Lok Sabha Question No. 1223 (UNSTARRED), answered on 2021-07-27
Subject: Shortage of Antiviral Drugs
Ministry: CHEMICALS AND FERTILIZERS
Asked by: Kumbakudi Sudhakaran, Faizal P.P. Mohammed, D.K. Suresh, Gaurav Gogoi, A. Chellakumar, Pradyut Bordoloi, Amar Singh, M. Selvaraj, Sisir Kumar Adhikari, Saptagiri Sankar Ulaka

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

LOK SABHA UNSTARRED QUESTION No. 1223 TO BE ANSWERED ON THE 27 th  July, 2021

## Shortage of Antiviral Drugs

## 1223.   SHRI KUMBAKUDI SUDHAKARAN:

SHRI MOHAMMED FAIZAL P.P.:

SHRI D.K.SURESH: SHRI GAURAV GOGOI:

DR. A. CHALLAKUMAR:

SHRI PRADYUT BORDOLOI:

DR. AMAR SINGH:

SHRI M. SELVARAJ:

SHRI SISIR KUMAR ADHIKARI:

SHRI SAPTAGIRI SANKAR ULAKA:

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

- (a)  whether  the  Government  has  taken  cognisance  of  shortage  of  antiviral  drugs  such  as Remedesivir and Tocilizumab;
- (b) if so, the details thereof and action taken to address this shortage;
- (c)  whether  the  Government,  exercising  its  powers  under  the  Patents  Act  intends  to  issue compulsory  licenses  to  generic  pharmaceutical  companies  for  manufacturing  of  low  cost versions of Remdesivir and Tocilizumab;
- (d) if so, the details thereof and if not, the reasons therefor;
- (e) the number of Remdesivir manufacturers in the country and their production capacity, since 2019 till date; and
- (f) the number of Remedesivir and Tocilizumab manufacturing units set up between March 2020 and May 2021?

## ANSWER

## MINISTER IN THE MINISTRY OF CHEMICALS & FERTILIZERS (SHRI MANSUKH MANDAVIYA)

(a) to (b): Yes, Sir. Shortages were noticed in the months of April and May, 2021 in case of Remdesivir and Tocilizumab due to the sudden surge in demand of these drugs for managing COVID-19 patients. It may be noted that both these drugs are patented drugs. Remdesivir is manufactured in India whereas Tocilizumab is available in  India through imports only. To address the shortages, government immediately started working on augmenting supply of these drugs by augmenting domestic production in case of Remdesivir and by making efforts for increased quantity of imports in case of Tocilizumab. Due to collective efforts made in this direction by seven domestic manufacturers of Remdesivir and with the grant of expeditious approvals by Drug Controller General of India, the number of licensed manufacturing sites of Remdesivir  in  India  increased  from  22  in  mid-April,  2021  to  62  at  present.  The  domestic production capacity of Remdesivir increased from 38 lakh vials per month in mid-April, 2021 to 122 lakh vials per month now. Similarly, in case of Tocilizumab, the imported quantity was maximised  due  to  persistent  efforts  of  the  Government  with  the  sole  manufacturer  of Tocilizumab.

Further, in order to secure domestic supply of Remdesivir, the export of Remdesivir Injection and Remdesivir API (Active Pharmaceutical Ingredient) was prohibited from 11 th April, 2021. In addition, Department of Pharmaceuticals (DoP) and Ministry of Health and Family Welfare (MoH&FW) jointly undertook an exercise for allocation of available stocks of Remdesivir and Tocilizumab to all the States/UTs of the country in a move to mitigate shortage and to ensure fair and equitable distribution across the country. The total allocation and supply of these two drugs is given as under:

|   Sr. No. | Name of the drug               | Allocation to States/UTs and Central Institutions (in vials)   | Supply till 18.07.2021 (in vials)   |
|-----------|--------------------------------|----------------------------------------------------------------|-------------------------------------|
|         1 | Remdesivir Injection           | 98,87,000                                                      | 97,03,393                           |
|         2 | Tocilizumab (400 mg) Injection | 9,900                                                          | 9,578                               |
|         3 | Tocilizumab (80 mg) Injection  | 65,000                                                         | 53,284                              |

In addition to the above allocation of commercial supplies to States/UTs, the MoHFW has also distributed the following, free of cost, to the States/UTs:

-  21,86,936 vials of Remdesivir purchased from the domestic manufacturers.
-  8,23,862  vials  of  Remdesivir  sourced  from  outside  India  through  donation  and commercial purchases.
-  1,001  vials  of  Tocilizumab  (400  mg)  received  in  donation  from  Oman  have  been distributed to States/UTs.
-  27,381  vials  of  Tocilizumab  (80  mg)  received  in  donation  from  Roche  have  been distributed to States/UTs.

As on date, the demand of Remdesivir has come down considerably and the demand supply gap has reversed in the sense that supply is much more than the demand. Accordingly, Remdesivir has been moved from Prohibited to Restricted Category of Exports on 14 th June, 2021. Similarly, the demand-supply position for Tocilizumab has stabilized considerably and some States are not placing purchase orders with the company marketing Tocilizumab as per quantities allocated by Central Government to them. The States and UTs have been advised to procure buffer stocks to deal with any future requirements.

(c) to (d):     No sir. There is no application filed for invoking compulsory licensing under Section 84 of the Patents Act with central Government by manufacturer or party intending to manufacture Remdesivir or Toculizumab. Further, the manufacturing capacity of Remdesivir, a patented drug has been ramped up from 38 lakh vials per month to 1.22 crore vials per month now, by the seven domestic manufacturers that have been licensed in 2020 by Gilead Sciences Inc, a USA based multinational company, holding the patent for Remdesivir. Tocilizumab is also a patented drug of Hoffman La Roche, a Switzerland based multinational company and is not  manufactured  in  India.  It  is  pertinent  to  note  that  the  Central  Drugs  Standard  Control Organisation (CDSCO) under MoHFW, has on 12 th  May, 2021 given permission to one Indian pharmaceutical company for conducting phase three clinical trials for a bio-similar drug.

(e) to (f):   As per CDSCO, Remdesivir injection was approved on 20.06.2020 in the country. Presently,  62  manufacturing  sites  of  7  manufacturers  are  approved  for  manufacturing Remdesivir injection with total monthly installed capacity of 122 lakh vials/month. Presently Tocilizumab is not manufactured in India but marketed in India only by way of imports.