Software as a Medical Device: What the law says?

Software as a Medical Device: What the law says?

As everything is going digital it is necessary to upgrade the pharmaceutical sector too. Since the advent of technology in the healthcare, the evolution increasing rapidly. New technologies emerged like wearable, telemedicine, and clinical decision making tools that use Artificial Intelligence, Machine learning etc. Central Drugs Standard Control Organisation (hereinafter referred as CDSCO) is taking due initiatives to make development in the health care sector with the help of software technologies and making new regulation to address the transformation.

What are the different classes of Software as Medical Device by the CDSCO?

CDSCO has classified the software as medical device in 4 classes in compliance   with International Medical Device Regulators Forum risk classification. The classification is done on the basis of low risk, low moderate risk, moderate risk, high risk.

Class A – Class A comprises of those devices which is not directly interpret or interfere with the patient clinical data. In this class those software are added which record the pre medical conditions of the patient. This software has retrospective effect.

Class B – Class B comprises of those devices which provide electronic data of the patient but are not used for providing clinical diagnosis. For example Electrocardiograph software is used for home analysis and provides graphic data for cardiac arrhythmias.

Class C – Class C comprises of the devices which are used for disease diagnosis directly and are very important in the healthcare department. For e.g. Angiographic Coronary Vascular Physiologic Simulation software intended to aid in the identification of functionally significant cardiovascular disease.

Class D – Class D is not yet classified in India.

What are the recent developments in law?

The CDSCO has recently made amendment in the definition of medical devices under the Medical Device Rules, 2017. According to the new definition software is included in the medical device if it is used for one of the following reason:

  • Diagnosis, prevention, monitoring, treatment or alleviation of any disease or disorder;
  • Diagnosis, monitoring, treatment, alleviation or assistance for, any injury or disability;
  • Investigation, replacement or modification or support of the anatomy or of a physiological process;
  • supporting or sustaining life;
  • Disinfection of medical devices; and
  • Control of conception


The World Health Organization (WHO) defines telemedicine as, “The delivery of health care services, where distance is the major factor, by all health care practitioner using information and communication technologies for the exchange of necessary information for diagnosis, treatment and prevention of disease and injuries, research and evaluation, and for the continuing education of health care providers, all in the interests of advancing the health of individuals and their communities.”

As we all witnesses in the Covid time that it was difficult to attend each and every patient physically and to give effective treatment to them. Then the need for more and more doctor arises and it was difficult to train medical practitioners in a very short span of time and also risk cannot be taken as the health of public at large was at stake.

Therefore, the concept of telemedicine is introduced. This is the combined project of Ministry of Health and Family Welfare and Department of Information Technology. The Government of India has set up a telemedicine portal for implementing a green field project on e-health establishing a National Medical College Network for interlinking the medical colleges across the country with the purpose of education and a National Rural Telemedicine Network for the e-Healthcare delivery.

What are the rules and regulations for Software as Medical Device? 

The Software as Medical Device must comply with the following rules and regulations.

  1. O 648 (E) definition of medical device Notified on 11. 02.2020.

“All devices including instruments, implant, software etc to be used especially for human beings or animals which does not achieve primary intended actions by an pharmalogical or immunological will be defined as medical device.”

It is important to analyse the definition of medical device in order to understand whether the particular software falls in the preview of medical device or not.

  1. Medical Device Rules, 2017- The software specified as medical device must comply with the rules provided under the Medical Device Rules, 2017. Non compliance of the rules can attract the penalties provided under the rules such as cancellation of licence etc.
  2. ISO 13485: 2016- The document clarify the needs for quality management where a company needs to present its ability to provide medical device that fulfils customer and regulatory requirements. The company may involved in one or more stages, including design and development, production, storage and distribution, installation, or other related activities such as technical support.
  3. ISO 14971: 2019- The document defines terminology, principles and process for risk management of medical device inclusive software as medical device. The motive of this document is to guide the manufacturers of medical device to identify the risk associated with the medical device to measure and evaluate the associated risk, control and monitor the effectiveness of control.


Medically we are highly dependent on software as medical device for diagnosing, preventing, monitoring, and treating diseases; this makes it highly important to enact some data protection policies to prevent a data breach of patients’ personal and sensitive information. Keeping this in consideration, the Indian Parliament is working on the Personal Data Protection Bill (2019).

