Aditya Jain is the founding and managing partner of J&G Advocates. He is an Advocate on Record in Supreme Court of India, since 2020. He has 7 years’ of experience driving success in Commercial and Criminal law litigation. He holds a B.A.L.L.B (Hons) degree from Gujarat National Law University, Gandhinagar (2008-2013).
Neha Gyamlani is co-founder and partner at J&G Advocates, a law firm. She practices in Supreme Court of India and Rajasthan High Court , Jodhpur and Jaipur bench. She has extensive experience in litigations arising out of trade and commerce, contracts, employment contracts, Arbitration, Banking laws. She holds a Bachelor of Socio-Legal Sciences. LLB degree From Fergusson College, University of Pune.
They have been interviewed by EBC/SCC Online Ambassador, Shreya Agrawal, who is currently pursuing law from Vivekananda Institute of Professional Studies.
For the Video of the Interview, click HERE
The healthcare sector is at the epicentre of this unprecedented global pandemic challenge, It’s been said that the healthcare sector has the potential to be the next sunrise sector for India, and the country can be the saviour for our part of the world admist the covid crisis. In view of the present situation, we have invited our guests to give their insights into the legal and regulatory framework and problems and challenges that are being faced by Healthcare and Pharma Industry in these times.
- The COVID-19 crisis surely is one of its kind and has no precedent to it – there are no rulebooks, no standards that tell governments what to do; how to shut down economies; when to re-open; and a how to exit strategy! What are the challenges that our healthcare system is facing today; what are some of the most important innovations our healthcare industry needs to battle against this pandemic.
Neha: The major challenges which are being faced by our healthcare sector today can be related to the 5 “A’s” which are harming the sector, the essentials that are lacking in this industry:
- Awareness: Awareness in the rural section of the people is lacking.
- Access to Healthcare: The overall access by all the sections of the society. It’s just not about one section of the society, the middle or the high class. If the public sector is not able to provide access to healthcare to the rural population, then there is problem in the healthcare system of the country which is prevailing.
- Absence of the Human Power Crisis: There is lack of resources in the terms of public and private sector which is not being managed by both the sectors appropriately to address the needs of all the sections of the society.
- Affordability: Cost of healthcare gives rise to the problem of affordability.
- Accountability
Besides these, some of the major problems are- in India, particularly we have to reduce the out of pocket expenditure, which is being spent by the public onto to the healthcare. So the pocket doesn’t allow so much of healthcare expenditure for them- be in terms of the medical insurance or in terms of the over the counter medicines, which is not being affordably provided to them.
Furthermore, the big challenge, which is again, coming in the industry, is that India has not been able to recognize the manpower or the skills of the people who are into the sector. These are the various challenges which we have to overcome to usher into a new age of the healthcare, which is called as the digital healthcare or the e- healthcare.
So until and unless we can address these problems, there will be problems again in the next sector and the next phase. Nevertheless, simultaneously with these challenges, some innovations have come into the healthcare sector, which Aditya will guide you about.
Aditya: Some of the innovations which has come into the picture, especially during the COVID-19 phase. And I think we need to adopt Disruptive technologies like AI, Robotics, IOT, Big Data, Healthacare aggregators to deliver top class healthcare.
As we all know, India faces shortage of doctors and qualified medical practice professionals and good medical hospitals as well, especially in the public health infrastructure. Hence we need to leverage these technologies to make sure that these technologies could at least be used for basic things like, you know, physician, treatment, diagnostics x-rays, etc. Then actual doctor physical meeting is not required. There are some States who have actually adopted these technologies to deliver healthcare.
Rajasthan has this policy called Rajasthan Bhamashah Swasthya Bima Yojana, which is one of the most successful insurance Healthcare programmes and gives insurance of Rupees Thirty Thousand for general illness and Rupees Three Lakhs for critical illness. This program has achieved a lot of success because of its efficacy in implementation by the State Govt. This program was introduced a few years back and it has also been replicated by various States. Similarly, the state of Andhra Pradesh has a program called Chandranna Sanchara Chikitsa, a flagship program, where medical care is provided on wheels. It ensures availability & accessibility of medical services to remote villages with the help of 289 vehicles,so that people can access best medical facilities. This was done under the Chandra Babu Naidu Government and has been funded by the new government as well. And this has been a very successful program.Another state program, which was adopted by the Andhra Pradesh Government was Mukhyamantri Aarogya Kendralu, which is also the state of art healthcare where services are provided to the slum dwellers and the urban poor. There’s also the NTR Vaidya Pariksha program,for laboratory services where state governments provides the diagnostic tests to patients within government hospitals. Madhya Pradesh also has a Sardar Vallabhbhai Patel free drug distribution Yojna, which has been implemented in various cities of Madhya Pradesh and also the villages.
