LEGAL AND REGULATORY REGIME OF MEDICAL DEVICES IN INDIA

LEGAL PROVISIONS

1. Legal & Regulatory Regime of Indian Medical Device Sector:

1.1 The Drugs and Cosmetics Act, 1940, (“DCA”), together with Rules framed

thereunder, viz. Drugs and Cosmetics Rules, 1945 (“D&C Rules”) and the

Medical Devices Rules, 2017 (“MDR”) regulates the Indian medical device

sector, by governing their authorization, import, manufacture, distribution and

sale in India.

1.2 The MDR classifies medical devices into four classes as Class A (low risk), Class

B (low-moderate risk), Class C (moderate-high risk) and Class D (high risk).

1.3 Each manufacturing location requires a separate license for each Notified

Medical Device. The license for manufacturing a Class A or Class B device is

issued by the State Licensing Authority whereas the licensing to manufacture a

Class C or Class D device is issued by the Central Licensing Authority. Importing

a Notified Medical Device into India requires additional legal formalities,

including under the provisions of the Export and Import Policy of India.

1.4 The MDR regulates only certain categories of medical devices specifically

notified for regulation by the Ministry of Health and Family Welfare. At the time

of enactment of the MDR, only 15 categories of medical devices were regulated

under those rules. 14 additional medical devices were notified and included

within the regulatory framework in 2018 and 2019 with effect from different

points of time in 2019, 2020 and 2021.

Recent Amendments:

1.5 On 11th February, 2020, the Government of India gazetted two Notifications,

whereby (a) vide S.O. 648(E), in pursuance of Section 3(b)(iv) of DCA, a new

definition of medical devices was incorporated and (b) vide G.S.R. 102 (E), the

Medical Devices (Amendment) Rules, 2020 were issued.

1.6 By virtue of the above S.O. 648(E) issued by the Ministry of Health and Family

Welfare, which came into force on 1st April 2020, all medical devices were

effectively brought within the scope of the MDR (“Definition Notification”).

Rather than notifying each individual medical device, the Definition Notification

includes an expansive and catch-all definition of medical devices.

1.7 The Definition Notification defines a medical device as follows.

“All devices, including an instrument, apparatus, appliance, implant, material

or other article, whether used alone or in combination, including a software or

an accessory, intended by its manufacturer to be used specially for human

beings or animals which does not achieve its primary intended action in or on

human body or animals by any pharmacological or immunological or metabolic

means, but which may assist in its intended function by such means for one or

more of the specific purposes of ―

(i) diagnosis, prevention, monitoring, treatment or alleviation of any

disease or disorder;

(ii) diagnosis, monitoring, treatment, alleviation or assistance for, any injury

or disability;

(iii) investigation, replacement or modification or support of the anatomy or

of a physiological process;

(iv) supporting or sustaining life;

(v) disinfection of medical devices; and

(vi) control of conception.

1.8 By virtue of the above G.S.R. 102 (E) issued by the Ministry of Health and Family

Welfare, Medical Devices (Amendment) Rules, 2020 were published, stating

inter alia that Chapter IIIA of MDR (Registration of Certain Medical Devices) shall

be applicable to all devices notified under clause (b) of section 3 of the DCA

except the medical devices and devices specified in the Annexure of Eighth

Schedule of these Rules and further that those Medical devices shall be

registered with the Central Licensing Authority through an identified online

portal established by the Central Drugs Standard Control. Provided that

registration under this Chapter shall be on voluntary basis for a period of

eighteen months from the commencement of this Chapter, after which, it shall

be mandatory.