As the health sector is progressing in digital form, the Indian government and the CDSCO are taking necessary steps to determine device safety and moderate possible breach of user information. Few regulations are still under discussion and may come into force and regulate the Software as Medical Devices.

-Surbhi Singla

Associate at Aggarwals & Associates, S.A.S. Nagar, Mohali








Recent Legal Developments in Pharmaceutical Sector

Recent Legal Developments in Pharmaceutical Sector

Pharmaceutical sector comprises of drugs and cosmetics. The whole medical sector is covered under the pharmaceutical sector. The medical sector requires changes with effect to the time, as we all have witnessed recently when the Covid 19 outbreaks. In the Covid time period a lot of changes were made in the pharmaceutical as and when required. The Government is taking initiative to uplift the pharmaceutical industry to provide best medical assistance to the society at large. Some of the key developments are highlighted in this article.

Drugs and Cosmetic (Amendment) Rules, 2020 (DC Rules):

The Ministry of Health and Family Welfare (hereinafter referred as MOHFW) notifies the DC rules which came into effect from March, 2021.

  • In the DC Rules, the definition of word Marketer is added, and it is defines as “a person who as an agent or in any other capacity, adopts any drugs manufactured by the other manufacturer under an agreement for marketing of such drug by labelling or affixing his name on the label of the drug for its sale and its distribution.” Moreover it is clearly stated that the marketer shall be held responsible for quality of that product and the regulatory compliances, along with the manufacturer of the drug.
  • If the drug is marketed by the marketer not being the manufacturer, apart from the prescribed information in the principal law, name and address of the marketer should also be printed on the label in a conspicuous manner in the innermost label of the drug.

Drug Delivery Notification:

The MOHFW issued notification on 26th March 2020 that now retailer can deliver medicine on door steps to the consumers. The notification provides the delivery of drug mentioned in schedule H, H1, X (other than the narcotics defined under the Narcotics Acts) mentioned in the Drugs and Cosmetic Act, 1945.

The validity of prescription for chronic disease is 2 months and for acute disease 7 days.

Medical Device Rules (Amendment in 2020):

The Central Drugs Standard Control Organization (hereinafter referred as CDSCO) publishes two amendments in the medical device rules which came into force on April 1, 2020. The two amendments are as follows:

  1. In the first amendment the definition of medical device is enhanced and the definition under clause 3 (b) (iv) of the Medical Device (Amendment) Rules, 2020 are 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 the 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 ―

  • Diagnosis, prevention, monitoring, treatment or alleviation of any disease or disorder;
  • Diagnosis, monitoring, treatment, alleviation or assistance for, any injury or disability;
  • Investigation, replacement or modification or support of the anatomy or of a physiological process;
  • supporting or sustaining life;
  • Disinfection of medical devices; and
  • Control of conception.  
  1. The second amendment of the medical device rule added chapter 3 A in the rules which says that all the devices in the Clause 3 (b) (iv) should be added in the list except the devices notified under schedule 8 of the rules. The changes should be made according to the newly added provision from 19 A to 19 F.

The striking features of the amendment are explained below: –

  • The medical device should be voluntarily registered for 18 months after that it should be made mandatory.
  • The information should be uploaded on the portal by the manufacturer regarding the medical device in respect of manufacturing entity, certificate of compliance with respect to ISO 13485 and the duly signed undertaking that the information provided by him is true and authentic.
  • Those who import medical device shall furnish the free sale certificate from the country of origin as per the provisions specified under Rule 19 (D) (2) (ii) of the Medical Device Rules.
  • After uploading all the information on the online portal, the manufacturer needs to print registration number on the label of device.
  • The Central Licensing Authority may verify the quality and procedure at any time and the procedure of non compliance is also provided by the amendment rules.

Drugs (Price Control) Order 2013:

This order enables the Government to fix minimum or ceiling price of drug in an extraordinary situation for the interest of public as it deems fit notwithstanding the wholesale price index. The price of oxygen is fixed since 2016 but due to increase in the demand of oxygen during the Covid time period the prices of oxygen are revised (Revised Price Cap). The period is further extended till December 31, 2022 or until further ordered whichever is earlier.

Permit to import of drugs:

The CDSCO has extended its previous order to import the drugs having shelf life less than 60%. The extension is granted till October 31, 2022 or further orders whichever is earlier.

Upcoming legislation for Pharmaceutical Sector

Proposed Amendment to the Schedule K of the Drugs and Cosmetic Rules, 1945:

The MOHFW has proposed an amendment to schedule K of the aforesaid Rules which grants exemption to certain kinds of drug from obtaining the sale license. The exemption grants permission to sell the certain class of drugs over the counter without the prescription of registered medical practitioner. However the doses sold can’t be sold for more than the 5 day doses. The sale for more than the prescribed quantity is still prohibited without the prescription of registered medical practitioner.

Some of the listed drugs are Antifungal, Analgesics, Decongestants, and Laxatives etc.

Inclusion of QR code (Quick Response Code) in API (Active Pharmaceutical Ingredient) Labelling:

The MOHFW has issued the notification that a QR in API should be inserted on the labels of manufactured and imported goods in India. This amendment will come in effect from 1st January, 2023.

The QR code should label at packaging level to store data or information with a well managed software application to facilitate tracking and tracing of the product. The QR code must include the name of API, unique product identification code, brand name; batch no, batch size, date of manufacturing, date of expiry etc. It will help tracking and tracing of goods and would collect all the information in one place for easy access.


The government of India has made various changes in the laws for pharmaceutical industry and trying to make India self dependant in the medical sector. The initiative has been taken to make things easily provided by introducing new factors in the digital form such as adding of QR code, Drug delivery notification, Telemedicine etc.

Surbhi Singla

Associate at Aggarwals and Associates, S.A.S. Nagar, Mohali


Labour Laws Compliances for Pharma Industries in India

Labour Laws Compliances for Pharma Industries in India

Nowadays all the work is dependent on machines but still the machines can’t be equated with human beings, since their intellectual’s work on different pages. Labour is considered the most important asset of any industry and same in the case of Pharma Companies. Pharmaceutical industries work in different phases and for regulating these phases’ different legislations exists in India. The strict compliance with these pieces of legislation is required to avoid future legal hassles as well as to handle the present issues adroitly. This write up will shine some light on the compliances

Compliances under Labour laws: –

There are various legislations in India, which regulates different areas of employer-employee’s relationship. Presently, Indian Govt. has enacted four labour law codes i.e. Code on Social Security, 2020, Code on Wages, 2019, Industrial Relation Code, 2020, and Occupational Safety, Health, and Working Conditions Code, 2020, which have repealed 29 labour law legislations. While all the Codes have received presidential asset, the central govt. is yet to notify the date of their implementation.

Notably, the Pharmaceuticals firms are also regulated by these labour law legislations. Therefore, there are some mandatory provisions, which need to be complied with by the Pharma industries. The compliances are enumerated below in different categories: –

Registration & Renewals: –

The Pharmaceuticals firms must register themselves under the Shops & Establishment Act, if their registered/corporate office is located separately and there are regional/ branch offices or godowns. In the case of employment of medical representatives for the exclusive purpose of sales promotion operations, the Sales Promotion Employees Act would be applicable to such employees. Social security legislations like ESI, EPF, Gratuity, and Maternity Benefit would be applicable taking the establishment as a whole. The Pharma Company must register for the purpose of ESI and EPF. Moreover, CLRA (Contract Labour Regulation and Abolition Act) licence is necessary to be obtained by the Pharmaceutical firm to continue its hiring process, if it employs contract labour.

Apart from this, license under the Factory Act, 1948 is compulsory for pharma companies in order to carry out their manufacturing process. This Act gives various provisions related to the definitions i.e. worker, factory, employee etc, their working place, working hours, leaves, facilities must be provided by the industry to their employees. The Act makes it sure that there should be proper hygiene at the work and all the necessary precautions are taken care for the safety of employees

Recurring Compliances: –

The Pharmaceuticals companies need to file ESI return once every six months in two periods i.e. from 1st April to 30th September, and 1st October to 31st March.  Moreover, the PF return need to be filed every month alongwith details such as name of the organization, address of the organization, its code, account number of the employee, etc.

Additionally, notice of commencement/completion of each contract must be filed within 15 days from the date of such commencement/completion, in case of contract labour.

Apart from this, under the Factories Act, the Pharmaceutical companies have to file annual return with the Chief Inspector.

Social Security Benefits: –

  1. The EPF scheme is applicable to employees earning basic salary below or upto Rs. 15,000/-p.m. 12% of basic salary will be contributed by both employer and employer.
  2. In addition to this, employees earning monthly salary (excluding overtime, conveyance wages) below or upto Rs. 21,000/- p.m are covered under ESI scheme. An employee will contribute 0.75% of basic salary, whereas the company shall contribute 3.25 % of the basic wages. If salary of an employee exceeds Rs. 21,000/- after starting of contribution period then he/she will be continues to be covered under the scheme till the end of that contribution period (divided into six monthly contribution periods i.e. 1st April to 30th September and 1st October to 31st March). There is no wage ceiling limit for employees with disability.
  3. Payment of bonus is also required to be paid, if workforce is 20 or more. An employee earning upto Rs. 21,000/- basic salary and has worked for atleast 30 days in an accounting year, will be eligible for bonus. If salary exceeds than Rs. 21,000/- then bonus shall be paid at Rs. 7000/-. The bonus shall be paid at rate of 8.33% of the salary (not exceeding 20% of wages). It must be paid within a period of 8 months from the closing of the accounting year (1st April to 31st March).
  4. Gratuity if there are 10 or more employees, an employee who has completed 05 years of continuous employment shall be eligible for gratuity benefit. It shall be payable on cessation of employment by reason of resignation/termination/death/disablement. The same must be paid within a period 30 days when it becomes payable. Moreover, completion of five years of service is not necessary if employment has been terminated because of death or disablement or expiration of fixed term employment.
  5. Maternity benefit in case of 10 or more employees. Pharmaceuticals firms cannot knowingly employ a woman is their office/manufacturing unit during the six weeks after the day of her delivery, miscarriage or medical termination of pregnancy. It must be clarified before appointing. For married female employee who has completed 80 days of employment in last one year shall be eligible for maternity benefit of 26 weeks (8 weeks preceding the expected date of delivery), and female having 2 or more surviving children shall be eligible for 12 weeks (6 weeks preceding the expected date of delivery) maternity benefit.


  • Sexual Harassment Policy is needs to be drafted if there are more than 10 female employees. If the count of female employees is less, then an aggrieved employee can file complaint before Local Complaints Committee of District. Otherwise, Internal Complaints Committee is required to be incorporated to entertain sexual harassment complaints in the office/manufacturing unit.
  • Formation of Grievous Redressal Committee is also one of the compliance, as law provides that if there are 20 or more employees in any work place, there must be one Management Committee or Grievous Redressal Committee, which consists of equal number of members representing employer and employees to hear individual grievances.
  • Drafting of HR Manual depicting terms & conditions of the employment, since as per labour laws every employer must specify its terms & conditions for employment. Moreover, a written document in hand relating to terms & conditions can eliminate any future disputes between the employer and employee.


Compliance is essential to a business’s performance and to building a strong brand. Legal repercussions for breaking these laws and regulations include penalties and, in the worst situations, the closure of a corporation. Under the current labour regulations, India has a strict compliance regime. In order to make submitting returns with regulatory bodies under labour laws simpler, the Indian government has combined 29 labour regulations into 4 Labour Codes, which have not yet been put into effect.

-Kiranpreet Kaur

Associate at Aggarwals & Associates, S.A.S. Nagar, Mohali








Mandatory compliances for Pharmaceutical Companies in India

Mandatory compliances for Pharmaceutical Companies in India

The pharmaceutical industry is heavily regulated and subject to stringent oversight because to the fact that it is a chemical-based, life-saving, and industry. It is mandatory and unavoidable for pharmaceutical companies to comply with the law. Pharma compliance standards are quite strict, and infractions of Indian Pharma regulations are taken very harshly.

Before we gained independence, India began its journey towards pharmaceutical production. The first pharmaceutical business to be established in India was Bengal Chemical and Pharmaceutical Works Limited, afterwards known as BCPL. The Indian pharmaceutical market size increased to over 1, 29,000 Crores in 2018 because to strong growth. Remarkably, nearly 20% of the world’s supply of pharmaceuticals comes from India. Moreover, the pharmaceutical industry makes up around 2% of India’s GDP and about 8% of its total merchandise trade, according to the Reserve Bank of India (RBI).

It can be said beyond a shadow of doubt that being in a pharmaceutical sector, it is mandatory to strictly comply with numerous statutory compliances. Let’s shed some light on the statutory compliances for pharmaceuticals firms in India enshrined under the different legislations.

What are the legal enactments applicable on Pharma Industry?

Pharmacy Act, 1948

It establishes guidelines for pharmacy education and practise in India. In the event of a proved crime, a registered pharmacist may lose his or her licence and be prosecuted.

Drugs and Cosmetics Act, 1940

The Act explains the laws and rules governing the production, marketing, distribution, and import of medicines, cosmetics, and particular medical devices. Additionally, this Act establishes the guidelines for the handling, distribution, and prescription of medications.

The Drugs & Magic Remedies (Objectionable Advertisements) Act, 1954

Outlines regulations for drug advertising that discuss how to diagnose, treat, control, and prevent diseases and other conditions. It forbids the declaration of any drug having any “magical” therapeutic, restorative, or rehabilitative properties. This piece of legislation is applicable to a wide range of medical ailments and diseases.

Indian Patent Act, 1970

Keeps track of and controls new patents for pharmaceutical procedures and goods. An organisation or person’s name is typically used to register a patent for a 20-year period. The practise of “ever-greening,” in which the patent holder tries to extend the patent period by making small changes to the original patented formula, results in a sort of monopoly over a specific drug, is specifically prohibited by a special rule.

Drugs Price Control Order, 1995

This legislation oversees and regulates the cost of formulations and bulk medications. Additionally, this law specifies the profit margins at which pharmaceutical producers must sell their products to wholesalers and retailers in the Pharma sector.

Uniform Code for Pharmaceutical Marketing Practices 2014

It is a voluntary code of behaviour for pharmaceutical businesses, medical device companies, and equipment manufacturers. It was released by the Department of Pharmaceuticals. Doctors, pharmacists, and hospitals are specifically impacted by this Code. The prohibition of manufacturers giving gifts of any kind, including money, goods, vacations, etc., to anybody with the authority to prescribe or sell medications or drugs is one of the code’s most important provisions.

Trade Marks Act, 1999

It regulates the use of names, logos, and symbols for corporate branding and identification. An organisation or person with a registered trademark has the sole authority to produce and market goods under a certain brand name. It is unlawful and can result in legal action if someone else uses the name, logo, or symbol. A new entity is seen to be trying to “imitate” or “pass off” as the identity of the organisation that has been in operation for some time if it attempts to utilise a name or Trademark that has been used by an organisation or firm for many years without being registered.

What are the mandatory compliances for Pharma Companies?

The industry is faced with a variety of difficulties in the form of onerous general and sector-specific compliances that are applicable to various kinds of pharmaceutical enterprises. In India, compliances can be roughly categorised as one-time and continuing.

In four stages—setting up, pre-commissioning, post-commissioning, and post-production—a pharmaceutical firm is often subject to various one-time registrations and approvals.

Allotment of land, project-related approvals, construction approvals, labour, safety and health approvals, tax-related registrations, etc. approvals are included in this list. Then there are the continual compliances that the business must follow throughout the entire production process. They mix Central compliances with state-specific requirements.

The Drugs and Cosmetics Act of 1940 and its regulations, including the schedule on Good Manufacturing Practices and Requirements of Premises, Plant, and Equipment for Pharmaceutical Products, serve as the primary regulatory framework for the pharmaceutical business. Other significant industry-specific legislation includes the Essential Commodities Act of 1955, the Drugs (Price Control) Order of 2013, the Drugs and Magic Remedies (Objectionable Advertisements) Act of 1954, and the Drugs and Magic Remedies (Objectionable Advertisements) Rules of 1955.

The pharmaceutical industry often has the following sorts of compliance obligations: –

  • Inspection-related Compliances
  • Audit and Accounts
  • Display Requirements
  • Register and Records
  • Employee Safety and Welfare
  • Payments
  • Cleanliness
  • Examination and Testing

To sum up, an effective pharmaceutical sector exists in India, producing reasonably priced medications both for the domestic market and for export. One of the industries with the highest regulation worldwide is the pharmaceutical and life sciences sector. Unsurprisingly, one of the biggest problems facing Pharma around the world is the difficulty of effectively managing complicated rules and regulations. The reputation of the company may be at risk, so these difficulties must be overcome. Now is the time for companies to adopt a 360-degree strategy for their compliance programmes, taking into account both internal ethical codes and compliance with regulatory obligations. Long-term competitive advantage in this cutthroat environment will go to a compliant pharmaceutical or life sciences company with a strong tone at the top.

-Kiranpreet Kaur

Associate at Aggarwals & Associates, S.A.S. Nagar, Mohali


Extradition Law: An Overview

Extradition Law: An Overview

The majority of the time, a person who committed or was accused of committing an offence is tried in the nation where it was committed or allegedly committed. What transpires, though, when a person leaves such a nation to avoid going to court? Or what if someone who has been found guilty flees the country where they were found guilty? In these situations, the nation where the accused or guilty fled makes a formal request to the nation where he fled to bring him home. Extradition is the procedure used to send the accused or sentenced back to the country from which they fled.

What is the extradition?

The Latin terms “ex” and “tradium,” which mean “out” and “give up,” respectively, are the source of the word “extradition.” Its foundation is the Latin dictum “aut dedere aut judicare,” which means “either extradite or prosecute.”

“Extradition is the delivery of an accused or a convicted individual to the State on whose territory he is alleged to have committed or to have been convicted of, a crime by the state on whose territory he happens to be for the time,” according to Oppenheim.

The territorial state and the requesting state are both parties to the extradition process. Wherever the accused or convicted flees to avoid the trial or penalty is known as the “territorial state.” However, the “requesting state” is the location where the crime is allegedly or actually being committed. The requesting state formally requests the accused or convicted person’s surrender through diplomatic channels and in accordance with any treaties.

What is the purpose of extradition?

The majority of accused or convicted fugitives flee to other nations from the area of jurisdiction where they are charged or convicted in an effort to avoid the approaching punishment. To ensure that their crimes do not go unpunished, such unjustifiably motivated accused individuals or convicts should be extradited.

In addition to this, every successful extradition serves as a warning sign for offenders who seek to leave the area of the state with legal jurisdiction. Therefore, extradition serves to prevent criminal activity. Besides, criminals who intend or plan to flee the territorial grasp of the legally competent state will get the wrong message if the territorial state does not extradite the guilty or accused parties. More of those living there will be encouraged to flee into the territory of the territorial state if it refuses to extradite the accused or prisoners who are already there. As a result, such a nation might wind up serving as a sanctuary for criminals from around the world, endangering the security and stability of its citizens.

What are the principles of extradition?

Extradition normally follows the following four concepts, which are described below:

Principle of reciprocity: –

The foundations of the reciprocity principle are found in many areas of international law. It stipulates that every favour, deference, reward, or punishment bestowed by one country on its inhabitants or legal residents must be reciprocated (repaid) in kind. It enables the reciprocal manifestation of global solidarity. The principle of reciprocity, which states that the territory state must extradite the suspects or criminals in exchange for any diplomatic courtesy extended by the requesting state, is applicable when it comes to extradition. Any act, from tariff reductions to the implementation of foreign judgments to financial or military assistance, can be considered a kind of diplomatic kindness. This idea may also apply to the extradition of suspects or prisoners between the two nations.

Principle of double jeopardy: –

The phrase “non-bis in-idem” is another name for the double jeopardy principle. It states that if the request relates to the same crime, a person who has already been prosecuted and sentenced cannot be extradited. Except for the finished sentence, no offender tried and convicted once may be extradited for the same offence.

Principle of double criminality:-

According to the principle of double criminality, the offence for which the requesting state is asking the extradition of the suspect or convicted person must also constitute a crime in the territory state. In other words, the fugitive’s actions must be illegal in both the seeking state and the territory state. For instance, if a person is found guilty of “perjury” under English law but his actions do not qualify as “perjury” under American law, America may refuse England’s request to extradite that person.

Principal of speciality: –

A fugitive can only face justice for the specific crime for which he was extradited. The extradited fugitive must be brought to the status quo ante, meaning that he must first be returned to the State that granted the extradition before a new extradition request is made for the crime for which the fugitive is sought to be prosecuted. This is because the requesting state may decide that it is desirable to try the extradited fugitive for another crime committed before his extradition.

What are the conditions of extradition?

For the accused or prisoners to be extraditable, they must not fall into one of the following three categories.

Territorial State’s own nationals: –

The majority of nations argue that they have the right to exercise state sovereignty over their citizens, notwithstanding the fact that the crime was done in another nation, and so refuse to extradite their citizens who are accused of committing a crime in the requesting nation.

Political offenders: –

The fact that many nations refuse to extradite political offenders is one of the most contentious issues surrounding extradition. 

Persons already punished: –

The majority of nations uphold the principle of double jeopardy and decline to extradite individuals who have already been convicted and sentenced for the same crime for which extradition is sought.

Extradition Laws: International Scenario

One of the early accords that dealt with extradition to some extent was the Geneva Conventions and their Additional Protocols, 1949, which acknowledged the state’s cooperation in extradition. Since then, most nations have ratified a number of extradition-related international and bilateral agreements. To illustrate, more than centuries of nations have extradition treaties with the United States of America. Additionally, several nations’ penal codes now include extradition clauses.

The United Nations Model Treaty on Extradition, 1990

The UN Model Law on Extradition, which takes its cues from the UN Model Treaty, intends to improve global extradition cooperation. Additionally, it attempts to serve as an additional law in cases involving nations without extradition treaties. Extradition is expressly forbidden in Sections 5 and 6 of the Model Law if, in the opinion of the territorial State, it is requested in order to torture or punish the fugitive on the basis of his caste, ethnic origin, race, or other characteristics.

Extradition Laws: Indian Context

Pre-independence, extradition was governed by the United Kingdom’s Extradition Act, 1970 and then by the Extradition Act, 1903. Currently, the Extradition Act, 1962, hereinafter referred to as Act, governs extradition in India.

The Act allows for the return of wanted convicts from and to India. According to any extradition agreement with the requesting or territory state, extradition may take place. Section 3 of the Act further stipulates that, in the absence of such a treaty, any Convention to which such a requesting or territory state and India are party may be regarded as the extradition treaty in question.

The Act does not specifically prohibit the extradition of Indian citizens to the State making the request; nonetheless, the prohibition on extradition changes from treaty to treaty. It is marked here that presently, India has extradition treaties in force with 48 countries.

In addition, India currently has extradition agreements with the 12 nations. Extradition agreements are agreements between the requesting and territorial states where it is agreed that extradition will take place in accordance with the territorial state’s local laws and international norms rather than the requesting state’s local laws.

What is the procedure for extradition from India?

When a foreign government requests the extradition of a wanted criminal from India, the Consular, Passport and Visa (CPV) Division of the Indian Ministry of External Affairs (MEA) receives the request and any supporting documentation. The arrest warrant must be issued by the Magistrate of Extradition, who is often a Magistrate of First Class, once the Government of India receives it. The Magistrate issues the arrest warrant on the basis of the evidence put forth before him.

After being apprehended, the wanted criminal is subjected to a court investigation, the results of which are reported to the Government of India. The Government of India may issue a warrant for the fleeing criminal’s custody and return if satisfied with the report. The wanted criminal subsequently handed over to the State making the request at the location noted on the warrant.

What is the procedure for extradition to India?

To commence with the extradition of a fugitive criminal to India from the territorial state, the concerned Magistrate upon finding the prima facie case against the fugitive criminal, sends a request to the CPV division of MEA. The Magistrate makes the request alongwith supporting documents and an open-dated arrest warrant. Following that, the request is formally transmitted to the territorial state through diplomatic channels, where it is subsequently delivered to an inquiry magistrate.

The Territory State’s inquiry Magistrate issues a warrant to arrest the wanted criminal after making his decision. He further informed the CPV and Indian Embassy about the arrest. To bring the wanted criminal home, concerned Indian law enforcement officials visit the territory state to get such criminal back to the home country.


In concluding words, extradition is a crucial instrument for both carrying out justice and evaluating diplomatic relations. However, the fugitive criminals take advantage of absence of extradition agreements with many nations. An all-encompassing international extradition law must be established. This gap could have far-reaching effects, such as security dangers in the nation where the fugitive seeks asylum, and causing economic or legal problems in the fugitive’s home country.

Kiranpreet Kaur

Associate at Aggarwals & Associates, S.A.S. Nagar, Mohali