Asia Regulatory Roundup: Indian Device Industry in Favor of Regulation Overhaul Proposal (16 June 2015)

Regulatory NewsRegulatory News | 16 June 2015 |  By 

Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia.

Indian Medical Device Industry Welcomes Regulatory Proposal, with Caveats

The Indian medical device sector has reacted favorably to the government's plans to regulate its industry, with vocal critics of current regulations such as the Association of Indian Medical Device Industry (AIMED) speaking out in favor of the draft policy. 

Officials at the Department of Pharmaceuticals (DoP) included several provisions to support local manufacturers in the draft policy that have been noted and warmly received by AIMED. If the policy comes into force in its current form, Indian medical device manufacturers could benefit from procurement procedures that prioritize local products, long-term tax breaks and the elimination of import duties on raw materials.

"We feel that most of the points or provisions enlisted are favorably inclined to support the domestic industry's growth and are in line with AIMED's recommendations," Rajiv Nath, forum coordinator of AIMED, told PharmaBiz. Nath, a vocal critic of the perceived bias toward imported medical devices, thinks there is still more to do, though. "We need some fine-tuning for ensuring more clarity of direction and effectiveness."

While Nath wants the government to make some tweaks to the draft following its six-week public feedback period, this is less important to AIMED than fast-tracking adoption and implementation of the policy. "Most importantly, what industry wants is the implementation of this policy at the earliest so that we can finally start developing the domestic sector," Nath said.

PharmaBiz, Reuters

WHO Prequalifies Second Chinese Vaccine as Industry Starts to Come of age

The World Health Organization (WHO) has prequalified a vaccine made in China for only the second time. WHO awarded the status to an influenza vaccine manufactured by Hualan Biological Bacterin, and in doing so opened the door to sales of the product to programs run by the United Nations (UN).

Officials at WHO last deemed a China-made vaccine to be eligible for prequalification in 2013, when it signed off on the use of a Japanese encephalitis shot from China National Biotec group (CNBG). The approvals were the result of deliberate, multi-year initiatives, both within the companies and the broader Chinese vaccine industry, to raise standards to the level needed for prequalification. At Hualan, prequalification has been a priority since at least 2012, at which time it was aiming to build on its compliance with China's new good manufacturing practices (GMP) and meet WHO's criteria.

Having succeeded, Hualan, its 300 million-dose-a-year influenza vaccine production plant and China as a whole join an elite club. GlaxoSmithKline, Green Cross, Novartis and Sanofi are the only other manufacturers with prequalified seasonal influenza vaccines. With the exception of Korea's Green Cross, the production plants of all the other manufacturers are located in North America or Western Europe, meaning China has received prequalification before any of the other emerging vaccine hubs, notably India.

"WHO prequalification of the Hualan vaccine is another feather in the cap of China's growing vaccine manufacturing industry. [It] shows that the country is set to become one of the preeminent vaccine manufacturers globally," Bernhard Schwartländer, WHO representative in China, said in a statement. The ability of Chinese manufacturers to achieve such regulatory standards could have a major effect on the cost of sourcing vaccines. CNBG sold its Japanese encephalitis vaccine for 30 cents a dose, almost 90% less than even Indian-made alternatives traded for on the open market.


Bangladesh Moves to Bring Dietary Supplements Under Regulatory Oversight

Bangladesh is planning to extend regulatory oversight to cover dietary supplements. The change is being implemented to counter an alleged alliance between some doctors and importers of dietary supplements to promote such unregistered products to patients, The Financial Express reports.

A regulatory policy established in 2006 should prevent physicians from prescribing unregistered drugs, but this has proven to be insufficient to stop doctors from recommending dietary supplements. As such, Bangladesh's Directorate General of Drug Administration (DGDA) drafted amendments to the drug control law that are now nearing approval by the ministry of health. The changes are intended to close loopholes DCGA thinks are allowing doctors to make decisions that are detrimental to the health and finances of patients.

"Once the amended ordinance is passed, the importers and marketers of such food supplements will have to prove safety, efficiency and usefulness of their goods before marketing," Ruhul Amin, a director of DGDA, said. The Financial Express article suggests bolstering awareness and enforcement of legislation will be as important as tweaking the text. An anonymous medical officer said: "We do not know what is in the drug control ordinance. We see that food supplements work better. So we prescribe." The view is countered by criticism from patients of the cost and efficacy of supplements.

The Financial Express

Other News:

The Indian government has abolished import duties on HIV drugs and testing kits. Officials made the change to counter the shortage of HIV drugs in the country that arose after changes were made to the distribution of the AIDS control program's $1.3 billion budget. The new policy means first- and second-line antiretrovirals will be free from import duties until March 2016. Reuters

China Food and Drug Administration (CFDA) has publicly criticized eight companies for violating its advertising standards. The CFDA notice picks the companies up for making unsubstantiated claims and misleading consumers, for example by saying a drug can cure hair loss within 60 days or treat obesity. CFDA Notice (Chinese)

Maharashtra Food and Drug Administration (FDA) increased the number of raids it conducted by almost 150% last year. The jump in enforcement activities uncovered the stocking of products by organizations that lacked the appropriate licenses and their sale without the required paperwork. Around 4,000 pharmacy licenses were canceled or suspended last fiscal year. PharmaBiz

A halving of the growth rate of the Pakistani pharma industry has prompted calls for improvements to the regulatory environment. In particular, industry representatives want the Drug Regulatory Authority of Pakistan (DRAP) to urgently deal with the backlog of 1,300 submissions and implement a more predictable, transparent system for registering medicines. Dawn

The former drugs controller of Kerala has criticized quality control standards in the Indian state. Dr Satheesh Kumar said the regulator in Kerala is ill-equipped to monitor the quality of drugs sold in the state, a shortcoming he advocates overcoming through the creation of public-private testing partnerships and the compulsory sampling of government-procured products. PharmaBiz

China has freed the British corporate investigator and his wife who were jailed in connection to the GlaxoSmithKline bribery case. The couple became a target for police after helping GSK to investigate a sex tape involving one of its top managers, leading to them being found guilty of illegally collecting data on Chinese citizens. The Guardian, BBC

The number of clinical trials approved by India's Central Drugs Standard Control Organization (CDSCO) has slumped. Having approved 16 trials in the first two months of the year, CDSCO cleared just three studies in March and April. The quick start means India is on track to top the 19 trials that began in 2013, but is unlikely to approach the 500-study-a-year boom period of 2010. CDSCO Notice

Roche has cut the price the Indian government must pay for its hepatitis C drug Exxura by 65%. The move brings the cost down to Rs 3,250 ($50) per prefilled syringe. PTI


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