Asia-Pacific Roundup: India approves cooperation agreements with 3 countries

The Indian government has signed off on agreements to cooperate on the regulation of medical products with its counterparts in the Dominican Republic, Ecuador and the Netherlands.

Through the agreement with the Netherlands, which was signed last year but only approved by the Indian government last week, officials aim to establish a framework for cooperation and exchange of medical products regulatory information between India’s Central Drugs Standard Control Organization (CDSCO) and the Dutch Medicines Evaluation Board (MEB) (RELATED: India and the Netherland agree to cooperate on medical product regulation, Regulatory Focus, 13 November 2023).

The cooperation, which the Indian government said will be “in line with [the agencies’] international responsibilities,” is intended to “facilitate better understanding of medical products regulation with regard to pharmaceuticals including raw materials for pharmaceutical use, biological products, medical devices and cosmetic products.”

The pact “will facilitate export of medical products leading to foreign exchange earnings” and regulatory convergence “could help in increasing export of medicines from India and consequently help in better employment opportunities for educated professionals in the pharmaceutical sector,” according to an Indian government statement.

The government framed the benefits to exports and the pharmaceutical industry as “a step towards an Atmanirbhar Bharat,” a phrase ruling politicians use that translates to “self-reliant India.” Officials also positioned the agreements with the Dominican Republic and Ecuador as steps toward a self-reliant India.

The focus of the agreements with the Dominican Republic and Ecuador differs somewhat from the work with MEB, according to the government statements. In the notice about cooperating with the Dominican Republic, officials said the agreement will facilitate “interaction amongst regulatory agencies” to “tackle issues of substandard, falsified medicines moving in the international markets.”

CDSCO and other bodies in India and the three partner countries signed memorandums of intent and understanding (MoIs/MoUs) in October and November. However, the cabinet of the government led by Prime Minister Shri Narendra Modi had not approved the memoranda until last week.

Press Release

New Zealand starts monitoring safety of Novartis drugs after intestine dysfunction review

A potential safety concern has prompted New Zealand’s Medicines and Medical Devices Safety Authority (Medsafe) to add type 2 diabetes drugs from Novartis to its medicines monitoring scheme.

Last year, New Zealand’s Medicines Adverse Reactions Committee (MARC) discussed whether dipeptidyl peptidase-4 (DPP-4) inhibitors may cause ileus, a condition defined by the intestines inability to push food and waste out of the body despite the absence of mechanical obstruction.

MARC considered whether to recommend updates to the data sheets for DPP-4 medicines and GLP-1 receptor agonists, classes with a possible common mechanism, in response to “an FDA Newly Identified Safety Signal with DPP-4 inhibitors.” The committee recommended updates to the GLP-1 data sheets but found insufficient evidence to rule on DPP-4 inhibitors, in part because of the limitations of a study that informed its conclusions.

Lacking evidence, MARC recommended Medsafe publish a monitoring communication to gather more information on a possible association between DPP-4 inhibitors and intestinal obstruction including ileus. Medsafe published the communication last week. The notice is designed to encourage the reporting of ileus in people who are taking Galvus (vildagliptin) and Galvumet (vildagliptin plus metformin), diabetes medicines sold by Novartis.

Medsafe Notice

CDSCO adds drug application forms to new portal ahead of next month’s SUGAM switch

CDSCO has added pharmaceutical application processes to its National Single Window System (NSWS). The agency began accepting applications via the portal last week and plans to complete the transition from the current SUGAM system next month.

NSWS is designed to provide “a one-stop shop for all the approvals required by the investor and facilitate ease of doing business.” CDSCO recently made the use of the portal mandatory for some medical device applications, which were previously processed on cdscomdonline, and is now working to move medicine submissions across to the new system.

Last week, CDSCO began accepting applications to manufacture and import new drugs and unapproved active pharmaceutical ingredients for use in clinical trials and other studies via the portal. The regulator is set to start using the portal for applications for another import license this week.

CDSCO wants companies to use NSWS for the five applications from now on. Companies can currently still use SUGAM, an older portal, to send submissions for the permissions and licenses but CDSCO plans to make NSWS mandatory on 10 February. The regulator attached a guide to using NSWS to the notice about the transition to the new portal.

CDSCO Notice

Philippine FDA finds no link between product quality and reports of failed anesthesia

The Philippine Food and Drug Administration (FDA) has found medicines linked to failed or incomplete spinal anesthesia conform to approved specifications, leading it to conclude the events “may not be associated with the product quality.”

Between November 2008 and October 2023, FDA received 139 reports of failed or incomplete spinal anesthesia or lack of efficacy related to bupivacaine products. Reports said physicians needed to increase the dose, change to a different product or give a general anesthetic to compensate for problems achieving the desired effect.

FDA began including bupivacaine in its annual postmarketing surveillance plan in 2020. The agency shared details of the finding of its investigation into the reports, which came from healthcare facilities including private and public hospitals, last week.

“From the annual investigation and sampling, collected Bupivacaine products were tested and found conforming with the approved specifications,” FDA wrote. “In addition, specific batches reported to have failed anesthesia were likewise tested and found conforming with the approved specifications. Based on this data, the reports of failed spinal anesthesia may not be associated with the product quality.”

Unable to find a cause related to product quality, FDA cited other factors such as abnormalities of the spine that may contribute to failed anesthesia. The agency identified the other potential factors in a review of the literature.

FDA Notice

Takeda expands Australian shortage of ADHD drug as demand for other strengths rises

Takeda has expanded its shortage of the attention deficit hyperactivity disorder (ADHD) drug Vyvanse to cover 40 mg capsules after seeing an “increase in demand for other strengths.”

Australia’s Therapeutic Goods Administration (TGA) shared details of the shortage of three doses — 30 mg, 50 mg and 60 mg — of the Takeda drug late last year. Last week, the agency added 40 mg to the list of Vyvanse doses that are in short supply in Australia. Takeda expects supply of the 40 mg dose to return at the end of April.

TGA’s database cites an “unexpected increase in consumer demand” as the cause of the shortage. The agency referred to the effect of increased demand for other strengths in a press release about the supply disruption. Takeda expects supply of the other doses to resume in March and April.

TGA Notice

Asia-Pacific Roundup: India approves cooperation agreements with 3 countries

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