CAM Comment: This blog post delves into the issue of improper disposal of unused/expired drugs in India and the current status and adequacy of the regulations for the same.
Introduction
India’s domestic consumption of drugs is around USD 23.5 billion[1], and it is the largest consumer of antibiotics globally, by volume.[2] While access to drugs and healthcare is a welcome step, there lies a cause for concern, i.e, the increase in the quantity of unused and expired drugs piling up at hospitals, homes, dispensaries and across the supply chain, especially when there is a lack of a proper disposal mechanism for the same.
The improper disposal of unused and/or expired drugs could lead to environmental as well as public harm. Unregulated disposal of such drugs contaminates water supplies and other local sources which are used by communities and wildlife, and the risk of reselling expired medicines in informal markets is not unprecedented. Further, improper disposal of drugs could lead to wide-scale anti-microbial resistance in the human as well as animal population as disposal of antimicrobial medicines in the environment can increase their exposure to microbes which can become resistant to such medicines.[3]
Keeping in view the consequences of improper disposal of drugs, the Central Drug Standards Control Organisation (CDSCO) has released detailed guidelines on the disposal of expired/unused drugs (Guidelines)[4]. This blog-post seeks to analyse the current scenario of drug disposal in India, and the suggestions made in the Guidelines.
What happens to expired or unused drugs?
Unused or expired drugs can accumulate at any level of the supply chain – from the manufacturer, the retailer, to the consumer. At present, the Bio-Medical Waste Management
Rules, 2016 (BMW Rules) cover the handling and disposal of expired and discarded drugs. However, the ambit of the said rules is narrow as the BMW Rules do not cover disposal of expired/unused drugs by the end consumer. BMW Rules cover clinical establishments, hospitals, laboratories, dispensaries, etc. which are required to dispose expired/discarded drugs either by sending them back to the manufacturer (who would then dispose the drugs in accordance with BMW Rules) or by incineration. The segregation, sorting, collecting, storage, transport, sale, further use, etc., of the discarded/expired drugs, is required to be undertaken in compliance with the BWM Rules, at every level. Additionally, the BMW Rules provide for a ‘bio-medical waste treatment and disposal facility’ which carries out the treatment and disposal of bio-medical waste.
Further, Rule 65(17) of the Drugs Rules, 1945 (Drugs Rules) prohibit storage or sale of expired drugs and prescribe that the concerned retail/wholesale outlet should store expired drugs separately from the trade stock. Similarly, one of the conditions for drug manufacturing license is compliance with Good Manufacturing Practices provided in Schedule M of the Drugs Rules [5], which further provide for the manner of disposal of waste. Schedule M refers to the BMW Rules for the disposal of bio-medical waste by the manufacturer and also states that additional precaution should be taken for the storage and disposal of rejected drugs, with an added compliance of maintenance of registers for such disposals.
While the Drugs Rules and the BMW Rules acknowledge and address the issue of waste generated due to unused and expired drugs, there is a lack of an adequate and detailed mechanism which caters to the intricacies of disposal of such drugs at the various levels of the supply chain – it is mostly the manufacturer who is at the focus in the said regulations. In this context, CDSCO’s Guidelines seem to address the issue of disposal of unused and expired drugs at the various levels of the supply chain, creating a somewhat extended producer liability mechanism or the proper disposal of discarded, unused, and expired drugs.
A Look at the Guidelines
The focus of the Guidelines is to ensure that a proper network of disposal chain is created right from the end consumer to the manufacturer in order to ensure that unused or expired medicines are disposed off in a proper and scientific manner, especially considering the impact of improper disposal on the environment and the human health. Therefore, the Guidelines are applicable across the drug supply chain – manufacturers, distributors, stockists, wholesalers, retailers, healthcare facilities, and the end consumer.
The Guidelines basically provide for a reverse logistics pathway for the disposal of drugs i.e. unused or expired drugs would be sent back from the retailer to the wholesaler or the distributor who would further send the drugs back to the manufacturer. The retailers/wholesalers/distributors may also dispose off the drugs on their own in accordance with the BMW Rules. For records and proper scrutiny, the stakeholders in the supply chain are required to maintain records of the expired/unused drugs which are meant to be disposed off. Further, the Guidelines provide for the detailed mechanism of collection, storage, transportation of different kind of drugs, by the stakeholders.
It is the manufacturer under the Guidelines, as well, who has the ultimate onus of handling and disposing the expired/unused drugs obtained from the retailers or wholesalers, or the drugs present at his own site, in accordance with the BMW Rules. The manufacturer is required to dispose off all the expired drugs (from his own site or received from retailers/wholesalers) within 6 months of the expiry.
Expired/unused drugs tend to accumulate in hospitals and other clinical establishments, and the Guidelines permit such establishments to dispose off the drugs on their own, in accordance with the BMW Rules. As far as the end consumer is concerned, the Guidelines propose for a coordinated effort by the local government for the collection of expired/unused drugs from the general public and disposal under the BMW Rules, which has been termed as the “Drug take back” programme. Further, the Guidelines also provide for a ‘Flush List’ which consists of 17 drugs which are extremely harmful if consumed without prescription. The medicines enlisted in the Flush List are permitted to be flushed down the sink or toilet if they are expired/unused/unwanted.
Conclusion – Are the Guidelines Adequate?
The Guidelines seem to have a comprehensive coverage along with detailed disposal methods. What may be an issue is the manner in of disposal of drugs by general public– much is left to the initiatives of the local government. While ‘Drug take back’ is an interesting step, it might fail if neither the local bodies nor the general public shows initiative, and there are not many successful models backing such a programme except for a similar programme started by the Kerala Government where volunteers collect unused/expired drugs at no cost and send the same for disposal.[6] Further, there has to be strict adherence by all stakeholders in the supply chain to ensure proper working of the reverse pathway from the retailer to the manufacturer. Therefore, in a nutshell, coordination between drug regulators, local bodies, sellers and manufacturers is a pre-requisite for the satisfactory implementation of the Guidelines.
For further information, please contact:
Biplab Lenin, Partner, Cyril Amarchand Mangaldas
biplab.lenin@cyrilshroff.com
[1] Press Release: Press Information Bureau
[2]Antibiotic consumption in India: geographical variations and temporal changes between 2011 and 2019 – PMC
[3] Access, use and disposal of antimicrobials among humans and animals in Wakiso district, Uganda: a qualitative study – PMC
[4] Guidance document on disposal.pdf
[5] Rule 74(o), Drugs Rules, 1945
[6] Drug Disposal Guidelines: India Urges Safe Methods for Expired Medicines
