NIB Noida Notified as an Additional Facility for Covid-19 Vaccine Management – Eshwars
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NIB Noida Notified as an Additional Facility for Covid-19 Vaccine Management

Authored by Ammu Brigit

Under the Drugs and Cosmetics Act 1940 (DCA) and Drugs and Cosmetics Rules 1945 (DCR), the Central Drug Laboratory (CDL) is designated with the responsibility of analysing and testing the samples of drugs as sent to it, and to carry out other functions entrusted to it by the Central Government or by a State Government after consultation with Drugs Technical Advisory Board. Central Drug System Control Organisation (CDSCO) has recognised seven CDLs which are in Kolkata, Mumbai, Guwahati, Chandigarh, Kasauli, Hyderabad and Chennai along Indian Veterinary Research Institute, Ghaziabad, National Institute of Biologics Noida (NIB Noida) and Indian Pharmacopoeia Commission, Ghaziabad.

Out of these, CDL Kasauli, Himachal Pradesh  is responsible for the testing of the vaccine, and  National Institute of Biologics, Noida (NIB Noida), an autonomous institute under the control of Ministry of Health and Family Welfare (MoHFW) is responsible to  carry  out the function of the CDL in respect of blood grouping reagents and diagnostic kits for HIV, Hepatitis B surface antigen, and Hepatitis C Virus pursuant to Rule 3 of DCR.

Since the outbreak of Covd-19, CDL Kasauli has been undertaking the evaluation of vaccine for Covid-19 as instructed by Central Drug System Control Organisation (CDSCO). Recently, MoHFW vide a notification dated 24th November 2020 (Notification) has decided that NIB Noida will act as an additional facility to perform the functions of the CDL with respect to Covid-19 vaccines along with its existing functions.

The Director of NIB Noida shall perform the functions of the Director of CDL in relation to Covid-19 vaccine. MoHFW has notified NIB Noida as a CDL with respect to Covid-19 vaccine  by  MoHFW after the consultation with Drug Controller of India and by exercising its power under DCA and DCR to prescribe the functions of CDL to any laboratory with respect to any drug or class of drug(Section 6) and to regulate or restrict the manufacture, sale or distribution of a drug which is essential to meet the requirement of an emergency and which is expedient and necessary for public interest(Section 26B).

This Notification was released by MoHFW in the wake of Covid-19 to regulate the testing and supply of Covid-19 vaccine and shall remain effective till 30th November 2021.

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