Lok Sabha Question No. 1868 (UNSTARRED), answered on 2021-07-30
Subject: Flouting Norms for Mask and Sanitizer Specifications
Ministry: HEALTH AND FAMILY WELFARE
Asked by: Mala Rajya Laxmi Shah, Pushpendra Singh Chandel

## GOVERNMENT OF INDIA MINISTRY OF HEALTH AND FAMILY WELFARE DEPARTMENT OF HEALTH AND FAMILY WELFARE

## LOK SABHA UNSTARR ED QUESTION NO. 1868 TO BE ANSWERED ON 30 TH JULY, 2021

## FLOUTING NORMS FOR M ASK AND SANITIZER SP ECIFICATIONS

## 1868.SHRIMATI MALA RAJYA LAXMI SHAH: SHRI KUNWAR PUSHPEND RA SINGH CHANDEL :

Will the Minister of HEALTH AND FAMILY WE LFARE be pleased to state:

- (a) whether the Government has also taken cognizance of PPE kits, sanitizers and masks n being manufactured as per the norms laid down in the country;
- (b) if so, the details thereof, State/UT - wise along with the steps being taken by the Government in this regard;
- (c) whether the quantum of medical waste has been increasing constantly in the country; an
- (d) if so, details of steps being taken by the Government for disposal of the said waste?

## ANSWER THE MINISTER OF STATE IN THE MINISTRY OF HEALTH AND FAMILY WELFARE ( DR. BHARATI PRAVIN P AWAR )

(a) & (b): Ministry of Health & Family Welfare issued notification vide S.O. 648 (E) dated 11.02.2020 specifying all medical devices by definition under Section 3 (b)(iv) of the Dr Cosmetics Act, 1940 in order to regulate them for quality, safety & performance. In ad throu gh G.S.R 102(E) dated 11.02.2020, mechanism for regulation of all non - notified medical devices in phased manner has also been specified. As per the above notification, PPE ki masks which fall under class B of Medical Devices will come under license r egulation after 30 months from the date of effect of the notification.

Also  CDSCO  has  requested  all  States/UTs  Licensing  authorities  through  severa advisories to instruct their enforcement staff to keep strict vigil especially at sensit att empts at black - marketing/hoarding of Covid management drugs and to take stringent action against the offenders.

As per information available  from  various  State Licensing Authorities,  vari enforcement actions like seizure, arrests of accused persons / r egistration of FIR etc. have been carried out by the State Licensing Authorities.

(c): The Central Pollution Control Board (CPCB) has informed that the non -COVID waste generated in the country during 2017 - 18, 2018 - 19 and 2019 - 20 is estimated to be 531 Tons / Day (TPD), 608 TPD and 615 TPD respectively.

(d): The Ministry of Environment, Forest and Climate Change (MoEFCC) had notified the Biomedical  Waste  Management  Rules,  2016  (BMWM  Rules,  2016)  under  Environment (Protection) Act, 1986, which stipulate source segregation of the Bio - Medical  waste  (BMW). The  Rules  also  stipulate  technological  options  available  to  treat  the  source - segregated  waste categories  and  prescribe  standards  for  incinerator  stack  emission,  treated  effluent,  a microwave/ hydroclave and chemical disinfection. The State Pollution Control Boards/ Polluti Control  Committees  (SPCBs/  PCCs)  issue  authorisation  to  Healthcare  Facilities,  Commo Biomedical Waste Treatment Facility operators; and monitor them for compliance of prescr sta ndards of emissions, liquid effluents and waste.