Pharmaceutical waste is an emerging issue due to its impact on the environment and human health. It is essential to manage this waste effectively and efficiently to prevent harmful substances from being released into the environment. Extended Producer Responsibility (EPR) is a promising approach that empowers producers to take responsibility for the entire lifecycle of their products and promotes sustainable waste management.
EPR for pharmaceuticals involves implementing a take-back system, establishing collection centers, or both, and making arrangements with EPR authorized dismantlers or recyclers, either individually or collectively. This approach helps ensure that waste is disposed of or recycled in an environmentally sound manner.
Pharmaceutical producers must obtain EPR certification to show that they are complying with EPR regulations. This involves filling out Form-1 and obtaining authorization from the relevant regulatory bodies after inspection. Producers must also file compliance reports obtained from the regulatory bodies to renew their EPR certification before the expiration period. They must also submit annual records to show that they are complying with EPR regulations.
EPR implementation for pharmaceutical waste management promotes sustainable practices and encourages producers to take responsibility for the end-of-life of their products. It also helps reduce the burden on waste management systems and minimizes the release of hazardous substances into the environment. By implementing EPR, the pharmaceutical industry can contribute to sustainable waste management and help protect human health and the environment.
Under the Pharmaceutical Waste Management Rules of 2016, Extended Producer Responsibility (EPR) requires producers to take physical and financial responsibility for the proper treatment and disposal of their waste. The Central Pollution Control Board (CPCB) has emphasized the need for all producers of pharmaceutical products to obtain EPR certification.
These rules apply to every entity involved in the manufacture, sale, transfer, purchase, collection, storage, and processing of pharmaceutical waste. This includes manufacturers, producers, consumers, bulk consumers, collection centers, dealers, e-retailers, refurbishers, dismantlers, and recyclers.
To obtain EPR certification, the concerned producer must fill out Form-1, after which CPCB will grant the respective authorization within 120 days after thorough inspection. Once acquired, the certificate is valid for five years from the announcement date.
To renew their certificate before the 120-day expiration period, producers must file a compliance report obtained from the relevant State Pollution Control Board. Furthermore, every year, producers must submit their annual records on or before the 30th day of June.
EPR mandates producers to manage e-waste responsibly through proper channelization, which may include take-back systems, collection centers, and agreements with authorized dismantlers or recyclers.
Category | Examples |
---|---|
Manufacturers | Pfizer, GlaxoSmithKline, Novartis, Sanofi, Roche |
Distributors | McKesson, AmerisourceBergen, Cardinal Health, CVS Health |
Retailers | Walgreens Boots Alliance, Walmart, CVS Health |
Hospitals | Cleveland Clinic, Mayo Clinic, Johns Hopkins Hospital |
Pharmacies | CVS Pharmacy, Walgreens Pharmacy, Rite Aid Pharmacy |
Patients/Consumers | Individuals who use prescription drugs and dispose of them |
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