Lok Sabha Question No. 2176 (UNSTARRED), answered on 2023-12-15
Subject: Drug Price Control Mechanism
Ministry: CHEMICALS AND FERTILIZERS
Asked by: Gajanan Chandrakant Kirtikar

## GOVERNMENT OF INDIA MINISTRY OF CHEMICALS & FERTILIZERS DEPARTMENT OF PHARMACEUTICALS

LOK SABHA UNSTARRED QUESTION NO. † 2176 TO BE ANSWERED ON 15 th  December, 2023

## Drug Price Control Mechanism

## †2176. SHRI GAJANAN KIRTIKAR:

Will the Minister of CHEMICALS AND FERTILIZERS be pleased to state:

- (a) whether life-saving drugs and some other drugs are being sold at very high prices due to its shortage in the country;
- (b) if so, the details thereof along with the percentage rise in the price of each of the medicines; (c) the steps taken/proposed to be taken by the Government to ensure that the prices of the said drugs are maintained within affordable limit in the country;
- (d) whether the Government has laid down any criteria to maintain the minimum stock of lifesaving drugs in the country and if so, the details thereof;
- (e)  whether  the  Government  has  constituted/  proposes  to  constitute  any  high-powered committee to review the drug price control mechanism in the country and if so, the details thereof; and
- (f) the steps taken/proposed to be taken to strengthen research and development in this regard so as to explore the possibility of low cost production of drugs in the country?

## ANSWER

## MINISTER OF STATE IN THE MINISTRY OF CHEMICALS & FERTILIZERS (SHRI BHAGWANTH KHUBA)

(a) to (c): The essential medicines included in the National List of Essential Medicines (NLEM) published by the Ministry of Health & Family Welfare (MHFW) are included in Schedule-I of the Drugs (Prices Control) Order, 2013 (DPCO, 2013) and their ceiling prices are fixed by the National Pharmaceutical Pricing Authority (NPPA) under the Department of Pharmaceuticals (DoP).  No manufacturer can sell these medicines at a price more than the ceiling prices fixed by the NPPA. No reports have been received recently by NPPA regarding the selling of drugs at high prices due to shortage in the country.

- (d):   As  per  the  extant  provisions  of  DPCO,  2013,  to  achieve  adequate  availability  and  to regulate the distribution of drugs, in case of emergency or in circumstances of urgency or in case of non-commercial use in public interest, Government can direct any manufacturer of any active pharmaceutical ingredient (API) or bulk drug or formulation to increase the production and  sell  such  API  or  bulk  drug  to  such  other  manufacturer(s)  of  formulations  and  direct formulators to sell the formulations to institutions, hospitals or any agency as the case may be.
- (e): As per its mandate, the NPPA, a body of experts, controls/ regulates the prices of medicines in accordance with the provisions of DPCOs.

(f): R&D in the Pharma sector is undertaken by several institutions and organizations under various scientific ministries/ departments. Department of Pharmaceuticals (DoP) has notified a National Policy on Research & Development and Innovation in Pharma-MediTech Sector in India on 18.8.2023 to encourage R&D in pharmaceuticals and medical devices and to create an  ecosystem  for  innovation  in  this  sector.  Further,  DoP  has  also  notified  the  Scheme  for Promotion of Research & Innovation in Pharma sector (PRIP) on 17.08.2023 with an outlay of Rs.  5000  Crore  for  a  period  of  5  years  i.e.,  2023-24  to  2027-28  with  the  objective  of transforming  Pharma  MediTech  sector  from  cost-based  to  innovation-based  sector  by strengthening research infrastructure in the country. In addition, DoP has set up seven National Institutes  of  Pharmaceutical  Education  &  Research  (NIPERs)  as  institutes  of  national importance, which besides imparting postgraduate and doctorate education, conduct high-end research in various pharma specializations.

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