The Government of India has put in place a new system that will help it control the pricing and quality of medical devices in the country. The system works through laws, regulations, and government agencies. The aim of the system is to ensure that medical devices are accessible and of high quality. Controlling the price ensures that people are not overcharged, while quality regulations ensure that the products are safe.
The National Pharmaceutical Pricing Authority controls prices, and the Ministry of Health and Family Welfare controls quality and safety. Medical devices are now subject to drug laws, strengthening regulation. Digital systems, testing laboratories, and audits support this framework. These steps together help patients, hospitals, and manufacturers while maintaining trust in the healthcare system.

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Price Regulation of Medical Devices by NPPA

The National Pharmaceutical Pricing Authority works under the Department of Pharmaceuticals. This authority fixes the prices of medicines listed in the National List of Essential Medicines. These medicines are included in Schedule I of the Drugs (Prices Control) Order, 2013.
Manufacturers, marketers, and importers must sell scheduled medicines within the fixed ceiling price. Goods and Services Tax applies separately as allowed.
Four medical devices are included in Schedule I of DPCO, 2013. These devices include Bare Metal Stents, Drug-Eluting Stents (including metallic DES and Bioresorbable Vascular Scaffolds or Biodegradable Stents), Intrauterine Devices, and condoms. NPPA has notified ceiling prices for all these devices.
In addition to these scheduled devices, NPPA has taken action in the public interest. In August 2017, ceiling prices were fixed for orthopedic knee implants used in knee replacement systems. During June and July 2021, NPPA capped trade margins for COVID-essential medical devices. These devices included oxygen concentrators, pulse oximeters, blood pressure monitoring machines, nebulizers, digital thermometers, and glucometers.

Medical Devices Brought Under Drug Laws

The Ministry of Health and Family Welfare notified all medical devices as “drugs” under the Drugs and Cosmetics Act, 1940. This notification took effect on April 1, 2020.
Following this notification, the NPPA declared that the Drugs (Prices Control) Order, 2013, would govern all medical devices, effective from that date.
Non-scheduled medical devices are also monitored under Paragraph 20 of DPCO, 2013. Manufacturers of such devices cannot increase the maximum retail price by more than 10% over the previous 12 months.

Quality, Safety, and Performance Regulation of Medical Devices

The quality, safety, and performance of medical devices are regulated under the Drugs and Cosmetics Act, 1940, and the Medical Devices Rules, 2017. The Ministry of Health and Family Welfare administers these rules.
The Central Drugs Standard Control Organization regulates medical devices. This organization has taken several steps to improve and simplify medical device regulation in India. The key regulatory measures taken by the CDSCO are:

• The Medical Devices Rules, 2017, bring Indian regulations in line with the internationally accepted systems
• All medical devices are covered under the rules
• There is a single online interface for licenses and permissions
• The online interface enhances transparency and accountability
• Timelines are defined for faster processing of applications
• Class A non-sterile and non-measuring devices do not need manufacturing or import licenses
• Such Class A devices require only online registration
• Government medical device testing laboratories support quality testing
• Registered testing laboratories test devices for manufacturers
• Notified Bodies conduct audits for Class A and Class B manufacturing units
• Audits focus on compliance with Quality Management Systems

Testing Infrastructure for Medical Devices

The Medical Devices Rules include provisions to establish government medical device testing laboratories. Both central and state governments can notify such laboratories. Several government testing laboratories have already been notified. These laboratories test medical devices to ensure quality, safety, and performance.
Medical Device Testing Laboratories also operate on behalf of manufacturers. These laboratories are registered under the Medical Devices Rules and help manufacturers meet regulatory requirements. Testing infrastructure plays an important role in maintaining trust in medical devices available in the market.

Support Systems for Medical Device Manufacturers

The government has also created support systems for innovators and manufacturers. The MedTech Mitra portal was created with the support of ICMR and NITI Aayog.
This portal provides guidance and support to startups, innovators, and manufacturers. Support includes regulatory guidance, financial assistance, help with clinical studies, and support for the commercialization of medical devices.
Such handholding helps manufacturers understand regulatory requirements and bring devices to the market smoothly.

Government Schemes to Promote Medical Device Manufacturing

The government has taken steps to encourage domestic manufacturing of medical devices. These steps include the Production Linked Incentive scheme for medical devices. Another initiative promotes Medical Device Parks. These parks help manufacturers by providing shared infrastructure.
The Scheme for Strengthening the Medical Device Industry provides support in key areas. These areas include manufacturing of components and accessories, skill development, support for clinical studies, development of common infrastructure, and industry promotion.

Conclusion

India has established a structured system to regulate the pricing and quality of medical devices. NPPA controls prices under the Drugs (Prices Control) Order, 2013. Both scheduled and non-scheduled devices are also being monitored. The notification of medical devices as drugs has improved the regulatory system. The Drugs and Cosmetics Act, 1940, and the Medical Devices Rules, 2017, regulate quality and safety. The CDSCO is dealing with licensing, testing, and audits through electronic means and labs. Support schemes by the government promote local manufacturing. All these efforts combined ensure public health and affordability, as well as the development of the medical device industry in India.