Need to amend Schedule P of D&C Act to include stringent norms on disposal of unused & expired medicines
There is a growing concern about the lack of stringent norms on disposal of unused and expired medicines that pose a threat to health and the environment. The key issue is the lack of dedicated guidelines on the disposal under the Drugs & Cosmetics Act. Currently, only the Central Pollution Control Board mandates Biomedical Waste Management Rules.
Experts opine that one option could be to modify Schedule P of D&C Act that describes provisions for the shelf-life and storage conditions of various drugs, to incorporate ‘Expired and unused medicines’ from households. This could be through bins that can be kept with lock and key, at pharmacy outlets or any other designated place, until they are collected by the biomedical waste aggregators.
On the occasion of the World Environment Day observed annually on June 5, even if this year’s theme is #BeatPlasticPollution, environmental experts call for a concerted effort in this direction on the disposal of unused and expiry dated medicines.
Scientifically it is proven that incineration of these medicines at prescribed specifications within the Bio-Medical Waste Guidelines, issued by the ministry of forest and environment is the only way to go. However, the weakest link in the entire process is collection/segregation of the unused and expired medicines from households. No guidelines are available for their storage at a location, permissible by law, prior to the final stage of disposal through incineration. The developed world has established take-back provisions from the community at designated time and place. Few countries that have a robust sewage system permit the use of toilet flushing, stated experts.
Data collected from surveys conducted by Delhi Pharmaceutical Trust reveals that almost 80% of such medicines collected from households are disposed either through the municipal waste dumps or by flushing through the toilet.
Quoting a 2020 study of a locality in Delhi, experts said for a population of 2.5 crore, comprising 50 lakh families average unused/expired in a household accounted for 15-30 units annually. The estimated expired medicines per family was 10 crore units. The trash was 6.3 crore units. The returns of expiry-unused drugs from pharmacies was 1.7 crore units. Those flushed down to the toilet was 1.3 crore units.
Such estimates, for the whole country, are not available, adding to lack of data hindering policy development. Studies conducted by other institutions reveal similar concerning results, they added.
In the absence of clear-cut guidelines, only some large and few MSME pharmaceutical manufacturers dispose of them as per their standard operating procedures, incinerate and document disposal details. Pharmacy outlets too are seen to periodically put the stocks in boxes labelled as ‘Expired medicines Not For Sale’. But experts noted that many a time disposal from pharmacy outlets are also not clearly known and uniformity may not exist.
Some experts feel that the nearest place that consumers can access is their pharmacy outlets, who can if permitted be a part of the chain to receive household unused and expired medicines.
Alternatively, municipal corporations may be asked to keep separate bins with lock and key at predefined locations for unused-expired medicines. “Since pharmacy outlets cannot account for these stocks, the provisions of the law need to be suitably amended. Involvement of the state drug regulators to provide guidelines or regulatory support is paramount. There is need for some pilot studies which are supported under Union government’s Swachata Abhiyaan or other Sanitation programmes involving local authorities and drug controllers,” said a senior regulatory expert on condition of anonymity.
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