Lok Sabha Question No. 2221 (UNSTARRED), answered on 2025-12-12
Subject: Optimization of  Pharmaceutical Regulation
Ministry: CHEMICALS AND FERTILIZERS
Asked by: Shri Tatkare Sunil Dattatrey

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

LOK SABHA UNSTARRED QUESTION No. 2221 TO BE ANSWERED ON THE 12 th  DECEMBER 2025

## Optimization of Pharmaceutical Regulation

## 2221. Shri Tatkare Sunil Dattatrey:

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

- (a)  the  steps  being  taken  by  the  Government  to  ensure  efficient  monitoring  and  evaluation regarding compliance with pharmaceutical rules and regulation in the country;
- (b)  the  details  of  the  data  streams  from  the  pharmaceutical  sector  (such  as  pricing,  sales, prescription, research, etc.) that are combined and monitored by the Government; and
- (c) whether there are any plans to set up a unified body dedicated to monitoring and analyzing data from the pharmaceutical sector to better guide policy making and intervention, if so, the details thereof?

## ANSWER

## THE MINISTER OF STATE IN THE  MINISTRY  OF  CHEMICALS  AND FERTILIZERS

(SMT. ANUPRIYA PATEL)

(a): The National Pharmaceuticals Pricing Policy, 2012 has the objective of putting in place a regulatory  framework  for  pricing  of  drugs  with  a  view  to  ensure  availability  of  essential medicines at reasonable prices. The Drugs (Prices Control) Order, 2013 ('DPCO, 2013') has been  issued  based  on  the  principles  of  NPPP,  2012  and  is  implemented  by  the  National Pharmaceutical Pricing Authority (NPPA).

In  accordance with the provisions of DPCO, 2013, NPPA fixes ceiling prices of scheduled formulations, i.e. ,  medicines  included  in  the  National  List  of  Essential  Medicines  (NLEM) issued by the Ministry of Health and Family Welfare and incorporated in Schedule-I to DPCO, 2013. NPPA also fixes retail prices of new drugs as defined in DPCO, 2013. Further, in case of non-scheduled formulations, manufacturers are not permitted to increase the maximum retail price (MRP) of such formulations by more than 10% of MRP over a period of the preceding 12 months.

In addition, every manufacturer is required to issue a price list and supplementary price list in specified form to dealers, State Drugs Controllers and the Government, indicating reference to prices fixed or revised as aforesaid from time to time.

NPPA monitors compliance with DPCO, 2013 based on the references received from the Price Monitoring and Resource Units set up in States, State Drugs Controllers, NPPA's Pharma Sahi Daam  app,  samples  purchased  from  the  open  market,  reports  from  market  database and complaints lodged through various grievance redress channels. Appropriate action is initiated against  drugs  manufacturers  for  any  violations  after  examination,  in  accordance  with  the provisions of DPCO, 2013. Further, the Ministry of Health and Family Welfare has informed that regulatory control over manufacturing, sale and distribution of drugs is exercised through a system of licensing and inspection  by  State  Licensing Authorities  (SLAs)  appointed  by  State  Governments,  while regulatory control over drugs imported into the country is exercised by the Central Government through  the  Central  Drugs  Standard  Control  Organisation  (CDSCO).  Drugs  inspectors  are required to inspect the facilities licensed under the Act from time to time, with a view to verify compliance with the provisions of the Drugs and Cosmetics Act, 1940 and the rules made thereunder. Further, joint inspections of licensees are carried out by the drugs inspectors of CDSCO and States on a risk-based approach. (b): NPPA utilises market-based data such as pricing, sales, quantity, moving average turnover etc.  provided  by  third-party  agency.  It  analyses  and  monitors  the  data  to  perform  its  core functions of fixation of ceiling/retail price, monitoring, overcharging assessment and overall market surveillance under DPCO, 2013. (c): No such plan is currently under consideration.

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