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Posted 15 March 2016 | By Nick Paul Taylor
Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia.
India has quickly reversed its opposition to the off-label ophthalmic use of Roche’s Avastin (bevacizumab). Drug Controller General of India Dr. GN Singh warned against using Avastin in ophthalmology conditions in January after reports linking it to loss of vision emerged, only to withdraw the alert this week on the recommendation of experts.
The initial alert was triggered by reports of post-treatment vision loss in the state of Gujarat. Singh took the adverse event reports seriously enough to tell regulatory officials to monitor the use of Avastin in ophthalmology conditions, a set of indications in which it is widely used on an off-label basis. Experience gained in the global off-label use of Avastin has contributed to the U-turn by Singh, who took his latest action after assessing the judgement of an expert committee that met to discuss the issue last month.
At the meeting, the experts discussed Avastin’s inclusion in the ophthalmic section of the World Health Organization’s list of essential medicines, as well as its off-label use in countries including France and Italy. The credibility conferred on off-label use of Avastin by these institutions, plus the safety data they have helped to generate, contributed to the expert committee recommending the withdrawal of the alert. Cost was the other factor behind the recommendation. With Avastin costing significantly less than the alternatives, the committee ruled it can be used to treat more people.
To prevent a recurrence of the vision loss cases that prompted the original DCGI alert, the experts have suggested the All India Ophthalmological Society and Vitreo Retina Society of India draw up guidelines on the safe use of Avastin in ophthalmology conditions. The committee also wants the organizations to work to ensure surgeons are trained to perform the procedure.
DCGI Alert, Business Standard
India has banned the production and sale of 344 fixed-dose combination (FDC) drugs, including products marketed by Abbott Laboratories and Pfizer. The clampdown, which follows years of criticism of India’s approach to FDCs, has sparked a retaliation by the affected manufacturers, some of which are taking the government to court to fight the ban.
Government officials detailed the actions against the FDC drugs in a 295-page entry in The Gazette of India, after which the Drug Controller General of India (DCGI) sent a letter to alert the country’s regulators to the ban. The list of 344 FDCs was drawn up by an expert committee appointed by the central government. Each of the FDCs lacks “therapeutic justification,” according to the committee, and as such should be pulled from the market. The action comes four years after a parliamentary committee criticized regulators for allowing the sale of FDCs that lacked safety and efficacy data.
In 2013, the Central Drugs Standard Control Organization (CDSCO) tried to improve the situation by asking manufacturers to submit data on the safety and efficacy of their FDCs. However, research published in PLOS Medicine last year found unapproved FDCs still make up a substantial proportion of drug sales in India. The ban implemented this week, which is aimed at products including cough syrups sold by Abbott and Pfizer, is designed to clear therapeutically unjustifiable combinations of drugs from the market, but the government has already encountered pushback from the industry.
Within days of the government initiating the ban, Pfizer had secured an interim injunction against the action, according to Reuters. Local media organizations report Abbott is also pursuing a legal fix to the problem. The stakes are high for the companies. Pfizer’s cough syrup, Corex, generated sales of $26 million over the first nine months of the financial year. While the sum is small in the context of Pfizer’s global operation, it is significant for its Indian unit. In Mumbai, shares in Pfizer fell 9% following news of the ban.
Industry attempts to overturn the bans are advancing in parallel to government efforts to broaden the scope of the clampdown. Investigations into other FDCs are ongoing, an anonymous official told The Times of India. As it stands, around 1,000 FDCs are under “severe scrutiny.” The official expects the government to ban around 500 more FDCs within the next six months.
DCGI Letter, Gazette Notification, Reuters, The Times of India
The China Food and Drug Administration (CFDA) has found fault with tens of medical devices after conducting a sampling and testing campaign. Having identified a list of products that fall short of its standard requirements, CFDA has told its regional departments to ensure manufacturers resolve the problems.
CFDA has targeted disposable infusion sets, infant incubators, diagnostics, assays and other classes of products in the clampdown. In each case, CFDA has identified a shortcoming with the product that it wants the manufacturer to fix. The implications of the action could be severe for some companies. As well as asking manufacturers to fix the failings of the tested devices, CFDA wants them to look at the broader production quality management systems that failed to stop the substandard products from coming to market. Companies that fail to improve could be banned from making products.
The initiation of recalls, production bans and other tough actions is indicative of the severity of some of the failings identified by CFDA. In the case of the infant incubator tested by CFDA, the alarm that is supposed to sound when the power is interrupted failed to meet standard requirements. CFDA also criticized the accuracy of a diagnostic for the rubella virus and found a wide range of other products fell short of its standards. CFDA grouped the affected products into four categories on the basis of the nature of their failings.
Officials published the findings in the first National Medical Device Quality Bulletin of 2016. The text was released against a backdrop of CFDA’s evolving approach to medical devices, which have been the subject of multiple regulatory documents over the past year. Implementation of the regulatory documents was designed to improve the standards of the medical devices sold and used in China, an agenda CFDA is trying to enforce through the testing of products and punishment of companies that fail to meet its standards.
CFDA Notice (Chinese), More (Chinese)
China has introduced regulations covering products that sit at the intersection of food and medicine. From 1 July, manufacturers of such medical foods have to register their products with CFDA, which will demand to see details of the formulation, production process data and test sample reports.
Infant formula, a class of products blighted by quality scandals in recent years, is covered by the new regulations, as are foods designed to help people who have respiratory and renal diseases. In a Q&A, CFDA clarified that nutritious meals, such as rice, prepared by medical institutions for patients are not the target of the regulations.
For the products affected by the text, the regulatory process has more in common with the one followed by drugs than food. Submissions to CFDA must include details of the production process and evidence to back up any intended clinical effects.
CFDA Regulation (Chinese), CFDA Q&A (Chinese)
Tags: Avastin, DCGI, FDC ban, medical devices in China
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