DCC Calls For Strict Implementation Of Revised Schedule M, State-Level Activities To Address AMR

New Delhi: The Drugs Consultative Committee (DCC), the advisory committee formed by the Central government to advise the Central and state governments on matters that require uniform implementation of drug laws across the country, has called for implementation of provisions of waste disposal available in the revised Schedule M in letter and spirit and measures involving State drug regulators for waste management to address the issue of antimicrobial resistance (AMR).

Considering issues related to pharmaceutical waste management, the latest DCC meeting proposed creation of dedicated nodal cells in each States to handle issues related to AMR.

The Committee opined that provisions of waste disposal are available in the revised Schedule M and emphasised that the same need to be implemented in letter spirit. It was also opined that it needs to be addressed by the Drugs Inspectors while carrying out the inspections, especially the manufacturing units which are into production of antimicrobials.

Considering disposal of the antimicrobials specifically on account of growing concerns regarding antimicrobial resistance being developed in the general population, States were also requested to provide inputs regarding current practices in their respective jurisdiction.

“Further, it was proposed to create dedicated nodal cell at each state level for handling issues related to antimicrobial resistance. It was further opined that States will be requested to share current practices on the disposal of antimicrobial drugs and accordingly a SOP will be prepared by CDSCO and shared to States for their comments,” it opined.

Apart from the need of implementation of Schedule M provisions related to AMR, the Committee also considered proposals including conducting regular stakeholders interactions for implementation of Good Manufacturing Practices (GMP) principles to ensure monitoring of antimicrobial waste in industrial effluents, implementing recommendations of pharmaceutical manufacturers regarding waste management to mitigate and prevent potential AMR, and developing guidance for the State Drugs Controllers and especially, the GMP inspectors for management of waste and waste water from the production of antimicrobials.

It also discussed the role and contribution of State Drugs Controllers on State Action Plans for Containment of AMR (SAPCAR) and augmentation of enforcement activities. The pharmaceutical wastes are defined as the drugs and medicines, which are generated during manufacturing and maintenance operations, and can no longer be used. Improper disposal of unused medicines including antimicrobial is a growing problem throughout the world and traces of these wastes were found in the environment which may cause serious health effects including AMR to human life.

The sub-clause 16 of Part 1 of revised Schedule M under the Drugs Rules, 1945, stipulates various provisions to ensure safe storage, handling and disposal of waste materials. According to this, provisions shall be made for proper and safe storage of waste materials waiting disposal and toxic substances and flammable materials shall be stored in suitably designed, separate, enclosed cupboards.

Waste material shall not be allowed to accumulate and it shall be collected in suitable receptacles for removal to collection points outside the buildings and disposed safely and in a sanitary manner at regular and frequent intervals. The disposal of sewage and effluents including solid, liquid and gas, from the manufacturing area shall be in conformity with the requirements of the guidelines issued by the Environmental Pollution Control Board.

All bio-medical waste shall be destroyed as per the provisions of the Bio-Medical Waste (Management and Handling) Rules, 2016. Rodenticides, insecticides, fumigating agents and sanitising materials shall not be permitted to contaminate equipment, starting materials, packing materials, in-process materials or finished products, mandates revised Schedule M.

According to a study – First Multi centric Point Prevalence Survey of Antibiotic Use at 20 NAC-NET Sites India 2021-22 – conducted by the Union Health Ministry’s National Centre for Disease Control (NCDC) and released in January, this year, has raised concerns on finding that more than half of the antibiotics prescribed in the country has potential to cause high AMR. More than four per cent of the patients are getting four or more antibiotics and in  out of the 20 sites it assessed, had more than 95 per cent prevalence of antibiotic use.

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