Definition of medical devices under the Drugs and Cosmetics Act, 1940.
Medical Devices per se do not have a separate and distinct definition under India Laws. Medical devices covered under the definition of “drug” as has been defined in the Drugs and Cosmetics Act of 1940 (Act) read together with the Drugs and Cosmetics Rules (Rules).
Section 3(b)(iv) of the Act includes certain devices under the definition of a Drug stating:
(iv) …such devices intended for internal or external use in the diagnosis, treatment, mitigation or prevention of disease or disorder in human beings or animals, as may be specified from time to time by the Central Government by notification in the Official Gazette, after consultation with the Board”.
As the above definition indicates, Medical Devices that are notified and identified so by The Indian Ministry of Health and Family Welfare (Ministry) have to be so identified and notified as a Drug under Section 3(b) (iv) of the Act.
Given the above, there is ambiguity regarding the regulatory regime applicable to devices that have not been so expressly classified. The but logical conclusion to draw therefore is that Medical Devices that are not classified as or do not fall under the definition of Drug as above, there is nothing under the Act pertaining to Medical Devices which would appear to hinder imports (into India) of Medical Devices that are not expressly identified and notified by the Government.
Central Drugs Standard Control Organization guidelines
The Central Drugs Standard Control Organization (CDSCO), part of the Directorate General of Health Services within the Ministry, is the regulator responsible for regulating medical devices in India. It is the responsibility of the CDSCO to monitor regulatory approvals granted Medical Devices in India and in furtherance of this purpose, the CDSCO has issued specific guidelines that pertain to certain identified devices primarily in the area of blood and blood products, IV fluids, vaccines and heart stents. The CDSCO has promulgated draft guidelines that identify a Common Submission Format for Import Licenses for medical devices in India. In addition, the CDSCO has also drafted a Guidance Document on the “Common Submission Format for Registration of Medical Devices in India”. While these are at best guidance documents, they may be considered as an outline of the pathway for future medical device regulation in the country, an indicative guidance regarding the direction which CDSCO is likely to take in establishing its import and registration requirements for medical devices in the future.
In addition to existing regulations and guidelines, there has been an attempt to amend the Act as well. In the proposed revisions to the Act, the Central Licensing Approval Authority, a branch of CDSCO, has been identified as the central approval authority for medical devices in India.
Registration and import licenses under the Act
Registration and import license are subject to the control of the Central Government. Registration and import licensure requirements under the Act are limited to Medical Devices that are included in the above noted classification as drugs. To the extent that a device is not identified and notified, it could be inferred that such Medical Device would not come under the definition of drug as under the act and as such regulatory requirement might not apply. It may however be noted that, if a device is, at a later date identified as a Medical Device, falling under the definition of the term “drug”, vide a Government notification to that effect, in such a scenario, the applicability (retrospective or prospective) of such notification would be based on the text of such notification and as such regulatory approval could very possibly be required at that time. There is usually a grace period given in case applicability of a notification is retrospective in nature.
Marketing and distribution licenses
Marketing and distribution licenses are subject either to the control of the State or Central Government, depending on specific circumstances.
Part VII of the Rules deals with licensure requirements for the “Manufacture for sale or for distribution of drugs other than homeopathic medicines.” Relevant licenses are applied for under Form 20 (Rule 61(1)) and Form 24(Rule 69(1) (c).
However, if a device does not fall within the category of devices that have been classified as a drug, it could very well be inferred that these requirements will not apply. However it may be kept in mind that if a device is, at a later date identified as a Medical Device hence falling under the definition of the term “drug”, vide a Government notification to that effect, in such a scenario, the prospect or retrospect applicability of such notification would be based on the text of such notification and as such regulatory approval could very possibly be required.
If a device is not included within the definition of a drug, the provisions of the Act and Rules would not apply as far as regulatory requirements under the Act and Rules are concerned.
If the proposed revisions to Schedule M-III result in enlarging the scope of the definition of Drug under the Act to include additional devices. The amendment proposes the following revision:
“For the purposes of this Schedule any instrument, apparatus, implement, machine, appliance, implant, in vitro reagent or calibrator, software, material or other similar or related article shall be deemed to be a Device under the meaning of Section 3 (b) (iv), which is:
- intended by the manufacturer to be used alone or in combination for human beings for one or more specific purpose(s) of;
- diagnosis, prevention, monitoring, treatment or alleviation of disease,
- diagnosis, monitoring, treatment, alleviation of or compensation for an injury,
- investigation, replacement, modification or support of the anatomy or of a physiological process,
- supporting or sustaining life,
- control of conception,
- disinfection of medical devices,
- providing information for medical or diagnostic purposes by means of in vitro examination of specimens derived from the human body;
- which does not achieve its primary intended action in or on the human body by pharmacological, immunological or metabolic means, but which may be assisted in its intended function by such means.”
However the above amendments will only be applicable if and when they are notified in the Official Gazette of India or otherwise form a part of a suitably titled Law.
The enlargement of the scope of medical devices falling within the category of drugs can at most be taken as indicative of where the government and the industry might be headed when it comes to regulations affecting Medical Devices in India.
Import of a device that is not identified and included under the definition of Drug under the Act and Rules would be subject to Indian Customs Laws and procedures. That said, it may also be kept in mind that a customs official, at the port of entry in India, could possibly exercise his powers of seizure and seize the imported item for want of more information as regards the regulatory status of the device at the time of import.