Executive Summary:
The Ministry of Chemicals and Fertilizers addresses concerns regarding the high cost of lifesaving drugs for diseases such as cancer, diabetes, and cardiovascular conditions. It details measures to regulate and reduce prices, the role of the National Pharmaceutical Pricing Authority (NPPA), and the expansion of the National List of Essential Medicines (NLEM). The response also covers the availability of medicines through Jan Aushadhi Kendras and actions against pharmaceutical companies found overcharging.
Key Points / Main Content:
Drug Price Regulation:
* Prices of drugs in India are regulated by the Drugs Prices Control Order (DPCO), 2013.
* NPPA fixes ceiling prices for scheduled medicines listed in the First Schedule to DPCO, 2013.
* Ceiling prices are revised annually based on the Wholesale Price Index, effective April 1st each year.
* Manufacturers must sell products within the ceiling price plus local taxes.
* NPPA also fixes retail prices for new drugs (combinations, strength/dosage changes).
* DPCO, 2013 allows for price fixing in public interest during extraordinary circumstances and monitoring of non-scheduled drug price increases.
Specific Price Controls and Savings:
* NPPA has fixed ceiling prices for 930 scheduled formulations, including 131 anticancer, 11 antidiabetic, and 66 cardiovascular formulations.
* Average price reduction under NLEM 2022 was about 17%, saving patients approximately ₹3,788 crore annually.
* Retail prices of 3,482 new drugs are fixed (as of 14.7.2025), with 1,924 in antidiabetic, anticancer, and cardiovascular categories.
* Maximum retail prices of 22 diabetic and 84 cardiovascular non-scheduled medicines have been capped, saving patients approximately ₹350 crore annually.
* Trade margins of 42 non-scheduled anticancer medicines have been capped, reducing prices of 526 brands by about 50%, saving patients approximately ₹984 crore annually.
* Manufacturers cannot increase the MRP of non-scheduled formulations by more than 10% in 12 months.
* Details are available on NPPA's website www.nppa.gov.in.
National List of Essential Medicines (NLEM):
* The Standing National Committee on Medicines (SNCM) recommends drugs for inclusion in NLEM, considering safety, efficacy, availability, affordability, WHO's Essential Medicines List, national health programs, etc.
* The Ministry of Health and Family Welfare publishes NLEM, which is notified as the First Schedule to DPCO, 2013.
* SNCM reviews and revises NLEM periodically to address changing disease prevalence, treatment modalities, and risk-benefit profiles.
* Drugs under NLEM are categorized under therapeutic groups; no drugs are specifically categorized as "lifesaving."
Jan Aushadhi Kendras (JAKs):
* The Pradhan Mantri Bhartiya Janaushadhi Pariyojana offers 2,110 medicines and 315 surgical/medical consumables, covering major therapeutic groups.
* Almost all generic medicines included in NLEM, except lab reagents and vaccines, are included.
* The Pharmaceuticals and Medical Devices Bureau of India promotes the scheme through various media channels.
* As of 30.6.2025, 16,912 JAKs are open across the country, including 1,432 in Tamil Nadu, with specific numbers in Karur, Dindigul, Trichy, and Pudukottai districts.
Overcharging and Enforcement:
* From 1.4.2020 to 31.3.2025, NPPA initiated 436 overcharging cases and recovered ₹133.19 crore.
* Details of overcharging cases are available on NPPA's website www.nppa.gov.in.
Impact Analysis:
Pharmaceutical Manufacturers, Importers, and Marketers:
* Impact: Must adhere to ceiling prices fixed by NPPA for scheduled medicines and retail prices for new drugs. Subject to monitoring and potential penalties for overcharging.
* Action Required: Ensure compliance with DPCO, 2013, including selling scheduled medicines within ceiling prices, not increasing MRP of non-scheduled formulations by more than 10% annually, and cooperating with NPPA investigations.
Patients:
* Impact: Benefit from price controls on essential medicines, leading to reduced healthcare costs and increased affordability.
* Action Required: Utilize Jan Aushadhi Kendras for affordable generic medicines and be aware of maximum retail prices.
