150 Circular regarding pocdure for lot release of Human vaccine in view of prevailing COVID-19 pandemic 2020-Apr-03 454 KB

==> picture [426 x 488] intentionally omitted <==

----- Start of picture text -----<br> ) File No. X-11026/65/2020-8p<br>Government of indi<br>Directorate General of H ate<br>Central Drugs Stand ealth Services<br>ndard Control Organization<br>(BiologicalBi Division)<br>FDA Bhawan, Kotla Road,<br>New Delhi 110 002, India<br>CIRC LA Dated: alulrac<br>1. . TheThe Di Director, Central p<br>a: Al ZaneiSie dons pe a Sapte Kasauli, Himachal Pradesh-173204.<br>3. All Human Vaccine manufacturers a ee ene Sen<br>Farrin-cogardina,tc P for lot release of Human vaccine in view of prevailing COVID-19<br>References:<br>1. E-mail of domestic manufacturerdated 01.04.2020.<br>e Le ea letter to all port offices vide file no. DCGI/Misc/2020(101) dated<br>3. This Directorate’s order issued vide File No. X-11026/11/2017-BD dated 15.02.2017.<br>Sir/Madam,<br>i received‘ Witha representationreference to thefromsubjectdomesticcited manufacturerabove, this is ofto Humaninform thatVaccinethis Directoratewherein it hashas<br>been requested to grant permission for testing and lot release of Human vaccine on the basis<br>of internal quality system and approval of batch summary protocol by Central Drugs<br>Laboratory (CDL), Kasauli due to current situation of lock-down and constraints in supply<br>management due to COVID-19 pandemic situation in the country.<br>In this regard, the matter has been examined in light of requirements & availability of<br>essential Human vaccines in the country and it is decided that the manufacturer shall send<br>the samples as per usual procedures to CDL, Kasauli for evaluation when logistics are<br>restored. Till such time, CDL, Kasauli may carry out lot release activity for Human vaccines<br>manufactured domestically by review of summary lot protocol on case by case basis. The lot<br>release is subject to the condition that manufacturer shall forward summary lot protocol of<br>each batch/lot to CDL, Kasauli through e-mail along with certificate of analysis and an<br>undertaking that Human Vaccine released in the market shall be recalled in case of quality<br>failures. However CDL, Kasauli may not issue lot release certificate wherever it is of the<br>opinion that data is insufficient to take the decision. This procedure may be followed till the<br>situation returns to normal.<br>In order to ensure continued availability of vaccines, being an essential drug, and due<br>to the prevailing outbreak of COVID-19, lock down announced by Government of India,<br>logistic problem, man power problem at each level including laboratory, this order is being<br>issued in the public interest.<br>----- End of picture text -----<br>

Yours faithfully, \ — (Dr. V. G. Somani) Drugs Controller General (India)

• Copy to:

• 1. PPS to Directorate General of Health Services, Ministry of Health and Family Welfare. 2. PPSNirman to Bhawan, the Joint SecretaryNew Delhi (R),110Ministry011. of Health and Family Welfare, Nirman— Bhawar New Delhi110 011. tne