Need stringent guidelines for treatment of pharmaceutical waste: Experts

There is a need to implement stringent guidelines for treatment and monitoring of waste discharged from pharmaceutical industries, experts have said and asserted that plants are not adequately equipped to treat antibiotic content in the discharges.

According to them, surveillance and monitoring of these plants is virtually non-existent.

The experts have said that the government urgently needs to adopt an anti-microbial resistance(AMR)-centric approach to waste management by treating active pharmaceutical ingredients (API) as a "critical" chemical contaminant and that the existing laws need to be strengthened to introduce proper environmental standards.

According to Banwari Lal, Senior Director, The Energy and Resource Institute (TERI), pharmaceutical wastes are generated during manufacturing of active pharmaceutical ingredients (API) and formulations.

In 2017, the US Food and Drug Administration approved about 10,000 pharmaceuticals with up to 3,000 ingredients for usage and are regularly applied by humans. Most common sources of pharmaceutical wastes into environment include disposal by patients and hospitals, livestock feed additives, agricultural wastes due to veterinary use, API and formulation industries, he said.

Extensive usage and improper disposal of pharmaceutical drugs cause spreading of multi-drug resistant microbes, he noted.

In India, effluent generated from these industries are treated as per the pharmaceutical waste water discharge guidelines prescribed by the Central Pollution Control Board (CPCB).

He said the current standards unfortunately do not include antibiotic residues, and thus they are not monitored in the pharmaceutical industry effluent while there is also no consensus guidelines on the antibiotic residue discharge limits in industrial waste even outside India.

"There is a need to implement stringent guidelines in treatment and monitoring of waste discharge from pharmaceutical industries. Best available technology including advanced next generation methods need to be adopted by pharmaceutical industries to tackle the pharmaceutical waste management issue," Lal said.

He pointed out that companies should ensure that every level of the antibiotics supply chain must priorities environmental management.

"In particular, the factories supplying intermediates or APIs must be required to prove that they are committed to clean production throughout the manufacturing process.

"Moreover, pharmaceutical companies need to work with governments to encourage and support a tougher stance on law enforcement in developing counties," he said.

Rajeshwari Sinha, programme officer, food safety and toxins programme, Centre for Science and Environment (CSE), said that the Indian Environment Ministry classifies pharmaceutical manufacturing as a "red category" activity, due to the hazardous nature of the waste produced.

This is in sharp contrast to the drive to boost the Indian bulk drug industry by establishing manufacturing zones since 2015, she said.

The Indian pharmaceutical industry is the fastest growing segment in the economy and globally contributes to 80 per cent of the drugs produced, alongside China.

"There is increasing evidence from multiple studies conducted by several researchers as well as entities like Nordea that have recently explored the impacts of pollution from pharmaceutical production sites and supply chains on India’s burgeoning AMR problem, vis-à-vis the creation of 'hotspots', especially around manufacturing sites pharmaceutical hubs like Hyderabad (Telangana)," Sinha said.

She said the existing waste treatment plants are not adequately equipped to adequately treat the antibiotic content in the discharges.

"Surveillance and monitoring of these plants is virtually non-existent. The current effluent standards do not consider active pharmaceutical ingredients (APIs) as contaminants and remain limited to chemical contaminants like heavy metals.

"However, with the release of the Indian Strategic National Action Plan on AMR, there is increased momentum. The environment regulators are working on addressing this issue," she said.

The Indian government urgently needs to adopt an AMR-centric approach to waste management by treating APIs as a critical chemical contaminant, she said.

"The existing laws need to be strengthened to introduce proper environmental standards and ensure that there is no-very limited presence of any APIs in effluent. Small-scale manufacturers must be supported in the installation and implementation of environmentally sound waste treatment and disposal processes.

"Those with high-end treatment plants must be strictly monitored and the state pollution control boards must conduct surveillance of antibiotic residues in effluent. Related data must be made publicly available in order to increase awareness around the severe health and environmental impacts of pharmaceutical pollution," she added.