**Executive Summary**
This document, released by the Ministry of Chemicals and Fertilizers, Department of Pharmaceuticals, outlines the steps taken to regulate the pricing and quality of medical devices in India. It details the role of the National Pharmaceutical Pricing Authority (NPPA) in setting ceiling prices and the regulatory measures implemented by the Central Drugs Standard Control Organization (CDSCO). The information was provided on 03 FEB 2026.
**Key Points / Main Content**
* **Pricing Regulation:**
* NPPA fixes ceiling prices for medicines in the National List of Essential Medicines (NLEM) under the Drugs (Prices Control) Order, 2013 (DPCO, 2013).
* Manufacturers must sell these medicines within the ceiling price (plus applicable taxes).
* Specific medical devices (e.g., stents, IUDs, condoms) are included in Schedule-I to DPCO, 2013, with notified ceiling prices.
* Ceiling prices have also been fixed for orthopedic knee implants (August 2017) and trade margins capped for COVID-essential medical devices (June/July 2021).
* Non-scheduled medical device manufacturers cannot increase maximum retail price by more than 10% annually.
* **Quality and Safety Regulation:**
* All medical devices are regulated under the Drugs and Cosmetics Act, 1940 and Medical Devices Rules, 2017, administered by MoHFW.
* CDSCO has taken regulatory measures to streamline medical device regulation, including aligning with global regulatory standards.
* **Streamlined Regulatory Framework:**
* Medical Devices Rules, 2017 align regulatory mechanism with globally harmonized systems, bringing all medical devices under its purview.
* A single online portal facilitates license and permission granting, increasing transparency.
* Prescribed timelines are in place for licensing application processing.
* Class A non-sterile and non-measuring devices are exempt from manufacturing/import licenses, requiring only online registration.
* **Testing and Auditing:**
* Government Medical Devices Testing Laboratories are being notified/established by Centre/State.
* Medical Device Testing Laboratories for testing of medical devices on behalf of manufacturers have been registered under the said Rules.
* Notified Bodies, registered with CDSCO, audit Class A and Class B manufacturing units for Quality Management System (QMS) conformance.
* **Support for Innovation and Manufacturing:**
* The MedTech Mitra portal, created with ICMR and NITI Aayog, supports startups/innovators in regulatory guidance, financial assistance, and clinical studies.
* The Government encourages domestic manufacturing through Production Linked Incentive schemes and support for critical areas like manufacturing, skill development, clinical studies, and infrastructure.
**Impact Analysis**
**Stakeholder: Medical Device Manufacturers, Marketers and Importers**
* **Impact:**
* Subject to ceiling price regulations for scheduled medical devices.
* Must comply with quality, safety, and performance standards under the Drugs and Cosmetics Act and Medical Devices Rules.
* May need to adapt to a streamlined regulatory framework, including online licensing processes.
* **Action Required:**
* Adhere to ceiling prices set by NPPA.
* Ensure compliance with Medical Devices Rules, 2017.
* Utilize the online portal for licenses and registration.
* Participate in audits for QMS conformance.
**Stakeholder: Patients / Consumers**
* **Impact:**
* Potentially benefit from controlled prices of essential medical devices.
* Improved quality and safety of medical devices due to regulatory oversight.
* **Action Required:**
* No direct action required.
**Stakeholder: Startups / Innovators in Medical Devices**
* **Impact:**
* Increased support through the MedTech Mitra portal for regulatory guidance and financial assistance.
* **Action Required:**
* Utilize the MedTech Mitra portal for support.
* Explore government schemes for domestic manufacturing.
**Stakeholder: Government (MoHFW, NPPA, CDSCO)**
* **Impact:**
* Enhanced regulatory control over medical devices.
* Increased administrative efficiency through streamlined processes and online portals.
* **Action Required:**
* Enforce pricing regulations through NPPA.
* Administer quality and safety regulations through CDSCO.
* Maintain and improve the online licensing portal.
* Support domestic manufacturing through incentive schemes.
Key Entities Referenced
Drugs (Prices Control) Order, 2013 (DPCO, 2013): Order that regulates the prices of medicines and medical devices included in the National List of Essential Medicines (NLEM).
Drugs and Cosmetics Act, 1940: Act that regulates the quality, safety, and performance of all Medical Devices.
Medical Devices Rules, 2017: Rules that streamline the regulation of Medical Devices.
National Pharmaceutical Pricing Authority (NPPA): Authority under the Department of Pharmaceuticals responsible for fixing ceiling prices of medicines and medical devices.