1.9 Rule 90 of MDR provides that the medical devices specified in the Eighth

Schedule shall be exempt from the provisions of these rules to the extent and

subject to the conditions specified in that Schedule. The Eighth Schedule lists

the following devices:

1. Disposable Hypodermic Syringes

2. Disposable Hypodermic Needles

3. Disposable Perfusion Sets

4. Substances used for in vitro diagnosis including Blood Grouping Sera

5. Cardiac Stents

6. Drug Eluting Stents

7. Catheters

8. Intra Ocular Lenses

9. I.V. Cannulae

10. Bone Cements

11. Heart Valves

12. Scalp Vein Set

13. Orthopedic Implants

14. Internal Prosthetic Replacements

15. Ablation Devices

16. Ligatures, Sutures and Staplers

17. Intra Uterine Devices (Cu-T)

18. Condoms

19. Tubal Rings

20. Surgical Dressings

21. Umbilical tapes

22. Blood/Blood Component Bags

23. Organ Preservative Solution*

24. Nebulizer (effective from 1 Jan.2021)

25. Blood Pressure Monitoring Device(effective from 1 Jan.2021)

26. Glucometer (effective from 1 Jan.2021)

27. Digital Thermometer (effective from 1 Jan.2021)

28. All implantable medical devices Equipment (effective from 1, April,2021)

29. CT Scan Equipment (effective from 1, April,2021)

30. MRI Equipment (effective from 1, April,2021)

31. Defibrillators (effective from 1, April,2021)

32. PET Equipment(effective from 1, April,2021)

33. X-Ray Machine (effective from 1, April,2021)

34. Dialysis Machine (effective from 1, April,2021)

35. Bone marrow cell separator (effective from 1, April,2021)

36. Disinfectants and insecticide specified in Medical Devices Rules, 2017

37. Ultrasound equipment (effective from 1, November, 2020)

1.10 The Medical Devices (Amendment) Rules, 2020, also amended the Eighth

Schedule. The amended Eighth Schedule provides that such exemption shall

cease after a period of thirty months for low risk - Class A devices and low

moderate risk - Class B devices and after a period of forty-two months for

moderate high risk – Class C devices and high risk – Class D devices, respectively

from the date of the notification.

1.11 The cumulative effect of these two notifications is that all medical devices will

be brought under the fold of quality and safety regulation from the effective

date of both these notifications – 1st April, 2020.

1.12 To allow manufacturers/importers of newly notified medical devices sufficient

time to ensure compliance with the MDR, the Health Ministry introduced a

temporary exemption from compliance requirements under the MDR. The

exemption commenced on 11th February, 2020, and extends for a period of 30

months for Class A and Class B devices and 42 months for Class C and Class D

devices (“Exemption Notification”). The exemption is conditional on

manufacturers/importers registering their devices on the Online System for

Medical Devices established by the CDSCO for this purpose.

Pricing

1.13 The Drugs (Prices Control) Order, 2013 (“DPCO”) regulates the prices of all

drugs and notified medical devices in India. Under the DPCO, prices of notified

medical devices are regulated in two categories:

i. Medical devices specified in the National List of Essential Medicines/First

Schedule to the DPCO (“Scheduled Formulations”); and

ii. Other notified medical devices (“Non-scheduled Formulations”).

1.14 The ceiling prices of Scheduled Formulations is fixed by the NPPA. The prices of

Non-scheduled Formulations are controlled indirectly.

1.15 As all medical devices in India are regulated from 1st April, 2020, they are

consequently subject to price control since then. The Exemption Period under

the MDR does not apply to price control as the prices of medical devices are

controlled under a different regulation than the MDR.

Regulatory Authorities governing medical devices

1.16 The following regulatory authorities have jurisdiction over medical devices in

India:

i. The Central Drugs Standard Control Organisation (“CDSCO”) headed by

the Drugs Controller General of India (“DCGI”) under the Ministry of

Health and Family Welfare

The CDSCO regulates import, manufacture, marketing and clinical trials

of drugs, biologics and medical devices for the entire territory of India.

Apart from co-ordination with state licensing authorities, the DCGI is

responsible for handling matters of: (a). import of all Classes of medical

devices; (b). manufacture of Classes C and D devices; (c). clinical

investigation and approval of investigational medical devices; and (d).

clinical performance evaluation and approval of new in vitro diagnostic

devices.

ii. State drug licensing authorities (‘SLAs”).

SLAs (who are the state-level Food and Drug Administration),

independently regulates manufacture and sale of drugs, biologics and

medical devices within the territory of that State. SLAs are responsible

for handling matters of: (a). manufacture (for sale or distribution) of

classes A and B devices; (b). licensing for sale, stocking, exhibition or

offer for sale or distribution of medical devices of all classes

In certain cases, there is an overlap of function between DCGI and SLAs.

