National Pharmaceutical Pricing Authority (NPPA) vide Office Memorandum dated January 09, 2018 has revised the format of Form-I for application of new drug under Para 2(a) of DPCO, 2013. All the manufacturers/ marketing companies shall comply with the following formalities and submit the information/ documents as mentioned below, alongwith the Form-l application for retail price fixation of new drug
1. Information as per Schedule-II, Form I of the DPCO, 2013.
a) Name of the formulation
b) Name and address of the manufacturer/importer
c) Name of the Marketing Company, if any
d) Composition as per label claimed and approved by Drug Control Authorities
e) Drugs Control Authority Permission Number and Date (copy to be enclosed)
f) Proposed date of commencement of production /import.
g) Type of formulation (Tablets/Capsules/Syrup/Injection/Ointment/Powder etc.)
h) Size of packs (10’s/100's/1 ml/2 ml/10 ml/5 gms/10 gms etc.)
i) Therapeutic category/use of the formulation
j) The Retail Price claimed for approval
k) Name of the scheduled drug/drugs proposed to be part of the new drug
l) Whether NPPA has already approved price of similar drug, if yes, the name of the company, S.O. number and the date.
m) Any other information relevant to the product and its process of manufacturing/packaging/ distribution.
2. Other information/documents to be provided under Paras (9), (20), (21) and (29) etc. of DPCO, 2013.
a) Status of drug category (a, b, c, d, etc.) as per the report of the Kokate Committee for FDC’s.
b) Status of drug as per Drug Technical Advisory Board.
c) Whether there is any proposal by the company to discontinue or reduce production of scheduled formulation already being manufactured by it under NLEM. 2015, which has been combined with the new drug or if the strength is proposed to be changed.
d) Provide details of quarterly production, sales, etc. in the last six quarters duly certified by CA/CMA for the scheduled drug component of the proposed new drug as per Form-III of IPDMS, if being made as per (C).
e) Joint undertaking between the manufacturer and marketer company for the new drug, duly attested by their respective authorized signatories (without any trade secret).
3. The manufacturers who have already submitted their applications-
a) But not compliant with these instructions may submit the remaining documents by January 16, 2018 to avoid rejection of their applications.
b) No proposal for retail price fixation of new drug shall be considered unless complete in all respects as per this OM in future
The revised format for application of new drug in Form-I is effective from January 09, 2018.
[F. No. 19(78)/2014/Div. II/NPPA]