The environment ministry has urged all states and Union Territories to fast-track state-level pollution clearances for allowing bulk drug or key pharmaceutical ingredient manufacturers of the country to change their product mix to meet the country's demand requirements. The plea has come in the wake of India's over-dependence on China for raw materials to produce essential medicines.
The supply disruption caused by the outbreak of novel coronavirus (COVID 19) pandemic globally has increased the risk of India running out of bulk drugs needed to manufacture over a dozen medicines in the medium term. The ministry attempts to help manufacturers be better prepared to produce more categories of bulk drugs without procedural hurdles.
In a letter addressed to the chief secretaries of all states and administrators of Union Territories, CK Mishra, the Union Environment Secretary, sought their personal intervention to instruct state pollution control boards and other state-level authorities to speed up the issue of 'no increase in pollution load certificate' to pharmaceutical manufacturers to go ahead with their bulk drug manufacturing plans.
In January 2020, the environment ministry had permitted changes in raw material-mix, product-mix, change in quantities within products or number of products in the same category etc, up to 50 per cent increase in cumulative production by bulk drug manufacturing units without any fresh environment clearance certificate if there is no increase in the overall pollution load from respective state pollution control boards. In the wake of COVID-19 outbreak in the country, the ministry wants this to be facilitated by the states on a priority basis by issuing 'No Increase in Pollution Load' certificates to manufacturers who are keen to diversify their product outputs.
On March 11, the ministry had decided to extend 'out of turn' priority treatment to projects or activities in respect of bulk drugs and bulk drug intermediates as preparedness to the outbreak of COVID 19. It had asked the pollution control boards to ensure that drug availability and its production to reduce the impact of COVID 19 is given preference when it comes to environmental clearances.