The National Pharmaceutical Pricing Authority (NPPA) has asked the pharma companies, who have received prior price approval of the NPPA for launch of 'new drug', to submit compliance report within one month to prove that these new drugs do not fall in the category of prohibited drugs and have the approval of the Drug Controller General of India (DCGI).
The NPPA has so far approved retail price in respect of 112 'new drug' formulations, as defined under paragraph 2(u) of the DPCO 2013 for which applications were received in the Form I of Second Schedule to the DPCO 2013 subject to meeting all statutory requirements.
Accordingly, all applicant companies that have already received prior price approval of the NPPA for launch of a “new drug”, as defined under paragraph 2(u) of the DPCO 2013, are requested to submit compliance report within one month of the date of this notification to the effect that subject “new drug(s)” in question
does/ do not fall in the category of prohibited drug and has/ have the approval of the competent authority under the Drugs and Cosmetics Act 1940 and Drugs and Cosmetics Rules 1945 as reiterated in DCG(I)’s letter F.No. 4-01/2013-DG(Misc-13-PSC) dated 15.01.2013 failing which NPPA would be constrained to withdraw the respective retail price notification, the NPPA notice said.
Similarly, in respect of all pending applications received in Form-I of Second Schedule to the DPCO 2013 for which retail price is yet to be fixed, the applicant company has to submit an undertaking within 10 days of the date of this notification to the effect that the applied “new drug” possesses requisite approval of the competent authority and is not prohibited drug in terms of DCG(I)’s letter F.No. 4-01/2013-DG(Misc-13-PSC) dated 15.01.2013.
Failure to comply with this requirement will lead to automatic rejection of the application in question, and the applicant will not be able to launch the product in the market. Market launch and/ or sale of a “new drug”, as defined under paragraph 2(u) of the DPCO 2013 without prior approval of retail price by the NPPA or where such approval stands withdrawn shall not only attract recovery of overcharged amount along with interest and penalty but also prosecution under Section 7 of the Essential Commodities Act, 1955, NPPA chairman Injeti Srinivas in the order said.