Private enforcement

Causes of action

What private causes of action may citizens or other private bodies bring to enforce a healthcare regulation or law?

Under the Consumer Protection Act 1986, a person can approach the Consumer Tribunal to denounce unfair practices (eg, unfair prices for medical services) or to help improve the enforcement of healthcare regulations. Further complaints can be lodged under the Drugs and Cosmetics Act 1940 and the Clinical Establishment Act 2010 for investigation in relation to proper working of a clinic, for instance. Citizens or private bodies may also approach a court by way of a writ petition or public interest litigation.

Framework for claims

What is the framework for claims of clinical negligence against healthcare providers?

What is the framework?

In cases of medical negligence, a person has three avenues of recourse:

  • file a complaint with the State Medical Council;
  • file a criminal complaint; or
  • file a complaint with the National Consumer Disputes Redressal Commission.

 

What is the standard of care for a successful claim and breach?

 

The standard of care which is expected of a medical professional is the treatment which is expected of one with a reasonable degree of skill and knowledge. A medical practitioner would be liable only where the conduct falls below the standards of a reasonably competent practitioner in the field…

 

Manglik v Chirayu Health and Medicare Private Ltd, Civil Appeal Nos. 227–228 OF 2019 (@SLP (C) Nos. 30119–30120 of 2016)

 

Are the courts reluctant to penalise public or quasi-public healthcare providers?

The courts are not reluctant to penalise public or quasi-public healthcare providers.

 

What are the damages available?

The Supreme Court has resorted to the principle of restitutio in integrum in awarding damages. Under this principle, an aggrieved person should get the sum of money that would put him or her in the same position as if he or she had not sustained the wrong (Krishnakumar v State of Tamil Nadu). Damages will largely depend upon the case at hand. However, in a recent case of medical negligence, the Supreme Court awarded damages of 11 million rupiah.

Seeking recourse

How and on what grounds may purchasers or users of pharmaceuticals or devices seek recourse for regulatory and legal infringements?

Whistle-blowers may inform the authorities of any irregularities. Even purchasers or users may inform the authorities by way of representations of any non-compliance. Additionally, purchasers or users may file claims and complaints before a court if these users and purchasers are aggrieved parties. Complaints can also be filed before consumer forums.

Compensation

Are there any compensation schemes in place?

Class actions can be filed under the Consumer Protection Act 2019; health as such is outside the purview of the law, but in cases of defective drugs or deficient devices the consumer can seek remedy under the Act. There are no specific provisions pertaining to compensation under any of the healthcare acts, but in cases of consumer protection and medical negligence the parties are provided with adequate remedy, including compensation where necessary.

Class and collective actions

Are class actions or other collective claims available in cases related to drugs, devices and provision of care?

Class actions can be filed under the Consumer Protection Act 2019; health as such is outside the purview of the law, but in cases of defective drugs or deficient devices the consumer can seek remedy under the Act.

Review

Are acts, omissions or decisions of public and private institutions active in the healthcare sphere subject to judicial or administrative review following a complaint from interested parties?

In which fora are complaints heard?

Under section 33 of the Clinical Establishment Act 2010, the authority or officer has powers to inspect any registered clinical establishments or the work conducted or done by them.

Complaints made under the Drugs and Cosmetics Act 1940 are dealt by the inspector; the inspector further institutes a prosecution before the Session Court once his or her report is ready. Such proceedings fall under the Code of Criminal Procedure 1973.

 

Who has standing?

The inspector under section 33 of the Clinical Establishment Act and the inspector under section 23 of the Drugs and Cosmetics Act 1940 have standing.

 

On what grounds can complaints succeed? What remedies can the adjudicator order?

Under section 13 of the Drugs and Cosmetics Act, anyone who imports drugs that are adulterated or that are prohibited under the Act shall be punishable under the Act with a fine or imprisonment.

Section 27 of the Act provides for penalties for the manufacture, sale and distribution of any drug that is deemed to be adulterated under section 17 of the Act. Furthermore, section 31 provides for the confiscation of drugs that are in contravention of the Act. The Central Government has been given powers to regulate or restrict the manufacture, sale and distribution of drugs in the public interest under sections 26A and B of the Act.

Whistle-blowers

Are there any legal protections for whistle-blowers?

Yes. The Whistle-blowers Protection Act 2011 provides legal protection to whistle-blowers. (However, the Act does not apply to the private sector.) A Reward Scheme for Whistle-blowers has been formulated by the Central Drugs Standard Control Organisation (CDSCO) to ensure the protection of the identity of the whistle-blower. The identity of the whistle-blower is known only to the concerned zonal and sub-zonal officers of the CDSCO, the Drug Controller General of India and the Director General Health Services.

Does the country have a reward mechanism for whistle-blowers?

Yes, under the Reward Scheme for Whistle-blowers run by the CDSCO that is applicable in respect of drugs, cosmetics and medical devices, a reward of up to 20 per cent (not exceeding 25 million rupiah) of the total cost of the consignments seized will be payable to the whistle-blower. A quarter will be given at the time of filing of the charge sheet, another quarter will be given at the time of disposal of the case in favour of the government in a court of first instance and the remaining 50 per cent will be paid when the case has been finally disposed of in favour of the government and no appeal can be instituted. The eligibility of a whistle-blower and the quantum of rewards to be received shall be decided by a committee chaired by the Director General Health Services.

Are mechanisms allowing whistle-blowers to report infringements required?

The Drug Controller General of India and other relevant officials will be the nodal authority who will oversee the functioning of the Reward Scheme. Whistle-blowers may approach zonal and sub-zonal officers of the CDSCO to inform them of the manufacture or even the movement of spurious or adulterated drugs. Upon receiving such information, the relevant officers will immediately proceed with an investigation in coordination with the State Drugs Control Administration.

Law stated date

Correct on

Give the date on which the information above is accurate.

26 June 2020.