Lok Sabha Question No. 819 (UNSTARRED), answered on 2021-07-23
Subject: Integrated Action Plan to Tackle Fungal Outbreaks
Ministry: HEALTH AND FAMILY WELFARE
Asked by: Adoor Prakash, Amar Singh, Behanan Benny, Gaurav Gogoi, T.N. Prathapan, Mohammad Jawed, D.K. Suresh, Anto  Antony

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

## LOK SABHA U NSTARRED QUESTION NO. 819 TO BE ANSWERED ON 23 RD JULY, 2021

## INTEGRATED ACTION PL AN TO TACKLE FUNGAL OUTBREAKS

## 819. ADV. ADOOR PRAKASH:

DR. AMAR SINGH:

SHRI BENNY BEHANAN:

SHRI GAURAV GOGOI:

SHRI T.N. PRATHAPAN:

DR. MOHAMMAD JAWED:

SHRI D.K.SURESH:

SHRI ANTO ANTONY:

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

- (a) whether the Government has formed an integrated plan of action to tackle the fungal infection outbreaks consisting of the black, white and yellow variants;
- (b) if so, the details thereof and if not, the reasons therefor;
- (c) whether the Government has taken cognizance of the shortage in the supply of Amphotericin -B injections used for the treatment of Mucormycosis;
- (d)  if  so,  the  details  thereof  and  the  manner  in  which the  Government  proposes  to  meet  the demand, and if not, the reasons therefor;
- (e)  whether  the  Government  intends  to  assist  the healthcare  system  with identification  and treatment of these diseases; and
- (f) if so, the details thereof and if not, the reasons herefo ?

## ANSWER

## THE MINISTER OF STATE IN THE MINISTRY OF HEALTH AND FAMILY WELFARE (DR . BHARATI PRAVIN PAW AR )

- (a) &(b):  In the wake of second wave of COVID - 19 in the country, an increased number of Mucormycosis cases were reported from many States/UTs. Ministry of Health & Family Welfar after thorough gap analysis and expert consultations took several steps to addre ss the problem arising out of Mucormycosis and other fungal infections. The main actions initiated are as
- Although Mucormycosis is not a new disease, but its true incidence during the beginni second wave was unknown, as it was not a notifiable d se se. Ministry of Health & Family Welfare in May 2021 requested States to declare Mucormycosis a notifiable disease un

Epidemic  Disease  Act,  1897  to  get  an  objective  assessment  of  Mucormycosis  in  t community.

- Taking cognizance of association betwe en elevated blood sugar levels (whether in patients with preexisting diabetes mellitus, or hyperglycemia due to steroid therapy) Mucormycosis, an updated '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 group s, 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.
- Amphotericin - B  has  been  prescribed  as  a  drug  of  choice.  The  drug  is  available  in formulations (i) Liposomal Amphotericin B and (ii) Amphotericin B Deoxycholate, whic are similar in efficacy, however the latter needs to be used with greater caution wit to its effects on kidney function test and electrolyte imbalance. Second drug of choice is Posaconazole which may be used in cases with compromised renal function, drug reaction Amphotericin B, electrolyte imbalance or in non - availability of Amphotericin B.
- Similarly  realizing  the  multi - disciplinary  approach  required  to  manage  pat ients  suffering from Mucormycosis and other fungal infections, a checklist for managing Mucormycosis a 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 Mini stry 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  immunosuppressive  drugs,  'Advisory  for  rati onal  use  of  Steroids  and Tocilizumab in the treatment of Covid -19  patients'  was  issued  by  Directorate  General  of Health Services.
- For the reporting of cases and deaths due to Mucormycosis, Union Ministry of Health requested the States and UTs to submit the details on COVID - 19 India portal. States were asked to update the data on the portal which helped Union Health Ministry to analyze keep a track of evolving nature of problem across the country.

(c) to (f) :Since early May, 2021 the details of pr oduction, stock, supplies made and purchase orders 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 Mucormycosis cases i.e. Amphoterici n B Deoxycholate and Posaconazole are currently amply available in Indian markets.

Department  of  Pharmaceuticals  (DoP),  Central  Drugs  Standard  Control  Organization (CDSCO) & National Pharmaceutical Pricing Authority (NPPA) have been jointly monitoring the production and availability of critical (COVID) drugs including Amphotericin - B injections. Accordingly, Union Government has taken various measures to improve the availability of

Amphotericin B (liposomal) through a multipr onged approach of augmenting production and  import  and  ensure  equitable  distribution  to  States/UTs.  The  various  measures  ado 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)  hav actively coordinated with the industry for identification of manufacturers, alternat and expeditious approvals of new manufacturing facilities.
- Five  existing  manufact urers  were  called  upon  to  increase  production  of  Liposomal Amphotericin - B.
- DCGI, after consultation with the association of Drugs manufacturers, has is manufacturing  /  marketing  permission  of  Amphotericin  B  Liposomal  Injection  to  s additional firms.
- Ramping  up  production  of  alternative  drugs/forms  for  treating  the  disease  is  also actively pursued with the manufacturers.
- Various concerns of manufacturers and importers, including those related to licensin availability of raw material issues , mport license are being speedily addressed.
- Ministry  of  External  Affairs  (MEA)  is  reaching  out  to  various  manufacturers  abr Through its missions all over the world, MEA has identified new sources of Amphoterici Liposomal Amphotericin B injection s and alternative drugs for treatment of Mucormycosis. MEA has also been actively working on ensuring supplies of key excipients from sour abroad for production of Liposomal Amphotericin B in India.
- Department  of  Pharmaceuticals  and  the  Indian  Embassy in  the  USA  are  working continuously with the Mylan Labs for increasing import and ensuring early delivery M/s Gilead Inc. USA.
- For equitable distribution, allotments are being made to the States/ UTs in accordanc the proportion of their reporte d case load in respect of the entire country.
- Supply arrangements are being monitored by the National Pharmaceuticals Pricing Author (NPPA) to ensure expeditious availability of the drug.
- NPPA has put in place a strongly responsive system to ensure timely supplies of allocated volumes and maintains continuous contact with States/UTs and suppliers to trouble shoo issues in reaching the drugs to the Health Departments of States/ UTs.