In a booster dose, pharma industry gets 'green' signal in New Year

Drug makers allowed to tweak product mix or quantity without fresh environment clearance until effluent load is same

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.

Last year, the Indian Drug Manufacturers’ Association (IDMA) had approached the government for an exemption for bulk drug manufacturers from fresh clearances in the case of a change in product mix at existing manufacturing facilities. Following this, the matter was taken up by the Central Pollution Control Board (CPCB) and a final clearance was given by the MoEF.

Jayant Tagore, owner of Synthokem Laboratories and a member of the executive committee of the Bulk Drug Manufacturers’ Association of India, said, “This has been one of the long-standing demands of the industry and is much needed. The bulk drug industry is largely seen as polluting, and expansion of manufacturing units has been difficult,” he said. 

Ankleshwar in Gujarat was declared critically polluted in 2009 and there was a moratorium on setting up fresh units or expansion of existing ones till 2016. The Gujarat Pollution Control Board has initiated strict action after the NGT declared the two industrial estates of Ankleshwar and Panoli in Bharuch critically polluted in 2019.