Lens on antibiotic makers disposing untreated effluents

New Delhi: The National Centre for Diseases Control (NCDC) has written to the ministry of environment for keeping a strict vigil on antibiotic manufacturing companies that are disposing industrial waste without proper treatment and contributing to antimicrobial resistance.

“The practice is causing dual damage in terms of pollution and causing antimicrobial resistance as these untreated antibiotic residues are reaching humans and animals through the food chain,” said Dr A.C. Dhariwal, advisor, NCDC.

The government, on its part, also accepted that some companies were disposing waste into rivers or dumping effluents in the ground without proper treatment, and is set to develop anti-dumping standards under the National Programme on Containment of Anti-Microbial Resistance (AMR).

“We are developing a national framework for surveillance of antibiotic residues and contaminants in environment, including waste from farms, factories such as pharmaceutical industry, making animal feed and processing meat, dairy, fish, veterinary and human health care settings,” said Dhariwal.

“We have asked the environment ministry to keep the antibiotic manufacturing companies on radar and direct them to adopt better and advanced technologies to treat their effluents.” he added.

Antimicrobial resistance in pathogens causing important communicable diseases has become a matter of great public health concern, globally, including in India.

According to the scoping report on antimicrobial resistance in India by the Department of Biotechnology in November 2017, it is estimated that 80% of antibiotics sold by multinational pharmaceutical companies in the global market are manufactured in India and China. The effluents from antibiotic manufacturing units contain a substantial amount of antibiotics, leading to contamination of rivers and lakes in India.

Pharmaceutical companies can be broadly classified as active pharmaceutical ingredient (API) manufacturers and formulation companies. API manufacturers produce antibiotics in bulk that are then sold to formulation companies to produce finished products such as tablets, syrups and vials.

“Effluents coming from both types of manufacturing units contain antibiotic residues, but significantly higher amount of residues are expected in the effluents of API manufacturing units,” the report said.

In India, there are at least 40 antibiotic API manufacturers and at least 250 antibiotic formulation companies manufacturing at least one antibiotic for human use.

Some antibiotic API manufacturer hot spots include, Ankleshwar and Karkhadi in Gujarat, Aurangabad, Mumbai area, and Tarapur in Maharashtra, Baddi and Paonta Sahib in Himachal Pradesh, Derabassi in Punjab and Hyderabad area in Telangana, the report stated.

The report also highlighted that the existing good manufacturing practices (GMP) framework is restricted to drug safety, and does not include environmental safeguards and regulation of environmental discharges. In India, the Central Pollution Control Board (CPCB) established effluent standards for pharmaceutical industry waste, and all state pollution control boards follow the same standards.

“Unfortunately, the current standards do not include antibiotic residues, and thus they are not monitored in the pharmaceutical industry effluents under the CPCB Effluent Standards 2013,” the report said.