In such cases, SLAs operate under the direction of DCGI.

iii. Gazetted officers authorised by the State Governments to enforce drug

advertising regulations.

iv. National Pharmaceutical Pricing Authority (“NPPA”) under the

Department of Pharmaceuticals (“DoP”).

NPPA fixes prices of certain essential drugs, biologicals and medical

devices for the entire territory of India. It monitors price movements of

other drugs, biologicals and medical devices to ensure that the prices do

not increase more than 10% year on year.

v. Controller of Legal Metrology (“Controller”)

Each State, through its Controller, regulates packaging and labelling of

medical devices. The Controller does not have jurisdiction over drugs

and biologicals.

2. Statutes governing Labelling requirements of Medical Devices (MDs)

2.1 The labelling of Notified Medical Devices is governed by the following statutes:

2.1.1 Drugs & Cosmetics Rules, 1945 (“D&C Rules”) & The Medical Devices

Rules, 2017 (“MDR”) – A Notified Medical Device must be labelled

according to specifications outlined in the MDR before it is sold or

distributed in India. It is permissible for importers to print the mandatory

declarations on a label and stick the label to the package. The MDR

prescribes the contents of the label to the package, such as name of the

medical device, name of manufacturer and address of manufacturing

premises, the details necessary for the user to identify the device and its

use, etc.

2.1.2 Legal Metrology Act (“LMA”) and the Legal Metrology (Packaged

Commodity) Rules, 2011 – The LMA and the Rules, notified under the

Legal Metrology Act, 2009, regulates the packaging and labelling of prepacked

commodities in India. Since 1st January, 2018, Notified Medical

Devices are required to bear additional declarations and particulars on

retail package as prescribed under the Legal Metrology (Packaged

Commodity) Rules, 2011.

2.1.3 Drug (Prices Control) Order, 2013 – It requires all manufacturers and

importers of Notified Medical Devices to declare the MRP on the label.

3. Analysis of Provisions for Labelling of MDs

3.1 Under D&C Rules & MDR

3.1.1 Rule 32 of D&C Rules provides that no drug shall be imported unless it is

packed and labelled in conformity with the rules in Parts IX and X and

further conforms to the standards laid down in Part XII provided that in

the case of drugs intended for veterinary use, the packing and labelling

shall conform to the rules in Parts IX and X and Schedule F.

3.1.2 Rule 96 of D&C Rules provides the Manner of Labelling of any Drug.

3.1.3 Rule 109 of D&C Rules provides specifically for Labelling of Medical

Devices:—The labelling of Medical devices shall confirm to the Indian

Standards Specifications laid down from time to time by the Bureau of

Indian Standards in addition to any other requirement prescribed under

the said rules.

3.1.4 MDR are applicable to devices notified from time to time under subclause

(iv), of clause (b) of section 3 of DCA. MDR provides that before

a Notified Medical Device is sold or distributed in India, it must be

labelled according to specifications outlined in the MDR.

3.1.5 Rule 44 of the MDR prescribes the contents of the label of medical

devices, such as name of the medical device, the details necessary for

the user to identify the device and its use, name of manufacturer and

address of manufacturing premises where the device has been

manufactured, statement as to the net contents (in terms of weight or

measure), license number, date of manufacture, date of expiry

(alternatively, its shelf life), applicable storing and handling conditions,

warnings and precautions, the batch number, as well as the

manufacturing license number under which it is manufactured (if

manufactured in India).

3.1.6 Imported products must display the import license number, name and

address of the importer, address of the actual manufacturing premises

and the date of manufacture. Medical devices that are manufactured for

export to other countries are exempted from certain labelling

requirements and are instead required to adopt the requirements of the

law to which the device is being exported.

3.1.7 The precise labelling requirements for medical devices under the MDR

are contained in Rule 44 of MDR for devices intended to be marketed in

India and Rule 45 of MDR contains exemption from labelling

requirements for export of medical devices.

