Asia-Pacific Roundup: India delays stronger ultrasound regs by a year

| 27 October 2020 |  By 

Manufacturers of ultrasound equipment now have until the start of November 2021 to comply with an Indian government plan to regulate their products as drugs.
In October 2019, the Indian government outlined plans to start regulating ultrasound equipment as drugs from November 2020 onward, thereby giving the Central Drugs Standard Control Organization (CDSCO) more power to oversee production and sale of the devices. The timeline put ultrasound in the middle of the broader shift to treating devices as drugs, which began its current phase in 2018 with a proposal covering nebulizers and culminated in February in plans for a sector-wide change.
The one-year deferral comes 10 months after the Indian government gave manufacturers of nebulizers and other equipment covered by the 2018 notice another year to comply. Officials pushed back the April 2020 deadline for imaging equipment by one year at the same time.
The delays mean the product-by-product move to treating devices as drugs is set to run from January to November 2021. In February, the government said it would adopt a new, drug-like regulatory system for all medical devices in April but give the industry up to 18 months to adapt.
Gazette Notification
New Zealand confirms November 2020 change in codeine regulation
The New Zealand Medicines and Medical Devices Safety Authority (Medsafe) is set to classify all codeine-containing medicines as prescription products from 5 November, three years after it was recommended at the Medicines Classification Committee. 
Codeine-only medicines are available by prescription in New Zealand; the new rule extends that regulatory status to all medicines that contain codeine. Medsafe aims to use the new restriction to foster conversations between patients and health care professionals regarding codeine alternatives.
During the multi-year consultation period, critics of the proposal argued making all codeine products prescription only would limit access and place additional burdens on healthcare professionals. The same concerns were raised before Australia made codeine prescription only in 2018.
Medsafe cited the Australian experience in its discussion of the merits of the change, noting that the concerns about access and burdens have not been realised. In June, Australia’s Therapeutic Goods Administration (TGA) said use of high-strength codeine increased at the time of the change but fell back to normal levels by the following year.
Medsafe Notice, More
Malayasian regulatory sites at 30% staffing levels amid new restrictions
COVID-19 restrictions mean only 30% of Malaysia’s National Pharmaceutical Regulatory Agency (NPRA) staff are allowed on its premises and staff will be on rotation.  The agency is asking companies to contact officers via email as they may not be among the people at its offices on a given day.
NPRA is continuing to offer a counter service on weekday mornings. The Malaysian Medical Device Authority (MDA) is also continuing to offer a reduced counter service but is discouraging in-person interactions. Face masks, social distancing and hand hygiene are urged for those who must visit MDA offices.  
MDA Notice, NPRA Homepage
Medsafe starts urgent investigation into Novo Nordisk insulin product
Medsafe is working with Novo Nordisk to urgently investigate complaints from users of NovoRapid Penfill rapid-acting insulin. The complaints detail difficulties managing the blood sugar levels of children and adults using a particular batch of NovoRapid Penfill.
Novo Nordisk’s preliminary investigation found no evidence of a product quality issue with the batch. The probe is in the early stages, though, with the first complainant only raising the problem last week. Medsafe is treating the situation as urgent and working with Novo Nordisk to get to the root of the problem.
The organizations conducted a similar investigation in 2017 in response to reports of problems with blood sugar control. After reviewing batch documents and the results of testing by an independent laboratory, Medsafe found no evidence of a quality issue and took no action.
Medsafe noted that high and low blood sugar are the most commonly reported adverse events for all insulin products. The frequency of the adverse events across the insulin class likely reflects the complexity of diabetes and potential for a variety of factors to drive changes in blood sugar levels.  
Medsafe Notice
Pakistan sets maximum price for Gilead’s remdesivir
Pakistan has fixed the maximum retail price (MRP) for a vial of Gilead Sciences’ COVID-19 antiviral remdesivir at Rs9244 ($57.38). The price is around 10% of the rate charged to private insurance plans in the US.
In Pakistan, the same MRP applies to both remdesivir sold as a lyophilized powder and in solution. Both versions contain 100 mg of the active ingredient.
The antiviral will be provided by some of the seven companies, including Pakistan’s own Ferozsons Laboratories, that entered into voluntary licensing agreements with Gilead to supply remdesivir in 127 countries. In India, the presence of multiple manufacturers of remdesivir has pushed the price of the drug down below the MRP in Pakistan.
India’s National Pharmaceutical Pricing Authority held off on imposing a MRP on remdesivir. In the absence of a price cap, one company on the Indian market, Hetero Healthcare, priced remdesivir up to 27% above Pakistan’s MRP. However, other companies undercut Hetero, most notably Zydus Cadila, which charged 34% less than the MRP in Pakistan.
Government Notice
Roche among companies to pull COVID antibody tests from Philippine market
Roche has voluntarily withdrawn two COVID-19 antibody tests from the Philippiine market. The tests are among 19 antibody kits that received Special Certification that are no longer available.
FDA, like some of its peers, responded to the coronavirus pandemic by allowing COVID-19 tests to come to market without undergoing the typical pre-market evaluation. Later, FDA began requiring all COVID-19 tests with Special Certification to undergo performance validation at the Research Institute for Tropical Medicine.
Now, FDA has shared a list of manufacturers that have voluntarily surrendered their authorizations. The list includes two Roche assays that use its Lightmix technology alongside others from local businesses.
One voluntarily withdrawn Roche assays was the subject of an assessment by the United Kingdom’s public health agency, which found the test accurately identified all positive and negative specimens in a pool of 165 samples.
FDA Notice
Other News:
TGA has approved Medsurge Healthcare to import oral contraceptive pills containing ethinylestradiol and norethisterone to counter a shortage of products sold by Pfizer. Typically, Pfizer sells Brevinor and Norimin, both of which contain ethinylestradiol and norethisterone, but the drugs have been in short supply since August. TGA Notice
India’s Directorate General of Foreign Trade (DGFT) has relaxed its policy on the export of nitrile gloves. Exports are now restricted, rather than prohibited. DGFT Notice


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