Making stability data mandatory will be a huge burden on SMEs with respect to funds required, infrastructure and time. SMEs do not have so much funds to conduct stability data for each and every molecule. Specially, SMEs are in old molecules such as paracetamol, which is world proven. Therefore, there is no such need to have such a stipulation. I believe this order will hamper growth of SMEs and generics. Also, the exhibit batches will prove to be a huge burden on SMEs.
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