Similarly, innovations in the cardiology space, radiologial imaging space are already available and are being adopted by several States. Now, one thing which I would like to point out is the use of telemedicine in the medical innovation space. One thing which I can think of at this stage is the Agra model which is called Sarvamsetu where they have a separate cell which is providing telemedicine services to the poor and the needy in the healthcare space. So this has achieved a lot of success.
Similarly, diagnostics and initial cancer care could be provided by using telemedicine space. And what we need to make sure is that while we use technology for these things, we need to make sure that confirmation that is given is critical patient information and that needs to be safeguarded. So these are the things which are being used and similar models could be adopted by different States to make sure that we overcome this Corona Crisis, especially in face of a poor public infrastructure that India has.
- The Telemedicine Practice Guidelines,2020 were introduced amidst the pandemic to cater to the urgent need of the present times. Can you tell us the significance and loopholes of the same?
Aditya: There are two parts to the questions – Significance of the Guidelines and the loopholes in the guidelines. I’ll be focusing on the significance part of it. Neha will throw some light on the loopholes that are there in the guidelines which needs to be addressed.
Coming onto the significance part of it, I think the telemedicine guidelines of March 25th 2020 are really significant because for the first time, our policymakers have provided some kind of regulatory infrastructure for telemedicine to thrive upon. Now, what we were seeing was that there was telemedicine, tele video, telemedicine consultation sessions, which were going on in several cities, but there were no guidelines to this effect. Now with the arrival of these guidelines, where we are is at a stage where we can make sure that seamless telemedicine consultation sessions that are going on across the length and breadth of the country. Now, what does the guideline means for the patient?
The patients now, even at a remote village could avail the services of a good medical practitioner by telemedicine sessions. The guidelines as such have provided certain norms, which would make sure that the data which is there during the session is kept safely and securely. The guidelines cast a duty on the doctor, the one who is using the telemedicine for consulting, and also the intermediaries to make sure that the data is not leaked. There are strict conditions which are laid down in the guidelines and the also the prescription part of it. Now since the guidelines say that prescription could be sent via email and express patient consent is required and even a doctor’s consent is required before beginning our telemedicine session. So these all procedural safeguards are there to make sure that telemedicine is conducted in a seamless environment.
Secondly, informed consent is one another material aspect of these guidelines where a patient is informed of the implications which could be there. Now, I think telemedicine should be used only for the first and the follow-up care. It should not be used for some typical or technical kind of surgeries or, you know, where actually it is required to meet a doctor. So it is good for the initial and the follow-up care. So it is not very healthy for the post-care. Now Neha would we telling you more about the loopholes that are there in the guidelines.
Neha: Before talking about the loopholes, we should understand the very basic features and the salient features of telemedicine guidelines which includes that doctor can choose any medium of telecommunication or tele consultation which includes- the emails, the WhatsApp, and all these kinds of instant messaging services. The first loophole we need to see here is that in this feature itself is that when they’re saying that the doctor can use any mode of communication and these communication methods are encrypted, or they can be coded or decoded. So there’s no such information in these telemedicine guidelines with respect to the data privacy issues. So this is the foremost concern of the patients and even the doctors. It will be a concern of how this trail will be regulated. So when we are going in a telemedicine or when we are going at the tele-consultation support, I’m going to a doctor with some disease of mine where I want to be confidential about it.
But my biggest concern is that I’m leaving a trail of my disease. So how could that be regulated? How could that be secured from the eyes of the public and later from the eyes of the government, because these kinds of apps, instant messaging services, these are very well in the eyes of public.
Google is not safe – we all know that.
Second thing is that the guideline which is a significant basically is the doctor has to maintain the same standard of care during tele-consultation as he’s doing during the in-person consultation, but the guidelines never tell us that, how are we regulating this. They have not picked any standards. They are saying that the terms that is used in the guidelines is the professional judgment of the doctor. Now, how this professional judgment of the doctor is guided-nobody knows. So they say that MCI (The Medical Council of India Act) will regulate it but Medical Council of India at the same time hasn’t amended the definitions of the professional judgment that has been there in the Act itself. So this is a second major new loophole.
Third is that the guidelines say that the patient is responsible for the accuracy of the information. Now, this is a very generic statement to say that patient is responsible for the accuracy of the information. Now, here the patient who is will be using the online medium cannot understand the nuances of this kind of transaction which is happening online and not. The accuracy of the patient biometric information is definitely the responsibility of the patient. But what about the prescription? What about the standard of the care which is coming from the other side. Who’s responsible for that? Surely the doctor won’t take the responsibility of the professional judgment. These are some of the loopholes.
