APPCB amends the process of granting CFE and CFO for manufacturing of Hydroxychloroquine

Apr 29, 2020 | by Avantis RegTech Legal Research Team

EHS Compliance

The Andhra Pradesh Pollution Control Board (APPCB) on April 17, 2020, has decided to amend the process of granting CFE (Consent for Establishment) and CFO (Consent for Operation) for manufacturing and formulation of Hydroxychloroquine in the state due to the COVID-19 outbreak. 

Therefore, the following amendments are made in the process of granting CFE and CFO to ensure the availability and production of Hydroxychloroquine to handle the COVID-19 pandemic: 

1. Any existing bulk drug unit and existing Hydroxychloroquine or its intermediates bulk manufacturing unit can start the formulation activity immediately.

2. The industry shall ensure that total production capacity including Hydroxychloroquine in bulk shall not exceed the consented production capacity of existing unit. Also, pollution load shall not exceed the quantities permitted in the existing CFE order issued by the Board.

3. The existing industries shall inform their intention on their letter head to the Member Secretary of the Board. The scanned copy of above request letter along with copies of CFE order and CFO order are to be sent to the Member Secretary through e-mail duly marking copy to the Jcee, UH-1; Jcee, UH-4; concerned Zonal Officer and concerned Regional Officer for record. 

4. That subsequently the industry shall apply for CFE / CFO of the Board along with EMP in 1 month through A.P. Single Desk Portal along with required CFE / CFO fee as per present practice. The CFE / CFO orders will be issued by the APPCB for a temporary period of 6 months as per the powers delegated by the Board. 

5. That environment clearance shall be obtained by the project exponent from the SEIAA, AP and apply for CFE of the Board. And CFO order will be issued after completion of construction of the plant.

6. That the existing or new industries shall submit the production details of all the products every fortnight to the concerned Regional Officer and Zonal Officer. 

This Circular shall remain in force till September 30, 2020.

[Circular No: 11/APPCB/CFE/RO-ZO/HO/2010]


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