Asia-Pacific Roundup: CDSCO advises drugmakers on how to dispose of expired or unused medicines

India’s Central Drugs Standard Control Organization (CDSCO) has published guidelines on the disposal of expired or unused medicines.

CDSCO said the safe disposal of medicines is crucial for protecting the environment and public health. Improper disposal may be hazardous to people, animals and the environment, the agency said and is linked to the rise of antimicrobial resistance. The concerns led CDSCO to assess how to safely dispose of medicines that are beyond their expiry dates or have not been used by the patient who received them.

Manufacturers are responsible for disposing of medicines returned from distributors, retailers and other organizations in the supply chain. CDSCO said manufacturers must dispose of medicines at their own site or through a vendor approved by the Pollution Control Board. Companies need to keep records of drug disposals for verification by regulators.

The guideline outlines eight methods for disposing of medicines. CDSCO said landfill is the most widely used method of disposing of solid waste but advised against using open uncontrolled non-engineered dumps to get rid of medicines. Untreated waste put into open dumps can harm the environment. CDSCO said drugs “should preferably be discharged after immobilization by encapsulation or inertization.”

Encapsulation involves immobilizing the pharmaceuticals in a solid block within a plastic or steel drum, the agency said. The guidance explains the technique and addresses the specific requirements of drugs used to treat cancer. Inertization is a variant of encapsulation that involves removing pills from their packaging, grinding them and mixing the powder with water, cement and lime to form a paste. The paste can be poured into landfill, where it will set as a solid mass.

Three of the methods discussed by CDSCO relate to incineration. CDSCO said medicines should not be burnt at low temperatures in open containers because toxic pollutants may be released into the air. Paper and cardboard packaging can be burnt if the materials are not being recycled.

In emergencies, authorities may allow companies to dispose of drugs using “a two-chamber incinerator that operates at the minimum temperature of 850°C, with a combustion retention time of at least two seconds in the second chamber,” CDSCO said. The agency will allow the use of furnaces that are hotter than 850°C to get rid of halogenated compounds, X-ray contrast media and povidone iodine.

Manufacturers can chemically decompose medicines if an appropriate incinerator is not available. The method is not recommended unless chemical expertise is readily available, CDSCO said, and the process is “tedious and time consuming.” The method may be practical for disposing of small quantities of cancer drugs, but CDSCO is recommending companies use other methods above 50kg of medicines.

CDSCO Guidelines

Australia’s TGA commits to temporary risk-based strategies to cut GMP clearance backlog

Australia’s Therapeutic Goods Administration (TGA) is preparing to implement temporary risk-based strategies to help address its backlog of good manufacturing practice (GMP) clearance applications.

TGA will automatically extend all existing mutual recognition agreement and non-sterile active pharmaceutical ingredient compliance verification GMP clearances that are due to expire between 1 July 2025 and 30 June 2027. Manufacturers do not need to apply for the two-year extension and will not receive a notification. TGA will publish the updated expiry dates in its business services portal.

The agency is implementing the extension measure in two stages. TGA said it will extend “all applications in our repository that are expiring within the date range” and then “consider any correlating applications sitting in our lodgement queues.”

When looking at its queues, TGA will close renewal or extension applications that are no longer required, consider applications with more recent evidence which, if approved, would result in a longer expiry date and assess variation applications to increase the scope of the existing GMP clearance approval.

Automatic extension is one of three strategies that TGA is implementing. The agency is also performing abbreviated evaluations of manufacturing sites performing certain lower-risk activities. Examples of sites performing lower-risk activities include testing laboratories, secondary packaging and storage sites, and cell-banking facilities.

Finally, TGA is ending GMP clearance regulatory flexibilities introduced during the COVID-19 pandemic. From 1 July, the agency will stop accepting evidence from inspections conducted more than three years ago, including supporting documentation such as the GMP clearance questionnaire.

“This will remove one of the major contributing factors in creating the backlog and provide clear guidance on whether a GMP clearance or GMP certification application should be applied for,” TGA said “Applications submitted prior to 1 July that provided the above documentation as evidence will continue to be evaluated.”

TGA will implement the actions three months after outlining progress on efforts to reduce its backlog, which peaked in mid-October. At the time, the agency said it expected the backlog to continue to shrink in the coming months as new GMP evaluators progress with training.

TGA Notice

Philippine FDA urges health department to immediately suspend increased regulatory fees

The recently appointed director general of the Philippine Food and Drug Administration (FDA) has called for the immediate suspension of an order to increase the fees for registering facilities and products.

FDA Director General Paolo Teston asked the Department of Health to approve a 60-day suspension of the fee increase. The health department signed off on the new fees in December, before Teston took up his new role at FDA. Teston’s push to suspend the fees to allow time to review funding is one of his first major actions as head of the agency.

“Under DG Teston’s leadership, the FDA is adopting a whole-of-government approach to ensure that policy changes remain fair, transparent, and aligned with broader efforts to strengthen healthcare regulation,” FDA said. “He underscored that any increase in regulatory fees must be supported by visible improvements in service delivery and operational efficiency.”

Philippine newspaper BusinessMirror reported that the health department approved the suspension and is working with FDA “to ensure any revised or new fees are necessary and primarily for cost recovery.”

Press Release

India proposes legal change to support alternatives to pyrogen testing on rabbits

India has proposed updates to the Drugs Rules, 1945 to revise the law on testing for substances that can cause fever.

The current edition of the legislation states “substances intended for parenteral administration in large volumes (10 ml. or more at a time) shall be pyrogen-free and tested for pyrogens.” Water or other aqueous solutions supplied with the substances must also be pyrogen-free and tested for pyrogens. The traditional pyrogen test measures changes in the body temperature of rabbits.

With Europe moving away from the rabbit pyrogen test, Indian officials have put forward changes to the section on testing for fever-causing substances.

“Solution of substances intended for parenteral administration (as well as water or any other aqueous solvent supplied along with such substances) shall comply with a test for bacterial endotoxins or where justified and authorized, with the test for pyrogens,” the draft text reads. “The test for Bacterial endotoxins-Pyrogens shall be carried out as per current edition of Indian Pharmacopeia.”

Officials proposed the revised section alongside other planned changes to the Drugs Rules, 1945. The other changes affect license conditions, competent persons and other topics.

CDSCO Notice

Asia-Pacific Roundup: CDSCO advises drugmakers on how to dispose of expired or unused medicines

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