Lok Sabha Question No. 2440 (UNSTARRED), answered on 2021-08-03
Subject: Supply of Essential Drugs
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. 2440 TO BE ANSWERED ON 03 rd  August, 2021

## Supply of Essential Drugs

## 2440.   SHRI PRATHAP SIMHA: SHRI L.S. TEJASVI SURYA:

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

(a) the details of the measures taken by the Government in increasing the supply of essential drugs during the second wave of the COVID-19 pandemic in the country;

(b) the details of the incremental supply and production of remdesivir, tocilizumab, liposomal amphotericin B and other drugs that were used in the treatment of COVID-19 infections in the country; and

(c) the statewise supply information of the above drugs used in the treatment of COVID-19 during each increment/phase?

## ANSWER

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

(a) : The Government took various measures to increase the supply of essential drugs such as  granting  expeditious  approvals  to  new  manufacturing  sites  of  existing  manufacturers  to enhance their production capacity, issuing licenses to new manufacturers/importers, helping the manufacturers in sourcing raw material and helping importers of drugs in getting maximum supplies on priority from the importing countries through support from diplomatic channels, restricting  exports  for  a  certain  period,    and  allocating  the  drugs  namely  Remdesivir, Tocilizumab and Amphotericin B, during the period of limited supply,  to States in an equitable manner  to  ensure  availability  of  these  drugs  across  the  country.  Domestic  production  and import of critical drugs was monitored regularly by the Government. Regular meetings were held with manufacturers to identify and address the issues faced by the manufacturers in the augmentation of the production. The availability of all major drugs required for management of COVID-19 was regularly monitored through weekly surveys of retail pharmacies.

(b) & (c):

(i) Remdesivir is a patented drug of Gilead Life Sciences USA, manufactured in India under voluntary licenses granted by the patent holder to 7 Indian pharmaceutical companies. With  the  accelerated  approval  of  40  additional  manufacturing  sites  by  the Central  Drugs Standard Control Organisation ( CDSCO ),  the number of approved manufacturing sites has increased from 22 in mid-April, 2021 to 62 in June, 2021. The domestic production capacity of all the seven licensed manufacturers was thus augmented from 38 lakh vials per month in mid-April, 2021 to nearly 122 lakh vials per month in June, 2021. Total domestic production of  Remdesivir  by  seven  licensed  manufacturers  between  1 st April  and  25 th July,  2021  is 1,68,14,752 vials.

(ii) Tocilizumab is a patented drug of Hoffman La Roche, a Swiss multinational company. It  is  not  manufactured in  India and is available in India through imports only.  Its imported quantity was  maximized  through  persistent  efforts  of  the  Government  with  the  sole manufacturer  of  Tocilizumab.  1,00,020  vials  (80  mg)  and  13,001  vials  (400mg)  were commercially imported between 1 st April and 25th July, 2021. In addition, 50,024 vials (80 mg) were received in donation from Roche in the month of May, 2021.

(iii) Department  of  Pharmaceuticals  and  the  Drug  Controller  General  of  India  (DCGI) actively  coordinated  with  the  industry  for  identification  of  manufacturers  and  expeditious approvals  of  new  manufacturing  facilities.  The  DCGI  issued  manufacturing/marketing permission of Amphotericin B Liposomal Injection to 11 new companies in the months of May and June, 2021.  The domestic production of Liposomal Amphotericin B between 1 st  May and 30 th June,  2021  is  4,53,555  vials.  The  expected  production  in  the  month  of  July,  2021  is 3,45,864 vials.

Department  of  Pharmaceuticals  and  the  Indian  Embassy  in  the  USA  worked continuously  with  importers  and  manufacturers  to  maximise  the  quantity  of  imports  of Liposomal  Amphotericin  B  and  also  for  early  delivery  of  supplies.  The  total  import  of Liposomal Amphotericin B between 1 st  May and 29 th July,  2021  is  10,77,677  vials.  Indian Missions all over the world were instructed to immediately identify additional sources of the Liposomal Amphotericin B. MEA also helped domestic manufacturers in getting supplies of key excipients viz. HSPC and DSPG-Na required for production of Liposomal Amphotericin B from sources abroad.

(iv)    The  domestic  production  and  imports  of  other  drugs  required  for  the  management  of COVID-19  namely  dexamethasone,  methylprednisolone,  paracetamol  etc.  was  monitored regularly and there was sufficient availability of these drugs to meet the increased demand.

The allocation of Remdesivir, Tocilizumab and Amphotericin B was started on 21 st April,  27 th April  and  11 th May,  2021  respectively.  The  allocation  of  Remdesivir  and Amphotericin B has now been discontinued due to sufficient availability of these medicines. The last allocation of Remdesivir was done on 23 rd May, 2021 and that of Amphotericin B was done on 24 th July, 2021. The State-wise supply of Remdesivir, Tocilizumab and Amphotericin B by pharmaceutical companies in pursuance to allocation given by the Central government and purchase orders placed by States/ UTs is given in a Table in Annexure 1. In addition to above commercial supplies, Central government has supplied to States free of cost Remdesivir, Tocilizumab and Amphotericin B received through Donation and also procured by the Central Government. The State-wise data of Remdesivir, Tocilizumab and Amphotericin B supplied by the Central government free of cost is given in a Table in Annexure 2.