Central Drugs Standard Control Organization (CDSCO): Organization responsible for various regulatory measures to streamline the regulation of Medical Devices.
Ministry of Chemicals and Fertilizers :
Department of Pharmaceuticals
Steps to regulate the pricing and quality of
medical devices
Posted On: 03 FEB 2026 2:45PM by PIB Delhi
The National Pharmaceutical Pricing Authority (NPPA) under the Department of Pharmaceuticals (DoP)
fixes ceiling prices of 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 the Drugs (Prices Control)
Order, 2013 (DPCO, 2013). All manufacturers, marketers and importers of scheduled medicines are
required to sell their products within such ceiling price (plus applicable Goods and Service Tax).
Four medical devices, namely, Bare Metal Stents, Drug Eluting Stents (DES) including metallic DES and
Bioresorbable Vascular Scaffold (BVS)/Biodegradable stents, Intra Uterine Devices (IUDs) and condoms
are included in Schedule-I to DPCO, 2013 and ceiling prices have been notified for these four devices. In
addition to these four (04) scheduled medical devices, NPPA, in public interest, fixed and notified the
ceiling prices for Orthopedic Knee Implants for knee replacement system in August 2017 and capped the
trade margin of covid essential medical devices i.e. oxygen concentrators, pulse oximeter, blood pressure
monitoring machine, nebuliser, digital thermometer and glucometer in June/July, 2021.
Further, MoHFW through S.O.No.648(E) dated 11.02.2020 notified all the medical devices intended for
use in human beings or animals as ‘Drugs’ under the Drugs and Cosmetics Act 1940 w.e.f. 01.04.2020.
Accordingly, NPPA vide SO. No.1232(E) dated 31.03.2020 has notified that all medical devices shall be
governed under the provisions of DPCO, 2013 w.e.f. 01.04.2020. The non-scheduled Medical Devices are
also monitored under Para 20 of the DPCO, 2013 and manufacturers of such medical devices are required
to not increase the maximum retail price of that medical device by more than 10% of the maximum retail
prices during the preceding 12 months.
Quality, safety and performance of all Medical Devices are regulated under the provisions of Drugs and
Cosmetics Act, 1940 and Medical Devices Rules, 2017 administered by MoHFW. As informed by
MoHFW, the Central Drugs Standard Control Organization (CDSCO) has taken various regulatory
measures to streamline the regulation of Medical Devices. Such key measures are as under:
(i). In order to simplify and align medical devices regulation framework with globally accepted
regulation, Government has come up with Medical Devices Rules, 2017 aligning its regulatory mechanism
at par with globally harmonized regulatory system. Further, all the medical devices have been brought
under the purview of said rules.
(ii). A single unified online portal has been created to facilitate the granting of various licenses and
permissions under the said rules, ensuring greater transparency and accountability in the licensing process.
(iii). The rules also outline a prescribed timeline for licensing, ensuring the timely processing of
applications received by the Licensing Authority.
(iv). Class A Non-sterile and Non-measuring medical devices has been exempted from the requirement
of Manufacturing/Import licenses. Such devices require simple registration on the online portal.
(v). In order to have ecosystem for testing of medical devices for ensuring quality, safety, andperformance of such devices, provision to notify/establish Government Medical devices Testing
Laboratories by Centre/State has been incorporated and various Government Medical Testing laboratories
have been notified and Medical Device Testing Laboratories for testing of medical devices on behalf of
manufacturers have been registered under the said Rules.
(vi). Notified Bodies have been registered with CDSCO to carry out audits of Class A and Class B
medical device manufacturing units with respect to conformance to the Quality Management System
(QMS).
(vii). The MedTech Mitra portal has been created in coordination with ICMR and NITI Aayog to provide
handholding support to the startup / innovator / manufacturer in respect of regulatory guidance, financial
assistance, conducting clinical study, etc. for development of their devices and its commercialization.
The Government has taken measures to encourage domestic manufacturing of medical devices which,
inter alia, include Production Linked Incentive scheme for promoting domestic manufacturing of Medical
Devices; Scheme for Promotion of Medical Devices Parks; and Scheme for Strengthening Medical Device
Industry that provides support in critical areas of the medical device industry, covering manufacturing of
key components and accessories, skill development, support for clinical studies, development of common
infrastructure and industry promotion.
This information was given by Union Minister of State for Chemicals and Fertilizers, Smt. Anupriya Patel,
in a written reply in the Rajya Sabha today.
***
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