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Challenges faced by bulk drug manufacturers in India
Last Updated: 07-Jun-2018
India produces over 1/5th of bulk drug production in the world. However, the bulk drugs manufacturers are facing regulatory hurdles in many area. Currently, irrespective of pollution load, change in product mix have to be notified with Ministry of Environment and has to be approved by them. There are many cases, where there may be drop in pollution load because of change in product mix, but the company has to spend over 6 months to get approval. Besides, the effluent treated out of the company has to be mandatoriy treated again in Common Effluent Treatment plants of same standard. This increases cost and capital expenditure. In global export scenario, Chinese are proactive to tweak regulation to suit their interest, while India takes more time. No wonder, we import more than 60% of our bulk drug requirement from China.