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Journal of Banking and Insurance Law (JBIL)

  ISSN: 2582-6875

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The Journal of Banking and Insurance Law is prepared under the aegis of eminent scholars, Legal experts, academicians, attorneys and other professionals. The scope of the journal is broad and covers topics such as banking, securities, financial services, administrative and general banking & Insurance related laws & issues arising out of them. The Journal welcomes all scholars exploring the general subject matter of financial institutions including financial products and markets. Law and strategy makers are under consistent pressure to watch the enthusiasm of buyers. JBIL welcomes contributions from scholarly community and experts involved in banking & insurance industries. It's a biannual journal (frequency January-June and July-December), started in 2018 .

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The Journal of Banking and Insurance Law focuses on the various laws and regulations under which a banking system is functioning. The various laws relating to banking are as follows: · Law of Limitation - Provisions of Bankers Book Evidence Act - · Special Features of Recovery of Debts Due to Banks  · Financial Institutions Act, 1993 · TDS · Banking Cash Transaction Tax · Service Tax · Asset Reconstruction Companies · The Securitization and Reconstruction of Financial Assets and · Enforcement of Security Interest Act, 2002 · The Consumer Protection Act, 1986 · Banking Ombudsman · Lok Adalats · Lenders Liability

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Insurance law in india.

Insurance has a deep-rooted history in India. Various forms of writing can be seen in Manusmriti, Dharmasastra, and Arthashastra. This blog unfolds the history of Insurance law and its development in India. It further discusses the regulatory body of Insurance in India, its roles and functions, and powers and responsibilities. We further delve into the different kinds of Insurance Acts that govern India. This blog also discusses the process of licensing and regulation of Insurance companies in India and gives us a glimpse of the different types of insurance, insurance contracts, and policies and key components of insurance contracts. It concludes with recommended Insurance law books and frequently asked questions.

What is Insurance Law?

Insurance laws frame a legal outline to govern the insurance business and its contracts. Insurance is a type of contract of indemnity in which an insurer indemnifies the other party against a loss that happens due to the happening of a contingent event. This segment of law is governed by the IRDAI. It covers various types of risks. Insurance is a contract of indemnity. It works on the principle of Uberrimae Fides which means in utmost good faith. It means that both the insurer and insured must disclose all the material facts about the person or property being insured. An entity that provides insurance is known as an insurer and the entity to which the insurance is provided is known as the insured.

Historical Development of Insurance Law in India

The evolution of Insurance law in India dates back to the year 1818 when India saw the advent of life insurance in India. The returns of insurance companies in India started getting published in 1914. In 1956, the Life Insurance Corporation came into existence. Concerning the General Insurance laws in India, in 1957 general insurance in India was formed and in 1973 it was nationalized. In April 2000, the Insurance Regulatory and Development Authority of India was established as a statutory body and in August 2000 it opened up the market in India.

Insurance Regulatory and Development Authority of India (IRDAI)

IRDAI stands for Insurance Regulatory and Development Authority of India. It was formed in the year 1999 under the IRDA Act. It came into effect on 19th April 1999. The IRDAI is a statutory body of India governing the insurance laws of India. The primary role of IRDAI is to protect and safeguard the interest of the policyholders of India and to focus on the development of the insurance sector in India. IRDAI has its own set of rules and regulations to govern the insurance laws in India. It is also vested with the power to investigate matters that involve malpractice by an insurance company. IRDAI also has the power to pass orders, give directions to other bodies, and make awards. IRDAI also works closely with government bodies like the Reserve Bank of India and the Securities and Exchange Board of India.

Roles and Functions:

It looks after the fair treatment and interest of the insurance holder. It frames regulations to ensure the operation of the industry without any ambiguity.

Powers and Responsibilities:

The major power and responsibility of the IRDAI is to promote and regulate the orderly growth of the insurance and reinsurance business in India. Its key responsibility is to protect the policyholders’ interest and encourage fairness in the insurance industry.

Insurance Laws and Acts in India

After the nationalization of both general and life insurance in India, many acts and legislations came into power to address the various types of insurance. This laid down the Acts to check the functioning of the insurance business in India. Different Acts govern different aspects of the insurance laws in India. Below are a few Acts and laws that govern the insurance sector in India.

The Insurance Act, 1938

The main purpose of this Act is to lay out a legal framework to carry out insurance business in India. This Act is the parent legislation that aims at consolidating and amending the previous insurance laws that existed during British rule. This Act lays down ground rules for the operation of the insurance business in India.

