Asia-Pacific Roundup: India's health minister urges industry to create self-regulatory body for drug quality

India's health minister has urged the pharma industry to create “a self-regulatory body to maintain the quality” of drug products. Mansukh Mandaviya made the statement in a speech in which he called on the industry to maintain the reputation of India as the “Pharmacy of the World.”

Mandaviya gave the speech at the closing ceremony of the Indian Pharmaceutical Association’s Global Pharmaceutical Quality Summit in Mumbai. The summit took place after a year in which the quality of medicines exported from India has been called into question by the deaths of children who took cough syrups contaminated with the toxic substances ethylene glycol and diethylene glycol.

Against that backdrop, Mandaviya praised the Indian pharma industry for the role it played in making drugs and vaccines for use in the COVID-19 pandemic, adding that nobody ever thought of their own profit or became selfish and took undue advantage of the situation. India exported products to more than 150 countries, the health minister said, and no country complained about drug quality because the Indian pharma industry never compromised on the quality of the medicines.

Yet, having praised the industry for having an uncompromising approach to quality, Mandaviya added that, like all sectors, pharma has a few people who try to compromise on quality. The government press release about Mandaviya’s speech makes no specific reference to the toxic cough syrup exports.

According to Mandaviya, the government has a zero-tolerance policy against people who compromise the quality of medicines and is taking stringent actions against companies involved in such malpractice. The government is looking for help from the industry, though, with Mandaviya using the speech to urge pharma companies to collectively establish a self-regulatory body to monitor product quality.

The government press release about the speech lacks further information about Mandaviya’s vision for a self-regulatory body and how it would work in practice. The Business Standard reported that the health minister “did not divulge further details on the nature and composition of the self-regulatory body.” The article includes some information absent from the press release, such as Mandaviya’s comment that the government is industry-friendly but wants to eliminate chances for anyone to point out quality flaws.

“If any company’s products have a history of failure, then we are auditing these sites. If someone needs handholding, the industry at the regional level should help to improve quality. However, if anyone is callous about quality, they have no right to operate,” Mandaviya said.

Press Release

TGA shares guidance on transition away from ISO certificates to support in vitro diagnostics

Australia’s Therapeutic Goods Administration (TGA) has published guidance to help manufacturers of in vitro diagnostic (IVD) medical devices to transition to its new evidence requirements.

TGA accepts a range of manufacturer evidence to support the inclusion of IVDs in the Australian Register of Therapeutic Goods (ARTG). As of January, more than 60% of IVDs were supported by certificates for ISO 13485, a standard that covers the management of medical device quality. More than 10% of IVDs relied on certificates issued under the old European Union directive.

Now, with the European Union’s IVD Regulation replacing the directive and the transition period covering TGA’s acceptance of ISO 13485 ending, manufacturers of around 70% of the diagnostics in the ARTG will need to provide an alternative form of evidence. TGA expects most companies to switch to IVDR certification or Medical Device Single Audit Program (MDSAP) certification. MDSAP already accounts for around 20% of IVDs.

To support the transition, TGA has released guidance that explains the types of certificates that TGA can accept as evidence and clarifies that, while it still recognizes ISO 13485, it no longer accepts certificates issued under the International Accreditation Forum framework.

TGA stopped accepting ISO 13485 certificates to support new applications for class 2 and 3 IVD medical devices last month. Existing ARTG entries supported by a valid ISO 13485 certificate can continue to use the standard as evidence until it expires. TGA is strongly encouraging manufacturers that currently rely on ISO certificates to obtain another form of evidence before their certificate expires.

Manufacturers can continue to use certificates issued under the EU IVD directive until between May 2025 and May 2027, depending on the risk classification of the device. Similarly, the cut-off dates for the use of an ISO 13485 certificate with EU Declaration of Conformity are in May 2026 and May 2027, again depending on the risk classification.

Switching to an alternative form of evidence “may result in the sponsor needing to notify the TGA of additional changes or apply to the TGA for regulatory approvals,” the guidance states. Such notifications and applications may be needed if the new certification covers a different scope of activities or limits the intended purpose of the IVD. The guidance features multiple examples of the implications of switching to a different certification and outlines the steps companies must take to transition to new evidence.

TGA Notice, Guidance

Philippines seeks feedback on package insert and patient information leaflet publication guide

The Philippine Food and Drug Administration (FDA) is holding a consultation into draft guidelines on the publishing of package inserts (PIs) and patient information leaflets (PILs) on its verification portal system.

FDA’s online portal provides a list of establishments with License to Operate and a list of health products with Certificate of Product Registration/Notification. As such, the portal provides the public with a way to determine if an establishment or product has the required regulatory paperwork to support safe use.

Now, FDA is asking all marketing authorization holders (MAHs) to submit their PIs and PILs for inclusion in the portal. The agency is asking MAHs to submit the information via email, with PDFs of the PI and PIL attached. FDA wants companies to regularly update the PIs and PILs uploaded to the portal.

How long MAHs will have to comply with the request depends on the nature of their products. FDA plans to give manufacturers of drugs with monitored release status two months from when the guidelines take effect to provide their PIs and PILs. Manufacturers of generics will have three to eight months, and MAHs with biologicals will have nine months.

Draft Guidelines

India acts to control backlog of cough syrup samples awaiting testing at Mumbai laboratory

India’s Central Drugs Standard Control Organization (CDSCO) has issued new advice on the testing of cough syrups for export after seeing a backlog of samples emerge at one of the laboratories.

At the start of June, the Indian government began requiring manufacturers of cough syrups to send samples for testing to get a Certificate of Analysis (CoA). A CoA is now required to export cough syrups to prevent products that are contaminated with ethylene glycol and diethylene glycol from leaving India.

Multiple laboratories offer the testing service, but manufacturers have overwhelmingly chosen to send samples to the Central Drugs Testing Laboratory in Mumbai. As of June 21, the Mumbai laboratory had 93 samples awaiting testing while “some” of the other sites had no samples, according to CDSCO.

In response, CDSCO asked manufacturers not to send samples to Mumbai for testing for the time being. The agency wants manufacturers in the state of Maharashtra to check the CDSCO website each day and send samples to the laboratories that have the fewest cough syrups awaiting testing.

CDSCO Notice, More

Asia-Pacific Roundup: India's health minister urges industry to create self-regulatory body for drug quality

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