The Union Government has asked the Ministry of Environment, Forest and Climate Change (MoEFCC) to expedite the prior environmental clearance to projects or activities in respect of APIs/bulk drugs and intermediates.
The objective is to put a robust system to handle the novel coronavirus (COVID-19) outbreak in the country and ensure drug availability or production to reduce the impact of COVID-19.
The above consideration will be for the disease profiles which have symptoms similar to COVID-19 and it is for the period up to 30th September 2020.
This is an interim measure taken by the central government to ensure that all necessary projects or activities in respect of bulk drugs and intermediates manufactured for addressing ailments such as Coronavirus (COVID-19) and with similar symptoms have been categorised as B2.
Commenting on the government’s move, Dr Dinesh Dua, Chairman, Pharmexcil and Director, Nectar Lifesciences said, “Category B2 under EIA 1986, which consists of screening, scoping, public hearing and appraisal do not require the following stages, which are highly time consuming and inefficient leading to almost complete stagnation of API production for new projects and also to a large extent for old project expansion. Therefore, it’s a welcome notification. However, pharma bulk drug industry is assessing the interpretation by the State Pollution Boards to move further with new projects ”
As per the issued notification by the government, all proposals for projects or activities in respect of Active Pharmaceutical Ingredients (API) received up to the 30th September 2020 shall be considered under B2 category projects and any subsequent change, amendment or expansion in the product mix, after the 30th September will be considered as per the provisions in force at that time.
The notification mentions that the power conferred by subsection (1) and clause (v) of subsection (2) of section 3 of the Environment (Protection) Act,1986 (29 of 1986), the Central Government, as after having dispensed with the requirements of notice under clauses (a) of sub-rule (3)of rule 5 of the rule in public interest makes the amendments in the notification.
Besides this, the government of India has also set up of control room in the Department of Pharmaceutical (DoP) to coordinate transportation and other logistic services for essential services in India. The services can be available between 8 am to 6 pm on all days on helpline number 011-23389840 with an email address, helpdesk-pharma@gov.in. The control room at the NPPA can also be reached though another helpline number ie, 1800111255.
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