Smart Regulation of Antibiotic Use in India Blog: Standards for antibiotic residues are leaving the pipeline
Wed 26 February 2020
In an earlier post, we informed you that standards for antibiotic residues in India were in the pipeline. On 23 January 2020, the Ministry of Environment, Forest and Climate Change, Government of India published the draft Environment (Protection) Amendment Rules, 2019. Among other changes, these rules introduce the maximum values for concentration (ug/l) of 121 individual antibiotic residues in the treated effluent of the Bulk Drug and Formulation Industry and CETP with membership of Bulk Drug and Formulation units. They also require incineration of sludge containing antibiotic residues in accordance with the notified standards for common hazardous waste incinerator or industry specific incinerator. This regulatory development has been welcomed (see "India to ban antibiotic pollution from pharma factories" and "Govt's fast tracking of draft rules on antibiotic residues commendable").
After a 60-day consultation period, the bill will become binding law. This means that violators would be subject to the penal provision set out in section 15 of the Environment (Protection) Act, 1986. However, compliance will depend on the ability and willingness of the statutory authorities to enforce the law. This aspect deserves more attention given the concerns relating to poor or no environmental compliance and enforcement in India (see "Report on Environmental Compliance and Enforcement in India" and "Environmental Compliance and Enforcement in India: Rapid Assessment").