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Regulatory News | 31 March 2015 | By Michael Mezher • Nick Paul Taylor
Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia.
The Asian Harmonization Working Party (AHWP) has released its Playbook for Implementing Medical Device Regulatory Frameworks, which provides guidance to countries on implementing harmonized medical device regulations. The playbook is designed to help countries implement effective medical device regulations while keeping in mind member countries’ priorities and resource limitations.
Due to resource limitations, full implementation of the regulatory policies outlined in the playbook may not be possible in each AHWP member country. As such, countries are urged to implement “selected framework elements” in a strategic approach to maximize safety when full implementation is not possible. – Michael Mezher
The Association of Indian Medical Device Industry (AIMED) has fired another broadside against India's Central Drugs Standard Control Organization (CDSCO). AIMED’s complaint relates to Schedule M-III, the much-maligned regulation covering medical device good manufacturing practices (GMP) in India.
CDSCO proposed changes to the regulations in January, but AIMED has somewhat belatedly found fault with the text. AIMED wants the government to delete references to Schedule M-III and adopt ISO 13485, which would provide manufacturers with a framework for quality management systems (QMS). Underpinning this specific and technical dispute is a broader argument over how India should regulate medical devices, in particular the degree to which it needs oversight distinct from drugs.
AIMED is deeply and vocally unhappy with how authorities are managing GMPs and the split as it stands. “The government has resorted to tactics to prolong their control over the medical device sector even though they do not have the expertise nor the manpower to do so. This attitude is having a huge impact on the industry and we want the government to take cognizance of this fact at least now,” Rajiv Nath, forum coordinator of AIMED, told PharmaBiz.
The issue is one of many facing the sector. The Economic Times reports India has become a dumping ground for refurbished devices originally used in other countries, a situation Nath attributes to the government’s failure to provide certification and regulation of many classes of products. India is trying to get on top of some of the problems, notably through a planned safety monitoring program. – Nick Paul Taylor
PharmaBiz, The Economic Times, More
The Drugs Regulatory Authority of Pakistan (DRAP) has adopted the first comprehensive regulations for medical devices in the history of the country. DRAP is implementing the rules to cut the time it takes for medical devices to come to market and protect patients from unsafe products.
Companies will have an as-yet undefined window in which to ensure their operations are compliant with Medical Devices Rules, 2015, work on which began in the wake of the 2012 legislation that created DRAP. A medical device expert committee shaped the policy in response to feedback from a wide range of industry and governmental groups and in light of the approaches taken by other members of the Asian Harmonization Working Party (AHWP).
Pakistan’s medical device policy is more advanced than some other AHWP members, including its neighbor India, a fact Minister for National Health Services Saira Afzal Tarar pointed out to the Daily Times. The challenge now for DRAP is to use its new powers to stop the sale of counterfeit medical devices, the reuse of disposable products and importation of illegal items, while also creating an environment in which legitimate manufacturers can prosper. – Nick Paul Taylor
The Comptroller and Auditor General of India (CAG) has criticized state-run manufacturing operation Oushadhi for failing to test its products for heavy metals. Oushadhi admitted it lacks the capabilities to test for heavy metals, despite manufacturing standards mandating such assessments.
CAG laid out the failings at Oushadhi — which manufactures ayurvedic traditional Hindu medicines — in a report to India politicians. The auditor found testing capabilities at Oushadhi were limited to microbial and physicochemical parameters, meaning it was unable to comply with the heavy metal elements of the Ayurvedic Pharmacopoeia of India. Oushadhi could have sold products containing heavy metals, aflatoxins and pesticide residues without ever knowing.
The report is an embarrassment for the government at a time when it is trying to promote ayurvedic medicines globally and reassure the local population of the quality of the generics it provides through its Jan Aushadhi program. Jan Aushadhi is sourcing drugs from a network of private manufacturers for sale for as little as 20% of market cost, but critics have questioned the government’s ability to ensure the quality of the products it provides. – Nick Paul Taylor
Press Trust of India, More
The Ministry of Health, Labour and Welfare (MHLW) has approved Gilead Sciences’ Sovaldi for the treatment of hepatitis C (HCV) genotype 2. Gilead says it will continue working with the regulators as it reviews the company’s application to approve Sovaldi for treating HCV genotype 1 as well. While HCV genotype 1 is by far the most prevalent worldwide, genotype 2 accounts for 20-30% of cases in Japan.
Additionally, Gilead says it has filed a new drug application (NDA) for an investigational product combining sofosbuvir, the international non-proprietary name for Sovaldi, and ledipasvir. – Michael Mezher
Gilead Press Release
Citing concerns that locally manufactured drugs are not as “effective” or “trustworthy” as products manufactured in Japan or the West, a growing number of Chinese tourists are buying up over-the-counter medicines while on vacation. The Global Times interviewed a local primary school teacher, who says she prefers to give her child medicines from overseas. One doctor interviewed said he feels foreign manufactured medicine is not necessarily better than domestic products, and says that media reports may be driving fear in patients. – Michael Mezher
The Indian union territory of Puducherry is to move the drug licensing process online from 1 April 2015, putting it at the forefront of a nationwide digitalization of regulation. Puducherry is initiating the change in an attempt to prevent a reoccurrence of the illegal licensing scandal that dogged it in 2013.
