In what can be a game changer for the Indian pharmaceutical industry, the Ministry of Environment and Forests (MoEF) has cleared a proposal to allow drug manufacturers to tweak their product mix or raw materials used without a fresh environmental clearance as long as their pollution load remains constant. The move is expected to bring much sought-after relief for bulk drug makers, and the industry feels it can trigger fresh investments worth Rs 10,000 crore every year for the next few years.
According to government sources, a notification is expected soon. “Earlier, clearance was required for any change in raw materials or product mix or change in quantities within products or number of products in the same category for which approval had been granted. Now, this has been given a waiver, provided there is no increase in pollution load and the increase in production capacity is not more than 50 per cent of the production capacity permitted in the earlier environmental clearance,” said a source.
Such clearances used to take four to eight months, according to the industry estimates. Following the latest decision, drug companies will only have to obtain a ‘no increase in pollution load’ certificate from the state pollution control board concerned for any expansion, the official added. This would mean ease of doing business and companies will be able to respond to market opportunities faster.
The Department of Pharmaceuticals (DoP) has been pursuing the issue with the environment ministry for some time. “It is a significant step in the right direction and will help the local drug industry. We are very happy that the MoEF considered the industry’s request,” P D Vaghela, secretary, DoP, said.-Business Standard