Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia.
India Expands Cost Controls for Cancer Drugs, Cutting Prices by up to 87%
India’s National Pharmaceutical Pricing Authority (NPPA) has brought 390 brands of non-scheduled cancer medicines under tougher price controls. The changes impose a 30% trade margin cap on the products, resulting in price cuts of up to 87% on certain products.
NPPA outlined plans to change the price caps on the cancer medicines late last month and brought the new rules into force this week. The action affects 390 brands featuring 42 active ingredients, including the molecules found in Novartis’ Afinitor, Pfizer’s Sutent and Roche’s Avastin. All the drugs now have lower maximum retail prices, although the impact of the NPPA action varies considerably from brand to brand.
The Novartis and Pfizer drugs affected by the action illustrate the range of price cuts enforced by the changes. NPPA is cutting the maximum price of a 10 mg tablet of Afinitor by 63%. In contrast, the price of Pfizer’s Sutent is falling by 3% to 4%, depending on the dose of the product. The differences in the price changes of some other drugs is even greater. While the price of a Tarceva generic is down 87%, Bayer and Zydus’ joint venture can sell Resihance for 0.45% less than before the NPPA action.
Most of the cuts fall into the 25% to 75% range. Less than one-tenth of the cuts are greater than 75%. Around one-quarter of the cuts are less than 25%.
The Indian government thinks the reductions will add up to significant savings. In a statement about the cuts, the government predicted the changes will benefit 2.2 million people and save consumers Rs 800 crores ($115 million) a year.
To achieve those savings, the government will need to stop manufacturers from taking actions that counter its cost-cutting efforts. The government preempted such actions by directing manufacturers affected by the cuts to continue producing the drugs at current volumes.
, NPPA List
TGA to Accept UK Conformity Assessments in No-Deal Brexit Scenario
Australia’s Therapeutic Goods Administration (TGA) is to accept conformity assessment documents from notified bodies in the UK in the event of a no-deal Brexit. The TGA decision will insulate device manufacturers active in Australia from the effects of a hard split between the UK and EU.
If the UK leaves the EU without a deal, notified bodies based in the departing member state will no longer be covered by Australian legislation on the acceptance of documents from overseas agencies. The legislation lists notified bodies “designated by a member state of the European Union” among the overseas foreign bodies whose reports are accepted in Australia. A separate piece of legislation describes the use of reports from notified bodies in applications to sell medical devices in Australia.
Notified bodies based in the UK are currently covered by the legislation but that will cease to be the case in the event of a no-deal Brexit. In that scenario, the UK will be a third country that, under the current law, would be on the long list of countries with regulatory agencies that are not considered to be comparable to TGA by Australia.
TGA wants to avoid that outcome and the effects it would have on the availability of medical devices in Australia. As such, the agency will continue to accept conformity assessments for products already in the Australian Register of Therapeutic Goods (ARTG) for as long as they are current for the purpose of UK market authorization. TGA will also continue to accept conformity assessments from notified bodies in the UK as part of applications to add new devices to the ARTG.
The approach outlined by TGA will necessitate changes to Australian laws on overseas regulators and the information that must be included in medical device filings. The changes will ensure the ongoing recognition of notified bodies regulated by the UK Medicines and Healthcare products Regulatory Agency and specify that the documents they issue will be accepted in filings for ARTG inclusion.
The changes will be necessary to ensure the continued importation and supply of medical devices if the UK leaves the EU without a deal later this month. That may not happen, though. At the time of writing, UK politicians are hours away from voting again on the withdrawal terms agreed with the EU. The possible outcomes of the upcoming votes include acceptance of the agreement or a request to delay Brexit. In either event, TGA notes that there will be no immediate effects on manufacturers.
TGA Revises Permissible Indications for Listed Medicines Following Feedback
TGA has updated the list of permissible indications for listed medicines. The changes reflect feedback sent to the Australian regulator since it began enforcing the original list one year ago.
Prior to the introduction of the list, manufacturers of complementary medicines and other low-risk listed products could use a free-text field to enter their preferred indication when applying to have a substance included in the ARTG. TGA moved away from that model in March 2018 to prevent sponsor noncompliance and protect consumers from misleading and inappropriate claims.
Now, TGA has updated the list of permitted indications based on experience gained over the first year of the new model. TGA has created 15 new indications and removed seven others, either because they were duplicates or following reassessments of their suitability and supporting evidence.
Companies applying to bring new products to market will need to comply with the new list straight away. TGA is taking a more flexible approach to existing products. Medicines found noncompliant with the 2019 list, but compliant with the original, are likely to get away with a reminder about the new requirements until the end of the transition period in two years.
There are benefits to acting sooner, though. TGA is offering fee-free changes for companies affected by the changes to the list until 8 September.
India Clarifies Rules on the Display of Brand Names on Drug Labels
India has proposed changing its legislation on the display of brand names on drug labels. The new law would require companies to print the generic names of products at least two font sizes larger than the brand name.
Existing Indian legislation is designed to ensure the generic name is visible but is light on specifics of how to achieve this goal, stating only that it must “appear in a more conspicuous manner than the trade name.” The trade name, if present, should come either below or after the generic name.
The proposed legislation retains these stipulations but adds the comment about the font size. If the font size change is passed, it will create a rule on how to make the generic name more conspicuous.
Indian officials put forward the change alongside another proposed revision to the conditions for granting an approval. The other change would eliminate the need for “the innermost container of the drug and every other covering in which the container is packed ... [to] bear a conspicuous red vertical line.”
The rule is to be replaced with a requirement that “a caution or warning, as applicable, depending on whether the drug is covered under Schedule G or Schedule H or Schedule H1 or Schedule X, as specified in rule 97, in legible black coloured font size in a completely red rectangular box.”