Related book: Insurance Act, 1938

Insurance Regulatory and Development Authority Act of 1999

This act establishes the statutory authority that will look into the protection of the rights and interests of the policyholders. The objective of this act is to promote and regulate the insurance industry in India. It also checks to create a fair business environment.

The Life Insurance Corporation Act, 1956

The main objective of this Act is to nationalize the life insurance business in India. This regulated the necessity for the certification of premium rate tables and periodical valuations of the companies.

Related Book: Life Insurance Corporation Act, 1956

The General Insurance Business (Nationalization) Act, 1972

The purpose behind the enforcement of this Act was to provide Indian insurance companies and other existing insurers shares to be enabled for the acquisition and transfer of for better economic needs. This was to ensure the safeguarding and development of the general insurance business. It was established to look into the best interest of the community and control businesses.

The Marine Insurance Act, 1963

This act focuses on the maritime industry. This legislation ensured that any loss or damage of ships, terminals, cargo, or any transport in which property was transferred or held between two points of origin and final destination was given coverage.

The Motor Vehicles Act, 1988

This Act has been legislated to govern road transport vehicles. This act compels the insurance of motor vehicles plying on roads. The owner is also bound by this act to insure the vehicle against third-party risks.

Related book: Motor Vehicles Act, 1988

Licensing and Regulation of Insurance Companies

The licensing and regulation of the insurance company gives it the authority to operate its business in India. This licensing and regulation is done by the IRDAI. The State insurance commissioner is in charge of the issuance of the license. Only after attaining the license, the insurance company can sell its policy and products to the general public.

Criteria for Licensing

The issuance of license and registration of an insurance company in India is governed by the IRDA Registration of India Insurance Companies (Seventh Amendment) Regulation, 2016. The eligibility criteria are that to get a license to have been a registered public company under the Companies Act, 2013, to have 100 crores of cash, and to build a reinsurance company you need to have 200 crores.

Regulatory Compliance for Insurance Providers

IRDAI compliance is required for any insurance provider to function in India because it is the regulatory body. This regulatory body safeguards the interest of the policyholders and ensures the uniform and fair functioning of all the insurance providers with clarity.

Types of Insurance in India

Insurance in India is segregated into various types depending upon the subject matter of the risk being insured. Insurance is available for living and non-living properties. Several factors are considered to bifurcate the various policies as per the property being insured. The types are broadly divided into two major categories: life and general insurance. It is crucial to select the right kind of policy as per the need to secure oneself from financial risk.

Life Insurance

Life insurance is a contract between an individual and a life insurance company. In this type of insurance, the beneficiary/beneficiaries are paid a sum of amount depending upon the premium on the demise/disability of the policyholder. This ensures the financial protection of the family members of the policyholder.

General Insurance

General Insurance is a type of insurance or agreement between the policyholder and insurer in which the insurance company protects the valuable assets of the policyholder from any unfortunate accident like fire, theft, burglary, etc.

Insurance Contracts and Policies:

All the contractual agreements in India are governed by the Indian Contract Act, of 1872. Insurance being a contract of indemnity is also guided by the same Act. But with evolving times and the rise of different situations, courts have laid down principles to balance the interest of both the insurer and the insured without going against the principle of the contract law.

Formation of Insurance Contracts:

Offer and acceptance.

Offer and acceptance in an insurance contract refers to the willingness of the policy-holder to accept a certain policy of the insurance company in exchange of a premium amount to cover a certain loss.

Premiums and Consideration

Premium is the amount of money paid by the policy-holder to the insurance company which is the consideration of the agreement in return for which the insurance company will do a certain kind of loss on the occurrence of a certain event.

Policy Terms and Conditions

Policy terms and conditions of the insurance are certain prerequisites of the agreement of the insurance which is to be abided by the policy-holder and on acceptance of which the premium is paid.

Key Components of Insurance Policies:

An insurance policy also has some key elements that look into how the policy will operate or function. As the insurance is a contract of indemnity, the contract is comprised of few essential components and so is the policy of insurance. Any insurance policy has three main components which are the premium, policy limit, and deductibles. The policy contains the premium that is to be paid by the insured, the subject matter that is being covered from risk or loss, up to what limit/amount the risk is being covered and under what conditions, and against what types of risk the subject is covered.

Declarations

The declaration of a policy tells you in detail about the entire policy. It discusses everything from who is covered to which all coverages are paid. It includes personal details of the policyholder, type of coverage, coverage limit, cost of coverage, and deductibles.

Insuring Clauses

This mentions the risk that is covered by insurance. This clause entails the risk for which the insurer is liable for paying and also outlines the scope of coverage.

Exclusions and Conditions

These are the clauses of an insurance contract that prevent or limit a liability or legal obligation in cases where a certain occurrence takes place.

Claims Process:

Claiming insurance is a process that has a few steps. There are a few steps involved which lay down a guideline as to how one can proceed to make an insurance claim. The claim of insurance involves the necessary steps to be taken by the insured to file the claim on the happening/non-happening of the event that caused damage to the property or subject matter that was insured.

Filing a Claim

Filing a claim in the insurance process refers to the request made by the policyholder to the insurance provider to do good the loss or reimburse against the losses that were supposed to be covered as per the insurance policy.

Investigation and Settlement

When a claim is filed by the policyholder, a dedicated team of the insurance company investigates the matter and the loss that has happened and checks for the fulfillment of certain parameters. If they are ticked off, the claim is settled. In situations where the parameters are not met, the claim might also be rejected. The investigation needs to be done within 90 days of the claim intimation. The settlement needs to be done in 30 days thereafter.

Dispute Resolution Mechanisms

Many times, when in the investigation process, the necessary elements are not met, the claim can be rejected by the insurance provider. In these cases, the parties resort to dispute resolution mechanisms. Dispute resolution mechanism in insurance of what happens through arbitration. In this method, the parties of insurance i.e. the policy-holder and the insurance provider sit amicably to resolve the issue in the presence of a third party.

Recommended books for further reading:

Commentary on the insurance regulatory and development authority act  by s k sarvaria and apoorv sarvaria.

This is an illustrative book that gives a detailed overview of the features and regulations of the IRDA. It also gives the details of the insurance laws in India. This book is a reference and a great guide for scholars, practitioners, and even students.

Principles of Insurance Law  by M N Srinivasan and K Kannan

This is not just a guide but gives a critical overview of the insurance law. This includes all the aspects of the insurance law including the general principles, practices, procedures, and special chapters on tax planning.

Law of Insurance  by B N Banerjee & S K Sarvaria

This is a comprehensive book that gives an exposure to all kinds of insurance laws. It includes all the laws of different insurances that are followed in India along with commentaries on the Motor Vehicle Act and the latest amendments.

The insurance laws in India are growing with the evolving times and because India as an economy is transitioning, all the assets have an economic value attached with it. Insurance acts as an important tool to provide security. Insurance acts as a useful instrument to indemnify against a loss. IRDAI as a regulatory body governs the policies and safeguards the interest of people in the insurance business. This law is a tool to protect and maintain the legal and regulatory architecture of the country.

• What is the General Insurance Act in India?

With the goal of better serving the needs of the economy, the General Insurance Act was introduced to facilitate the acquisition and transfer of shares in Indian insurance companies and other related undertakings of various existing insurers.

• What was the first insurance act in India?

The Indian Life Assurance Companies Act, of 1912 was the very first insurance act in India.

• What is the Insurance Laws Amendment Act 2015 in India?

The Insurance Laws Amendment Act, 2015 removes archaic and redundant provisions present in the legislation. It also incorporates certain provisions to provide the Insurance Regulatory and Development Authority of India with some flexibility to discharge the function effectively as well as efficiently.

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A Study on the Growth of Indian Insurance Sector

International Journal of Management, Volume 1, Issue 1, May 2010, pp. 17-32

16 Pages Posted: 22 Dec 2012

Independent

Date Written: 2010

The Insurance sector in India governed by Insurance Act, 1938, the Life Insurance Corporation Act, 1956 and General Insurance Business (Nationalisation) Act, 1972, Insurance Regulatory and Development Authority (IRDA) Act, 1999 and other related Acts. With such a large population and the untapped market area of this population Insurance happens to be a very big opportunity in India. Today it stands as a business growing at the rate of 15-20 per cent annually. Together with banking services, it adds about 7 per cent to the country’s GDP .In spite of all this growth the statistics of the penetration of the insurance in the country is very poor. Nearly 80% of Indian populations are without Life insurance cover and the Health insurance. This is an indicator that growth potential for the insurance sector is immense in India. It was due to this immense growth that the regulations were introduced in the insurance sector and in continuation “Malhotra Committee” was constituted by the government in 1993 to examine the various aspects of the industry. The key element of the reform process was Participation of overseas insurance companies with 26% capital. Creating a more efficient and competitive financialsystem suitable for the requirements of the economy was the main idea behind this reform. Since then the insurance industry has gone through many sea changes .The competition LIC started facing from these companies were threatening to the existence of LIC .since the liberalization of the industry the insurance industry has never looked back and today stand as the one of the most competitive and exploring industry in India. The entry of the private players and the increased use of the new distribution are in the limelight today. The use of new distribution techniques and the IT tools has increased the scope of the industry in the longer run.

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Biosimilars in India: Regulatory, Legal, and Industry Landscape

Introduction

Biosimilars, a category of biologic medications, are offering new hope for patients by providing cost-effective alternatives to original biologics, which are often expensive and complex. Biosimilars are a type of biologic medication that is safe and effective for treating many illnesses. A biosimilar and its original biologic have the same treatment risks and benefits. However, biosimilars may be available at a lower cost than the original biologics. Biosimilars are highly similar to their reference biologics but offer comparable safety, efficacy, and potency. They play a significant role in treating diseases like cancer, diabetes, and autoimmune disorders, making them essential in modern healthcare.

India, with its strong pharmaceutical sector, is at the forefront of biosimilar production. The country approved its first biosimilar in 2000, making it one of the early adopters globally. Since then, Indian companies have not only supplied the domestic market but have also become global leaders in biosimilars, contributing significantly to making biologic therapies more accessible.

This blog delves into the regulatory, legal, and industry landscape of biosimilars in India. It is designed for professionals in the pharmaceutical and healthcare sectors, legal experts dealing with intellectual property rights, and anyone interested in understanding the challenges and opportunities within the biosimilar industry. The authors hope to provide stakeholders with some insights into India's evolving role as a leader in biosimilar development and the legal complexities that shape this fast-growing market.

Regulatory Framework in India

In India, biopharmaceuticals and generic medicines are considered to be drugs and regulated by the Central Drugs Standard Control Organization (CDSCO) under the Drugs and Cosmetics Act, 1940. The key regulatory documents governing biosimilars include the Drugs and Cosmetics Act (1940), New Drugs and Clinical Trial Rules (2019), Guidelines on Similar Biologics (2012, updated 2016), and more.

Due to their complexity, in general, rules regarding clinical trials are much more stringent for biosimilars than those applied to generics. Biosimilars are also regulated for various processes (e.g., clinical trials, import, and manufacture). These regulations ensure that biosimilars undergo rigorous testing through pre-clinical and clinical trials to guarantee their safety and efficacy.

However, the regulatory framework in India has been criticized for lacking clarity, particularly regarding enforcement. The Guidelines on Similar Biologics are comprehensive but remain guidelines rather than enforceable laws, leaving room for interpretation and legal disputes, and meaning that neither government nor industry can be held liable for violating these guidelines. Moreover, the existing biosimilar guidelines are poorly drafted, leaving the door open for innovators like Roche to raise a cloud of doubt over the launch of new biosimilars.

Comparison with the US

In the US, a legal framework for approving biosimilars was established in 2009, via the Biologics Price Competition and Innovation Act of 2009 (BPCI Act). The BPCI Act establishes an abbreviated approval pathway for biological products that are demonstrated to be ‘highly similar’ (biosimilar) to, or ‘interchangeable’ with, a US Food and Drug Administration (FDA)-licensed biological product. As of July 2024, the FDA has approved 58 biosimilars under this framework.

Unlike in India, where regulatory guidelines lack the legal force of law, the BPCI Act provides robust legislative backing, ensuring that both innovators and biosimilar manufacturers adhere to clear, enforceable rules.

Legal Challenges

Despite India’s advances in biosimilar development, legal challenges continue to arise due to the ambiguous regulatory environment. Several high-profile cases highlight the difficulties faced by biosimilar manufacturers in India.

A notable example is the Roche v. Zydus Lifesciences case, where Roche sued Zydus over its breast cancer biosimilar, Sigrima. Roche sought interim relief against the sale and distribution of Sigrima, claiming it infringed upon their patents IN 268632 and IN 464646. Zydus had entered a commercial licensing agreement with Dr. Reddy’s Laboratories to co-market Sigrima in India. Despite the ongoing legal proceedings, Zydus launched Sigrima after obtaining regulatory approval without informing the court on time. The Court recognized that allowing Zydus to continue selling Sigrima could unfairly disadvantage Roche if the product was later found to infringe on Roche’s patents. Therefore, in July 2024, the Delhi High Court issued a temporary injunction preventing Zydus from selling Sigrima due to patent infringement claims by Roche.

In another case, Roche v. Cadila Healthcare and Hetero Drugs , Roche was the innovator of two cancer drugs ‘Trastuzumab INN’(brand name Herceptin) as well as 'Bevacizumab INN' (brand name Avastin). The patent for Trastuzumab lapsed in 2013, and Roche did not have a patent in India for the reference biologic Bevacizumab. In 2016, Roche filed separate suits against Cadila and Hetero Drugs, seeking a declaration that approvals granted by the DCGI for pre-clinical trials, and marketing its drug claimed to be a biosimilar version of Trastuzumab and Bevacizumab respectively, be declared invalid. Roche alleged that Cadila and Hetero are attempting to ride on the goodwill of their drugs to take unfair advantage of the same in selling their respective drugs by terming them as biosimilar, in the absence of conducting requisite tests and/or obtaining requisite approvals in consonance with the applicable laws.

The court, siding with Roche, held that the defendants claimed similarity with Roche’s innovator drug Trastuzumab/Bevacizumab without establishing bio-similarity through appropriate tests and conditions under the applicable laws. Given inherent differences in the compositions of alleged biosimilar drugs and innovators' biological drugs and inadequate testing, defendants' drugs should not have been approved, and they should be restrained from promoting and marketing their respective drugs.

The court further added that the impugned actions of the defendants are classic textbook cases of extended passing off and amount to dilution of the formidable and globally known reputation and goodwill of the plaintiffs’ innovator drugs, at the same time giving unfair and undue advantage to defendants. Without adequate testing and assessment pertaining to safety, efficacy, quality, and composition, using International Non-Proprietary Names (INNs) is legally impermissible and adds to public confusion.

Furthermore, the court added, “ it is the pleaded case of the plaintiffs that they are not asserting rights under the patent, which has expired in 2013 as also that plaintiffs have no objection to the manufacture and sale of the impugned drugs by Cadila and Hetero as long as they are not claimed to be biosimilar and/or the parties do not use the INN, in the absence of the alleged non-compliance with the applicable laws.”

These cases demonstrate the legal complexities that arise from India’s underdeveloped biosimilar regulatory framework, creating a need for more robust laws to streamline the approval process.

Patenting Biosimilars in India

In addition to regulatory hurdles, patenting biosimilars poses another challenge. biosimilars are not exempt from fulfilling the patentability criteria of being novel, which involves inventive step and industrial application. However, patenting biosimilars becomes complicated, as the nature of biosimilars requires that they should be as close as possible to products that are already on the market and accordingly examined critically for patenting.

If novelty and inventiveness can be established, Indian patent law allows biosimilars to be patented, but manufacturers must carefully navigate this process to avoid infringing on existing patents while developing biosimilars that are similar enough to provide therapeutic equivalence. This complexity often results in patent disputes, as seen in the Roche cases, where the fine line between biosimilarity and patent infringement is often contested.

Industry Growth: Opportunities and Challenges

While legal challenges create uncertainty, India's biosimilar industry continues to grow. The country’s pharmaceutical companies have become global leaders in biosimilar production, with Indian firms gaining USFDA approval for products like Herceptin (Trastuzumab), marking a significant milestone for the industry.

Despite the successful development and marketing of some biosimilars by Indian companies, research and development in this area will continue to face challenges regarding the development of biologics and biosimilars. In contrast to generics, which are similar rather than identical to the branded drug, biosimilars are much more complex and expensive to manufacture.

Further, contrary to the generics industry, biosimilars are also subject to more stringent clinical timelines, clearly defining regulatory procedures for large-scale, comprehensive clinical programmes establishing the safety and efficacy for the treatment of indicated disorders. The novelty of the biologic and biosimilar development process makes it difficult for new companies to enter this space.

India’s biosimilar industry has made impressive strides in the past two decades, becoming a global leader in this emerging sector. However, regulatory ambiguities, legal challenges, and the complex nature of biologic manufacturing continue to pose significant hurdles. The lack of clear, enforceable guidelines has led to costly legal battles and delayed market entry for many biosimilars.

For India to maintain its leadership position in the global biosimilar market, it must focus on refining its regulatory frameworks and patenting processes. With stronger laws and greater investment in R&D, India can continue to provide affordable biologic therapies to millions of patients worldwide, ensuring that biosimilars remain a key part of the future of healthcare.

Kan and Krishme is dedicated to providing high-quality services for IP prosecution in India and the Indian subcontinent. If we can be of assistance, please visit www.kanandkrishme.com or email us at [email protected] .

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UK’s health-related benefits bill rose to £48bn in 2023-24, research finds

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