The recent move by the Government of India, along with the Department of Pharmaceuticals (DoP), Niti Aayog and the Ministry of Environment, Forest and Climate Change (MoEFCC) to expedite environmental clearance for increase in cumulative production for upto 50 per cent of any projects related to active pharmaceutical ingredients (APIs) and drug intermediates has found favour with the Indian pharmaceutical industry. However, the industry is also expecting the government to consider a higher percentage.
However, on behalf of the pharma industry, a representative of the Indian Drugs Manufacturers Association (IDMA), recently made a presentation to the MoEFCC which pointed out that state governments have not been granted the aforementioned permissions to pharma companies despite the notification issued by the MoEFCC on January 16, 2020. The representative also highlighted that the notification clearly mentions that a change in raw materials mix or product mix, change in quantities within products or number of products in the same category, etc. is permitted upto 50 per cent increase in cumulative production, and they shall be exempted from the provision of prior environment clearance subject to no increase in pollution load certification from the State Pollution Control Board. Expressing concerns on the industry’s behalf, he cautioned that the delay in clearance will cause more challenges while the industry is already dealing with the Covid 19 pandemic and might lead to unavailability of certain drugs/APIs.
In response, the Ministry of Environment, Forest and Climate Change issued an office memorandum instructing all the States and Union Territories State Pollution Control Board to expedite the environmental clearance on March 13, 2020.
Commenting on this move, Mahesh H Doshi, President, IDMA, said, “This is the first step towards making Indian pharma industry self reliant in API and bulk drug manufacturing and will boost API production in India. Besides this, we are also in talks with the government for other initiatives which will be in favour of the industry.”
BR Sikri, Chairman, Federation of Pharma Entrepreneurs (FOPE), said, “The Indian pharma industry is thankful, and appreciates the move initiated by the government. If implemented immediately it will strengthen the domestic API industry. However, the industry also suggests that there should not be any cap on percentage, as it does not increase any pollution load of a respective unit.”
Commenting on the recent development, SV Veerramani, Chairman and Managing Director, Fourrts (India) Laboratories said, “It is a welcome move for API manufacturers. This will help to expand their product mix and reduce dependence on China. But it remains to be seen how fast the State Pollution Boards will give clearance. It would have been better if manufacturers are allowed to increase their production. So far, they are within the approved production load on self-regulation basis.”
The move has been taken to make the Indian pharma industry self-reliant of/for API and to reduce the impact of Covid-19 on drug supply chains in India. But, the notification does not mention that is a temporary move and hence the industry assumes that it is a permanent amendment.
The sources close to the development inform that the government is likely to agree to give permission to APIs and drug intermediates ‘Category’ wise instead of ‘Product’ wise. And, it is in the process of setting up its first API park in Telangana, as the land has been already identified and the construction work has initiated.