An insight into medical devices in India. Prepared in association with Nishith Desai & Associates, a leading law firm in India, this is an extract from The Pharma Legal Handbook: India, available to purchase here for GBP 75.
1. Who are the regulatory authorities governing medical devices in your jurisdiction?
The following regulatory authorities have jurisdiction over medical devices in India.
- The Drugs Controller General of India (“DCGI”)
- The Central Drugs Standard Control Organisation (“CDSCO”)
- State drug licensing authorities (also referred to as the state licensing authorities or SLAs).
- Gazetted officers authorised by the state governments to enforce drug advertising regulations.
- National Pharmaceutical Pricing Authority (“NPPA”).
- Department of Pharmaceuticals (“DoP”).
2. What is the regulatory framework governing the authorization, manufacture, import, pricing, sale, and advertisement of medical devices in your jurisdiction? Please provide a brief overview of the same.
The following legislations regulate medical devices in India.
Authorisation, Manufacture, Import and Sale
The Medical Device Rules, 2017 (“MDR”) is the primary legislation regulating authorisation, manufacture, import and sale of medical devices in India. The MDR is a set of rules framed under the Drugs and Cosmetics Act, 1940 (“D&C Act”) – India’s primary drug and medical device control legislation. The D&C Act (including the MDR) is enforced by the CDSCO at the central level and the SLAs at the state level.
The MDR is only applicable to the categories of devices notified for regulation under the MDR by the Ministry of Health and Family Welfare. 15 categories of devices were regulated under the MDR at the time of enactment on January 01, 2018. Since then, 14 additional categories have been notified to be regulated in a phased manner. 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).
On 11 February 2020, the Ministry of Health and Family Welfare published a notification (which came into force on 1 April 2020) effectively bringing all medical devices 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.
The Definition Notification defines a medical device as follows.
“Any device, 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 by pharmacological, immunological or metabolic means, but which can be assisted in its intended function by such means, for one or more of the following purposes:
- Diagnosis, prevention, monitoring, treatment or alleviation of any disease or disorder.
- Diagnosis, monitoring, treatment, alleviation of, or assistance for, any injury or disability.
- Investigation, replacement, modification or support of the anatomy or of a physiological process.
- Supporting or sustaining life.
- Disinfection of medical devices.
- Control of conception.
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 February 11, 2020 and extends for a period of 30 months for Class A and B devices and 42 months for Class C and D devices (“Exemption Notification”). The exemption commenced on 11 February 2020 and is conditional on manufacturers/importers registering their devices on the Online System for Medical Devices established by the CDSCO for this purpose.
Advertising and Promotion
The Drugs and Magic Remedies (Objectionable Advertisements) Act, 1954 (“DMRA”) regulates the advertisement and promotion of medical devices to consumers and healthcare practitioners.
The DMRA prohibits the advertisement of any medicinal product (including medical devices) in a way that suggests, or is calculated to lead to the use of that device for the:
- Procurement of miscarriage;
- Prevention of conception for women;
- Correction of menstrual disorders;
- Maintenance or improvement of sexual pleasure; and
- Diagnosis, cure, mitigation, treatment or prevention of any disease, disorder or condition specified in the Schedule to the DMRA (“Scheduled Disorders”).
The restrictions under the DMRA originally applied only to drugs, but the DMRA was later extended through judicial decisions to include medical devices as well. Nonetheless, advertisements of medical devices to HCPs on a confidential basis are permitted under the DMRA.
The DMRA also does not prohibit a medical device company from advertising its brand name publicly, provided the advertisement does not make any reference to a drug or medical device that can treat, diagnose, mitigate, cure a Scheduled Disorder.
Further, the Uniform Code of Pharmaceutical Marketing Practices (“UCPMP”) – a voluntary set of guidelines framed by the DoP – regulates the interactions of pharmaceutical and medical device companies with healthcare practitioners. The UCPMP broadly provides guidance on the information to be contained in promotional material and the nature of interaction and engagements between medical device companies and healthcare practitioners.
Separately, regulations generally applicable to advertisements in India should also be applicable to medical device advertisements. Advertising in India is self-regulated as there is no central authority to monitor or approve advertisements. The Advertising Standards Council of India (“ASCI”), a non-profit organizations comprising media, advertising agencies, advertisers, has published a code regulating the publishing of advertisements in India. The ASCI Code applies to advertisements relating to medical devices as well. The ASCI Code broadly requires that advertisements contain fair, true and honest representations and not mislead consumers.
India also has medium specific guidance regulating advertisements. For instance, advertisements broadcast over cable television networks are regulated under the Cable Television Network Rules, 1994 while advertisements published online are regulated under the Information Technology Act, 2000.
The Drugs (Prices Control) Order, 2013 (“DPCO”) regulates the prices of all drugs and notified medical devices in India.
Under the DPCO, prices of medical devices are regulated in two categories:
- Medical devices specified in the National List of Essential Medicines/schedule to the DPCO (“Scheduled Formulations”); and
- Other medical devices (“Non-scheduled Formulations”).
