Lok Sabha Question No. 2032 (UNSTARRED), answered on 2021-07-30
Subject: Black Fungus due to Steroid usage
Ministry: HEALTH AND FAMILY WELFARE
Asked by: Sudarshan Bhagat

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

## LOK SABHA UNSTARRED Q. No 2032 TO BE ANSWERED ON 30 th JULY, 2021

## BLACK FUNGUS DUE TO STEROID USAGE

## 2032 SHRI SUDARSHAN BHAGAT:

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

- ( a) whether  number  of  cases  of  the  black  fungus  disease  is  on  the  rise  in  people  d excessive use of steroids during the Corona pandemic;
- ( b) if so, the details thereof, State/UT - wise; and
- ( c) if not, the steps taken by the Government to put a check on the fungal infection/dis

## ANSWER THE MINISTER OF STATE IN THE MINISTRY OF HEALTH AND FAMILY WELFARE (DR. BHARTI PRAVIN PAWAR)

(a)  to  (c) : Mucormycosis  or  Black  Fungus  disease,  although  not  a  new  disease,  was  not  a notifiable disease till May 2021 when Ministry of Health & Family Welfare requested stat declare Mucormycosis a notifiable disease under Epidemic Disease Act, 1897 to get an objective assessment of Mucormycosis in the community.

Mucormycosis has been found to be causally associated with hyperglycemia (due to ne onset or pre -existing diabetes or steroid induced), irrational use of broad - spectrum antibiotics, co- morbidities su ch as hematological malignancies, use of immunosuppressants, etc.

Mucormycosis cases being reported by the states/UTs peaked in later half of May 2 and are now showing a declining trend .

State/UT wise details of Mucormycosis cases as reported by the States/UTs till 28 th July 2021 is at Annexure .

Ministry of Health & Family Welfare has taken a number of measures to address the issu Mucormycosis. Some of the initiatives to prevent occurrence of such cases are detailed bel

- Taking cognizance of as sociation between elevated blood sugar levels (whether in patient with  preexisting  diabetes  mellitus,  or  hyperglycemia  due  to  steroid  therapy),  an  u 'Clinical  Guidance  on  Diagnosis  and  Management  of  Diabetes  at  COVID - 19  Patient Management facility' was issued by Ministry of Health & Family Welfare on 1 st June 2021.
- After expert deliberations in the National Task Force on COVID - 19 comprising of experts drawn from NITI Aayog, ICMR, AIIMS (Delhi), NIV, WHO (India), eminent public health advocacy groups, a detailed advisory on treatment and management of COVID - 19 associated Mucormycosis (CAM) was formalized and disseminated to all States and UTs on 7 th June 2021.
- Similarly  realizing  the  multi - disciplinary  approach  required  to  manage  patients  suffering fr om Mucormycosis and other fungal infections, a checklist for managing Mucormycosis an other fungal infections was also circulated to all States/UTs on 11 th June 2021.
- The clinical management guidelines for managing COVID - 19 cases by Ministry of Health & Family Welfare advocates rational use of steroids for managing moderate to severe cas COVID - 19  under  strict  medical  supervision.  Further  noting  relationship  between  us steroids  and  other  immune -suppressive  drugs  'Advisory  for  rational  use  of  Steroi ds  and Tocilizumab in the treatment of Covid -19  patients'  was  issued  by  Directorate  General  of Health Services.
- Since early May, 2021 the details of production, stock, supplies made and purchase orde were obtained from the manufacturers and their co - operation was sought to overcome the gap between supply and demand.
- Both first -and second - line drugs used for managing Mucormycosi s cases i.e. Amphotericin B Deoxycholate and Posaconazole are currently amply available in Indian markets.
- Department  of  Pharmaceuticals  (DoP),  Central  Drugs  Standard  Control  Organisation (CDSCO) & National Pharmaceutical Pricing Authority (NPPA) have bee n jointly monitoring the production and availability of critical (COVID) drugs includ Amphotericin - B injections.
- Accordingly, Union Government has taken various measures to improve the availability Amphotericin B (liposomal) through a multipronged approach of augmenting production and import and ensure equitable distribution to States/UTs.

The various measures adopted include:

- Union Government is continuously engaging with the manufacturers to resolve their is related to raw materials.
- Department of Pharmaceuticals and the Drug Controller General of India (DCGI) active coordinated  with  the  industry  for  identification  of  manufacturers,  alternate  dru expeditious approvals of new manufacturing facilities.

thro of

- Department of Pharmaceuticals and the Drug Controller General of India (DCGI) actively coordinated with the industry to enhance availability of Amphotericin B identification of manufacturers, alternate drugs and expeditious approvals manufacturing facilities.
- Besides,  the existing  five  manufacturers,  DCGI  had  issued  permissions  to  manufacturing marketing of Amphotericin B to six additional firms.
- This led to the increase in production capacity from 0.62 lakhs in April 2021 to 1.4 May 2021 and was augmented further to 3.57 lakhs in June 2021.
- Various concerns of manufacturers and importers, including those related to licensin availability of raw material issues, import license are being speedily addressed.
- Ministry  of  External  Affairs  (MEA)  is  reaching  out  to various  manufacturers  abroad. Through its missions all over the world, MEA has identified new sources of Amphoterici Liposomal Amphotericin B injections and alternative drugs for treatment of Mucormycos MEA has also been actively working on ensuring supplies of key excipients from sources abroad for production of Liposomal Amphotericin B in India.
- For equitable distribution, allotments are being made to the States/ UTs in accordanc the proportion of their reported case load in respect of the e ntire country.
- Supply arrangements are being monitored by the National Pharmaceuticals Pricing Author (NPPA) so as to ensure expeditious availability of the drug.
- NPPA has put in place a strongly responsive system to ensure timely supplies of allo volumes and maintains continuous contact with States/UTs and suppliers to trouble shoot issues in reaching the drugs to the Health Departments of States/ UTs.

Annexure State/UT wise details of Mucormycosis cases as reported by the States/UTs till 2 July

## 8 th 2021

|   S. No. | State/UT          |   Total Cases |
|----------|-------------------|---------------|
|        1 | Andhra Pradesh    |          4209 |
|        2 | Assam             |            10 |
|        3 | Bihar             |           783 |
|        4 | Chandigarh        |           644 |
|        5 | Chhattisgarh      |           398 |
|        6 | Delhi             |          1815 |
|        7 | Goa               |            30 |
|        8 | Gujarat           |          6846 |
|        9 | Haryana           |          1705 |
|       10 | Himachal Pradesh  |            31 |
|       11 | Jammu and Kashmir |            47 |
|       12 | Jharkhand         |           132 |
|       13 | Karnataka         |          3648 |
|       14 | Kerala            |           128 |
|       15 | Madhya Pradesh    |          2276 |
|       16 | Maharashtra       |          9654 |
|       17 | Manipur           |             7 |
|       18 | Nagaland          |             1 |
|       19 | Odisha            |           164 |
|       20 | Puducherry        |           199 |
|       21 | Punjab            |           666 |
|       22 | Rajasthan         |          3536 |
|       23 | Tamil Nadu        |          4075 |
|       24 | Telangana         |          2578 |
|       25 | Tripura           |             1 |
|       26 | Uttar Pradesh     |          2351 |
|       27 | Uttarakhand       |           555 |
|       28 | West Bengal       |           275 |