Health Ministry Issues Regulatory Pathways For Foreign-Produced COVID-19 Vaccines | News

April 15, 2021 0 Comments



The government said that the decision will facilitate quicker access to foreign COVID-19 vaccines by India and would encourage imports

Highlights
  • CDSCO will process applications for emergency use within 3 working days
  • The first 100 beneficiaries shall be assessed for 7 days for safety outcome
  • Once found satisfactory, will authorise the applicant to use the vaccine

New Delhi: The Central Government on Thursday (April 15) issued the regulatory pathway in India for COVID-19 vaccines approved for restricted us e by US FDA, EMA, UK MHRA, PMDA Japan or which are listed in WHO Emergency Use Listing (EUL), said the Union Health Ministry. The Central Drugs Standards Control Organisation (CDSCO) headed by Drugs Controller General of India (DCGI) has explained that it prepare detailed guidelines specifying regulatory pathway for approval of foreign approved COVID vaccines based on NEGVAC recommendations.

Also Read: COVID Vaccine Equity: Where Does India Stand And How Can We Tackle Global Inequity Amid Rising Coronavirus Cases

These guidelines have since been prepared and posted by CDSCO on its website. CDSCO will take steps to widely disseminate these guidelines to the concerned stakeholders, the ministry said.

It said that the applicants for grant of approval for Restricted Use in Emergency situation may be submitted to CDSCO and the application can be made by the foreign manufacturer through its Indian subsidiary or through its authorized agent in India (in case it does not have an Indian subsidiary). The CDSCO will process such applications and take a decision within three working days from the date of submission of the complete application by the applicant. DCGI will issue permission for Restricted Use in Emergency situation if the vaccine will be used as per the guidelines prescribed under the national COVID-19 Vaccination Programme. The first 100 beneficiaries of such vaccines shall be assessed for seven days for safety outcomes before it is rolled out for further Vaccination programme.

Applicant shall initiate conduct of post-approval bridging clinical trials within 30 days of such approval, it said.

Also Read: Equitable Access To COVID-19 Vaccine Critically Important To Fight Pandemic, India’s ‘Vaccine Maitri’ Trying To Ensure Access To All: External Affairs Minister

As per the existing protocol of CDSCO for batch release of vaccines, each batch of the vaccine will be released by Central Drugs Laboratory (CDL), Kasauli before it can be used as per the guidelines prescribed under the National Covid-19 vaccination programme. The applicant will only use the COVID vaccine, after receipt of CDL approval, initially only on 100 beneficiaries and submit the safety data to CDSCO. CDSCO will then review the safety data submitted by the applicant, and once found satisfactory, will authorise the applicant to use the vaccine.

CDSCO will approve the protocol for the bridging trial in consultation with Subject Expert Committee (SEC) within 7 days of the receipt of the proposal, it further said.

Also Read: India To Have Five More COVID Vaccines By October, Sputnik V Expected To Get Emergency Use Nod In 10 Days

The applicant will conduct the bridging trial within the timelines specified in the approved protocol, and submit data generated in the bridging trial to CDSCO and after the receipt of the bridging trial results, the DCGI will review the permission granted for Restricted Use in Emergency situation. The Union Government on April 13, 2021, had approved a significant streamlining and fast-tracking of the regulatory system for COVID-19 vaccines approved for restricted use by US FDA, EMA, UK MHRA, PMDA Japan or which are listed in WHO Emergency Use Listing (EUL).

The government said that this decision will facilitate quicker access to such foreign vaccines by India and would encourage imports including import of bulk drug material, optimal utilization of domestic fill and finish capacity, etc., which will, in turn, provide a fillip to vaccine manufacturing capacity and total vaccine availability within the country.

Also Read: Indian Medical Association Urges PM Modi To Start Vaccination For All Above 18 Years, Suggests Limited Lockdown

(This story has not been edited by NDTV staff and is published from a syndicated feed.)

