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Regulatory Focus™ > News Articles > 2020 > 9 > Asia-Pacific Roundup: COVID-19 vaccine guidelines in India

Asia-Pacific Roundup: COVID-19 vaccine guidelines in India

Posted 22 September 2020 | By Nick Paul Taylor 

Asia-Pacific Roundup: COVID-19 vaccine guidelines in India

India’s Central Drugs Standard Control Organization (CDSCO) has published draft guidelines about the development of COVID-19 vaccines, falling in line other regulatory agencies by setting the bar for vaccine efficacy at a 50% reduction in infections, for example.
 
Several COVID-19 vaccines are in clinical development in India, including candidates from AstraZeneca, Bharat Biotech and Zydus Cadila (RELATED: COVID-19 vaccine tracker, Regulatory Focus 17 Sept. 2020). CDSCO is supporting the programs through the release of guidelines that detail what is expected of COVID-19 vaccine developers as they navigate preclinical, manufacturing, clinical trials and postmarketing.
 
The requirements are in line with those imposed by organizations including the US Food and Drug Administration (FDA) in some key areas. Like FDA, CDSCO wants sponsors to use the prevention of infection as the primary endpoint, rather than let them show an effect on biomarkers or the rate of hospitalization.
 
CDSCO copied FDA’s guidance on statistical considerations verbatim, as it did in other areas of its text. However, the Indian agency diverged from its US counterpart in some areas. CDSCO will decide on the size of the required preapproval safety database on a case-by-case basis. Developers of shots featuring components not previously used in approved vaccines will need to collect enough data to detect adverse events that affect between one in 100 and one in 1,000 people.
 
If there are “special concerns” to be addressed, CDSCO may require a “much larger database.” The agency, like FDA, is also considering placing additional requirements on adjuvanted vaccines and certain other vaccine platforms. CDSCO may ask developers of such vaccines to collect more than six months of data before bringing their products to market.
 
CDSCO’s approach to postmarketing evaluation differs from that of FDA. The Indian agency plans to consider postmarketing requirements on a case-by-case basis, factoring in “the category, nature of
vaccine and the quantum of data generated through the non-clinical and clinical development.”
 
Draft Guidelines, CDSCO Notice
 
TGA details how COVID-19 is shaping advertising compliance policies
 
COVID-19-related content drove a 52% increase in advertising complaints made to Australia’s Therapeutic Goods Administration (TGA) in its 2019-2020 fiscal year, according to the agency’s annual report.
 
TGA received 2,227 complaints in the fiscal year ending 30 June, meaning the COVID-19 pandemic occurred during a fraction of the period. Still, COVID-19 was the defining event for TGA’s advertising compliance unit during the year, accounting for many additional complaints and forcing the agency to prioritize its activities to cope with the extra work.
 
The pandemic has shown TGA “the value of timely preventative actions” such as sponsor fact sheets that help the industry understand the rules, according to the annual report. That finding is in keeping with the agency’s experience that “most advertisers want to comply.”
 
The agency has found requiring noncompliant advertisers to respond within 48 hours drives urgent attention. TGA has backed up its notices with “strong enforcement action where necessary,” the agency said, enabling it to use an action against one company to serve as a deterrent to others.
 
TGA said that it is braced for “new challenges in the regulation of advertising” when treatments and vaccines for COVID-19 emerge. Medicines and vaccines have played a small role in TGA’s advertising compliance work so far. TGA had 275 COVID-19 cases related to hand sanitizers last year. Just 24 of TGA’s COVID-19 cases related to medicines.
 
The agency will face the new challenges with a greater understanding of “how to streamline the implementation of a surge capacity through the rapid mobilization of staff from other areas within the TGA,” the report noted.
 
Annual Report
 
Malaysia’s MDA establishes policy on device refurbishment
 
Malaysia’s Medical Device Authority (MDA) will regulate all types of medical device refurbishment under Malaysia’s Medical Device Act 2012, the agency announced.
 
The policy covers “full” refurbishment, which MDA defines as a process that “aims to restore used medical devices to increase the level of its safety and effectiveness,” and other related activities that are not fully explained in the document. Whatever the type of refurbishment, the activity will be subject to the device act and must be performed under certain control methods.
 
MDA wants manufacturers with refurbished medical devices to submit registration applications via its portal. Manufacturers need to include refurbishment activities in the quality management system and submit their devices for evaluation by a Conformity Assessment Body.
 
Different requirements apply to registered medical devices that are set to undergo refurbishment. In that case, the manufacturer should notify regulators, perform the work in compliance with MDA’s good refurbishment practices and provide technical details for the medical device.
 
The policy also covers the obligations of third parties that refurbish devices. Such organizations need to obtain an establishment license. MDA will hold third parties responsible for registering a medical device.
 
MDA Circular
 
India’s NPPA to clamp down on medical oxygen hoarders
 
India’s National Pharmaceutical Pricing Authority (NPPA) has vowed to clamp down on people who hoard or otherwise interfere with the supply of medical oxygen. NPPA issued the notice in response to reports that COVID-19 has overstretched supplies of medical oxygen in parts of the country.
 
Government officials claim India has a surplus of medical oxygen. However, news outlets including the BBC have reported that a four-fold increase in demand due to COVID-19 has made it hard for people to source medical oxygen.
 
NPPA called on state officials to “prevent black-marketing and hoarding” of medical oxygen. If the price watchdog learns of those activities or profiteering, it plans to immediately act against the offending party.
 
NPPA Notice
 
Pakistan’s DRAP opens fast track to manufacturers of fludrocortisone
 
The Drug Regulatory Authority of Pakistan (DRAP) is offering fast-track registration to manufacturers of fludrocortisone in an effort to remedy a lack of access to the corticosteroid.
 
Fludrocortisone is used to treat several conditions such as postural hypotension. DRAP, responding to the petitions of groups including Pakistan Citizen's Portal, is focused on its role in the treatment of congenital adrenal hyperplasia. The significance of the drug to the salt wasting variety of the disease led physicians from Pakistan and other countries to apply to have it classed as an essential medicine.
 
However, DRAP has identified “the issue of unavailability of fludrocortisone tablets.” In response, the agency is open to registering fludrocortisone tablets on the strength of a limited dataset.
 
DRAP said it “may consider grant of registration and submission of data of product development and 6 months accelerated & 6 months real time stability studies data before sale of product along with other data as may be required.” DRAP wants companies with the required data to submit applications by the end of the month.
 
DRAP Notice

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