National Pharmaceutical Pricing Authority (NPPA):
* Impact: Responsible for fixing and revising ceiling prices, monitoring prices, and taking action against overcharging.
* Action Required: Continue to regulate drug prices, enforce DPCO, 2013, and update pricing information on the website.
Standing National Committee on Medicines (SNCM):
* Impact: Responsible for recommending drugs for inclusion in the NLEM.
* Action Required: Periodically review and revise NLEM to address changing disease prevalence and treatment modalities.
Key Entities Referenced
National Pharmaceutical Pricing Authority NPPA: The regulatory body in India responsible for price control of pharmaceuticals.
National List of Essential Medicines NLEM: A list of essential medicines considered important for healthcare needs in India.
Drugs Prices Control Order, 2013 DPCO, 2013: An order issued by the Government of India to regulate the prices of drugs.
Ministry of Chemicals and Fertilizers: The government ministry responsible for the chemicals and fertilizers sector in India.
Pradhan Mantri Bhartiya Janaushadhi Pariyojana: A scheme to make quality generic medicines available at affordable prices through Jan Aushadhi Kendras.
Tamil Nadu: A state in southern India, specifically mentioned in the context of medicine availability and Jan Aushadhi Kendras.
Jan Aushadhi Kendras JAKs: Retail outlets established under the Pradhan Mantri Bhartiya Janaushadhi Pariyojana to provide generic medicines.
Standing National Committee on Medicines SNCM: A committee consisting of stakeholders and experts, evaluates medicines and recommends drugs for inclusion in NLEM.
GOVERNMENT OF INDIA
MINISTRY OF CHEMICALS AND FERTILIZERS
DEPARTMENT OF PHARMACEUTICALS
LOK SABHA
UNSTARRED QUESTION NO. 3326
TO BE ANSWERED ON 8TH AUGUST, 2025
High Cost of Life Saving Drugs
3326. Ms. S Jothimani:
Will the Minister of CHEMICALS AND FERTILIZERS be pleased to state:
(a) whether the Government has taken note of the high cost of life-saving drugs for diseases
such as cancer, diabetes and cardiovascular conditions and if so, the measures taken to regulate
and reduce their prices;
(b) the details of drugs for the said diseases that are currently under price control by the National
Pharmaceutical Pricing Authority (NPPA) indicating the extent of reduction achieved in their
prices;
(c) whether the Government plans to expand the National List of Essential Medicines (NLEM)
to include newer life-saving drugs and make them affordable, if so, the details thereof;
(d) the status of availability of these medicines through Jan Aushadhi Kendras;
(e) whether there are gaps in supply or awareness, in the State of Tamil Nadu particularly in
Karur, Dindigul, Trichy and Pudukottai districts in this regards; and
(f) whether any pharmaceutical companies have been found overcharging for essential or
lifesaving drugs and if so the details thereof alongwith the action taken by NPPA in such cases
during the last five years?
ANSWER
THE MINISTER OF STATE IN THE MINISTRY OF CHEMICALS AND
FERTILIZERS
(SMT. ANUPRIYA PATEL)
(a) to (c): Prices of drugs in India are regulated as per the provisions of the Drugs (Prices
Control) Order, 2013 (“DPCO, 2013”). The National Pharmaceutical Pricing Authority
(NPPA) fixes ceiling prices of scheduled medicines specified in the First Schedule to DPCO,
2013. Further, as per the provisions of DPCO, 2013, the ceiling prices of scheduled medicines
are revised annually based on Wholesale Price Index (All commodities) for the preceding
calendar year, on or before the 1st of April of every year. All manufacturers, importers and
marketers of scheduled medicines are required to sell their products within the ceiling price
plus applicable local taxes. NPPA also fixes retail prices of “new drugs”, that is, formulations
launched by existing manufacturers of a medicine listed in NLEM by combining it with another
drug, or by changing the strength or dosage or both of such medicine. Further, DPCO, 2013
also provides for fixation of prices of drugs in public interest under extraordinary circumstances
and monitoring of price increase of non-scheduled drugs. Accordingly, prices of drugs,
particularly drugs for diseases such as cancer, diabetes and cardiovascular conditions are
regulated in the following manner:
(i) NPPA has fixed the ceiling prices for 930 scheduled formulations, including 131
anti-cancer, 11 anti-diabetic and 66 cardiovascular formulations. All manufacturers,importers and marketers of scheduled medicines are required to sell their products
within the ceiling price plus applicable local taxes. The average price reduction due
to fixation or refixation of prices under NLEM, 2022 was about 17%, resulting in
estimated annual savings of approximately ₹3,788 crore to patients.
