Welcome to our new website! If this is the first time you are logging in on the new site, you will need to reset your password. Please contact us at firstname.lastname@example.org if you need assistance.
Your membership opens the door to free learning resources on demand. Check out the Member Knowledge Center for free webcasts, publications and online courses.
Our new book is a comprehensive look at a vital part of medicines development and regulatory affairs. Grab your copy today!
Hear from leaders around the globe as they share insights about their experiences and lessons learned throughout their certification journey.
Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia.
India's Central Drugs Standard Control Organization (CDSCO) has told staffers to work overtime to compensate for their colleagues being inundated by a huge drug testing push. The call for people to work into the evenings, on weekends and during holidays was made to ensure mandatory deadlines are met despite the distraction of the sampling program.
Pitam Singh, deputy director of administration at CDSCO, outlined the exceptional situation in a letter to employees. With 75 drug inspectors supporting the initiative to test 50,000 drug samples — and more staffers possibly being transferred to the program in the future — CDSCO needs those who remain to cover for their colleagues. Work related to any mandatory deadline that might be missed as a result of the reassignments is to be made a top priority.
With CDSCO taking a zero tolerance approach to the deadlines, staffers are being encouraged to work outside of office hours to stay on top of the situation. The call for staff to work overtime comes six months after the Joint Secretary of the Ministry of Health & Family Welfare told the employees of a CDSCO laboratory in Mumbai to take on extra hours to boost productivity. While both requests suggest staffing issues at CDSCO, the latest letter is also indicative of the scale of the testing drive.
The sampling effort is around 20 times bigger than the last such initiative run in India. "A survey of this scale has not been done before. Data shows that the level of spurious or substandard drugs is well within acceptable limits. However, there are reports in both the domestic and international media about 25% to 40% of Indian drugs being substandard. This survey will conclusively put an end to such speculation," Drug Controller General of India (DCGI) Dr G N Singh told The Indian Express.
Singh is also looking to the survey to identify gaps in regulatory oversight.
CDSCO Letter, The Indian Express
Trade groups have criticized Australian plans to allow pharmacy-level substitution of biosimilars. The Alliance for Safe Biologic Medicines (ASBM) warned against making "an enormously retrograde step" after the Pharmaceutical Benefits Advisory Committee (PBAC) recommended allowing substitution of biosimilars for their reference products at the pharmacy level.
If the proposal comes into force, Australia will move to the forefront of a push to increase access to biosimilars that has triggered debate around the world. France and parts of the United States are at varying stages in the move toward allowing pharmacy-level substitution, but the idea is still untested enough to draw criticism. An advisory board member at ASBM, a trade group that lists Amgen, BIO and Genentech as members, said the plan is "completely out-of-kilter with world best practice."
Unfortunately for ASBM, members of PBAC have a different take on the situation. "I look at that dossier and am confident that substitution is a reasonable way to move forward," ABC quotes PBAC's Professor Geoffrey McColl as having said. McColl has the support of the Australian health minister, who said she has "absolute confidence" in PBAC's decisions. The government stands to save $680 million over the next five years if the substitution policy comes into force.
While the policy would allow pharmacy-level substitution, biosimilars would have to meet certain criteria before being included in the program. Data suggesting the safety or efficacy of a biosimilar differs from the reference product is one of five points for consideration listed by PBAC. Biosimilars that fail to meet the criteria will have the opportunity to be added to the list of interchangeable products as more data to support their inclusion is generated.
ABC, Press Release, PBAC Report
CDSCO is claiming to have cut the time it takes to grant fast-track licenses to locally developed drugs. The regulator told PharmaBiz that after introducing a "just-in-time" approach, it is processing such filings in around one month, compared to up to six months prior to the adoption of the model.
Details of what CDSCO has changed are sketchy, with PharmaBiz describing the new approach as "providing on-the-spot regulatory approval for hastening the regulatory approval process." Some details and their reported benefits are clear, though. CDSCO has tested the new approach on four areas of its operation, including the aforementioned fast-track licenses and export paperwork. The export-focused initiative has seen CDSCO set up 24/7 services at airports and seaports to save time.
CDSCO has now seen enough to warrant an expansion of the program. "We have seen a tremendous progress in our overall performance since this service has been launched...[and] we plan to expand its ambit in other categories as well wherever we feel it is feasible to adopt," DCGI Dr. GN Singh said. The expansion will see the approach applied beyond fast tracks, exports, medical emergencies and bioavailability-bioequivalence studies, the four fields in which it has been used to date.
DCGI has named the Federation of Indian Chambers of Commerce and Industry (FICCI) as the lead agency for the development of regulations covering the online sale of prescription medicines. The status gives FICCI responsibility for coordinating guidelines and gathering feedback from industry.
FICCI has a brief to liaise with national and state pharmacy associations, PHD Chamber of Commerce and Industry, the Indian Medical Association (IMA), the Organisation of Pharmaceutical Producers of India (OPPI) and other groups, some of which have been critical of the rise of online pharmacies. Pharmacy trade groups have led the criticism, with the Indian Pharmacist Association (IPA) adding its voice to the debate this week by telling DCGI to ban online pharmacies.
IPA argued such a move would be in the public interest, Business Standard reports, but momentum is against it and other critics. "The role, responsibilities and liabilities of e-commerce marketplace and the product sellers need to be clearly defined," DCGI Dr. GN Singh said. Such definitions will limit the ability of some groups to sell drugs online — FICCI Director General Dr. Arbind Prasad said "the marketplace has to be reined in" — but may also encourage others to enter the sector.
PharmaBiz, Business Standard, The Hindu
The Indian Pharmacopoeia Commission (IPC) is to piggyback on CDSCO's network of offices as it works to expand the Pharmacovigilance Programme of India (PvPI). IPC has already started setting up operations at a CDSCO office in Mumbai and is considering Hyderabad, Chennai and Kolkata as the next locations for its regional centers. PharmaBiz
New Zealand's Centre for Adverse Reactions Monitoring (CARM) has detected a jump in reports of hypersensitivity and local reactions among people receiving influenza vaccines. Hypersensitivity accounts for 36.8% of all reports this flu season, a 57% increase over the proportion recorded in 2011. Even so, the regulator said the risk-benefit tradeoff remains positive. Medsafe Notice
Bloomberg has reported on the risks expats face when bringing drugs into Japan. The issue was brought to the fore by the arrest of the managing officer of Toyota for allegedly having oxycodone shipped to her from the United States. Oxycodone is widely used in the US but it, along with all psychotropic drugs, is more strictly controlled in Japan. Bloomberg
Tags: Regulatory Roundup, Asia Regulatory Roundup