APAC Roundup: India’s CDSCO streamlines requests to export active substances to Europe

The Central Drugs Standard Control Organization (CDSCO) has simplified the processing of applications to export active substances to the European Union.

Under EU law, active pharmaceutical ingredients (APIs) shipped from India and other non-listed countries must be supported by a written confirmation certificate stating the product meets good manufacturing practices. The competent authority of the exporting country is responsible for issuing the certificates. In India, CDSCO issues certificates based on recommendations from its zonal and sub-zonal offices.

CDSCO said it has eliminated “the double layer of review.” Under the updated process, applicants file for the issuance or renewal of a certificate via the Sugam portal. Staff at zonal and sub-zonal offices verify the completeness, appropriateness, and legibility of the uploaded documents, but is not required to verify the adequacy of the content. On-site inspections are required only if the facility has not been assessed in the past two years.

The zonal and sub-zonal office staff prepare a compliance verification report and upload it to the Sugam portal. Staff also upload an inspection report, a recommendation letter, and a list of drug substances covered by the requested certificate to the portal. The zonal and sub-zonal offices have three weeks to process applications and upload the documents.

Reviewing officers at the CDSCO headquarters check if the zonal or sub-zonal office has uploaded the required reports and recommendations. After confirming nothing is missing, the reviewing officer assesses the adequacy of the documents, drafts queries if inadequacies are found, and prepares the electronic file and finalized certificate. A senior reviewing officer checks their colleague’s work.

The decision and licensing authorities verify the application’s adequacy. Based on the reviewing officer’s recommendation, the licensing authority either approves or rejects the request for the written confirmation certificate. Headquarters staff have three weeks to complete their part of the process.

CDSCO Notice

Philippine FDA seeks feedback on medical device good storage and distribution practices

The Philippine Food and Drug Administration (FDA) has published draft guidance on good storage and distribution practices for medical devices.

In 2024, FDA issued rules requiring health product establishments to comply with good storage and distribution practices. The agency said the practices are vital to maintaining device quality from the supplier to the end user.

The draft guidance proposes minimum requirements for manufacturers of medical devices, including in vitro diagnostics (IVDs), and other establishments involved in the medtech supply chain in the Philippines.

Records management is a core component of the guidance. Regulated entities must maintain detailed transaction records, including the dates of sales, medical device names, batch or lot numbers, expiration dates, quantities, and the names and addresses of both suppliers and customers. FDA has set different retention period requirements for each type of record maintained.

Organizations must implement comprehensive standard operating procedures across the device lifecycle, including procurement, complaint handling, and recalls. FDA expects companies to ship devices with the earliest expiry dates first, or operate a first-in, first-out system for products without a shelf life. Storage conditions must be monitored, recorded, and maintained using calibrated equipment.

Labels and containers cannot be altered. However, the guidance permits importers or distributors to affix stickers with the market authorization holder’s details or the registration number, if needed. Defective, recalled, or counterfeit devices must be physically segregated and disposed of at accredited facilities.

The agency has proposed giving existing licensed establishments two years to achieve full compliance, starting from the order’s effective date. Officials also plan to temporarily suspend certain labeling provisions for refurbished medical devices and some IVDs pending the release of registration guidelines for the products.

FDA is accepting feedback until 26 April.

FDA Consultation

CDSCO increases surveillance of GLP-1 supply chain as semaglutide generics hit market

CDSCO has intensified its surveillance of the GLP-1 supply chain, auditing and inspecting 49 entities in India to prevent the unauthorized sale and promotion of these diabetes and weight-loss drugs.

Earlier this month, CDSCO published an advisory clarifying its ban on the direct and indirect promotion of GLP-1 medicines. Last week, the Indian government shared details of the regulator's other actions. The audit and inspection program targeted online pharmacy warehouses, drug wholesalers, and other entities to identify unauthorized sales and misleading marketing practices.

The government framed the actions in the context of the loss of patent protection on semaglutide in India, which has enabled companies to launch generic copies of Novo Nordisk’s Ozempic and Wegovy. As more products have come to market, concerns have emerged about the on-demand availability of the drugs through retail pharmacies, online platforms, wholesalers, and wellness clinics.

Analysts expect more than 40 Indian drugmakers to launch over 50 semaglutide products, Reuters reported. The report named seven companies that launched generic copies of semaglutide in the days after it lost patent protection. The launches included injectable and oral formulations that could reduce treatment costs by about 70%.

Press Release, Reuters

Japan’s PMDA sets date for resolving problem with CDISC data validation software

Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) has committed to fixing an issue with data validation software on 13 April, according to an update of advice on new drug review with electronic data.

In a section on Clinical Data Interchange Standards Consortium data validation software, PMDA said it has found a problem that prevents the system from outputting all errors to the validation report. The agency will change the engine used when applying a specific validation rule to fix the problem.

Submissions prepared following prevalidation with the old engine can continue. PMDA said there is no need to redo validation with the new engine. However, the agency may request corrections to the data if it identifies errors during validation at the time of electronic submission.

PMDA Update

CDSCO clamps down on fertility device supply amid reports of unauthorized sales

CDSCO has increased oversight of assisted reproductive technologies amid reports that companies are selling devices in India without obtaining licenses.

The notice applies to in vitro fertilization devices, intrauterine insemination kits, sperm-washing centrifuges, and other fertility products. Because the products are classed as medical devices under Indian regulations, companies need licenses to import, manufacture, and sell the technologies.

CDSCO has received reports that companies are selling such products without the required license. In response, the agency asked its regional staff to “keep strict vigil” and ensure that no products come to market without meeting the requirements established in legislation, including the Medical Devices Rules, 2017.

CDSCO Notice

Other news

Singapore’s Health Sciences Authority (HSA) seized more than 1 million units of illegal health products in 2025, an increase of about 10% over the previous year. Cough syrups accounted for more than half of the seizures. Listings of illegal health products in 2025 dropped to 2,358, the lowest level seen in the past three years. HSA Notice