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Legal and Regulatory Regime: Medical Technology
  • By:
  • 04 Oct 2019
As technology is changing rapidly, it opens the new regime within the domain of health care. Advancement in medical technology such as personal medical devices, open-source hardware and mobile phone apps are creating opportunities to improvise the medical industry.  In order to regulate the new challenges, it is necessary to balance the need for regulation along with flexibility and efficiency in the use of technology.  With the comparison of new health technology the designs, standards and regulations evolve slowly and therefore some difficulties can be faced while applying the standards to these regulations. For instance, the current regulations may not be suitable for upcoming medical technology. The standards may not be that flexible while evaluating the usability of other upcoming medical technology. Regulation for medical technology in India is ambiguous, complex and opaque. There are certain issues pertaining to regulation on medical technology. The medical technology industry has no separate legal status. Earlier, it was regulated by the Drug Controller General of India (DCGI) under the Central Drugs Standard Control Organization (CDSCO). It was found that regulation covers few medical devices under the ambit of Drugs and Cosmetic Act 1940 with subsequent amendments. But it was necessary to distinguish medical devices from pharmaceutical products.

Absence of Specific regulation and coverage under the Drugs and Cosmetic Act has resulted in a lack of transparency and clarity about the regulations. These industry face problems pertaining to multiple levels of government authority involved in enforcing the guidelines and inconsistent interpretation of the regulatory guidelines by authorities. It resulted in a prolonged and cumbersome regulatory pathway for new and existing products.

India’s Ministry of Health and Family Welfare released the Medical Device Rules, 2017 which came into force from 2018. It contains the regulations applicable to medical devices and in-vitro diagnostic medical devices. The regulation states that all medical devices will be placed into four classes based on the use of device and the risk of using the device. The government has been selective in the regulation of medical devices as until the device has been notified under Drug Cosmetic Act and Medical Device Rules it will not be regulated. The government has overhauled the regulatory framework and has brought it at par with international norms with the concept of ‘risk-based regulation’.

Under the applicable regulatory framework of medical devices, the function of manufacture, import, sale and distribution of medical devices require licenses or permissions from the Central Drug Licensing Authority and State Drug Licensing Authority.

Manufacturing a medical device requires a separate license for each medical device which is notified. Also, for importing the medical device in India it is necessary to satisfy a few additional legal requirements. The import of all medical devices is governed under the Export and Import Policy.

To understand how the regulatory framework around medical technology is evolving, the comparison of Indian regime with other developed countries can be followed.

In recent years, due to the rapid advancement in scientific discovery and technology developments in the UK, it helps the patient to manage and track their health conditions on the go. Also, the growing number of health technologies available can be adapted to support personal care in terms of electronic devices.

For instance, three-dimensional printers are devices that create three-dimensional objects based on electronic data where printers have opened up the possibility to produce custom made medical devices as and when needed. These types of advances continue to provide solutions to health care problems that seem to be impossible to solve and they generate their own considerations about the procedure to see how these technologies fit into existing regulatory framework.

But the medical technologies do not always fit into the specified standards because they take a step ahead from what it is currently accepted as practised. There are possibilities that innovation may be hurt by the current regulatory system. However, sometimes the existing standards may not be applied or in use and after development in modern technology they are unable to apply. The steps followed for the development and testing the medical device was created with a traditional manufacturing process, at a certain point, the design would be freeze and considered as complete. Repeated change in standards and its requirements may be cumbersome for evolving medical technology.

Even though there has been progressing towards using explanatory method to investigate the context of use, standards are lacking in their treatment. The experience of user relates a context that the important factor in determining how people will accept the technology and interact with it.

There is an opportunity for standards to support consideration of a broader range of context.

Also, there are many issues in the certification of health-related apps. Regulation is required and although guidance on technologies may exist, it may not be clear whether such standards can be covered under regulations.

For medical technology, the standards and regulations are needed to ensure safety for protecting the public and guarantee that products are fit for purpose, the current approach towards regulation is not only feasible but difficult to enforce.