NDTV – Dettol Banega Swasth India campaign is an extension of the five-year-old Banega Swachh India initiative helmed by Campaign Ambassador Amitabh Bachchan. It aims to spread awareness about critical health issues facing the country. In wake of the current COVID-19 pandemic, the need for WASH (WaterSanitation and Hygiene) is reaffirmed as handwashing is one of the ways to prevent Coronavirus infection and other diseases. The campaign highlights the importance of nutrition and healthcare for women and children to prevent maternal and child mortality, fight malnutrition, stunting, wasting, anaemia and disease prevention through vaccines. Importance of programmes like Public Distribution System (PDS), Mid-day Meal Scheme, POSHAN Abhiyan and the role of Aganwadis and ASHA workers are also covered. Only a Swachh or clean India where toilets are used and open defecation free (ODF) status achieved as part of the Swachh Bharat Abhiyan launched by Prime Minister Narendra Modi in 2014, can eradicate diseases like diahorrea and become a Swasth or healthy India. The campaign will continue to cover issues like air pollutionwaste managementplastic banmanual scavenging and sanitation workers and menstrual hygiene

World

13,82,57,036Cases

5,65,60,696Active

7,87,23,763Recovered

29,72,577Deaths

Coronavirus has spread to 192 countries. The total confirmed cases worldwide are 13,82,57,036 and 29,72,577 have died; 5,65,60,696 are active cases and 7,87,23,763 have recovered as on April 15, 2021 at 3:51 am.

India

1,40,74,564 200739Cases

14,71,877 106173Active

1,24,29,564 93528Recovered

1,73,123 1038Deaths

In India, there are 1,40,74,564 confirmed cases including 1,73,123 deaths. The number of active cases is 14,71,877 and 1,24,29,564 have recovered as on April 15, 2021 at 2:30 am.

