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Regulatory News | 12 January 2016 | By Nick Paul Taylor
Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia.
India has pushed back the deadline by which manufacturers must comply with aspects of its system to track and trace drug exports. Having originally set a deadline of July 2015, the government has now once again delayed the date on which the export monitoring system must be implemented.
The Directorate General of Foreign Trade (DGFT) first revised its track and trace plans in May, at which time it told drug exporters they had fewer than five months to add barcodes to tertiary and secondary packaging and start uploading relevant data to a central portal. Now, with that deadline having come and gone, DGFT has revised its timeline by moving back the date for implementation and giving small-scale manufacturers longer to comply than their larger rivals.
Small-scale industry manufacturers are exempt from uploading data to a central portal, now known as the Drug Authentication and Validation Application (DAVA), for any drugs manufactured prior to 31 March 2017. Larger companies must start uploading data by 31 March of this year. The split deadline could be seen as an attempt to appease smaller manufacturers, which voiced concerns about their ability to adapt their operations to comply with the timeline set out in the original text.
As the blog of Indian research company TwoFour Insight notes, the delay also gives the government longer to develop the DAVA central portal. Currently, only companies that have participated in the design of the application are able to upload data. The major question now is whether DGFT and the majority of firms can put their respective systems in place ahead of the deadline, which would leave those that failed to do so unable to export, or whether the timeline will be pushed back again.
DGFT Notice, The Press Trust of India, TwoFour Insight,RxTrace
The Central Drugs Standard Control Organization (CDSCO) of India is making companies pre-register on its online portal, SUGAM. CDSCO said the step, which was not part of the process it released in November, is intended to ensure the security of the system and prevent spam.
Companies that want to use the portal to file applications with CDSCO must pre-register. Once a person has submitted pre-registration information, a member of the IT team at CDSCO will verify their details and clear them to use the system. Having been verified by CDSCO, the person will have continuous access to SUGAM. The pre-registration process was absent from a notice CDSCO posted in November to reveal SUGAM was accepting filings from firms seeking clearance to import drugs.
Since then, CDSCO has added the pre-registration step and a timeline for adoption of SUGAM. The latest notice warns that from 15 January, CDSCO will only accept hard copies of applications for import licenses and registration certificates from companies that have registered on the portal. From February 15, applicants must submit information on the portal and as a hard copy. CDSCO is yet to say when it will phase out the requirement to include hard copies of applications.
The regulator is also yet to provide details of when SUGAM will begin accepting applications other than Form 41 and Form 10, which respectively cover registration certificates and import licenses. Last year, Drug Controller General of India (DCGI) GN Singh said “everything should be online”, a stance the regulator is backing up by allocating some of its Rs 900 crore ($134 million) funding boost to IT initiatives. The expectation is that online filings will be able to adhere to fixed deadlines.
CDSCO Alert, TwoFour Insight
The Indian Pharmacopoeia Commission (IPC) has told all Adverse drug reaction Monitoring Centres (AMCs) they must supply their own equipment. AMCs, which are part of India’s pharmacovigilance program, will receive support, but not equipment, from the National Coordinating Centre (NCC).
GN Singh, who, as well as being DCGI, is IPC secretary-cum-scientific director, clarified the situation in a letter to AMC coordinators. The letter puts the onus for supplying everything that is needed to implement the pharmacovigilance program of India (PvPI), from the workplace itself through to the computers and printers it houses, on to the AMCs themselves. The role of NCC-PvPI is limited to the provision of trained technical associates to assist with the activities of the AMCs.
The notice is part of an ongoing attempt to sort out issues that are stopping PvPI from operating as effectively as possible. When the PvPI working group reviewed the status of AMCs in May, it found reasons for “deep concern” over the performance of some centers. Work to bring AMCs up to speed is taking place in parallel to talks to improve PvPI by involving the medical community more in the process. IPC is talking to the Indian Medical Association (IMA) to achieve this objective.
Government hospitals, institutions and colleges are already closely involved with PvPI, but private health practitioners are on the outside. Singh wants to involve more people in adverse drug reaction (ADR) reporting. “Most importantly, this is a patient centric move as doctors play a very important role in the healthcare system. They are the main interface between the patients and the medicines, making them a very important player in the ADR system,” Singh told PharmaBiz.
IPC Notice, PharmaBiz
China Food and Drug Administration (CFDA) has told regional officials to step up their search for websites that publish illegal health information. CFDA made the request after identifying seven sites that it says were publishing false health information in an attempt to mislead consumers.
The brief descriptions of the websites provided by CFDA cover some of the products about which health claims that lack scientific support are made most frequently. One of the websites provided information about a product aimed at bodybuilders, while another site was focused on resveratrol, a compound found in the skins of red grapes that has been marketed as an elixir of youth. CFDA plans to investigate and punish the people behind the websites.
Other websites have found themselves the target of CFDA investigations, too, which has provided periodic updates about its attempts to stop the publication of false health information. The regulator wants regional officials to do more to support the initiative, notably by stepping up their oversight of websites suspected of providing false health information or supplying counterfeit or substandard products.
CFDA Statement (Chinese)
Inspectors at the Drugs Control Administration (DCA) of Telangana have received training from the United States Food and Drug Administration (FDA). The DCA of Telangana, a state that is a big drug exporter, sought the training in a bid to align its practices with those of FDA. The next step is training on data integrity, an area in which many Indian firms have failed to meet FDA standards. The Hindu
Pharmacists have come out against proposed plans by DCGI to raise their registration charges. DCGI is reportedly considering implementing a 10-fold increase, moving the registration up from Rs 3,000 ($45) to Rs 30,000. Chemists view the move as an attempt to distract from the dispute over the laws covering online pharmacies. The government said fees have been flat for 15 years. Pune Mirror
Tags: CDSCO, India, CFDA, track and trace