Intellectual Property in Medicine
  • By:
  • 04 Oct 2019
Introduction: Access to medicine is a tool that plays a significant role in the lives of people. It has been a life-saving instrument which helps in eliminating diseases by its consumption, application or any other use as prescribed by doctors. World Health Organization with its research has reached to the conclusion estimating that one-third of the world’s population has no access to proper medicines, though the figure has changed from 2.4 billion to 4.3 billion between the year 1975 and 1999. India has been one of the countries where access to medicine has been a real-time issue for the government. As per statistics, 39 % of Indian people have issues relating to access to medicine. Income level of an individual also affects the life of the person regarding his right of access to medicine. Access treatment has also become a problematic thing as the medicine used in such treatment have become unaffordable or ineffective due to resistance or not sufficiently adapted to specific local conditions or constraints. Out of 1223 new medicines approved in the year 1975 and 1997, approximately one percent drugs specifically treat tropical diseases. India’s share coupled with Africa is just 2.3 % of the global market as compared to the developed nations.

Government’s Investment in Health Care

Though the government in its reports mention a higher amount of expenditure on healthcare in the country, globally the government sector is investing less as compared to the private sector. Government investment in percent to GDP (Gross Domestic Product) had a steady rise until the year 1990-1991 and it has remained to stagnate since then. The per capita expenditure is also same or stagnate since 2000-01. Cost of purchase of medicine is sixty- seventy percent of the treatment making it impossible for poor to pay the cost. At the same time, medicine accounted more for the countries which had a very low or low-income population as compare to high net income population. There is a long trend in communicable and non-communicable diseases with changes in lifestyles.

Reforms in patents

A dream of healthy India is becoming a reality but at the cost of time. There is a part of India that has adopted artificial intelligence, smart technologies for surgeries and operations and there's a part of India who is oblivious to advancement happening in the country. For a developing state, it is more important to make medicines which are more affordable so every person can afford to buy it. From the past two decades, complying with growth, India has made a significant contribution to healthcare by making medicines more accessible to the public. India as a developing nation needs new innovation in drugs, development in the therapeutic domain and building healthcare facilities. The revised version implemented by India regarding the Patent Law was made in order to comply with Trade-Related Aspects of Intellectual Property Rights. India before enacting the amended act of 2005 was at the following stage:

  1. Indian pharmaceutical industries grew as one of the fastest-growing industry in the production of generic medicines.
  2. Indian market encouraged the domestic players for manufacturing the drugs.
  3. The Act granted the patent on the process as against the global rule of registering the product alone or singly under the Patent.
  4. There was a wider distribution of generic product or medicines at a generally reasonable price making it more affordable for people to buy.
  5. There was no big peep from global market players in-country or global big players showed no interest in the Indian market.

After the amendment act 2005 the position of India was:

  1. A rule was introduced to the act stating the duplication of any medicine before 1995 will be illegal.
  2. Global players in the pharmaceutical industry showed a gradual interest in Indian markets for their expansion.

A favourable policy relating to Intellectual Property is required for attracting the investment in India by foreign players, patent registration system should be made more smooth eventually catalyzing the research and development in the healthcare sector.

Make in India has brought a lot of changes in patent law encouraging the patent protection for innovation. As per the report provided by the patent registration office in India, it has been stated that the pharmaceutical industry is the major contributor in the patent registration, registering more than 20,000 patent since 2015. However taking them into consideration it's been said that patenting the product will eventually make the price of the product higher, making it unaffordable for people to buy. But Supreme Court has been the custodial of the rights of common man, as the needs of the common man have never been compromised. Such claim has been proved not so long ago but in 2013 in Novartis case of Glivec. In 2013, the Supreme Court denied the plea for patenting the cancer drug Glivec by Novartis.
Consumer Protection Bill, 2019
On 30th July 2019, LokSabha passed the Consumer Protection Bill, 2019, which wholly replace the Consumer Protection Act, 1986. The bill was introduced by the Minister of Consumer Affairs, Food and Public Distribution in LokSabha to enact a new law for strengthening consumer rights in the modern market.  It proposes to set up a Consumer Disputes Redressal Commission and forums at District, State and National level for the speedy redressal of the Consumer Complaints.