The ceiling prices of Scheduled Formulations is fixed by the NPPA. So far, only cardiac stents and knee implant devices are considered to be Scheduled Formulations. All other medical devices are Non-scheduled Formulations.
The prices of Non-scheduled Formulations, though not specifically fixed are controlled indirectly. Manufacturers or importers of Non-scheduled Formulations are restricted from increasing the price of the product by more than 10% over any given 12-month period.
As mentioned above, all medical devices in India are regulated from April 01, 2020 and 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.
3. How are medical devices defined in your jurisdiction? Is software (whether standalone or part of a medical device) considered to be a medical device?
Please see the response to question 2 for the definition of medical device.
Further, both embedded and standalone software is considered to be a medical device in India. Embedded software i.e. software which drives of influences a device is regulated in the same manner as the medical device of which it forms a part. Standalone software came under regulation by way of the Definition Notification.
4. What is the process for obtaining approval to market a medical device? Are approvals granted by foreign regulators recognized in your jurisdiction?
Investigational medical devices and new in-vitro medical devices are required to undergo local clinical investigation and clinical performance evaluation respectively for obtaining approval to market the medical device in India.
The MDR defines an investigational medical device as a device which is the first of its kind to be approved in India. Devices previously approved in India, but which is sought to be approved for claims of new intended use, new population, new material or design change is also considered to be an investigational medical device. A new in-vitro diagnostic device is an in-vitro device which has not been previously approved in India and is being tested to establish its performance for relevant analyte or other related parameter.
Following the conclusion of the clinical investigation or the clinical performance evaluation, any resident Indian entity may apply to the CDSCO for marketing authorisation.
Approvals by Foreign Regulators
Approvals granted by foreign regulators are not per se recognised in India. However, devices which are approved and have been marketed in either Uni-ted Kingdom, United States, Japan, Australia or Canada may not be required to undergo clinical investigation prior to being marketed in India if all of the following conditions are fulfilled.
- The device is being marketed in the above-mentioned countries for a period of at least two years;
- The CDSCO is satisfied with the data on safety, performance and pharmacovigilance of the device;
- There is no evidence or theoretical possibility, on the basis of existing knowledge, of any difference in the behavior and performance of the device in Indian population; and
- The applicant has given an undertaking in writing to conduct post marketing clinical investigation with the objective of establishing the safety and performance of such investigational medical device as per protocol approved by the CDSCO.
5. What licenses/approvals are required to manufacture, import or sell medical devices? Can medical devices be sold directly to consumers?
The following licenses/approvals to manufacture, import or sell medical devices in India.
A license to manufacture medical devices should be obtained in respect of each manufacturing facility. The application for the manufacturing should be made to the SLA in case of Class A and B devices and the CDSCO in case of Class C and D devices. Manufacturing facilities are required to adhere to the Quality Management System specified in the Fifth Schedule of the MDR as a pre-requisite to grant of a manufacturing license.
The manufacturing facility will be inspected by a body authorised under the MDR to carry out inspections in case of Class B devices. The inspection will be carried out by the CDSCO in case of Class C and D devices. There is no requirement for prior inspection in case of Class A devices.
Following the inspection and review of documents, the SLA (in case of Class A and B devices) or the CDSCO (in case of Class C and D devices) may grant a manufacturing license to the applicant.
An import license is required to carry out the import of medical devices into India. An application for import license should be made to the CDSCO. The import license is specific to medical devices manufactured at the facilities listed on the import license.
The importer should hold either a manufacturing license or a license to sell drugs by way of wholesale as a pre-requisite to applying for an import license.
The provisions for sale of drugs under the Drugs and Cosmetics Rules, 1945 (“D&C Rules”) – a set of rules framed under the D&C Act to regulate the clinical trials, manufacture, import and sale of drugs – regulate the sale of medical devices. The D&C Rules require sellers of medical devices to obtain separate licenses depending on whether the medical device is sold on a wholesale or retail basis.
Sale to Consumers
Medical devices may be sold directly to consumers. The conditions listed on the manufacturing license or import license regulate whether the specific medical device may be sold directly to consumers. Generally, consumer facing medical devices such as glucometers, thermometers etc. may be sold directly to consumers.
6. What are the standards required to be adhered to for manufacturers/importers of medical devices?
The MDR stipulates that medical devices adhere to standards prescribed in respect of the specific medical device by the Bureau of Indian Standards (“BIS”) – India’s national standards body – or those notified by Ministry of Health and Family Welfare. In the absence of such standards, the device should conform to standards laid down by the International Standards Organisation (“ISO”) or the International Electrotechnical Commission (“IEC”). If ISO or IEC standards are also not available, the device may conform to the validated manufacturer’s standards.
Further, under the Exemption Notification, the person registering the device on the Online System for Medical Devices is required to upload a certificate of compliance with respect to ISO 13485 standard accredited by National Accreditation Board for Certification Bodies or International Accreditation Forum in respect of such medical device. Therefore, medical devices which have come under the MDR by way of the Definition Notification are required to adhere to the ISO 13485.
