Lok Sabha Question No. 348 (UNSTARRED), answered on 2020-09-15
Subject: Availability of Remdesivir
Ministry: CHEMICALS AND FERTILIZERS
Asked by: Prathap Simha, L.S. Tejasvi Surya

## GOVERNMENT OF INDIA MINISTRY OF CHEMICALS & FERTILIZERS DEPARTMENT OF PHARMACEUTICALS

LOK SABHA UNSTARRED QUESTION NO. 348 TO BE ANSWERED ON 15 th  September, 2020

## Availability of Remdesivir

## 348.   SHRI PRATHAP SIMHA:

SHRI L.S. TEJASVI SURYA:

Will the Minister of CHEMICALS AND FERTILIZERS be pleased to state:

- (a) the details of the current availability of Remdesivir with different pharmaceuticals companies and the demand for anti viral from different States;
- (b) whether production of remdesivir by Pharma companies in India is able to match the requirement, if so, the details thereof, and if not, the estimated shortage;
- (c)  the names of the companies with the license to manufacture Remdesivir in the country;
- (d) whether the Government has received more applications requesting for license to manufacture remdesivir, if so, the details and states thereof;
- (e)  whether  the  Government  is  permitting  pharma  companies  to  import  remdesivir from  foreign  countries  who  are  in  advanced  stages  of  production  and  if  so,  the details thereof; and
- (f)  the  measures  taken  by  the  Government to  bring  the  price  of Remdesivir  under control in the country?

## ANSWER

## MINISTER IN THE MINISTRY OF CHEMICALS & FERTILIZERS (SHRI D. V. SADANANDA GOWDA)

(a) & (b):         The details of total quantity of Remdesivir injection manufactured so far by the pharmaceutical companies are as follows:

|   Sl. No. | Name of the Pharmaceutical company   | Total quantity of Remdesivir manufactured for market till 08-09-2020   |
|-----------|--------------------------------------|------------------------------------------------------------------------|
|         1 | M/s Mylan Laboratories limited       | 500,000 vials                                                          |
|         2 | M/s Hetero Healthcare                | 14,46,000 Vials                                                        |
|         3 | M/s Jubilant Generics Limited        | 150,000 vials                                                          |
|         4 | M/s Cipla*(as on 28-08-2020)         | 143,329 vials                                                          |
|         5 | M/s Dr. Reddy's Laboratories         | 13286 units                                                            |
|         6 | M/s Cadila Healthcare Limited        | 1,86,957 vials                                                         |

The Central  Drugs  Standard  Control  Organisation (CDSCO) has  not  received  any report that Pharma companies are not being able to match the current demand.

(c) to (e):         Initially, CDSCO has granted permission to M/s Klinera to import and market  Remdesivir  injection  100  mg/20  ml  and  Remdesivir  100mg/vial  lyophilised powder of M/s Gilead for Restricted Emergency Use in the country for treatment of suspected or laboratory confirmed corona virus disease 2019 (COVID-19) in adults and  children  hospitalised  with  severe  disease  subject  to  various  conditions  / restrictions.

Based  on  the  above  import  and  marketing  permission,  M/s  Klinera  has submitted application for import registration certificate and import license to CDSCO for which firm needs to submit additional documents.

Subsequently, CDSCO  has  granted permission to manufacture and market Remdesivir  Injectable  Formulations  for  restricted  emergency  use  in  the  country, subject to various conditions and restrictions to the following manufacturers:

|   S. No | Firm Name                 | Permission Date   |
|---------|---------------------------|-------------------|
|       1 | M/s. Hetero               | 20/06/2020        |
|       2 | M/s. Cipla                | 20/06/2020        |
|       3 | M/s Mylan                 | 02/07/2020        |
|       4 | M/s Jubilant              | 22/07/2020        |
|       5 | M/s Cadila Healthcare Ltd | 06/08/2020        |
|       6 | M/s Dr. Reddy's           | 10/08/2020        |

Further,  CDSCO  had  received  applications  from  M/s  MSN  Labs  and  M/s  BDR Pharmaceutical limited for which applicant need to submit additional documents.

(f):        The  National  Pharmaceutical  Pricing  Authority  (NPPA)  fixes/revises  the ceiling price of Scheduled medicines specified in First Schedule of the Drugs (Prices Control)  Order,  2013  (DPCO,  2013).  The  NPPA  also  monitors  the  prices  of  nonscheduled medicines so that their MRP does not increase by more than 10 percent of the MRP during preceding twelve (12) months.

Further, Remdesivir is included under 'Investigational Therapy category' and is being used as off-Label and Emergency Use Authorization (EUA) drug. The Drugs Controller General of India (DCGI) has given conditional license to this formulation for  'restricted  emergency  use'.  These  medicines  are  being  administered  after obtaining  consent  of  the  patient.  Hence,  full  drug  status  has  not  been  granted  to these  drugs  for  COVID-19  treatment.  As  noted  above,  presently,  there  are  six manufacturers of Remdesivir Injection and its pricing is being governed by market dynamics.

Initially, the manufacturers of Remdesivir Injection namely M/s Mylan Laboratories, M/s Hetero Healthcare Limited and M/s Cipla Limited were advised by Central  Drugs  Standard  Control  Organization  (CDSCO)  to  upload  information regarding  distributors  and  supply  chain  details  along  with  the  quantities  on  their website, so as to prevent black-marketing and overcharging of the drug.

On  receipt  of  complaints  regarding  selling  of  Remdesivir  at  a  price  above MRP, necessary instructions were issued to the Drugs Controller General of India (DCGI) to  advise  the  manufacturers  to  start  a  24x7  helpline  for  patients  and  their families  in  case  the  medicine  is  not  available  or  higher  price  is  being  charged.  In compliance,  manufacturers  started  helpline  number  and  displayed  it  on  website. Further, contact details of manufacturers were provided on the website of the NPPA i.e.  www.nppaindia.nic.in,  to  facilitate  information  regarding  availability  of  medicine for the public.

The NPPA also set-up a Control Room with Helpline No. 1800111255 and email  monitoring-nppa@gov.in  on  20th  March  2020  to  respond  to  queries  and complaints  relating  to  COVID-19.   The  issues  raised  are  addressed  and  resolved; solutions  are  provided  and  forwarded  to  concerned  authorities  for  redressal  and followed up for final resolution.

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