Regulatory Focus™ > News Articles > 2022 > 3 > Asia-Pacific Roundup: India consults on voluntary medical device marketing code

RoundupsRoundups
Posted 22 March 2022 | By Nick Paul Taylor 

Asia-Pacific Roundup: India consults on voluntary medical device marketing code

2710 The Indian Department of Pharmaceuticals (DoP) is seeking feedback on a proposed Uniform Code for Medical Devices Marketing Practices (UCMDMP). DoP drafted the code in response to a request from the medical device industry, which currently must comply with the rules on pharmaceuticals but wants its own voluntary regulatory requirements.
 
UCMDMP shares a structure and some similarities with the Uniform Code for Pharmaceuticals Marketing Practices, published late in 2014.
 
The medical device retains restrictions providing free evaluation samples, but differentiates between samples and demonstration products, defined as either “single use products, mockups, temporary software or equipment that are used for [healthcare professional] and patient awareness and education.”
 
Demonstration products are returned to the company after being demonstrated, although the code notes that consumables usually cannot be returned. The clause restricting evaluation samples does not apply to demonstration products. Companies need to specifically identify and track demonstration products.
 
The section on gifts also diverges from the pharma code. The draft medical device code draft bans gifts to healthcare professionals, their families and other stakeholders such as retailers. It does allow occasional “modest, appropriate educational items to [healthcare providers] that benefit patients or serve a genuine educational function,” such as e-books, subscriptions and anatomical models. Companies also can give branded items worth up to INR 1,000 ($13).
 
As with the pharma code, the medical device requirements are voluntary. The draft states that all medical device manufacturer associations will upload UCMDMP to their websites. If a complaint is lodged, the company’s CEO or equivalent will investigate, take corrective actions and provide a response to the association. Complainants must make a refundable deposit of INR 1,000. 
 
DoP is accepting feedback on the draft until 15 April.
 
Draft Code
 
Malaysia updates post-registration section of crisis authorization guidance
 
Malaysia’s National Pharmaceutical Regulatory Agency (NPRA) has updated its guidance on the requirements on conditional registration of pharmaceutical products during disasters.
 
 
The changes in the third set of revisions are limited to a post-registration section, which now states: “If all conditions have been fulfilled, a full application for product registration can be submitted through QUEST3+ system. Once full registration is granted, Technical Evaluation Summary Report (TESR) will be published on the NPRA website (except for the products approved via recognition procedure).”
 
The earlier version of the guidance, published in January, lacked information about the need for the TESR to be published once full registration is granted. With the pandemic entering a new phase and companies generating more data on products approved early in the crisis, NPRA and other agencies around the world are paying more attention to the transition to full approvals.
 
The rest of the guidance is unchanged. The text still covers the eligibility criteria and timeline for the conditional registration of pharmaceutical products during disasters, plus the essential documents that are required and the post-registration monitoring rules.
 
NPRA Guidance
 
India assigns risk classifications to general hospital and orthopedic instruments
 
India’s Central Drugs Standard Control Organization (CDSCO) has assigned risk classifications to general hospital and orthopedic instruments such as stretchers, surgical mallets and products used with spinal cage systems.
 
The notice, which continues a wider move to categorize medical devices based on their risks, puts 146 classes of product into one of four categories ranging from A (lower risk) to D (higher risk). Most of the devices covered by the latest notice fall into class A or B, with a few in class C products and one (chemical cold packs for snake bites) in class D.
 
New class C devices include electronic monitors for gravity flow infusion systems, devices that record the time and date that they are ingested by patients, and ultraviolet radiation chamber disinfection devices.
 
Most of the remaining devices covered by the notice fall into class A or B. CDSCO has added devices that signal when a patient gets out of bed, scales intended for medical purposes, neonatal eye pads and medical insoles to class A. Class B features products such as forehead temperature strips, medical bassinets, pressure infusers for intravenous bags and electrically powered patient lifts.
 
CDSCO Notice
 
Pakistan changes rules on applying to advertise common painkillers, other drugs
 
Applications to advertise household remedies in Pakistan now will be decided by the the Drug Regulatory Authority of Pakistan (DRAP) Committee on Advertisement, under an update to the Drugs (Licensing, Registering and Advertising) Rules, 1976. The committee will decide after seeking comments from the Division of Health & OTC products about the enlistment status, composition quantity, recommended daily allowance level and verification with safety list.
 
The process applies to products such as analgesics aspiring, paracetamol and ibuprophen in tablet and liquid forms, as well as to topical analgesics, antiseptics, antacids, laxatives, contraceptives and certain supplements. Supplements may not be advertised as alternatives to “natural food and its sources” or in the treatment, diagnosis, prevention or curing of disease.
 
DRAP Notice
 
Philippine FDA grants emergency authorization to Sinovac COVID-19 vaccine in kids
 
The Philippine Food and Drug Administration (FDA) has granted emergency use authorization (EUA) to Sinovac’s CoronaVac vaccine to prevent  COVID-19 in children aged six to 17 years.
 
FDA’s review of clinical trial and real-world effectiveness data on CoronaVac in the population persuaded it to grant a third EUA to a COVID-19 vaccine in children. Pfizer/BioNTech’s Comirnaty is authorized for use in children aged five years and up, and Moderna’s Spikevax in children aged 12 years and up in the Philippines.
 
CoronaVac, an inactivated vaccine, has less restrictive storage requirements than mRNA vaccines, staying stable at refrigerator temperatures of 2 to 8 degrees Celsius.
 
FDA Notice
 
Other news:
 
DRAP has published a medical product alert about a substandard batch of 0.9% sodium chloride infusion from Otsuka Pakistan. The batch was tagged as “sterility: does not comply” by the Karachi central drugs laboratory. In response, DRAP has requested increased vigilance at facilities likely to be affected by the substandard batch, which should not be used. DRAP Notice

 

© 2022 Regulatory Affairs Professionals Society.

Discover more of what matters to you

5;18;23;25;