## Annexure 1

No. of vials of Remdesivir, Tocilizumab, Amphotericin B supplied to States and Union Territories  (UT) by  pharmaceutical  companies  against  allocation  given  by  the  Central Government ( Supply status as on 25 th  July, 2021)

| S.N.   | State/UT                           | Remdesivir   | Tocilizumab   | Amphotericin B   |
|--------|------------------------------------|--------------|---------------|------------------|
| 1      | Andaman and Nicobar Islands        | 3300         | 30            | 0                |
| 2      | Andhra Pradesh                     | 780152       | 2321          | 105315           |
| 3      | Arunachal Pradesh                  | 4946         | 0             | 0                |
| 4      | Assam                              | 117505       | 550           | 350              |
| 5      | Bihar                              | 162800       | 1415          | 12600            |
| 6      | Chandigarh                         | 25496        | 155           | 4960             |
| 7      | Chhattisgarh                       | 228366       | 430           | 6410             |
| 8      | Dadra and Nagar Haveli & Daman Diu | 3368         | 80            | 51347            |
| 9      | Delhi                              | 284809       | 1516          | 500              |
| 10     | Goa                                | 43550        | 400           | 1200             |
| 11     | Gujarat                            | 856288       | 2070          | 222282           |
| 12     | Haryana                            | 298469       | 1575          | 47758            |
| 13     | Himachal Pradesh                   | 42202        | 150           | 220              |
| 14     | Jammu and Kashmir                  | 74947        | 870           | 3270             |
| 15     | Jharkhand                          | 182187       | 770           | 3780             |
| 16     | Karnataka                          | 983844       | 9743          | 80684            |
| 17     | Kerala                             | 198113       | 8660          | 14180            |
| 18     | Ladakh                             | 1500         | 30            | 0                |
| 19     | Lakshadweep                        | 500          | 0             | 0                |
| 20     | Madhya Pradesh                     | 359525       | 1465          | 65611            |
| 21     | Maharashtra                        | 1873758      | 11253         | 198300           |
| 22     | Manipur                            | 22586        | 130           | 150              |
| 23     | Meghalaya                          | 18190        | 65            | 0                |
| 24     | Mizoram                            | 5618         | 30            | 0                |
| 25     | Nagaland                           | 834          | 30            | 0                |
| 26     | Odisha                             | 176251       | 1752          | 2660             |
| 27     | Puducherry                         | 23252        | 25            | 730              |
| 28     | Punjab                             | 195717       | 1403          | 21970            |
| 29     | Rajasthan                          | 363395       | 2875          | 124156           |
| 30     | Sikkim                             | 3930         | 0             | 0                |
| 31     | Tamil Nadu                         | 1123905      | 4637          | 83210            |
| 32     | Telangana                          | 466590       | 1113          | 75705            |
| 33     | Tripura                            | 5250         | 30            | 100              |
| 34     | Uttar Pradesh                      | 534914       | 625           | 75398            |
| 35     | Uttarakhand                        | 102370       | 2000          | 5830             |
| 36     | West Bengal                        | 237499       | 2247          | 3585             |
| Total  | Total                              | 98,05,926    | 6,0445        | 12,12,261        |

## No. of  vials  of  Remdesivir,  Tocilizumab,  Amphotericin  B  supplied  free  of  cost  by  the Central Government to States and Union Territories (UT) ( Supply status as on 25 th  July, 2021)

| S.No.   | State/UT                           | Remdesivir   | Tocilizumab   | Amphotericin B   |
|---------|------------------------------------|--------------|---------------|------------------|
| 1       | Andaman and Nicobar Islands        | 3380         | 10            |                  |
| 2       | Andhra Pradesh                     | 246436       | 2357          | 1147             |
| 3       | Arunachal Pradesh                  | 9839         | 11            |                  |
| 4       | Assam                              | 89109        | 263           | 2                |
| 5       | Bihar                              | 23826        | 659           | 54               |
| 6       | Chandigarh                         | 7149         | 52            | 16               |
| 7       | Chhattisgarh                       | 45008        | 790           | 34               |
| 8       | Dadra and Nagar Haveli & Daman Diu | 2685         | 10            |                  |
| 9       | Delhi                              | 62250        | 528           | 308              |
| 10      | Goa                                | 17664        | 261           | 7                |
| 11      | Gujarat                            | 32253        | 917           | 1251             |
| 12      | Haryana                            | 19042        | 786           | 411              |
| 13      | Himachal Pradesh                   | 9383         | 262           | 5                |
| 14      | Jammu and Kashmir                  | 23893        | 266           | 11               |
| 15      | Jharkhand                          | 15515        | 392           | 39               |
| 16      | Karnataka                          | 327378       | 3676          | 965              |
| 17      | Kerala                             | 224922       | 2763          | 37               |
| 18      | Ladakh                             | 4807         | 10            |                  |
| 19      | Lakshadweep                        | 3822         | 10            |                  |
| 20      | Madhya Pradesh                     | 136430       | 657           | 584              |
| 21      | Maharashtra                        | 447188       | 3940          | 1290             |
| 22      | Manipur                            | 17267        | 26            | 1                |
| 23      | Meghalaya                          | 6269         | 21            |                  |
| 24      | Mizoram                            | 6193         | 10            |                  |
| 25      | Nagaland                           | 5138         | 16            |                  |
| 26      | Odisha                             | 155857       | 526           | 20               |
| 27      | Puducherry                         | 8810         | 89            | 51               |
| 28      | Punjab                             | 46565        | 526           | 123              |
| 29      | Rajasthan                          | 123692       | 1316          | 1011             |
| 30      | Sikkim                             | 3814         | 16            |                  |
| 31      | Tamil Nadu                         | 556851       | 929           | 1063             |
| 32      | Telangana                          | 62069        | 394           | 965              |
| 33      | Tripura                            | 4927         | 16            |                  |
| 34      | Uttar Pradesh                      | 147223       | 1442          | 642              |
| 35      | Uttarakhand                        | 15133        | 525           | 26               |
| 36      | West Bengal                        | 37446        | 789           | 91               |
| ` Total | ` Total                            | 29,49,233    | 25,261        | 10,154           |