Under the exemption, notified by the Ministry of the Environment on Friday, all these proposals will be evaluated for fast green authorizations when putting activities related to ‘active pharmaceutical ingredients‘(API) in’ B2 ‘ category Projects.
Since category ‘B2’ projects do not require an environmental impact assessment or public hearings, drug manufacturers can obtain a quick green authorization. Flexibility can help domestic drug manufacturers to become self-sufficient in the manufacture of APIs that are used as raw materials to produce drugs.
“All project or activity proposals regarding active pharmaceutical ingredients, received from July 16, 2021 to December 31, 2021, will be evaluated as category ‘B2’ projects,” said the notification of the Law (of protection ) of the 1986 environment. At the same time, he clarified that all those projects / activities after December 31 would be considered according to the provisions in force at that time.
The ministry in its notification justified the liberal approach by granting green authorization due to the existing Covid-19 threat. He said: “The Center deems it necessary to provide another (exemption) window in view of the second wave of the Covid-19 pandemic and the continued requirement for rapid drug manufacturing.”
He noted that the ministry had received requests for a further extension of the time period beyond the previous one, which expired on March 30, as “there is an ongoing requirement to speed up drug manufacturing” in view of the outbreak of the second wave of the pandemic.
The regulations notified under the 1986 Act classify projects into three categories: category ‘A’ that must be evaluated by the ministry, category ‘B’ where the states must grant authorization, and category ‘B2’ that exempts the projects of EIA and public hearing.