(ii) Retail prices of 3,482 such new drugs also stand fixed as on 14.7.2025, of which 1,924
are in the anti-diabetic, anti-cancer and cardiovascular categories. The applicant
manufacturers and marketing companies are required to sell these drugs within the
said retail price.
(iii) Besides the above, the maximum retail price (MRP) of 22 diabetic and 84
cardiovascular non-scheduled medicines has been capped, resulting in estimated
annual savings of about ₹350 crore to patients.
(iv) Trade margin of 42 non-scheduled anti-cancer medicines have been capped, resulting
in reduction in prices of 526 brands of medicines by an average of about 50%, resulting
in estimated annual savings of about ₹984 crore to patients.
(v) For non-scheduled formulations, including for non-scheduled anti-diabetic, anti-
cancer and cardiovascular formulations, manufacturers are required to not increase
MRP of drugs launched by them by more than 10% during the preceding 12 months.
Details of prices fixed by NPPA are available on its website (www.nppa.gov.in).
The Standing National Committee on Medicines (SNCM), consisting of all stakeholders
and experts, carefully evaluates the relative safety, efficacy, availability and affordability of
medicines from each therapeutic class, consults all stakeholders and considers WHO’s
Essential Medicines List, drugs used in national health programmes, Indian Pharmacopoeia,
National Formulary, etc., to recommend drugs for inclusion in NLEM. Based on the said
recommendations, the Ministry of Health and Family Welfare publishes NLEM, which is
notified as the First Schedule to DPCO, 2013. SNCM reviews and revises NLEM from time to
time to address the issues of changing disease prevalence, treatment modalities, introduction of
newer medicines and identification of unacceptable risk-benefit profile as well as therapeutic
profile of medicine. Drugs under NLEM are categorised under therapeutic groups and no
categorisation of drugs as life-saving drugs is made.
(d) and (e): Under the Pradhan Mantri Bhartiya Janaushadhi Pariyojana scheme product basket,
2,110 medicines and 315 surgical, medical consumables and devices are available, covering all
major therapeutic groups, such as cardiovascular, anti-cancers, anti-diabetic, anti-infective,
anti-allergic and gastro-intestinal medicines and nutraceuticals. Almost all generic medicines
included in NLEM, except lab reagents and vaccines, are included in the scheme product
basket.
To spread awareness about the scheme throughout the country, including in the State of
Tamil Nadu, the Pharmaceuticals and Medical Devices Bureau of India, which is the scheme
implementing agency, regularly undertakes number of activities, including issuance of
advertisements in various modes, such as the print media, radio, television, mobile application,
cinema, hoardings, branding of bus queue shelters and buses, auto wrapping and television
screens at Common Service Centres, outreach through social media platforms and celebration
of Jan Aushadhi Diwas on the 7th of March every year.
As on 30.6.2025, 16,912 Jan Aushadhi Kendras (JAKs) have been opened across the
country under the scheme, of which 1,432 JAKs have been opened in the State of Tamil Nadu,
including 20 JAKs in Karur district, 40 in Dindigul district, 71 in Tiruchirappalli district and
32 in Pudukottai district.(f): During last five years, that is, during the period from 1.4.2020 to 31.3.2025, 436 cases of
overcharging have been initiated by NPPA and an amount of ₹133.19 crore has been recovered
from the companies concerned during the same period. Detailed list of overcharging cases
where demand notices have been issued is available on the website of NPPA
(www.nppa.gov.in).
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