Key provisions of Bill:

  1. The Consumer Protection Bill is enacted to protect the interest of consumers with the means of redressal mechanism that would lead to the effective and speedy settlement of disputes.
  2. It seeks to enlarge the scope of existing law to be more effective.
  3. It empowers the Central Consumer Protection Authority to protect the rights of the consumer and to solve issues related to misleading and false acts. 
  4. It has the provision of an alternative dispute resolution mechanism in the form of mediation.

The objective of the Consumer Protection Bill:
The main aim of the bill is to ease the process of addressing the grievances to the Consumer Forums and to protect and enhance consumer rights.

Central Consumer Protection Authority (CCPA) and its powers:
It is the National level regulator dealing the matters related to the violation of consumer rights, unfair trade practices and misleading advertisement that are prejudicial to the consumer’s interest.  It is an investigation wing with the power of search and seizure the consumer-related matters under the head of Director-General. The District Collector is empowered to report the Central Consumer Protection Authority if they receive the massive consumer complaints in the particular jurisdiction. CCPA has the power to file a complaint before the relevant Consumer Dispute Redressal Forum. It also has the power to recall the goods that are deemed to be hazardous or dangerous to the consumers and practising unfair trade practices. It can impose penalties on manufacturers and endorses for misleading advertisement.

The CCPA has the power to impose a penalty up to Rs. 10 Lakh and imprisonment up to 2 years for the false and misleading advertisement. Whereas, in case of a subsequent offence, the fine may extend to Rs.50 lakh and imprisonment for five years.

CCPA has the power to prohibit the endorser for endorsing the misleading advertisement on particular product and services for one year. Further for a subsequent offence, the period of prohibition may extend to three years.

Pecuniary jurisdiction:
The Bill has enhanced the pecuniary jurisdiction as follows:
  1. The District Consumer Dispute Redressal Commission will entertain the complaints where the value of goods and services exceeds up to Rs. One Crore.
  2. The State Consumer Dispute Redressal Commission has the power to entertain the complaints where the value of goods and service are more than Rs. One crore but less than Rs. 10 Crore.
  3. The National Consumer Dispute Redressal Commission will entertain the complaints with the value of goods and services over Rs. 10 Crore.

The Consumer Protection Act, 2019 refers to e-commerce as trading by using electronic technology, majorly internet services. As per the new Consumer Protection Act 2019, now all the rules applicable for direct selling will be extended to E-commerce. It will be liable to ensure that no counterfeits products are sold on the website.

Product Liability: 
The term product liability came into picture through the new Consumer Protection Act, 2019, as there was no specific statute dealing with the claims of product liability. Product liability is the liability of a service provider, the product manufacturer or seller who needs to compensate the consumer for any harm or injury caused by the defective product or services. The consumer has to prove any of the defect or deficiency in product to claim compensation.

  1. Product liability action for the manufacturer: The product should not contain the defect in its manufacturing, design, or there should not be any deviation from specifications in manufacturing the product. Also, the product should contain adequate instructions of usage to prevent any harm to the consumer. It should contain warnings regarding the improper usage of the product. Also, the warranty should be as per the standard rules and laws. 
  2. Product Liability for Service Provider: The liability for the service provider is that he should adequately monitor the quality or manner of performance as mandated under the law. Proper instructions and warnings must be issued by the service provider to prevent any harm.
  3. Product Liability for the seller: The product seller can alter or modify the product only to the extent until it is not harmful to the consumer. The seller of the product should ensure that the product or service is inspected properly before selling. He should provide adequate information to the consumers as described by the manufacturer.

Exceptions to product liability
The product manufacturer shall not be liable; 
  1. If he fails to instruct the consumer about the danger of a product which is expected to be commonly known to the user of the product. 
  2. If the consumer, while using the product, was under the influence of alcohol or any drug not prescribed by the medical practitioners, then the manufacturer is not liable for such product liability.
  3. For any harm, if the product is misused or altered.

Note: For earlier blog go on this link
Artificial Intelligence in healthcare
  • By:
  • 02 Oct 2019
Healthcare in India is growing and complex phenomena due to the increase in population with the same set of healthcare centres eventually resulting in inefficient service towards people suffering from various diseases. The problem still exists as the health care system in India has a complex structure. This health care industry structure is divided into multiple layers. Historically, the Indian sector was governed mainly by a government agency but due to an increase in the private sector, it has resulted in a growing or expansive presence of the private sector in this field. Even though the rules of this sector are governed under the primary health care sector, the presence of private sector is majorly in the secondary and tertiary sector. Technological development in a country with a population of 1.3 billion has its own significance in developing the health care system in the country. Artificial intelligence is the next big innovative and non-invasive method introduced in very own form in the country by many start-up firms. Introduction of technology in medical science has been a way by which there are higher chances of eliminating human errors.

