Lok Sabha Question No. 4650 (UNSTARRED), answered on 2026-03-20
Subject: Affordability of Medicines
Ministry: CHEMICALS AND FERTILIZERS
Asked by: Shri Adhikari Deepak Dev

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

LOK SABHA UNSTARRED QUESTION NO. 4650 TO BE ANSWERED ON THE 20 TH  MARCH 2026

## Affordability of Medicines

## 4650. Shri Adhikari Deepak Dev:

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

- (a)  the  initiatives  taken  by  the  National  Pharmaceutical  Pricing  Authority  to  ensure  the affordability of medicine;
- (b)  the  steps  taken  by  the  Government  to  end  Intellectual  Property  Rights  issues  arising between branded pharma companies and generic pharma companies; and
- (c) the steps taken by the Government to reduce revenue loss caused by Compulsory Licensing?

## ANSWER

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

## (SMT. ANUPRIYA PATEL)

- (a): The  National  Pharmaceutical  Pricing  Authority  (NPPA)  regulates  the  prices  of medicines  as  per  extant  provisions  of  DPCO,  2013.  NPPA  fixes  the  ceiling  prices  of formulations  specified  in  Schedule-I  to  DPCO,  2013.  All  manufacturers,  marketers  and importers of scheduled medicines are required to sell their products within such ceiling price (plus applicable local taxes). As on 18.3.2026, Ceiling prices of 935 formulations are effective.

NPPA also fixes retail prices of new drugs as defined in para 2(1)(u) of DPCO, 2013. As on 18.3.2026,  Retail  prices  of  3,702  new  drugs  are  fixed.  Further,  in  case  of  non-scheduled formulations, manufacturers are required to not increase their maximum retail price (MRP) of a formulation by more than ten percent of the MRP of that formulation during the preceding 12 months. In addition, NPPA also fixes the prices of drugs under Para 19 of the DPCO, 2013 in case of extra-ordinary circumstances and in public interest to ensure the availability of drugs at affordable prices which, inter alia, include the following:

- (i) MRP of 106 non-scheduled anti-diabetic and cardiovascular drugs were capped in 2014.
- (ii) Ceiling prices of coronary stents were fixed and notified on 13 th February, 2017 for the first time.
- (iii) Ceiling price of knee implants, which is one of the components under 'Orthopaedic Implants', was notified on 16 th August, 2017.
- (iv) A cap on Trade Margin of 42 selected non-scheduled anti-cancer medicines was put under 'Trade Margin Rationalization' approach, which brought down prices of 526 brands of anti-cancer medicines.
- (v) During  COVID-19,  the  price  of  Oxygen  Concentrators,  Pulse  Oximeter,  Blood Pressure  Monitoring  Machine,  Nebulizer,  Digital  Thermometer  and  Glucometer were regulated under 'Trade Margin Rationalisation' approach in June/July 2021.

Details of prices fixed or revised by NPPA are available on NPPA's website (www.nppa.gov.in). NPPA monitors the prices of drugs and instances of overcharging are dealt with as per the relevant provisions of DPCO, 2013.

(b): As informed by Department Promotion of Industry & Internal Trade (DPIIT), the Government has incorporated several safeguards under the provisions of the Patents Act, 1970 to maintain a balance between the interests of innovator pharmaceutical companies and  generic  manufacturers,  while  ensuring  access  to  affordable  medicines.  The  key measures are as under: -

- (i) Patent rights granted under Section 48 are private rights, providing the patent holder  exclusive  authority  to  prevent  others  from  making,  using,  selling  or importing  the  patented  product  without  consent.  Disputes  arising  from  such rights are adjudicated by competent courts, thereby providing a structured legal framework for resolving conflicts between innovators and generic manufacturers.
- (ii) Patent  applications  undergo  a  robust  two-stage  scrutiny  in  the  Indian  Patent Office. Under Sections 12 and 14, applications are first examined by a Patent Examiner for technical and legal compliance, including patentability criteria. The  findings  are  subsequently  reviewed  by  the  Controller  of  Patents,  and patents  are  granted  under  Section  43  only  after  due  consideration,  thereby ensuring quality and preventing grant of weak or frivolous patents.
- (iii) The Act provides a comprehensive opposition framework to safeguard public interest.  Pre-grant  opposition  under  Section  25(1)  allows  any  person  to challenge a patent before grant, while post-grant opposition under Section 25(2) enables interested parties to  contest a granted patent  within one year.  These provisions  allow  generic  manufacturers  and  other  stakeholders  to  challenge patents  not  meeting  statutory  requirements  of  novelty,  inventive  step  and industrial applicability, thereby reducing potential disputes.
- (iv) To  prevent  unjustified  extension  of  patent  monopoly,  Section  3(d)  restricts patentability  of  new  forms  of  known  pharmaceutical  substances  unless  they demonstrate enhanced  therapeutic efficacy. This ensures that  minor or incremental modifications cannot be used to prolong patent protection.

(c): As informed by DPIIT, the Patents Act, 1970 contains carefully designed safeguards to ensure that Compulsory Licensing (CL) is invoked only in exceptional circumstances, while protecting the legitimate interests of patent holders. The key provisions are as under:

- (i) Under  Section  84,  compulsory  licences  may  be  granted  only  when  specific conditions are fulfilled, such as non-availability of the patented invention at a reasonably affordable price, failure to meet the reasonable requirements of the public, or non-working of the patent in India. This ensures that CL is not granted arbitrarily.
- (ii) Under Section 90, the Controller of Patents determines the terms and conditions of the licence, including payment of reasonable royalty and remuneration to the patent holder. This balances public interest  with the commercial interests of innovators.
- (iii) Compulsory licences are granted only after detailed examination, hearing, and adherence to due process by the Indian Patent Office, ensuring transparency and fairness.

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