3.1.8 Rule 46 of MDR states that with effect from 1st day of January, 2022, a

medical device, approved for manufacture for sale or distribution or

import, shall bear unique device identification, which shall contain

device identifier and production identifier.

3.2 Under LMA and Rules framed thereunder

3.2.1 LMA is an Act to establish and enforce standards of weights and

measures, regulate trade and commerce in weights, measures and other

goods, which are sold or distributed by weight, measure or number and

for matters connected therewith or incidental thereto.

3.2.2 Section 18 of LMA contains provisions for Declarations on pre-packaged

commodities. It mandates that - No person shall manufacture, pack, sell,

import, distribute, deliver, offer, expose or possess for sale any prepackaged

commodity unless such package is in such standard quantities

or number, and bears thereon, such declarations and particulars in such

manner as may be prescribed. It also mandates that any advertisement

mentioning of the retail sale price of a pre-packaged commodity should

also contain a declaration as to the net quantity or number of the

commodity contained in the package in such form and manner as may

be prescribed.

3.2.3 The Legal Metrology (Packaged Commodity) Rules, 2011, (“PCR”)

notified under the Legal Metrology Act, 2009, regulates the packaging

and labelling of pre-packed commodities in India. From January 1, 2018,

Notified Medical Devices are required to bear additional declarations

and particulars on the retail package as prescribed under the PCR. Like

the MDR, it is permissible for importers to print the mandatory

declarations on a label and sticker the label to the package. PCR applies

to medical devices in addition to the MDR.

3.2.4 Chapter II of PCR contains provisions applicable to PACKAGES intended

for RETAIL SALE. Rules 3 to 23 fall under Chapter II.

3.2.5 Rule 3 states that the provisions of Chapter II shall not apply to-

(a) packages of commodities containing quantity of more than 25

kilogram or 25 litre;

(b) cement, fertilizer and agricultural farm produce sold in bags

above 50 kilogram; and

(c) packaged commodities meant for industrial consumers or

institutional consumers.

3.2.6 Rule 4 of PCR provides for Regulation for pre-packing and sale etc., of

commodities in packaged form. It states that on and from the

commencement of these rules, no person shall pre-pack or cause or

permit to be pre-packed any commodity for sale, distribution or delivery

unless the package in which the commodity is pre-packed bears thereon,

or on a label securely affixed thereto, such declarations as are required

to be made under these rules.

3.2.7 Rule 6 of PCR provides for Declarations to be made on every package. It

states that every package shall thereon or on label securely affixed

thereto, a definite, plain and conspicuous declaration made in

accordance with the provisions of this chapter as, to common or generic

names of the commodity contained in the package and in case of

packages with more than one product, the name and number or quantity

of each product shall be mentioned on the package.

Under Rule 6, the following Declarations are to be made on every

package:

(a) the name and address of the manufacturer, or where the manufacturer is not the packer, the

name and address of the manufacturer and packer and for any imported package the name and

address of the importer shall be mentioned on every package.

(b) The name of the country of origin or manufacture or assembly in case of imported products

shall be mentioned on the package;

(c) The common or generic names of the commodity contained in the package and in case of

packages with more than one product, the name and number or quantity of each product shall

be mentioned on the package.

(d) The net quantity, in terms of the standard unit of weight or measure, of the commodity

contained in the package or where the commodity is packed or sold by number, the number of

the commodity contained in the package shall be mentioned.

(e) The month and year in which the commodity is manufactured or pre-packed or imported

shall be mentioned in the package.

(f) If a package contains a commodity which may become unfit for human consumption after a

period of time, the 'best before or use by the date, month and year' shall also be mentioned on

the label:

(g) the retail sale price of the package shall clearly indicate that it is the maximum retail price

inclusive of all taxes and the price in rupees and paise be rounded off to the nearest rupee or

50 paise;

(h) Where the sizes of the commodity contained in the package are relevant, the dimensions of

the commodity contained in the package and if the dimensions of the different pieces are

different, the dimensions of each such different piece shall be mentioned.

