Context: The government’s regulation to classify all Medical Devices as Drugs for the prime purpose of quality control and price monitoring.
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- It is based on ‘Report on Roadmap of Medical Devices’ released by the Ministry of Health & Family Welfare.
- The decision was taken after consultation with the Drugs Technical Advisory Board (DTAB).
- The 24 classes of medical devices have been notified/regulated as drugs under Drugs & Cosmetics Act, 1940 and Drugs & Cosmetics Rules, 1945.
- The ceiling price for the scheduled devices such as Cardiac Stents, Drug Eluting Stents, Condoms and IntraUterine Device (Cu-T) have been fixed.
- These 4 medical devices are under price control.
- Regarding non-scheduled medical devices which are notified/regulated as drugs, NPPA is currently monitoring Maximum Retail Prices (MRPs) under the DPCO, 2013 to ensure that the price increase by the manufacturer/importers does not breach the ceiling of ten percent in comparison to the preceding twelve months.
- Need for the Changes in rules
- The need for change in rules came in following media reports which brought to the fore the faulty hip implants marketed by pharma major Johnson & Johnson.
- Present State of Regulation
- Drugs fall under Concurrent List, in this regard, GOI enacted Drugs and Cosmetics Act, 1940.
- Further, some of the Medical devices were classified as drugs in 1982.
- Presently, only 23 categories of medical devices have been classified as drugs under Medical Devices Rules, 2017.
- Of these, only a few including cardiac stents, drug eluting cardiac stents,condoms, intrauterine devices, have been brought under price control.
- Existing Penal provisions
- There are various penal provisions under the Drugs and Cosmetics Act, 1940 for various kinds of offences.
- For manufacturing or sale of substandard items: punishable with imprisonment of at least 10 years, which may extend to imprisonment for life.
Drugs Technical Advisory Board (DTAB)
- It is the highest statutory decision-making body on technical matters related to drugs in the country.
- It is constituted as per the Drugs and Cosmetics Act, 1940.
- It is part of the Central Drugs Standard Control Organization (CDSCO) in the Ministry of Health and Family Welfare.
- The Central Drugs Standard Control Organisation (CDSCO) under Directorate General of Health Services, Ministry of Health & Family Welfare, Government of India is the National Regulatory Authority (NRA) of India.
- Under the Drugs and Cosmetics Act, CDSCO is responsible for
- Approval of New Drugs
- Conduct of Clinical Trials
- Laying down the standards for Drugs
- Control over the quality of imported Drugs in the country and
- Coordination of the activities of State Drug Control Organizations by providing expert advice with a view to bring about the uniformity in the enforcement of the Drugs and Cosmetics Act.
- CDSCO along with state regulators, is jointly responsible for grant of licenses of certain specialized categories of critical Drugs such as blood and blood products, Vaccine and Sera.
National Pharmaceutical Pricing Authority (NPPA)
It was constituted by the Government of India Resolution in 1997.
It is an attached office of the Department of Pharmaceuticals (DoP), Ministry of Chemicals & Fertilizers .
- It is an independent Regulator for pricing of drugs and to ensure availability and accessibility of medicines at affordable prices.
- NPPA fixes ceiling prices of Essential medicines that are listed in Schedule I of Drug Price Control Orders (DPCO), 2013.
National List of Essential Medicines
- NELM is a list of medicines,which are considered essential in India.
- It is prepared by the Ministry of Health and Family Welfare.
- It is an order that is issued under Section 3 of Essential Commodities Act, 1955 to regulate the prices of drugs.
- It provides a list of price controlled drugs, procedures for fixation of prices of drugs, method of implementation of prices fixed by Government, penalties for contravention of provisions etc.
- NPPA has been vested with powers for the purpose of implementing provisions of DPCO.
Drugs and Cosmetics Act, 1940 and Rules 1945
- It regulates the import, manufacture and distribution of medicines in the country.
- It Also ensures that drugs and cosmetics sold in India are safe, effective and conform to state quality standards.
