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Posted 10 December 2014 | By Nick Paul Taylor
Welcome to our Asia Regulatory Roundup, a new weekly overview of the top EU regulatory news.
The Maharashtra FDA has angered local manufacturers by initiating a spate of surprise inspections. Some manufacturers view the clampdown as an unnecessary regulatory burden because the facilities already have World Health Organization (WHO) certification from earlier inspections, PharmaBiz reports.
Regulators have reportedly inspected more than 50 of the 450 WHO-certified facilities in the state. The apparent targeting of WHO-certified facilities has perplexed some manufacturers. Some of the plants — which include those run by Sandoz and Wockhardt — had also been inspected and certified by the Maharashtra FDA shortly before the regulator embarked on its new initiative.
“If the drive is taken on compliance issues logically then it should be done across the board and should start with the units that are not WHO certificied,” an anonymous industrialist said. The regulator has hit many of the inspected facilities with show cause notices, some of which were issued for what observers consider to be relatively minor offences.
The inspection spree in Maharashtra coincides with a clampdown on manufacturers in the north of India. Authorities in Himachal Pradesh have barred seven plants from manufacturing. The facilities were identified during a 15-day burst of 30 inspections, during which regulators found significant quality failings at 12 manufacturers.
PharmaBiz I The Tribune
Multinational pharmaceutical companies have long complained about the speed of the regulatory machinery in China, but the situation has recently deteriorated further still. Bloomberg reports regulators have put an extra step in the process for at least 34 applications, resulting in approval dates being pushed back by up to two years.
The delays stem from a shift in the drug approval process in China. In the past, manufacturers sent clinical trial data to regulators and received a marketing decision. Now, regulators have split the step in two. Manufacturers must first submit data for a clinical trial approval and then for marketing authorization. Regulators are not asking firms to run more trials, but the step is still causing delays.
With millions of dollars resting on the process, manufacturers are upset. “It is hard to understand from an international perspective that a practice implemented for 12 years was suddenly changed, without notice or a transition period,” Joseph Cho, managing director of industry group R&D-Based Pharmaceutical Association Committee (RDPAC) said. RDPAC provided the delay data to Bloomberg.
The Central Drugs Standard Control Organization (CDSCO) has released draft guidelines on medical device good manufacturing practices (GMP) for consultation. CDSCO has moved to allay companies’ complaints about current regulations by proposing the standards enforced in India more closely mirror international practices.
CDSCO goes into great detail in the 57-page document, but the main takeaway for manufacturers is the need to establish quality systems that conform to BIS 15579/ISO 13485. The draft also refers to other documents from the International Organization for Standardization (ISO), such as ISO 14644 for cleanrooms and ISO 14155 for clinical evaluations.
Manufacturers have been pressuring CDSCO to adopt internationally accepted standards to simplify the process of setting up a medical device production plant in India. CDSCO is accepting comments on the draft until 17 December.
PharmaBiz I Draft
US trade group the Natural Products Association (NPA) has called on the China Food and Drug Administration (CFDA) to implement GMPs for dietary supplements. NPA wants CFDA to enforce GMPs comparable to the standards set by FDA to ensure dietary supplements imported from China into the US are safe.
The trade group made the comments as part of its feedback to draft regulatory documents released by CFDA. NPA raised multiple concerns with the drafts, some of which deal with very fundamental issues. In particular, NPA wants CFDA to use one regulatory definition for functional foods and dietary supplements.
“The NPA is aware that China has created a nutritional supplement category. However, China needs to provide a document that says what dietary ingredients can be used in this category. China also needs to define the universe of ingredients that encompass this category of nutritional supplements,” Dr. Corey Hilmas, NPA’s senior vice president for scientific and regulatory affairs, told FoodNavigator-Asia.
Press Release I NPA Letter I FoodNavigator-Asia
The National Pharmaceutical Pricing Authority (NPPA) and Department of Pharmaceuticals are planning measures to strengthen oversight of drug pricing in India. NPPA hopes to stop companies from tweaking their products to sidestep its jurisdiction, while the government wants to create cells in each state to monitor drug prices.
In combination, the two initiatives are designed to block the tricks companies use to bypass price controls. The government controls the prices of 374 drugs, but different combinations, dosages and strengths of these active ingredients are exempt from NPPA oversight. NPPA wants this to change. All forms of price-controlled drugs will be classed as “new medicines,” The Economic Times reports.
The government is also supporting NPPA. Officials at the Department of Pharmaceuticals plan to create cells in each state to check on drug prices. The teams will monitor the price of medicines — including changes to the cost of scheduled and non-scheduled formulations — and their availability. NPPA is also asking medical device manufacturers to present pricing documents, PharmaBiz reports.
Economic Times I More I PharmaBiz
The Pakistan Pharmaceutical Manufacturers Association (PPMA) and Pharma Bureau (PB) have issued legal notices to the Drug Regulatory Authority of Pakistan (DRAP) over its handling of talks about drug pricing policy. DRAP had already received a notice from the Pakistan Chemists and Druggists Association (PCDA).
Each of the industry groups has grievances with how DRAP has managed the pricing policy talks, DAWN reports. PPMA’s complaints center on the pricing policy proposed in draft guidelines. The initial draft distributed by DRAP said either “reference” or “cost plus” pricing would be used, but an “average” model has now been proposed.
“This mechanism is unlawful and tantamount to a penalizing the industry,” the notice said. The process has angered a broad cross section of the Pakistani pharmaceutical industry. PB represents multinational manufacturers, while PPMA lists many local companies among its members.
CFDA has found almost one quarter of purified drinking water in China is substandard. The regulator reached the figure by testing 2,088 batches of water, many of which contained excessive quantities of bacteria.
Major beverage manufacturers were among the companies found to be producing substandard water, the official Shanghai Daily newspaper reported in an article seen by Reuters. China’s biggest drinks manufacturer, Wahaha Group, was on the list, prompting the company to recall affected batches and sever its ties to a water station that is believed to be the source of the contamination.
C'estbon Beverage and Danone SA's Robust brand were also reportedly responsible for some of the substandard batches. The findings are another blow to the reputation of China’s food supply chain, which has caused problems for many multinational companies in recent years. Burger King, McDonald’s and Starbucks were all affected by a suspect meat scandal in July.
Tags: Regulatory Roundup, Asia Regulatory Roundup