Authority to examine discontinuation of medical devices on case-to-case basis
Through an recent office memorandum, Government of India, Ministry of Chemicals & Fertilizers, Department of Pharmaceuticals and National Pharmaceutical Pricing Authority (NPPA) has released the revised guidelines regarding discontinuation of scheduled formulations under para 21(2) of DPCO, 2013.
The notice states that the authority in its meeting held on 26.04.2017 has approved following addendum to the Revised Guidelines regarding discontinuation of scheduled formulations under para 21(2) of DPCO, 2013 to be inserted therein as para 4.6:
“The provisions of para 4.1- 4.5 above are applicable to scheduled formulations only. All Form-IV applications for discontinuation of medical devices which are part of the NLEM and Schedule-I of DPCO, 2013 shall be put up before the Authority. Such cases shall be examined on case-to-case basis”.
Attached is the notification regarding the same.