What is Artificial Intelligence?

It is basically called as machine intelligence in terms of computer science. It a contrast version of natural intelligence depicted by the human in real sense.

Artificial Intelligence in Healthcare

Increase of technological use in the healthcare system has been a virtue or kind of a blessing for doctors or medical caregivers. Use of medical devices in hospitals and health care centres, various mobile applications and wearable devices helps to maintain the health condition of the customers who buy it and also helps the doctors for early detection of any health issues. Many hospitals these days use technologies. Introduction of artificial intelligence is expected to reduce this manual effort making it probably negligible. For Example:
  1. Manipal Hospital, one of the leading hospitals in India uses the artificial intelligence technique to get the early diagnosis of diseases they intend to cure. Manipal hospital is using IBM’s Watson for Oncology a cognitive computing platform for helping physicians discovering new ways for cancer protection and care options.
  2. Columbia Asia Hospital uses an artificial intelligence technique for the purpose of early diagnosis of heart diseases or anything related to cardiovascular.
Most of the pioneering players in India are introducing artificial intelligence techniques to enhance the productivity of the health care options by medical sciences. Microsoft has been a leading player in the techno-medical environment by use of cloud computing and artificial intelligence unit known as Healthcare Next. Some of the initiative by Microsoft India that has its roots in eliminated the eye diseases, Microsoft by working parallel with State Government has launched a scheme known as Microsoft Intelligence Network for Eyecare. The state of Telangana has launched a scheme called as Rashtriya BalSwasthya Karyakram helping children to eliminate the diseases regarding eye. 

Policy and Regulatory Framework

As any new technology is to be introduced in India, there is a framework that has been build in which such technology needs to comply with certain parameters and provisions as per the law for smooth implementation.

  1. Indian Medical Council Act, 1956 and Indian Medical Council (professional, conduct, ethics and etiquette) Regulation, 2002
  2. Electronic Health Records: Government has introduced the electronic health records, 2016 as a standardized method for regulating the data ownership and privacy standards for collecting health data from patients, this regulatory code also includes the data collected from the medical establishment, medical devices and self-care devices and systems
Data Ownership: - Even though the data is stored by the medical establishment relating to the patient, the customer has the full right over such information.
Data Accesses: - Patients as the rightful owner should have complete access over the data as they are one who can permit its disclosure; no person should disclose the data without prior permission of the concerned person.
Changes to data: - Once the data entered by the person should not be allowed for changes, further changes regarding the data should be accompanied by an audit trail.
Disclosure of Health Information: - Any information related to health can be disseminated only if the identifiers were removed.
Access to health records by Courts: - Any health records demanded by the court should be presented in as it is stated, such information can be disclosed without prior approval and with the procedure established by law.
Responsibility of Health providers: - The responsibility of a health provider is to maintain the data and take its whole responsibility. Such a provider should not submit the data or disclose it without prior permission of the concerned person or by the procedure of the law.
Encryption of the data: - Electronic health records should compulsorily be encrypted with a minimum of bit encryption keys.
Identification: - Patients aadhar card should be used as an identifier and in the absence of aadhar card any two government IDs can be used.

Example of effects on Patient

In India, 50 % of the women die within half a decade due to a diagnosis of breast cancer, as the traditional cure pattern in medical science is not the upright solution for the disease. Usage of Artificial Intelligence can help in early detection of cancer. AI-based cancer screening test using machine intelligence over thermographic images have given a low cost, easy to operate and portable solution for detecting cancer, thus improving the health condition resulting in survival. Also, the screening test is non-contact, painless and free of radiations.

The Real Estate (Regulation & Development) Act
The Real Estate (Regulation and Development) Act gave India’s real estate sector its first regulator from, May 1, 2016. It seeks to bring clarity and fair practice that would protect the interests of buyers and also impose penalties on errant builders.

