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Regulatory News | 02 August 2016 | By Nick Paul Taylor
Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia.
The Therapeutic Goods Administration (TGA) of Australia has started talking to manufacturers about establishing an alternative source of glyceryl trinitrate (GTN) tablets. Officials initiated the search to minimize the impact of quality problems at Arrow Pharmaceuticals, the sole supplier of GTN tablets in Australia.
TGA ultimately expects Arrow’s GTN tablets, which are sold as Anginine and Lycinate, to be recalled, but it is unwilling to take this action until it has found an alternative source of supply. The reticence is underpinned by a belief that the quality problems faced by Arrow pose less of a threat to patients than the shortage of GTN tablets that would result from a recall. GTN tablets are used to treat chest pain resulting from coronary heart disease. A spray-based formulation of GTN is available for use in the same indication, but TGA wants to ensure patients have access to tablet forms.
The regulator has been put in the situation by Arrow, which ran into problems after reformulating Anginine and Lycinate. TGA began investigating the GTN tablets after receiving reports that the new formulations, which are taken sublingually, were taking longer to dissolve than the old versions. The reports raised concerns that the slow rate of dissolution could prevent patients from experiencing timely pain relief. TGA also used its investigation to look into reports that the new formulations are harder to break in half.
Having completed its investigation, TGA has confirmed the accuracy of the reports. Arrow is working to reformulate the drugs but, with this process anticipated to take some time, TGA is keen to ensure patients have access to a better option than the current, slow-dissolving versions of the drugs. For now, TGA is recommending patients who can use a GTN spray switch to this formulation. Patients who have to continue on the tablets are being advised to seek urgent medical attention if the drugs fail to relieve their symptoms as anticipated.
China Food and Drug Administration (CFDA) has released a list of 289 generic medicines that have undergone quality and efficacy testing as part of the country’s conformance assessment drive. The list is the first batch of drugs to come through a program intended to raise standards in China.
In keeping with its overall strategy, CFDA has enlisted the support of regional regulators from across the country to oversee the conformance tests. As such, while the National Institutes for Food and Drug Control oversaw the testing 25 products, assessments of the remaining 264 medicines were handled by regional officials. Regulators in the Chinese provinces of Hebei, Inner Mongolia and Liaoning are among those who contributed to the testing drive.
The geographic breadth of the testing initiative should ensure that any resulting improvements in the quality and efficacy of drugs are distributed around the country. Such improvements are part of what CFDA, at the encouragement of senior political figures in China, set out to achieve when it created the testing program. Generics that are shown to match up to their innovator products will benefit from inclusion in the national insurance program and prioritized hospital procurement practices.
To help companies ensure their drugs meet the standards needed to realize these benefits, CFDA has established a training program. At the free events, officials will teach manufacturers about how to perform conformance tests and educate them about regulatory expectations.
CFDA Notice (Chinese)
The Central Drugs Standard Control Organization (CDSCO) has reassigned 40 drug inspectors to posts across its network of offices. Overall, the batch of reassignments represents a transfer of capabilities away from CDSCO’s headquarters, for which the reshuffle amounts to a net loss of 15 inspectors.
CDSCO HQ is shipping out 24 drug inspectors and receiving nine new staffers in the reshuffle, leaving it down 15 people. The inspectors who are leaving the headquarters are taking up posts across the regulator’s network. CDSCO, West Zone (WZ) received the largest influx of drug inspectors from the headquarters. The Mumbai-based site welcomed seven drug inspectors from the headquarters. No inspectors were reassigned away from CDSCO WZ.
Most locations saw a small number of people leave, and a similar number join. Such reshuffles are built into the operating practices of CDSCO, which prohibit officials up to the rank of deputy drugs controller of India from working in the same district for more than 10 years. The same policy, which CDSCO revised in June, states that all officials will be considered for transfer after spending three years at a location. Officials are allowed to submit their three preferred locations for reassignment.
The Drug Regulatory Authority of Pakistan (DRAP) has urged the public to report manufacturers and retailers who increase medicine prices by more than the agreed rate. DRAP issued the alert after it signed off on an annual price increase.
Depending on whether DRAP classes a drug as scheduled, nonscheduled or lower priced, companies can increase what they charge by between 1.43% and 2.86%. The rates are derived from changes to the Consumer Price Index, which the Pakistan Bureau of Statistics said increased by 2.86% this fiscal year.
With the annual increase giving manufacturers a rare opportunity to legitimately charge more for their products, DRAP is alert to the potential for companies to bump up prices by more than the agreed rate. In response, DRAP has issued a public notice, in which it provides a phone number and email address people can use to report cases of illegal price increases.
While some manufacturers see the price control system as a threat to their ability to operate, there are people on the other side of the argument who view DRAP as being too liberal. The annual price increases drew criticism from the Young Pharmacists’ Association (YPA), Daily Times reports. YPA wants to see prices immediately reduced to levels last seen in 2012 to help access among the poor.
DRAP Notice, The Nation, Daily Times
India’s National Pharmaceutical Pricing Authority (NPPA) has cut the price of 23 drugs by up to 35%. The chemotherapy drug melphalan, HIV antiretroviral zidovudine and other essential medicines are affected by the action.
NPPA has set new ceiling prices for each of the drugs on the list, bringing, for example, the price of one 2mg melphalan tablet down to Rs 87.30 ($1.30). The revised prices are between 10% and 35% lower than the previous cap, The Economic Times reports. NPPA is threatening to recoup any money manufacturers make by overcharging, plus interest. However, to date, many companies have simply not paid such fines and not faced punishment.
Even so, NPPA continues to try to control the cost of medicines. The NPPA alert about the new ceiling prices also added another drug, the tetracycline antibiotic doxycycline, to the list of products under its purview. NPPA has capped the price of a 100mg doxycycline tablet at Rs 2.32 ($0.03).
NPPA Alert, The Economic Times
Tags: Angina, Arrow Pharmaceuticals, drug manufacturing inspections, DRAP, NPPA