(a) whether the National Pharmaceutical Pricing Authority keeps track of the
movement of non-scheduled drug, formulations;
(b) if so, the details thereof;
(c) whether the Government proposes to amend the Indian Patent Act, 1970 so as
to ensure sale of low cost medicines by the local drug makers;
(d) if so, the details thereof;
(e) if not, the reasons therefor; and
(f) the steps taken to ensure the availability of low cost essential drugs in the
country?
MINISTER OF STATE (INDEPENDENT CHARGE) IN THE MINISTRY OF
STATISTICS AND PROGRAMME IMPLEMENTATION AND MINISTER OF STATE IN
THE MINISTRY OF CHEMICALS AND FERTILIZERS (SHRI SRIKANT KUMAR JENA)
(a)to(f): A Statement is laid on the Table of the House.
STATEMENT REFERRED TO IN REPLY TO PARTS (a) TO (f) OF THE LOK SABHA STARRED Q.NO.54
(14 POSITION) FOR ANSWER ON 24.11.2011 REGARDING SALE OF LOW COST MEDICINES.
(a)&(b): Yes, Sir. In respect of drugs which are not covered under the Drugs
(Prices Control) Order, 1995 (DPCO, 95) i.e. non-scheduled drugs, manufacturers
fix the prices by themselves without seeking the approval of Government / National
Pharmaceutical Pricing Authority (NPPA). However, as a part of price monitoring
activity, NPPA regularly examines the movement in prices of non-scheduled formulations.
Wherever a price increase beyond 10% per annum is noticed, the manufacturer is asked
to bring down the price voluntarily failing which, subject to prescribed conditions,
action is initiated under paragraph 10(b) of the DPCO, 1995 for fixing the price of the
formulation in public interest. This is an ongoing process. Based on monitoring of prices
of non-scheduled formulation, NPPA has fixed prices in case of 30 formulation packs under
para 10 (b) and companies have reduced price voluntarily in case of 65 formulation packs.
Thus in all, prices of 95 packs of non-scheduled drugs have got reduced as a result of
the intervention of NPPA.
(c): No, Sir.
(d): Does not arise.
(e): The Indian Patents Act, 1970 (as amended in 2005) effectively balances and calibrates
Intellectual Property protection with public health concerns while meeting India`s international
obligations under the Agreement on Trade Related Intellectual Property Rights (TRIPS). The
Patent Law utilizes the flexibilities available within the TRIPS Agreement to address concerns
relating to public health and prevent misuse of rights by patent holders.
(f): The Department of Pharmaceuticals has launched `Jan Aushadhi Campaign` with the objective
of making available medicines at affordable prices for all. Under this campaign less priced
quality unbranded generic medicines are made available through Jan Aushadhi Stores. Till date
113 Jan Aushadhi Stores have been opened in different States/UTs in the country.
Further, the Department of Pharmaceuticals has prepared a draft National Pharmaceutical
Pricing Policy 2011(NPPP-2011) based on the criteria of essentiality and requirements as
stipulated by the Ministry of Health & Family Welfare. The draft NPPP-2011 has been circulated
among the concerned Ministries/Stakeholders. The draft Policy envisages bringing the National
List of Essential Medicines (NLEM) -2011 and associated medicines under price control.