RERA seeks to address issues like delay in possession, price issues, quality of construction, title, and other changes. Delay in projects is the most significant issues faced by buyers. Projects launched are often delayed due to several reasons. The reasons include deviation of funds to other projects, change in regulations by the authorities, the environment ministry, national green tribunal, involved in infrastructural development many places; the land acquisition becomes an issue, etc. Some builders often sell projects to investors without the approval of the plan or with poor quality of construction or unauthorized construction; such projects are often stuck in long litigation battles.

RERA establishes a state authority which will govern both residential and commercial real estate transactions. It ensures more clarity between the developers and buyers.

Homebuyers have been complaining fora long time about unbalanced real estate transactions heavily in favour of the developers. It aims to create a more impartial and equitable transaction between the seller and the buyer of properties. This Act mandates each state and union territory, to frame the rules which shall govern the functioning of the regulator.

Ongoing projects where the completion certificate or the occupancy certificate not been issued, are also required to comply with the registration requirements as per the Act. At the time of applying for registration, the promoters are required to provide in-depth information on the project, i.e., land status, details of the developer, promoter, approvals, schedule of completion, etc. Only when registration is completed, and other permissions related to construction are in place, then the project can be marketed.

One of the primary reasons for the delay of projects is that the funds collected from one project would invariably be diverted for funding different projects. To prevent such diversion, promoters are now required to deposit 70 percent of all project receivables into a separate account. These project receivable can only be used towards land and construction expenses and will be required to be certified by a professional.

Objectives of RERA

  1. To protect the interest of the customer in the real estate sector.
  2. To establish ways for a quick settlement of the dispute.
  3. Sale of the building, plot, an apartment to be transparent.
  4. To form the Appellate Tribunal to hear appeals.

Salient Features

RERA was established for enhancing accountability and transparency with respect to real estate transactions.

Following are the salient features of enacting RERA:

  1. All real estate projects should be registered under RERA.
  2. The registration of a particular project can be cancelled ifRERA authority receives any complaint to be true after an inquiry.
  3. A property cannot be sold if not registered with RERA.
  4. It is mandatory to upload the details of the project on the official website of RERA.
  5. If the buyer has any complaints against the builder regarding the violation of the provisions or rules of the RERA Act, they can file a complaint with the RERA authority. 
  6. If any decision of RERA is not satisfactory, the aggrieved party can submit an appeal before the Appellate Tribunal.

Benefits of RERA Registration

  1. Prevention of Funds: RERA prevents insolvency by creating a separate Escrow account for borrowers related to all transactions of real estate.
  2. Authenticity: The Certification of RERA assures confirmation to the promoters and brokers as it will attract more buyers in the future.
  3. Complaints: The registered promoters and brokers are empowered to file a complaint with an appropriate authority.
  4. Flexibility: RERA makes it convenient for the promoters to choose the date of delivery of the project as per their wish.
  5. Professionalism: This Act is for strengthening the real estate industry as well as it helps in creating a sense of professionalism.
  6. Defined Carpet Area: Before enacting RERA, the method by which builders calculated the price of the project was not precisely defined. Whereas, RERA has defined the standard formula for calculating the carpet area, to avoid the promoters in providing inflated carpet areas to increase the prices.
  7. Penalty Interest: Prior to RERA, if promoters delay the possession, the interest paid by the builder was much lower than paid by the buyers for delay in payments. This has changed with RERA; now both the parties have to pay the same amount of interest to each other in case of a penalty.
  8. Defect in Title: If buyers discover that there is a defect in the title of the property, at the time of possession, the buyer can claim the compensation, and there will be no limit to the amount to be compensated.
  9. Payment in Advance: As per RERA rules, a builder cannot take more than 10% of the project cost from the buyer as advance fees. This helps the buyer to arrange for the next payment as per the payment schedule discussed between builder and him. It gives time to the buyer for sourcing the funds. 

Real estate (regulation and development) Act, 2016 was implemented for better regulation of the real estate market. It stated that for better governance a real estate act was necessarily dealing with purchase, sale of land further pushing for a transparent dealing in land and other incidental requirements for such transaction between allotter and allottee. The Act specifically mentioned that the person to whom land is been sold should have clear detailed idea about the sanction plan, it was doubtful that person who administer the land as owner through power of attorney may not have the detail of sanction plan as the buyer of the land had or will have, so to make it more transparent it was suggested or is advised by the Act to upload the action plan, sanction plan and all other detail as suggested by the Act on website of the seller for public knowledge. In one of the recent rulings in the year 2018, under Ferani Hotels Pvt. Ltd. v/s The State Information Commissioner Greater Mumbai & Others said that “the fate of purchase of land development and investment is a matter of public knowledge and debate, any judicial pronouncement should squarely weigh full disclosure in this behalf. Further stating the court said any display of the action plan by the signboard or any other as stated in the act would not violate any provision under Right to Privacy, stating further the court stated that such display of information relating to land is not in nature of personal information against which contention can be tenable. It was advised that contrary to making it applicable to display sanction/ layout plan at the site land, to suggest a direction in which such information should be displayed resulting in hampering of any intelligent mischief born in the minds of culprit resulting in violation of the provisions of Act, objective enunciated was to provide a better governance and transparency in dealing and administering the land.

Warrant and its Types
What is a Warrant?

It is a written order issued by a judicial officer or other authorized person commanding a law enforcement officer to perform some incident or act to the administration of justice. Warrants are recognized differently as per the variety of purposes in the law. The person who ignores the appearance in court is also brought by issuing the Warrant. Mostly, police use warrants as the basis to arrest a suspect and to conduct a search of property for evidence of a crime.

Types of Warrants in India

There are three main types of criminal warrants;
Arrest Warrant: An arrest warrant is a warrant issued on behalf of the state by a magistrate or judge, which authorises the arrest and detention of an individual, or the search and seizure of an individual's property. Arrest Warrant includes a bailable arrest warrant and a non- bailable arrest warrant.

  1. Bailable Arrest Warrant -  Warrant to be executed by a policeman, but after the execution, the person arrested can be released by providing a bail which can be bond or cash as per the warrant.
  2. Non Bailable warrant - Warrant, where arresting or executing police officer, cannot do anything but remand the accused to police station and produce the accused before a magistrate who issued the warrant who will then either recall the warrant with fine or send the accused to judicial custody and order the accused to go to court and apply for regular bail.

 Essentials of Arrest Warrant:
  1. The Warrant must mention the name and other particulars of the person to be arrested.
  2. Every Arrest Warrant shall be in writing, as per section 70(1).
  3. It is to be signed by the presiding officer of the court and must have the seal of the court.
  4. It must show the person whom the authority to arrest has been given.
  5. A magistrate may direct a warrant to any person within his jurisdiction for the arrest of any person accused of a non- bailable offence and is evading his arrest. If a person who is arrested under the warrant executes a bond and gives the security for the attendance in court, he shall be released at the discretion of the court.

Bench Warrant: The arrest warrant that is ordered by a judge against the defendant in a criminal case or any similar proceedings is known as a bench warrant. A bench warrant is issued when one fails to appear before the court. The term "bench" is derived from the traditional meaning for the judge's seat.

In severe criminal cases, a failure to appear will most likely lead to a "regular" arrest warrant, which would drive immediate attempts to locate and detain the defendant or an accused. A bench warrant does not mean that the police will be at the door of the defendant the next morning. However, the name of the defendant will be circulated into a statewide computer system that usually serves the entire law enforcement centre. Once the name comes in the database, and an individual has to deal with the police for any reason – even from an incident that was not his fault, such as someone hitting the car from behind – individual will be taken into custody for the outstanding bench warrant.

Difference between Bench Warrant and Arrest Warrant

Arrest Warrant: Generally, the police are supposed to obtain an arrest warrant, issued by a judge based on probable cause, before taking an individual into custody. There are, however, exceptions to this general rule that allows police to conduct warrantless arrests.

Bench Warrant: A judge issues a bench warrant when an individual fails to appear in court. It is not at the request of the police. It is based on the court's jurisdiction over individuals to require their appearance in court.

Search Warrant: It is an order issued by magistrate or judge to authorize law officers to search for a person, his vehicle or location, to get evidence for a crime and to seize any evidence if found. In some countries, a search warrant cannot be issued in the civil proceedings.

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