelkar and a vote by the Drugs Technical Advisory Board (DTAB) that both supported the idea. As the idea has risen to prominence, the Indian Drug Administration (IDA) has typically been the preferred new name. DTAB favors IDA, but National Drug Authority, Central Drug Authority and Indian Medical Products Administration have their champions, too.
With a range of options open to it, CDSCO is seeking external input. Reddy wants people to propose names that reflect CDSCO’s “current role and encompass the areas administered by it.” Changes to CDSCO’s role and boundaries underpin the campaign to rebrand the agency.
In explaining the rebranding, Reddy highlighted the range of activities now overseen by CDSCO. The list spans from the regulation of new drugs through to oversight of online pharmacies and other emerging fields. Some of these fields and related regulatory tasks emerged well after India named CDSCO, leading Reddy to say, “The present nomenclature is not reflecting its role and responsibilities.”
Reddy is accepting proposed names and logo designs via email for two weeks.
TGA Rejects Pfizer Filing for OTC Viagra in Interim Decision
Australia’s Therapeutic Goods Administration (TGA) has turned down Pfizer’s request to reclassify Viagra as a pharmacist-only medicine. If upheld, the interim decision will prevent Pfizer from adding Australia to the list of countries in which the erectile dysfunction drug is available without a script.
Pfizer began selling Viagra over the counter in the United Kingdom earlier this year after authorities ruled the risks were outweighed by the potential to discourage the purchase and use of counterfeits. Big pharma rolled out similar arguments in seeking to get the drug reclassified in Australia, but has found TGA staff less amenable to the rationale that their peers in the UK.
TGA’s decision is underpinned by a belief that the underlying cause of erectile dysfunction should be identified before a drug is prescribed to treat the condition, and a worry that Viagra’s masking of the symptoms of cardiovascular disease will lead to the late diagnosis of serious health problems.
Pfizer sought to counter such concerns by proposing to limit the number of doses of Viagra in packs sold over the counter and highlighting the need to move people from counterfeits to genuine drugs. However, while TGA agreed with the sentiment of Pfizer’s anti-counterfeit rationale, it questioned whether rescheduling Viagra is the right response to the problem.
“Issues with counterfeit [Viagra] are recognized, however increasing consumer access to [Viagra] through down scheduling is not considered an appropriate mechanism to address this problem,” TGA wrote in its interim decision.
TGA is accepting feedback on its Viagra ruling and other interim decisions until 11 October.
China Delivers on Regulatory Reform Agenda With Approvals of Soliris and Furazolinib
China has come good on its promise to fast track important drugs. This week saw the approval of one of the 48 drugs prioritized by the Center for Drug Evaluation (CDE) and another medicine that is set to come to market in China before anywhere else.
The approved drug from CDE’s list is ultra-rare disease blockbuster Soliris. Alexion brought Soliris to market in the United States and Europe years ago, but shied away from tackling China’s notorious approval process. The approval comes one month after CDE included Soliris on a list of therapies it is willing to approve on the strength of clinical data generated outside China.
China’s other approval of the week also speaks to the country’s evolving place in the industry. The drug, a small molecule inhibitor of VEGFR, is set to come to market in China before making it to the US or Europe. Furazolinib will now be used in the treatment of metastatic colorectal cancer.
, Furazolinib Statement
is seeking feedback on its guidelines for the collection and reporting of adverse drug reactions. The Chinese regulator sees the guidelines helping to standardize the monitoring of adverse events and ensure marketing authorization holders take responsibility for the direct reporting of side effects. CNDA is accepting feedback on the proposals until 20 September. CNDA Notice
The Indian Pharmacopoeia Commission
(IPC) has extended the deadline for feedback on its medical device guidance. IPC was due to close the comment window at the start of the month but has pushed the deadline back until 25 September. IPC Notice