Take-back sites, flushing proposed in India’s expired drug disposal plan

This move follows India’s top drug regulator —Central Drugs Standard Control Organisation (CDSCO)— receiving representation about unsafe disposal and sumping of unused and expired pharmaceutical compounds into landfills, including in Delhi.

A guidance note prepared by the government, and seen by Mint, has suggested that 17 unused or expired medicines containing active ingredients such as Fentany, Fentanyl Citrate, Morphine Sulfate, Buprenorphine can be flushed down the sink or toilet to help prevent danger to people and pets at home by the general public other than retailers, wholesalers and manufacturers.

Active ingredients, or active pharmaceutical ingredients, in drug manufacturing are the substances that make the medicines work. They have a direct effect on the body to treat or prevent illness.

Also read: Online pharmacies, chemists at odds over home delivery of medicines as Centre mulls stopping the practise

It has also suggested ‘drug take-back sites’ under which state governments in coordination with local bodies may establish the methodology and facility for the collection and disposal of unused or expired drugs as per the provisions of the Biomedical Waste Management Rules, 2016.

“Initially, state Drugs Control Departments and concerned Chemists and Druggists’ Association may jointly launch ‘drug take-back’ site or program at designate locations, where people can drop expired or unused drugs from their homes and that can be disposed finally by such associations under intimation to concerned State Drug Licensing Authority with the help of registered/licensed external agencies as registered under Biomedical Waste Management Rules, 2016,” the guidance note states.

“The guidance note has been drafted detailing SOPs for safe disposal of unused or expired medicines describing the method and responsibilities of the various stakeholders such as general public, retailers, wholesaler/ distributor/ stockist, manufacturer, medical institutions and drug inspectors,” a government official said.

This entire effort is being made to minimize the environmental impact and mitigate public health risk including the antimicrobial resistance, the official added.

Also read: India should permit easier access to over-the-counter medicines

Queries sent to the Union health ministry remained unanswered.

In India, there is no proper channel to utilize the unused medicines. Some of the western countries like the US have already implemented the drug take-back system in their national healthcare system.

Expired drugs refers to drugs that have crossed the expiry, or use-by, date mentioned on the label. Further, unused drugs refer to the medications that have not been used by the individual for whom they were prescribed or purchased.

Dr. Aashish Chaudhry, managing director, Aakash Healthcare, said that unsafe disposal of pharmaceutical products and its unwanted exposure can decrease fertility and increase the risk of cancer, and lead to antibiotic-resistance causing illnesses and deaths.

Apart from the responsibilities of the general public, the guidance note has defined the methodology of disposing medicines by manufacturers, retailers, wholesalers, distributors and hospitals and drug inspectors.

The guidance note has indicated that as per the revised Schedule ‘M’ under Drugs Rule, 1945, provision shall be made by the manufacturers for proper and safe storage of waste materials awaiting disposal.

Also read: Trump’s worst ideas since tariffs

The guidance note has been prepared by a sub-committee under the directions of the Drugs Consultative Committee (DCC),  a panel that advises the Drug Controller General of India (DCGI) and the Drug Technical Advisory Board (DTAB) on matters related to drug regulations and policies.

International Journal of Pharmaceutical Research and Applications says that the Indian pharmaceutical market is estimated to be about ₹1.8 trillion and about ₹270 crore worth of medicines are wasted once they are past their shelf life.