Lok Sabha Question No. 728 (UNSTARRED), answered on 2025-02-07
Subject: Prices of Branded Drugs
Ministry: CHEMICALS AND FERTILIZERS
Asked by: Ms Sayani Ghosh

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

LOK SABHA UNSTARRED QUESTION NO. 728 TO BE ANSWERED ON 7 th  FEBRUARY, 2025

## Prices of Branded Drugs

## 728. Ms Sayani Ghosh:

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

(a)  whether  the  Government  is  considering  regulating  the  prices  of  branded  drugs  as recommended by experts, if so, the details thereof;

(b)  whether  the  Government  is  providing  any  incentives  to  pharmaceutical  companies  to develop  and  manufacture  orphan  drugs  for  rare  and  neglected  diseases,  if  so,  the  details thereof; and

(c)  whether  the  Government has taken note of the apprehensions of medical practitioners regarding the efficacy and safety of generic medicines, given that branded drugs have become unaffordable for the public, if so, the steps taken in this regard?

## ANSWER

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

(SMT. ANUPRIYA PATEL)

(a):  The  Department of Health and Family Welfare notifies the National List of Essential Medicines (NLEM), based on the report of the Standing National Committee on Medicines. The National Pharmaceutical Pricing Authority (NPPA) under the Department of Pharmaceuticals fixes ceiling prices under the provisions of Drugs (Prices Control) Order, 2013 (DPCO, 2013) in respect of the medicines included in NLEM, which are specified in Schedule-I to DPCO, 2013. Manufacturers of scheduled medicines (both branded and generic) are required to sell their products within the ceiling price (plus applicable Goods and Service Tax) fixed by NPPA. In addition, NPPA fixes the retail price of new drugs as defined in DPCO, 2013. The retail price of a new drug is applicable to the applicant manufacturer and marketer, who are required to sell the new drug within the price notified by NPPA. In case of non-scheduled  formulations,  a  manufacturer  is  at  liberty  to  fix  the  maximum  retail  price (MRP) of drugs launched by it. However, as per DPCO, 2013, a manufacturer is required to not increase MRP of a non-scheduled drug by more than 10% of MRP during the preceding 12 months. In addition to the above, the ceiling price of a drug may also be fixed under certain circumstances, in public interest. All price notifications for the formulations whose prices have been fixed by NPPA are available on its website (www.nppaindia.nic.in ) .

(b):  With  the  objective  of  enhancing  India's  manufacturing  capabilities  by  increasing investment and production in the pharmaceutical sector, the Department of Pharmaceuticals is  implementing  the  Production  Linked  Incentive  (PLI)  Scheme  for  Pharmaceuticals  to provide financial incentive for manufacturing product under identified product categories, which  include  orphan  drugs.  Under  the  scheme,  eight  orphan  drugs  for  treatment  of  rare diseases have been approved.

Further, under the Scheme for Promotion of Research and Innovation in the Pharma MedTech  Sector,  launched  by  the  Department  of  Pharmaceuticals,  provision  exists  for extending financial assistance to industries, MSMEs and startups for investing in research and development in identified priority areas, which include orphan drugs.

Moreover, DPCO, 2013 provides for exemption from its provisions for drugs used for treating orphan diseases as decided by the Ministry of Health and Family Welfare.

(c): The standards of quality and safety specified under the Drugs and Cosmetics Act, 1940 apply  equally  to  all  drugs  manufactured  in  the  country,  irrespective  of  whether  they  are generic or branded. As and when any complaints are received, the matter is referred to State Licensing Authorities, which are empowered to take action in respect of violations, for taking action as per the provisions of the Drugs and Cosmetics Act, 1940 and the Drugs Rules, 1945.

******