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Prior price approval mandatory for scheduled drugs


New Delhi : The government has referred 39 cases to state drug controllers to prosecute firms selling scheduled drugs without securing the mandatory approval of their prices, Minister of State for Chemicals Srikant Jena said Friday.

In a written reply to a question on pricing of scheduled drugs in the Rajya Sabha, Jena said it was mandatory to have prior price approval for any scheduled drug or any medicinal formulation having a scheduled category chemicals as its ingredient.

“It is mandatory on part of manufacturers to get prior price approval for medicinal formulations from the National Pharmaceuticals Pricing Authority (NPPA) if even one ingredient belongs to the scheduled category under Drug Price Control Order (DPCO),” said Jena.

He said as and when the cases relating to sale of the scheduled medicinal formulation without prior price approval were brought to the notice of NPPA, action was taken on a case-to-case basis.

The actions include seeking explanations from the defaulting companies and fixation of price of such formulation as per relevant legal provisions, the minister said.

He added that the NPPA had referred 39 cases to the various state drug controllers for taking appropriate action against the companies violating the rules.