As per the directives from the Department of Pharmaceuticals (D0P), the National Pharmaceutical Pricing Authority (NPPA) has withdrawn its controversial internal guidelines dated 29.5.14 which the national drug regulator had invoked to bring even non-scheduled drugs under price control.
It may be recalled that it was under this guidelines that the NPPA had brought prices of 108 non-scheduled formulation packs involving anti-diabetic and cardiovascular drugs under price control under Paragraph 19 of DPCO, 2013 on July 10 this year.
Ever since, the pharmaceutical industry in the country has been up in arms against the notification which it termed as a retrograde move by the NPPA that will adversely affect the growth of the pharma industry. The industry was also of the view that the NPPA had over-reached its powers by ringing even non-scheduled drugs under price control under Paragraph 19 of DPCO, 2013.
Paragraph 19 of DPCO, 2013, authorises the NPPA in extraordinary circumstances, if it considers necessary so to do in public interest, to fix the ceiling price or retail price of any drug for such period as it deems fit.
However, the fate of NPPA’s July 10 order is still hazy as the restrictions on NPPA’s powers are with prospective effect, and not with retrospective effect.
Meanwhile, two cases against the NPPA’s July 10 order filed by industry associations in Delhi and Mumbai high courts are still pending.