Another must-know for doctors: Legal aspects of BMW management

An inherently uninteresting topic can only be elevated to the 'less uninteresting' level, even if the author is an enterprising one. But I will still request your patience to read the article completely, especially if you are an owner of a healthcare establishment and wish to keep abreast with the increasing rules and regulations being implemented for the healthcare industry in India. The topic may be uninteresting but it is important nonetheless.

What is it?

Biomedical Waste Management Rules, 2016 were notified on 28th March 2016 under Environment (Protection) Act, 1986, vide G.S.R 343 (E).

Who are they applicable to?

The rules are applicable to all types of healthcare establishments including hospitals, nursing homes, clinics, dispensaries, pathology laboratories, blood banks, medical / surgical / blood donation camps, forensic and research laboratories etc. The rules are applicable irrespective of the quantity of biomedical waste generated.

What are the important definitions?

"Biomedical waste" means any waste generated during diagnosis, treatment or immunisation of human beings or animals or research activities pertaining thereto or in the production or testing of biological or in health camps.

"Occupier" means a person having administrative control over the institution or premises generating biomedical waste. The person who has administrative control of the healthcare establishment shall thus be responsible for carrying out the duties of the occupier under these rules.

Prescribed Authority is the State Pollution Control Board (for States) or the Pollution Control Committee (for Union Territories).

What is the hierarchy of authorities?

The hierarchy of authorities is as follows:-

Ministry of Environment, Forest and Climate Change (Ministry of Defence for armed forces)

Central Pollution Control Board

State Pollution Control Board

State Advisory Committee

District Level Monitoring Committee

What is the authorization process?

Every occupier has to make an application (Form II) with necessary documents to the prescribed authority for grant of authorization.

As per rule 10(1), for non-bedded healthcare establishments, the authorization is a one-time process. The authorization certificate (form III, point no. 3), however, provides an empty space for the authority to prescribe the period of validity. The Maharashtra Pollution Control Board is granting such authorisation for a period of 3 years (vide circular MPCB/PSO/BMW/B-5271 dated 13.12.2017).

The authorization of bedded healthcare establishments is subject to consents under the Water Act, 1974 and Air Act, 1981.

The authorization shall be deemed granted if not objected to by the prescribed authority within a period of 90 days.

A person aggrieved by an order of the prescribed authority can make an appeal to the State Secretary (Environment) within a period of 30 days.

What are the duties and liabilities of the occupier (healthcare establishment)?

1)—To take all necessary steps to ensure that biomedical waste is handled without any adverse effects to human health and the environment.

2)—To ensure that:

a) The location for segregation and storage of biomedical waste is safe, secured and ventilated.

b) There shall be no secondary handling, pilferage of recyclables or inadvertent scattering or spillage of the biomedical waste (by animals etc).

3)—Onsite pretreatment of laboratory waste, microbiological waste, blood samples and blood bags through disinfection or sterilisation, in a manner prescribed by World Health Organisation or National AIDS Control Organisation, before sending the same for final disposal.

4)—Phase out chlorinated plastic bags, gloves and blood bags within 2 years of notification of these rules i.e. before 28th March 2018.

5)—Dispose of solid waste other than biomedical waste as per the respective rules, and not to give biomedical waste with other municipal solid waste.

6)—To provide training to all healthcare workers in the premises who handle biomedical waste -- first at the time of induction and thereafter once every year. Details of the training programme and number of persons been trained and those untrained shall be provided in annual report.

7)—Immunise all healthcare workers in the premises who handle biomedical waste for - (a) Hepatitis B & (b) Tetanus.

8)Establish a bar-code system for bags or containers used for carrying biomedical waste out of the premises for any purpose within one year of notification of these rules i.e. before 28th March 2017.

9)Ensure segregation and pre-treatment / neutralization of liquid chemical waste prior to mixing with other effluent generated from the establishment.

10)Ensure treatment and disposal of liquid waste in accordance with the Water (Prevention and Control of Pollution) Act, 1974.

11)Provide appropriate and adequate equipment for protection of healthcare workers handling biomedical waste so as to ensure their occupational safety.

12)Conduct health check-up for healthcare for healthcare workers handling biomedical waste; first at the time of induction and then regularly once every year. The records of the same shall be maintained.