State & District Details

State Cases Active Recovered Deaths

DistrictCases

Mumbai45,478

Thane13,660

Pune9,920

Mumbai Suburban5,363

Aurangabad1,974

Nashik1,575

Raigad1,462

Palghar1,421

Solapur1,291

Jalgaon1,039

Akola757

Nagpur692

Kolhapur646

Satara629

Ratnagiri350

Amravati291

Dhule228

Hingoli208

Jalna201

Ahmednagar190

Nanded176

Yavatmal150

Sangli145

Latur139

Osmanabad125

Sindhudurg114

Buldhana88

Parbhani78

gondia69

Beed54

Nandurbar42

Gadchiroli42

Bhandara41

Chandrapur32

Washim13

Wardha11

35,78,160 58,952

6,13,635 19,050

29,05,721 39,624

58,804 278

DistrictCases

Kannur357

Kasaragod333

Palakkad224

Malappuram119

Kollam118

Thrissur106

Thiruvananthapuram104

Pathanamthitta98

Kozhikode90

Alappuzha76

Kottayam73

Ernakulam60

Idukki40

Wayanad36

11,89,175 8,778

58,564 6,114

11,25,775 2,642

4,836 22

DistrictCases

Udupi1,176

Kalaburagi669

Yadgir538

Bengaluru Urban529

Raichur369

Mandya346

Belagavi337

Bidar219

Hassan205

Davangere204

Vijayapura201

Dakshina Kannada179

Chikkaballapura149

Mysuru107

Bagalkote103

Uttara Kannada95

Shivamogga67

Dharwad61

Ballari60

Gadag45

Bengaluru Rural40

Tumakuru36

Kolar29

Haveri24

Chikkamagaluru19

Chitradurga14

Koppal5

Kodagu4

Ramanagara3

Chamarajanagara0

10,94,912 11,265

85,499 6,863

9,96,367 4,364

13,046 38

DistrictCases

Chennai23,324

Chengalpattu1,314

Thiruvallur774

Villupuram509

Kanchipuram503

Tiruvannamalai496

Cuddalore477

Ariyalur444

Tirunelveli433

Tuticorin333

Kallakurichi324

Madurai322

Salem258

Coimbatore188

Virudhunagar185

Dindigul175

Perambalur133

Ranipet133

Thanjavur130

Theni129

Tiruchirappalli119

Ramanathapuram119

Tiruppur116

Kanniyakumari110

Tenkasi103

Nagapattinam99

Karur88

Namakkal83

Erode75

Vellore71

Thiruvarur67

Pudukkottai53

Sivaganga46

Tirupathur45

Krishnagiri43

The Nilgiris17

Dharmapuri15

9,54,948 7,819

54,315 4,330

8,87,663 3,464

12,970 25

DistrictCases

Kurnool795

Krishna557

Guntur511

Anantapur428

East Godavari356

Chittoor319

Sri Potti Sriramulu Nell*296

Y.S.R.205

West Godavari199

Srikakulam183

Prakasam104

Visakhapatnam103

Vizianagaram23

9,37,049 4,157

28,383 2,533

9,01,327 1,606

7,339 18

DistrictCases

North West5,463

Central4,817

West4,768

New Delhi3,405

North3,059

East2,472

South East2,446

South West2,391

South2,329

North East1,914

Shahdara1,580

7,67,438 17,282

50,736 7,226

7,05,162 9,952

11,540 104

DistrictCases

Gautam Buddha Nagar1,119

Agra933

Ghaziabad794

Meerut504

Lucknow386

Saharanpur298

Kanpur Nagar286

Moradabad252

Varanasi243

Hapur225

Aligarh215

Basti214

Amethi206

Rampur203

Jaunpur194

Firozabad190

Barabanki168

Gorakhpur166

Bulandshahr166

Siddharth Nagar159

Ghazipur159

Bijnor157

Deoria143

Azamgarh138

Sant Kabeer Nagar132

Mathura129

Ayodhya120

Muzaffarnagar117

Sambhal116

Sultanpur97

Ambedkar Nagar92

Maharajganj85

Amroha80

Rae Bareli78

Bahraich73

Kheri72

Kannauj69

Baghpat68

Kushi Nagar67

Bhadohi60

Ballia60

Gonda59

Etah52

Hardoi49

Balrampur49

Mau48

Mainpuri46

Etawah46

Hathras43

Unnao42

Jalaun41

Jhansi41

Shamli40

Chandauli38

Auraiya37

Farrukhabad36

Sitapur32

Prayagraj30

Banda27

Shahjahanpur25

Shravasti23

Budaun23

Mirzapur22

Bareilly17

Kasganj16

Pratapgarh15

Pilibhit15

Sonbhadra10

Kaushambi6

Kanpur Dehat4

Chitrakoot4

Lalitpur3

Hamirpur3

Mahoba3

Fatehpur3

7,44,021 20,439

1,11,835 15,855

6,22,810 4,517

9,376 67

DistrictCases

Kolkata2,777

Howrah1,435

24 Paraganas North1,031

Hooghly604

24 Paraganas South281

Maldah235

Dinajpur Uttar216

Coochbehar210

Birbhum206

Medinipur West159

Medinipur East153

Nadia139

Purba Bardhaman130

Murshidabad125

Bankura116

Darjeeling97

Jalpaiguri88

Paschim Bardhaman70

Purulia66

Dinajpur Dakshin50

Alipurduar39

Kalimpong18

Jhargram9

6,30,116 5,892

32,621 3,571

5,87,037 2,297

10,458 24

DistrictCases

Bilaspur100

Korba100

Mungeli87

Baloda Bazar85

Jashpur77

Janjgir-Champa56

Mahasamund54

Rajnandgaon52

Kabirdham52

Raigarh47

Raipur46

Balod41

Korea39

Durg31

Bemetara21

Kanker19

Balrampur17

Surguja14

Gariyaband10

Surajpur9

Dhamtari6

Bijapur2

Bastar2

Dantewada0

Kondagaon0

Narayanpur0

Sukma0

4,86,244 14,250

1,18,636 9,497

3,62,301 4,633

5,307 120

DistrictCases

Jaipur2,177

Jodhpur1,748

Udaipur724

Bharatpur563

Kota503

Nagaur500

Ajmer379

Dungarpur374

Pali352

Jhalawar329

Bhilwara250

Sikar231

Chittorgarh188

Tonk171

Jalore164

Rajsamand140

Sirohi130

Bikaner112

Banswara91

Alwar90

Churu81

Jhunjhunu64

Dausa61

Dholpur60

Baran59

Jaisalmer53

Barmer34

Hanumangarh31

SawaiMadhopur26

Karauli17

Pratapgarh14

Ganganagar8

Bundi5

3,81,292 6,200

44,905 4,215

3,33,379 1,956

3,008 29

DistrictCases

Ahmadabad17,125

Surat2,311

Vadodara1,555

Gandhinagar410

Mahesana159

Banas Kantha147

Bhavnagar146

Rajkot135

Arvalli134

Mahisagar125

Anand107

PanchMahals107

Patan105

SabarKantha101

Kachchh99

Kheda98

Jamnagar63

Bharuch56

Botad55

Surendranagar55

Valsad47

GirSomnath45

Dohad43

Chhotaudepur37

Naysari35

Junagadh31

Narmada25

DevbhumiDwarka22

Amreli16

Porbandar11

Tapi6

Dang5

Morbi4

3,67,616 7,410

39,250 4,695

3,23,371 2,642

4,995 73

DistrictCases

Indore3,839

Bhopal1,880

Ujjain799

Burhanpur351

Neemuch319

Jabalpur276

East Nimar266

Sagar228

Gwalior211

Khargone196

Dewas140

Dhar132

Mandsaur112

Morena109

Bhind87

Raisen71

Barwani60

Ratlam51

Rewa39

Shajapur39

Hoshangabad37

Vidisha37

Chhatarpur35

Betul35

Rajgarh31

Dindori29

Sheopur26

Damoh26

Satna24

Anuppur22

Panna20

Tikamgarh18

Sidhi17

Narsinghpur17

Chhindwara16

Agar Malwa15

Mandla15

Shivpuri15

Jhabua14

Shandol14

Singrauli13

Ashoknagar13

Datia12

Sehore12

Umaria10

Balaghat9

Guna8

Harda4

Alirajpur3

Katni3

Seoni2

Niwari0

3,63,352 9,720

49,551 6,012

3,09,489 3,657

4,312 51

DistrictCases

Ganjam581

Jajapur322

Khordha238

Baleshwar190

Kendrapara164

Cuttack155

Bhadrak137

Balangir129

Puri103

Sundargarh102

Jagatsinghapur91

Nayagarh86

Mayurbhanj73

Nuapada69

Gajapati61

Dhenkanal36

Boudh34

Kendujhar34

Deogarh33

Kalahandi33

Sonepur29

Kandhamal28

Anugul26

Malkangiri20

Bargarh16

Koraput16

Sambalpur16

Jharsuguda8

Nabarangpur2

Rayagada2

3,55,353 2,267

11,687 1,654

3,41,733 610

1,933 3

DistrictCases

Hyderabad2,475

Ranga Reddy183

Suryapet87

Jagitial77

Nizamabad76

MedchalMalkajgiri75

Mancherial43

YadadriBhuvanagiri40

Jogulamba Gadwal40

Vikarabad40

Nalgonda33

Warangal Urban32

Mahabubnagar30

Sangareddy26

Khammam26

Adilabad22

Nirmal21

Karimnagar17

RajannaSircilla16

Medak11

Kamareddy11

Mahabubabad10

Jayashankar Bhupalapally9

Nagarkurnool8

Kumuram Bheem Asifabad8

Jangoan8

Siddipet7

Peddapalli5

Bhadradri Kothagudem5

Warangal Rural4

Mulugu3

Narayanpet3

Wanaparthy1

3,38,045 3,307

27,861 2,402

3,08,396 897

1,788 8

DistrictCases

Gurugram2,950

Faridabad867

Sonipat404

Rohtak145

Palwal120

Jhajjar114

Karnal104

Hisar98

Ambala93

Panipat78

Nuh68

Bhiwani60

Rewari56

Kurukshetra55

Sirsa50

Kaithal48

Mahendragarh47

CharkiDadri43

Panchkula39

Fatehabad38

Jind38

Yamunanagar19

3,29,942 5,398

27,421 3,214

2,99,205 2,166

3,316 18

DistrictCases

Patna279

Bhagalpur266

Rohtas256

Khagaria253

Begusarai243

Madhubani199

Munger188

Jehanabad178

Katihar175

Darbhanga143

Samastipur139

Siwan139

PurbiChamparan138

Purnia135

Banka134

Buxar134

Nalanda123

Gopalganj123

Nawada122

Sheikhpura118

Gaya115

Kaimur (bhabua)105

Bhojpur103

Saran101

Muzaffarpur96

Saharsa88

Supaul87

Vaishali87

Madhepura82

Kishanganj75

Aurangabad75

Sitamarhi73

Lakhisarai72

Araria68

Pashchim Champaran57

Arwal52

Jamui47

Sheohar20

2,95,171 4,786

23,725 3,576

2,69,795 1,189

1,651 21

DistrictCases

Amritsar485

Jalandhar297

Ludhiana293

Tarn Taran163

Gurdaspur154

Hoshiarpur140

S.A.S Nagar137

Patiala132

Sangrur107

Shahid Bhagat Singh Nagar (Nawanshahr)99

Pathankot86

Rupnagar (Ropar)74

Faridkot74

Sri Muktsar Sahib71

Moga65

Bathinda60

Fatehgarh Sahib57

Fazilka53

Firozepur50

Kapurthala44

Mansa31

Barnala25

2,82,505 3,302

28,250 66

2,46,583 3,173

7,672 63

DistrictCases

Kamrup Metro276

Golaghat203

Nagaon143

Hojai89

Dima Hasao86

Karimganj85

Tinsukia84

Cachar80

Dibrugarh61

Hailakandi57

Lakhimpur57

Marigaon50

Dhemaji47

Kamrup42

Kokrajhar37

Dhubri30

Charaideo29

Barpeta28

Udalguri28

Sonitpur27

Jorhat24

Nalbari23

Darrang20

Sivasagar20

Goalpara19

Biswanath16

Baksa14

KarbiAnglong13

Bongaigaon12

Chirang6

West KarbiAnglong5

South SalmaraMancachar4

Majuli2

2,21,868 385

4,547 276

2,16,199 106

1,122 3

DistrictCases

East Singhbum170

Ranchi148

Hazaribagh110

Garhwa80

Ramgarh75

Koderma58

Simdega48

Dhanbad32

Gumla28

Palamu27

West Singhbhum21

SaraikelaKharsawan20

Giridih19

Bokaro16

Latehar14

Khunti10

Lohardaga8

Deoghar5

Dumka5

Pakur4

Jamtara2

Godda2

Chatra1

Sahebganj0

1,47,792 3,198

18,524 1,369

1,27,976 1,798

1,292 31

DistrictCases

Anantnag395

Srinagar300

Kulgam295

Baramulla271

Shopian255

Kupwara231

Bandipora175

Udhampur155

Ramban151

Jammu138

Budgam110

Pulwama108

Kathua53

Rajouri39

Ganderbal37

Poonch35

Doda27

Reasi26

Samba25

Kishtwar10

Mirpur0

Muzaffarabad0

1,41,736 1,086

9,390 709

1,30,304 372

2,042 5

DistrictCases

Dehradun370

Nainital323

Tehri Garhwal110

Haridwar94

Udam Singh Nagar83

Almora71

Champawat45

Pithoragarh43

Chamoli36

PauriGarhwal36

Bageshwar31

Rudraprayag30

Uttar Kashi24

1,14,024 1,953

10,770 1,417

1,01,461 523

1,793 13

DistrictCases

Hamirpur117

Kangra105

Una41

Solan32

Chamba29

Bilaspur21

Mandi21

Sirmaur11

Shimla10

Kullu4

Kinnaur2

Lahaul And Spiti0

72,319 925

6,929 660

64,242 252

1,148 13

DistrictCases

South Goa69

North Goa57

63,815 473

5,112 224

57,846 245

857 4

DistrictCases

Pondicherry111

Mahe4

Karaikal2

Yanam0

45,449 476

3,032 232

41,719 242

698 2

DistrictCases

Dhalai196

Sepahijala174

Gomati74

South Tripura53

Unakoti49

West Tripura45

Khowai24

North Tripura14

33,871 27

334 22

33,143 5

394

DistrictCases

Chandigarh313

31,985 421

3,371 1

28,210 417

404 3

DistrictCases

Churachandpur32

Kangpokpi26

Imphal West21

Thoubal18

Imphal East10

Tengnoupal9

Bishnupur7

Senapati6

Chandel5

Kamjong5

Ukhrul4

Jiribam3

Pherzawl3

Kakching2

Tamenglong2

Noney1

29,561 21

133 15

29,052 6

376

DistrictCases

Changlang31

Papum Pare8

Lohit3

Namsai2

West Siang1

East Siang1

Upper Siang1

Tawang1

PakkeKessang1

West Kameng0

Upper Subansiri0

Tirap0

Siang0

Shi Yomi0

Anjaw0

Lower Subansiri0

Lower Dibang Valley0

Longding0

Leparada0

KurungKumey0

KraDaadi0

Kamle0

East Kameng0

Dibang Valley0

Lower Siang0

16,912 10

64 9

16,792 1

56

DistrictCases

East Khasi Hills22

West Garo Hills5

South West Garo Hills4

North Garo Hills1

West Jaintia Hills1

West Khasi Hills1

East Garo Hills0

East Jaintia Hills0

Ribhoi0

South Garo Hills0

South West Khasi Hills0

14,485 98

363 93

13,971 5

151

DistrictCases

Dimapur20

Mon8

Kohima7

Kiphire3

Tuensang3

Peren2

Phek1

Longleng0

Mokokchung0

Wokha0

Zunheboto0

12,440 13

84 90

12,263 103

93

DistrictCases

Kargil77

LehLadakh43

11,278 208

1,051 200

10,095 7

132 1

DistrictCases

East District3

South District3

North District0

West District0

6,456 21

193 18

6,127 3

136

DistrictCases

South Andamans33

Nicobars1

North And Middle Andaman1

5,247 38

106 13

5,078 24

63 1

DistrictCases

Kolasib11

Aizawl10

Mamit8

Lawngtlai2

Lunglei2

Saitual1

Champhai0

Hnahthial0

Khawzawl0

Saiha0

Serchhip0

4,722 37

240 36

4,470 1

12

DistrictCases

Dadra And Nagar Haveli20

4,420 113

662 84

3,756 29

2

DistrictCases

Lakshadweep District0

845 12

98 12

746

1





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