The Union Ministry of Health as part of World Bank funded Food and Drug Capacity Building Project, will have a comprehensive programme to suggest policy measures to strengthen the existing laws and regulatory provisions to specifically address the handling and management of hazardous chemicals used and bio-hazardous wastes generated in drug / food testing laboratories.
The objective is to develop and implement a generic Environmental Management Action Plan, which will enable review and mitigation of environmental risks, related to the up-gradation, construction and operation of laboratories in a manner to ensure compliance with environmental requirements in India and compatibility with the international environmental practices. The project will allow for the enhancement of the existing national Good Laboratory Practices (GLP) Guidelines with an environmental management health and safety component and standard Codes of Practice, it is learnt.
The laws which are to have added clauses for ensuring environmental safety in drug / food laboratories are The Environmental (Protection) Act, 1986, The Biomedical Waste (Management and Handling) Rules (1998), The Hazardous Wastes (Management and Handling) Rules (1989), The Manufacture, Storage, and Import of Hazardous Chemical Rules (1989), The Factories Act, 1948 and Drugs and Cosmetics Rules.
While the Manufacture, Storage, and Import of Hazardous Chemical Rules (1989) address storage and handling of flammable liquids and of compressed gases and communicating chemical hazards in the laboratories, it do not address the handling of hazardous chemicals with reference to their transportation and movement. Similarly, the provisions of the Drugs and Cosmetics Act & Rules are applicable to drug manufacturing units and provide guidelines on 'good manufacturing practices'. However, it does not mention environmental plans or have any significant reference on health and safety in the laboratories. There is a passing reference to first aid, but with no details. All seven related Central government rules will have specific additions on environment health soon.
Though the existing laws in India have established standards on occupational health, safety, waste management and general environmental protection for manufacturing units, they do not provide specifically for environmental health and safety in Drug and Food quality testing laboratories. Laboratories present unique working conditions, even though the quantities of chemicals used and amount of wastes generated are relatively small. The disposal of hazardous chemicals, empty containers and bottles and wastewater are issues which need to be addressed since indiscriminate use, storage, handling and disposal can have serious implications for the health of the public and of the environment.
The health ministry has already conducted a preliminary review of laboratories to be covered under the project. Site visits to the food and drug control laboratories like Food Research & Standardisation laboratory, Gaziabad (UP), Central Indian Pharmacopuea Laboratory, Rajnagar (UP), National Institute of Biologicals, Noida (UP) and Central Drug Research Institute, Kasauli (HP) were also undertaken. The ministry is in the process of having detailed consultations with the key stakeholders like laboratory staff, food and drug regulatory personnel, environmental NGOs and the affected communities.
One of the key areas proposed within the Food and Drug Capacity Building project relates to the upgradation of capacity and competency of the Central and State Food and Drugs testing laboratories. At the policy level, the project will allow the enhancement of the existing set of laws and regulatory provisions to clearly and specifically address the handling and management of hazardous chemicals and bio-hazardous wastes used and generated in such Drug and Food Testing Laboratories. The environmental management action plan will be implemented to minimize negative environmental impacts of current and future operations and to increase the overall safety at these laboratories.