Health Ministry Issues Regulatory Pathways For Foreign-Produced COVID-19 Vaccines | News
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.
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.
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.
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.
(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 (Water, Sanitation 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 pollution, waste management, plastic ban, manual 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 |