13)Establish an independent website for the clinical establishment within two years of date of notification of these rules i.e. before 28th March 2018. The website shall display

a) Monthly record of biomedical waste generated in terms of category and colour coding.

b) Annual report of biomedical waste management (before 30th June of the next year).

14)Maintain a daily register of biomedical waste management.

The format of annual report is given in Form IV, whereas the format of monthly record and daily register of biomedical waste management is not given in the rules.

15)Report major accidents (having potential to affect large number of people) which may have happened during biomedical waste handling and remedial action taken along with the annual report, and also submit a nil report in case there is no major accident.

16)Report to the prescribed authority if the operator of biomedical waste management facility does not collect the biomedical waste within intended time.

17)Clinical establishments having 30 or more beds shall form a committee for monitoring and reviewing the system of biomedical waste management. The committee shall hold a meeting at least once in 6 months and the minutes of the meeting shall be submitted along with the annual report. Clinical establishments with less than 30 beds shall appoint one qualified person for this role.

18)All records shall be maintained for a minimum period of 5 years.

19)Existing incinerators to achieve the prescribed standards as per these rules within 2 years of notification i.e. before 28th March 2018.

20)No occupier shall establish an on-site, independent biomedical waste treatment and disposal facility if a common facility is available within 75 km. In case a common facility is not available, the occupier shall establish an appropriate on-site facility after due authorization.

21)No occupier shall use a new technology for treatment of biomedical waste unless approved and notified in gazette by the central government. An occupier can make an application to the central government for the same.

22)If applicable, the occupier shall maintain the record of recyclables sold or auctioned off and the details of the same shall be provided in the annual report.

23)Untreated human anatomical waste, solid waste and biotechnology waste shall not be stored beyond a period of 48 hrs. If, for some reason, it becomes necessary to store the same, the occupier shall take measures to ensure that human health and environment is not endangered, and shall also notify the prescribed authority about the reasons for doing so.

24)All records are subject to inspection by the prescribed authority or the Ministry of Environment, Forest and Climate Change. As per the Environment (Protection) Act, 1986, the healthcare facility is bound to provide all assistance for inspection of its premises to the prescribed authority or a person empowered by the prescribed authority. Code of Criminal Procedure, 1973 is followed for search and seizure operations.

25)Any unauthorized change in personnel, equipment or working conditions by the person authorized shall constitute a breach of his authorization. Thus, any change in personnel, equipment or working conditions will require prior authorization by the prescribed authority.

26)Prior permission of the prescribed authority is needed before closing down a facility.

What are the offences and penalties?

Whoever (a person or a company) fails to comply with or violates any provision of the Biomedical Waste Management Rules, 2016 shall be punishable under section 15 of Environment (Protection) Act, 1986 with imprisonment up to a period of 5 years, or fine up to Rs. 1 lakh, or both. The central government is now considering the proposal to increase the amount of fine up to Rs. 1 crore. Complaints of civil nature against healthcare establishments are filed with the National Green Tribunal (NGT), an independent body which is empowered to impose fines, the amounts of which may vary from case to case.

In 2016, the NGT asked the Uttarakhand Pollution Control Board to impose Rs. 50,000 fine on all those hospitals that do not follow Biomedical Waste Management Rules. In 2017, the NGT imposed fines varying from Rs.75,000 to Rs.2,00,000 on nine government and private hospitals in Delhi, including hospitals like Fortis, Max and Safdarjung. Also in 2017, the NGT issued notices to four States viz; UP, Haryana, Punjab and Uttarakhand for improper disposal of biomedical waste by hospitals in these states. In 2016, a PIL was filed in the Madras High Court for ensuring proper implementation of Biomedical Waste rules.

I would encourage you, dear reader, to once again carefully go through the list of duties and liabilities of healthcare establishments, which I mentioned earlier. The rules are still young, and there is always a latent period between notification and actual implementation of rules. Don’t be caught unawares when the authorities start implementing the rules strictly.

(This write-up is only a general advisory and not a substitute for qualified legal opinion. Reader discretion is therefore recommended. If you find this write-up useful, please share it with your doctor-friends. TechnoScope Systems is a venture by doctors, for doctors. To know more about how we can assist you, please visit our website. You can write to the author at: