Lok Sabha Question No. 5008 (UNSTARRED), answered on 2022-04-01
Subject: Good Quality Medicine
Ministry: CHEMICALS AND FERTILIZERS
Asked by: N.K. Premachandran

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

LOK SABHA UNSTARRED QUESTION NO. 5008 TO BE ANSWERED ON 01 st  April, 2022

## Good Quality Medicine

## 5008. SHRI N.K. PREMACHANDRAN:

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

- (a)  whether  the  Government  proposes  to  fix  the  price  of  medicines  used  for  treatment  of lifestyle diseases;
- (b) if so, the details thereof;
- (c) the details regarding the reasons for shortage of life saving medicines;
- (d) the details regarding the action taken for ensuring the availability of life saving medicines;
- (e)  whether  the  Government  proposes  to  include  more  medicines  in  the  list  of  essential medicines so as to provide the same in a fixed price and if so, the details thereof; and
- (f) whether the Government proposes to start/setup pharmaceutical companies exclusively for production of good quality medicines of Jan Aushadi and if so, the details thereof?

## ANSWER

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

(a) & (b): As per the extant provisions of Drugs Prices Control Order, 2013 (DPCO, 2013), the ceiling price of all scheduled formulations figuring in the National List of Essential Medicines (NLEM) issued by the Ministry of Health & Family Welfare (MoH&FW) are fixed by the National Pharmaceutical Pricing Authority (NPPA) under the Department of Pharmaceuticals (DoP). However, there is no separate categorization in the said NLEM about drugs for lifestyle diseases. The manufacturers of scheduled drugs are required to sell their products at a price equal to or lower than the ceiling price. Further, NPPA monitors the prices of non-scheduled drugs so as to ensure that increase in their Maximum Retail Price (MRP) is not more than 10% of what was prevalent during the preceding twelve months. The details of various medicines under price control are available at the website of NPPA, i.e., www.nppaindia.nic.in.

(c)  and  (d):  The  manufacturers  of  scheduled  formulations  are  required  to  submit  quarterly returns of production/ import of scheduled formulations and their bulk drugs/active pharmaceutical  ingredients  to  NPPA.  Whenever  shortage  is  reported  by  the  State  Drug Controllers or when the matter comes to the notice of NPPA, remedial steps are taken for ensuring availability of drug by impressing upon manufacturers to rush the stocks to the places of shortage.

(e): National List of Essential Medicines (NLEM) is notified and revised by MoHFW from time to time. Once notified by the MoHFW, NLEM is incorporated in the first schedule of DPCO  for  regulating  the  price  of  the  same.  The  details  of  the  price  fixed  by  NPPA  for medicines are available on the website of NPPA, i.e., www.nppaindia.nic.in.

(f): There is no such proposal under consideration of the Department of Pharmaceuticals. PMBI already follows a robust practice of procurement from WHO-GMP certified manufacturing plants and quality control for medicines sold through Janaushadhi Kendras.

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