(i) such other matter as are specified in these rules:

3.2.8 Chapter III of PCR contains provisions applicable to Wholesale Packages.

Rule 24 thereunder states that every wholesale package shall bear

thereon a legible, definite, plain and conspicuous declaration as to:

(a) The name and address of the manufacturer or importer or where the

manufacturer or importer is not the packer, of the packer;

(b) the identity of the commodity contained in the package; and

(c) the total number of retail package contained in such wholesale

package or the net quantity in terms of standard units of weights,

measures or number of the commodity contained in wholesale package;

3.2.9 Chapter IV of PCR contains provisions pertaining to Export and Import

of Packaged Commodities. Rule 25 thereunder contains provisions for

restrictions on sale of export packages in India.

3.2.10 Chapter V of PCR contains provisions pertaining to Exemptions. Clause

(c) of Rule 26 exempted packages if it contains scheduled formulations

and non-scheduled formulations covered under the Drugs (Price

Control) Order,1995 made under Section 3 of the Essential Commodities

Act, 1955. However, by virtue of G.S.R. 629(E) dated 23rd June, 2017,

issued by the Ministry of Consumer Affairs, Food and Public Distribution

(Department of Consumer Affairs), Rule 26 was amended w.e.f.

01.01.2018 by inserting the following proviso:-

“Provided that no exemption shall be applicable to medical devices

declared as drugs”.

3.2.11 The impact of this amendment is that medical devices came under the

purview of PCR on and from 01.01.2018.

4. Penalties under LMA and PCR

4.1 Section 16 of LMA provides for Forfeiture of infringing package. It states that

every package made in contravention of section 18, used in the course of, or in

relation to, any trade and commerce and seized under section 15, shall be liable

to be forfeited to the State Government.

4.2 Section 36 of LMA provides for Penalty for selling, etc., of non-standard

packages. It states that whoever manufactures, packs, imports, sells,

distributes, delivers or otherwise transfers, offers, exposes or possesses for

sale, or causes to be sold, distributed, delivered or otherwise transferred,

offered, exposed for sale any pre-packaged commodity which does not conform

to the declarations on the package as provided in this Act, shall be punished

with fine which may extend to twenty-five thousand rupees, for the second

offence, with fine which may extend to fifty thousand rupees and for the

subsequent offence, with fine which shall not be less than fifty thousand rupees

but which may extend to one lakh rupees or with imprisonment for a term

which may extend to one year or with both. It further provides for a penalty in

the event of error in net quantity, which penalty shall be punishment with fine

of not less than ten thousand rupees but which may extend to fifty thousand

rupees and for the second and subsequent offence, with fine which may extend

to one lakh rupees or with imprisonment for a term which may extend to one

year or with both.

4.3 Section 48 of LMA provides for Compounding of offences. It inter alia states

that any offence punishable under section 25, sections 27 to 39, sections 45 to

47 of the LMA, or any rule made under sub-section (3) of section 52 may, either

before or after the institution of the prosecution, be compounded, on payment

for credit to the Government of such sum as may be prescribed.

4.4 Section 49 of LMA provides inter alia that where the offence is committed by a

company, it is only those persons who are specified in Clauses (a)(i) and (a)(ii)

who would be deemed to be guilty of the offence or, in other words, they would

be vicariously liable to be punished. However, even for such persons a succor is

provided under the proviso to sub-section (1) to establish and prove that the

offence alleged to have been committed by the company was without his/her

knowledge and he/she had exercised all due diligence to prevent the

commission of such offence. In fact, sub-section (2) of Section 49 enables the

company to nominate a person to be in-charge of, and responsible to, the

company for the conduct of the business of the company and in the event of

such nomination having been made, it would be such person only who can be

arraigned as an accused. In other words, those persons who are not even

remotely connected to the conduct of the business of the company and not

being responsible for the conducting of day-to-day business of the company or

persons who are not in-charge of the company cannot be implicated as an

accused, merely because they are either the officer of the company or the

director of the company, as the case may be.

4.5 Rule 32 of PCR contains provisions of Fine for contravention of rules - Whoever

contravenes any provisions of these rules, for which no punishment is provided,

shall be punished with fine of five thousand rupees. Rule 32A specifies the sum

of compounding of offences committed under the Act in the Table thereunder.

Manoj

MnA Chambers