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Industry and trade hail CDSCO’s guidance document for safe disposal of unused & expiry drugs
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Nandita Vijayasimha, Bengaluru
May 31 , 2025
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Pharma industry and pharmacy trade are of the view that the recent CDSCO guidance for safe disposal of expiry drugs is a good start to tackle the problem of unscientific disposal of unused and expired medicines. Even as it outlines procedures for the proper disposal of expired or unused drugs, ensuring legal compliance, protecting the environment, and safeguarding public health, issues of compliance are a concern, they noted.
Ashish Dasgupta, managing trustee, Delhi Pharmaceutical Trust, noted that framing of the guidelines is a good start to address this issue. More than the disposal procedure set forth for the manufacturers and retailers/distributors, disposal by consumers and public is more serious and grave. A mere publication of the guideline will not suffice until the public is made aware of the process, hence a continuous awareness programme has to be launched.
Another important point to note is the process described of flushing by the public. The products listed are opioids and habit forming and their disposal by flushing into the sewer system, which remains in dilapidated condition in many towns, cities and localities, will add to greater environmental hazards, Dasgupta pointed out adding that our towns and cities do not have a robust sewer system in our country.
“A simple ‘take back’ mechanism should be considered for the listed syrups too. Multiple pilot runs need to be conducted for the benefit of the consumers as per the guideline. It is ironical to note that it was Delhi Pharmaceutical Trust which started working on the project in 2018. Several reports from DPT were submitted and requests were made to the state and central drug control authorities to initiate the ‘take back’ mechanism for the public. Unfortunately, DPT was dissuaded to progress on the subject matter, citing legal issues,” stated Dasgupta.
According to C Jayaram, president, Karnataka Pharma Retailers & Distributors Organization (KPRDO), there is still to go a long way. Basically common man should be made well-educated about the changes happening in pharma industry and healthcare prescription practices. This is an age of targeted and personalized medicines where the onus is on the pharmacists to formulate and dispense medicines.
At present in India, we are just giving medicines what is prescribed by doctors under supervision of pharmacists. The guidance needs to be more focussed on ensuring a legislation for the recurrent violators of expiry drugs who deviate from the said guidance, Jayaram added.
Specifically from an Indian pharma industry perspective, the guidance is seen as a supportive measure and is a step towards aligning with global best practices. However, sections of the industry noted that ensuring full compliance is likely to pose significant challenges. These include a lack of standardized disposal infrastructure in India, limited awareness among smaller manufacturers and distributors, logistical complexities in collecting and transporting pharmaceutical waste, and cost implications for proper implementation. Addressing these challenges will require coordinated efforts between regulatory bodies, industry stakeholders, and environmental agencies. Capacity-building initiatives, incentives for compliance, and clear, enforceable protocols will be essential to ensure successful implementation.
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