Officials in the Puducherry government think making an online platform the only way for wholesalers and retailers to apply for licenses will increase the timeliness and transparency of the process, a view shared by the Drug Controller General of India (DCGI). The immediate shift to a fully online process and the lack of notice about the transition could lead to transition problems, though.
Puducherry officials are initiating the change in an attempt to restart the licensing process. In 2013, an investigation found Puducherry-based manufacturers were selling 500 fixed-dose combinations (FDC) across India without clearance from DCGI. Puducherry was accused of illegally awarding licenses to FDCs, leading to the cancellation of 200 approvals and a halt on the processing of new certifications. – Nick Paul Taylor
The New Indian Express
The Dhaka Tribune reports Bangladesh’s Minister of Commerce Tofail Ahmed announced the country exports pharmaceuticals to 107 countries around the world, including developed countries such as Canada, Denmark, France, Germany and the US. A report from the Directorate General of Drug Administration (DGDA) shows 39 local drug companies exported products 2012, worth more than Tk5.39 billion ($69 million USD).
The overall pharmaceutical market in Bangladesh is about Tk90 billion ($1.15 billion USD) and relies heavily on imported raw materials to manufacture pharmaceutical products. Bangladesh has a growing generic pharmaceuticals industry, which recently made headlines when Incepta Pharmaceuticals launched its generic copy of Gilead’s Hepatitis C drug Sovaldi. – Michael Mezher
The Taipei Times reports two agencies in Taiwan have found issues with products sold to the public. The Consumer Protection Committee found the majority of electronic pots used to cook traditional Chinese remedies failed to meet quality, safety or labeling requirements. Of 15 products tested, five were missing components and eight were not labelled properly. The agency says that the manufacturers must correct these issues, or risk losing their sales licenses. In the meantime, consumers are advised to be cautious when using these products.
Additionally, the Changhua County Public Health Bureau said that 80% of fish oil supplements it tested had far less eicosapentaenoic acid (EHA) and docosahexaenoic acid (DHA) than the packages stated. – Michael Mezher
China Food and Drug Administration (CFDA) has accepted an investigational new drug application for a monoclonal antibody from WuXi MedImmune for review. The filing from the WuXi-MedImmune joint venture covers an anti-IL6 monoclonal antibody for rheumatoid arthritis. WuXi’s role in the alliance is to act as a gateway into China for AstraZeneca’s MedImmune. Press Release
India’s Drug Technical Advisory Board (DTAB) has agreed to make a seaport in Nellore and inland container depot in Gandhinagar authorized entry points for drugs. The change follows a recommendation from the office of the DCGI, which also called for DTAB to clear other sea- and airports in Andhra Pradesh and Gujarat for the import and export of drugs. PharmaBiz
Regulators in Tamil Nadu, India have tasked 50 squads of drug inspectors with conducting surprise raids on retail pharmacies. The goal of the raids is to stop the sale of oseltamivir — marketed by Roche as Tamiflu — without a prescription. India is worried improper and illegal use of oseltamivir during the swine flu outbreak will lead to resistance. PharmaBiz
DTAB is to consult with the Indian Council of Medical Research (ICMR) and other experts before including stem cell and cell-based products under the definition of “new drug”. India began the process of establishing regulations for stem cell products in June 2013, but DTAB thinks the consultation must include a wider range of experts before it reaches any conclusions. PharmaBiz
Underwriters Laboratories (UL) is reportedly in negotiations to expand its training of Indian regulators beyond the state of Gujarat. UL, which provides training to regulators in the United States, began working with officials in Gujarat In January. Having already trained 45 officials in the state, UL is now looking to work with regulators in Goa and other parts of India. PharmaBiz
A pair of Indian trade groups has stepped up its efforts to ensure the proper use of prescription drugs. The Indian Pharmaceutical Association wants the government to formulate short to long-term strategies to curb the misuse of drugs. Similarly, the Indian Medical Association is working on guidelines to encourage proper use of nonsteroidal anti-inflammatory drugs. PharmaBiz, More
The World Health Organization (WHO) Regional Office for South-East Asia (SEARO) celebrated its first anniversary since being certified polio-free. On 27 March 2014, the South-East Asia Regional Certification Commission for Polio Eradication (SEA-RCCPE) declared the 11 member states of SEARO to be polio-free. To gain the certification, all member states must not have had any cases of polio for three consecutive years. SEARO is the fourth region to gain polio-free status, after the Americas, Western Pacific, and Europe. WHO says the region will need to continue its efforts to protect against polio, especially in light of the disease’s prevalence in Afghanistan, Nigeria, and Pakistan. WHO SEARO
Tags: Asia Regulatory Roundup, Regulatory Roundup