7. What acts of non-compliance are specifically provided for under the regulatory framework? What is the range of penalties in case of such non-compliance?
Please refer to chapter about Regulatory, Pricing and Reimbursement Overview, Question 9 for penalties for non-compliance under the D&C Act.
8. What are the remedies available to patients in case of harm/injury caused due to medical devices? What is the potential range of compensation/penalty in case of such harm/injury?
The following remedies are available to consumers in the event of harm/injury arising out of a medical device.
Product Liability Action
The patient may initiate a product liability action against the medical device manufacturer, seller or product service provider under India’s consumer protection legislation, the Consumer Protection Act, 2019 (“CPA”). The CPA provides for specific instances in which the manufacturer, seller or product service provider in respect of the medical device. In the event the claim is successful, the product manufacturer, product seller or product service provider will be required to pay compensation to the patient.
Complaint to Drug Regulator
The patient may also approach the drug regulator in the event they believe the medical device was not of standard quality or counterfeit. In such cases, the drug regulator will investigate the matter and proceed against the medical device manufacturer as per the provisions of the D&C Act.
The Ministry of Health and Family Welfare is in the process of amending the MDR to put in place specific provisions for determining the payment of compensation and the quantum of payment. Please see the response to question 13 for more information.
9. What information is required to be included on the label of the medical device?
The following particulars must be on the medical device.
- 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).
- 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.
The Legal Metrology (Packaged Commodities) Rules, 2011 (“LM Rules”) apply to medical devices in addition to the MDR. The LM Rules have prescribed labeling and packaging requirements. The label of any commodity covered by the LM Rules are required to have the following declarations:
- Maximum retail price
- Name and address of the manufacturer or importer
- Net quantity
- Common or generic name of the commodity
- Country of origin
- Month and year in which the commodity is manufactured or packed or imported
- Name, address, telephone number, e-mail address of the person who can be or the office which can be contacted, in case of consumer complaints
- Actual corporate name and complete address of domestic manufacturer or importer or packer
10. Are the prices of medical devices regulated and, if so, how?
Yes, prices of medical devices are regulated. Please see response to question 2 for further information.
11. Can medical devices be advertised directly to consumers? If not, what are the restrictions on marketing medical devices to consumers?
Advertisements in respect of medical devices which are not prohibited under the DMRA may be made directly to consumers. The following advertisements should not be restricted under the DMRA.
- Advertisements referring to a medical device in terms which suggest that the medical device may be used to diagnose, cure, mitigate, treat or prevent a condition other than a Scheduled Disorder;
- Advertisements referring to a medical device without making a reference to a Scheduled Disorder;
- Awareness campaigns imparting knowledge regarding a Scheduled Disorder without making a reference to a medical device that may be used to diagnose, cure, mitigate, treat or prevent such condition; and
- Advertisements publicizing the brand name of the company without making a reference to a medical device or a Scheduled Disorder.
12. How is the marketing of medical devices to healthcare practitioners regulated?
The DMRA and the UCPMP regulates the marketing of medical devices to healthcare practitioners.
The DMRA specifies that advertisements may be made to healthcare practitioners in a confidential manner. The rules framed under the DMRA provide for the manner in which such advertisements may be made. The advertisement should be sent directly to the registered medical practitioner. The document should bear at the top the words “for the use only of a registered medical practitioner or a hospital or a laboratory”.
The UCPMP provides detailed guidance on the information to be specified in promotional material shared with healthcare practitioners. The UCPMP specifies that a medical device should be promoted only once it has been approved in India.
13. Are there proposals for reform or significant change to medical device regulation? If yes, when are they likely to come into force?
The following proposals for reform have been proposed.
Medical Device Compensation
The Drugs Technical Advisory Board (“DTAB”) – India’s apex technical advisory board for drugs and medical devices – is in the process of amending the MDR to provide for a process to provide compensation to patients who have suffered harm from faulty medical devices. The DTAB convened a sub-committee under the chairmanship of Dr. D.B Athani to arrive at a process for determining the manner of adjudicating compensation claims and the quantum of compensation. The report of the sub-committee is yet to be released to the public. There is presently no visibility on when the report will be released.
Enacting a New Law for Medical Devices
In November 2019, the NITI Aayog – the Indian Government’s policy think tank – submitted a draft bill to the Indian Government proposing to create a separate regulator for medical devices. The bill, titled the Medical Devices (Safety, Effectiveness and Innovation) Bill, 2019 (“Medical Devices Bill”) aims to introduce a Unique Identification Number on all medical devices, increase penalties for non-compliance as well as tighten the regulation applicable to clinical investigations. As of March 2020, the CDSCO and NITI Aayog have reportedly arrived at a consensus on the approach for regulating medical devices in the future. The CDSCO and the NITI Aayog have agreed that medical devices should be regulated under a separate wing of the CDSCO with a technical expert heading the division. Further, medical devices would be regulated under a separate legislation altogether and not as a subset of drugs as is currently the case. The Medical Devices Bill is currently being considered by the Health Ministry before being introduced in Parliament.