Lok Sabha Question No. 894 (UNSTARRED), answered on 2021-07-23
Subject: Research Cell to study post COVID-19 Complications
Ministry: HEALTH AND FAMILY WELFARE
Asked by: Rahul Ramesh Shewale, Girish Bhalchandra Bapat, Pritam Gopinath Munde

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

## LOK SABHA U NSTARRED QUES TION NO. 894 TO BE ANSWERED ON 23 RD JULY, 2021

## RESEARCH CELL TO STU DY POST COVID - 19 COMPLICATIONS

## 894. SHRI RAHUL RAMESH SH EWALE: SHRI GIRISH BHALCHAN DRA BAPAT:

## DR. PRITAM GOPINATHR AO MUNDE:

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

- (a) whether the Indian Medical Association (IMA) has requested the Government to set up a separate research  cell  to  study  post COVID - 19  complication  come out  with  multi - faceted treatment guidelines in all disciplines of medicine;
- (b) if so, the response of the Government thereto;
- (c)  whether  post  COVID - 19  complications  of  lung fibrosis,  increased  thrombotic  events  and fungal infec tions are on the rise, if so, the details thereof;
- (d) whether drugs needed for the mucormycotic fungal disease are not available with ease; and
- (e)  if  so,  the  details  thereof  and  the  steps  taken  by the  Government  to  augment  indigenous production?

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

- (a) to (c): The  Indian  Medical Association vide letter dated 7 th June 2021 addressed to the Hon'ble Prime  Minister  has  mentioned  that  post - COVID - 19  complications  of  lung  fibrosis, thrombotic events and fungal infections are on rise and there is a need to prepare for th also urged Government to set up a separate research cell to study post COVI D - 19 complication come out with multi - faceted treatment guidelines in all disciplines of medicine.

In this regard the following activities have already been initiated:

Expert  group  consultations  under  Director  General  of  Health  Services  are  ongoing revi ew  emerging  evidence  on  organ  system  specific  (respiratory  system,  renal  syst cardiovascular and gastro - intestinal) sequelae of COVID - 19.

ICMR has established a National Clinical Registry on COVID with the following objective

- To  develop  National  Clin ical  COVID- 19  registry  to  collect  data  regarding  clinical  and laboratory features, treatments, and outcomes of hospitalized COVID - 19 patients in India.
- To  study  the  frequency,  clinical  and  laboratory  features,  treatments,  and  outcom COVID - 19  related  m ultisystem  inflammatory  disorder  in  children  and  adolescents  by analyzing the national COVID - 19 registry.
- To  utilize  data  to  answer  research  questions  on  COVID - 19  including  natural  course  of disease, spectrum of disease, prognostic factors, outcomes data, medications, health systems and context specific questions such as COVID - 19 in Tuberculosis, Malnutrition etc.
- To serve as a platform for additional clinical research studies in selected sites.
- To collect follow - up data of discharged COVID 19 patients, if po sible.

The  registry  follows  a  hub  and  spoke  model  with  primary  data  being  collected  in electronic data capture form by satellite centres (dedicated COVID - 19 hospitals) which are being trained, mentored, and supervised by medical institutes of natio nal repute chosen region - wise. In the first phase, 50 satellite centres and 14 registry sites have been included.

In addition, all AIIMS like institutions have been requested to undertake research t long term impact of COVID.

It  may  be  premature  t o conclude  that  complications  like  lung  fibrosis  and  increase thrombotic events directly due to COVID - 19 infection are on rise. However, a larger number of cases of fungal infections have been noted linked with COVID - 19 during the recent surge.

(d) &(e) : Although Mucormycosis is not a new disease, its true incidence was unknown as was not a notifiable disease. Ministry of Health & Family Welfare in May 2021 requested to  declare  Mucormycosis  a  notifiable  disease  under  Epidemic  Disease  Act,  18 97  to  get  an objective assessment of Mucormycosis in the community.

Since early May 2021 the details of production, stock, supplies made and purchase o were obtained from the manufacturers and their co - operation was sought to overcome the gap betweensupply and demand. Both first -and second - line drugs used for managing Mucormycosis cases  i.e.  Amphotericin  B  Deoxycholate  and  Posaconazole  are  currently  amply  available Indian markets.

Union Government has taken various measures to improve the availability of Amphoteric B (liposomal) through a multipronged approach of augmenting production and import and ens 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)  hav actively coordinated with the industry for identificatio n of manufacturers, alternate drugs and expeditious approvals of new manufacturing facilities.
- The 5 existing manufacturers have also been called upon to increase production of Lipos Amphotericin - B. DCGI, after consultation with the association of Dru gs manufacturers, has issued manufacturing / marketing permission of Amphotericin B Liposomal Injection to additional firms.
- 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 identify  new  sources  of  Amphotericin  B/  Liposomal  Amphotericin  B  injections  an alternative drugs for treatment of Mucormycos is. MEA has also been actively working on ensuring  supplies  of  key  excipients  from  sources  abroad  for  production  of  Liposo Amphotericin B in India.
- For equitable distribution, allotments are being made to the States/ UTs in accordanc the proporti on of their reported 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.