Faster green clearances to Pharma companies to overcome possible shortage of drugs during COVID-19 outbreak

NEW DELHI: In order to help overcome any possible shortage of raw materials in medicine formulations in the wake of coronavirus (COVID-19) outbreak, the Centre has decided that projects or activities relating to bulk drugs be considered out of turn and environmental clearances to be issued in this regard at the state level to expedite any such approval which may relate to pollution, effluent discharge or animal trials by pharma companies.
The move comes in the wake of certain concerns over possible shortage of some key medicines after coronavirus outbreak in China which is the major supplier of ‘active pharmaceutical ingredients (API) and bulk drugs intermediates to India. The decision will ensure drug availability in the country without any disruption.
"The decision, which is in line with ease of doing business, will enable project proponents relating to APIs to get Environmental Approvals at State level itself instead of (at) the Centre. This decision has also been taken to prevent any possible disruption in supply of APIs in India,” tweeted Union environment minister Prakash Javadekar on Tuesday.
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This changed clearance provision will be effective till September 30.
Faster environment clearances are meant to help Indian pharma companies to revive APIs production in local units in the wake of lockdown in China.
“In order to ensure drug availability/production to reduce the impact of the outbreak of Novel Coronavirus (COVID-19) and to improve overall preparedness of drugs, the ministry hereby directs projects or activities in respect of Bulk drugs (API and bulk drug intermediates) shall be considered out of turn and clearances shall be issued expeditiously,” said environment ministry in its office memorandum (OM).
The OM has been sent to the Central Pollution Control Board, Expert Appraisal Committee and pollution control boards in all states and Union Territories.