- Entrusts various responsibilities to central & state regulators for regulation of drugs & cosmetics.
- The related Rules,1945 contains provisions for classification of drugs under different schedules and prescribes guidelines for the storage, sale, display and prescription of each schedule.
Medical Devices - About
- Classification of medical devices
- Currently, medical devices are classified under four categories.
- Class A and B medical devices are low-risk ones like surgical dressing, alcohol swabs, thermometers, blood pressure monitoring devices among others.
- Class C and D are high-risk devices like implants, hemodialysis catheters, angiographic guide wire and heart valve.
Regulatory Structure - The Medical Devices (Amendment) Rules, 2020
- It is applicable to devices which are intended for internal or external use in the diagnosis, treatment, mitigation or prevention of disease or disorder in human beings or animals.
- Even commonly used items including hypodermic syringes and needles, cardiac stents, perfusion sets, catheters, orthopaedic implants, bone cements, lenses, sutures, internal prosthetic replacements etc. too fall under the purview of it.
- Such devices are required to go for registration of these devices with the Central Licensing Authority.
- It calls for a voluntary registration within a period of 18 months from April 2020 and obtaining manufacturing/import licence under the Medical Device Rules within 36 and 42 months depending upon the category of devices.
- The notification also calls for re-categorization of all medical devices that are sold in the market.
- The medical devices are related to life support, diagnosis, treatment or alleviation of any disease or disability, and even devices that are used to disinfect other medical devices.
- Manufacturing, Import and Sale of medical devices need to be certified by CDSCO.
Case for New Rules
- Consumer Side
- It will ensure certain standards of quality and efficiency which is important given the ability of medical devices to save or take a person’s life.
- It will ensure Accountability related to Companies involved in the Medical Devices sector.
- For Economy
- Growth of Ancillary Industries.
- The regulations will bring the Industry in line with International Standards. It will further entail flow of FDI in this sector.
- In turn it will increase the export potential of the sector.
- It will create uniform standards for Industry.
- A regulator will ensure a lesser number of casualties owing to faulty devices, in turn reduction in litigation.
- NITI Aayog’s Concern over the proposal:
- One size does not fit all as the Medical Devices are not drugs: An MRI or a CT scan machine by no stretch of the imagination can be called a drug, and, so, continued attempts to regulate devices as drugs are illogical.
- The CDSCO’s specialization is in drugs that are chemical-based whereas the medical devices are purely technological inventions.
- There is no clinical trial system for devices like we have for medicines.
- The regulatory framework seems to be an overkill for those SMEs which are involved in manufacturing Low Risk, Low Cost devices such as Spectacles, Wheel Chair, Orthopaedic Belts.
- It will increase their operational cost. For e.g. It is not expected of a low cost manufacturer in Bhagirath making masks or neck bracing collars to hire a qualified QMS manager with biomedical engineering.
- Also the manufacturers are demanding that Medical devices should be categorised as Engineering Devices not drugs.
- Long Term Planning
- The Report on Roadmap of Medical Devices and the proposed NITI Aayog’s Medical Device Bill are of the view that the transition in regulatory structure should be smooth as any sudden transition may be disruptive.
- Operational Challenges
- Importers and Manufacturers are not defined properly. It will lead to difficulties in enacting the rules.
- There should have been differentiation in treatment of High Risk and Low risk devices.
- Fear of License Raj
- The Drugs Act is very rigid and prescriptive to the extent that it treats any non-conformity as a Criminal Offence.
- Also it would place the manufacturers at the discretion of the Drug Inspector and may end up at Court of law.
- Regulators should be empowered to ensure the implementation of rules and imposition of penal provisions in case of fallout.
- Decriminalisation of most of the activities (Non conformity) in the Drugs and Cosmetic Act.
- There should be proper emphasis on growth of the Low Cost, Low Risk Devices sector.
- Long term roadmap should be adhered to ensure a smooth regulatory structure.
- Even worldwide, these require simple basic precautions like labels for traceability and consumer protection.
Source: PIB, Rajya Sabha
Image Source: Times of India