Worldwide, there are some concerns with respect to the e-health and the medical health. These are firstly, the money. Money means that how the cost of telemedicine or how the cost of e-health will be regulated. The people concerned feel that in-person consultation which is very basic at high cost. There also, we are facing such kind of high out of pocket expenditures. Now e- health again will be very expensive. E- Health means that the doctor has to enroll to an online forum. So of course the extra cost will be inculcated and it will be the responsibility of the patient itself, it will fall on the patient’s pocket again. So the money is the major concern.
The regulations are again, the major concern-adoption of the technology. The technology is not defined. Patients have to use a single technological model. They have said that they would be a platform. As of now, there are hundreds of platforms available on the internet, but doctors can register themselves as a registered medical practitioner and the tele-consultation will start. Now all these online platforms are they registered with a single sole entity who will take care of the data issue, who will take care of the medical trails and the medical records, where all would be stored- that is again a concern.
The last but not the least is the success of telemedicine. So India has to come up with some kind of success models to better adoption and the better adaptation of telemedicine in the industry. These are the major loopholes according to me.
- With everything going digital, there is an increasing need of a legislation that regulates the Health Data Privacy. While at present the India lacks a regulatory framework in this regard but PDP Bill and DISHA are in pipeline. According to you, will they be able to provide an effective framework of regulation of Healthcare Data?
Neha: As of now, the Healthcare Data Protection Law is under progress and everyone knows that. We don’t have a defined Healthcare Data Protection Bill. We came up with PDP and there are some other guidelines, for example, the DISHA to guide the data which is existing in the healthcare infrastructure. So we know that we have a very growing healthcare market and some new technologies are coming up. The Healthcare staffing is increasing. The health e- records are being maintained. We have come up with the telemedicine practices for the doctors. So all this is of course generating more and more data into the healthcare, but we don’t know that how this data is processed, how this data is stored. And how does this data is kept safe for both the doctors as well as for the patient. So with respect to that, the healthcare data protection bill is very mandatory in India now. What happened was that Ministry of Health and Family Welfare, they drafted and placed DISHA which is the Digital Information Security in the Healthcare Act. It simply means that whatever data is being built into the digital healthcare space- to how to store that data, how to keep that data in a secure environment. So this was the basic objective of the DISHA which Aditya will focus on into. I will focus on how as of now the Health Data is regulated in India.
So there are some points that I would like to tell to you all but as of now the data security and the privacy – this is the responsibility of the entity which pulls the data. This is not the responsibility of the patients. This is the responsibility of the hospital. In case any data breach happens, the entity could be penalized for the same in the IPC and according to the Information Technology Act.
But in India, as of now, we don’t have any system where, for example, the banking frauds. Now, whenever the banking frauds happen, the bank concerned has to report it to the RBI (The Reserve Bank of India), the apex bank. But, in our industry right now in the healthcare system, no such thing or processes are available that a small entity has to conform to the bigger entity. Although all these establishments are registered under The Clinical Registration Act and Clinical Establishment Act, but there is no such kind of an apex security organization, which will take care of the security policy of the healthcare industry.
But, there are Indian Medical Council Regulations, 2002 which say that physicians must maintain confidentiality, relating to individual or any domestic life that is interested by patients during various stages of their medical attendance and the procedures. But according to these Medical Regulations, nothing is being followed in India as of now. If you delve deeper into the kind of data approach, which is being taken by the various entities- I would point out that there are five to six sectors which are storing data and just keeping the data and which is the data concern. Now, the pharma manufacturer, the pharma suppliers and the pharmacies are also holding the data with respect to the data analytics that ring with respect to the drugs and the medical devices which is under the threat of foreign cyber-attack or the cyber-hacking etc. The providers of the healthcare, which are the hospitals, healthcare centers, specialists’centers- the AYUSH centers, diagnostic lab. They are holding our data. Even the vendors and suppliers are holding our data. Government is holding the largest data and the Indian government is holding the largest data because of the population. The bigger the size of the population, the bigger the data they are holding in the healthcare and the Peers. Peers means that Medical Insurance entities which are holding the data. Now these five to six entities, which are holding the data is not secure. They don’t have any organization that they have to report. Everyone is holding data in their database, and this is under threat. So we have to come up now urgently with some kind of regulation in the healthcare data protection itself. We cannot be surviving on the general data protection, which is generic in the country. We cannot be guided by the data protection guidelines, which are evolving in the other sectors. We have to come up with some kind of Healthcare Data Protection Bill now.
Aditya: When you go to the latter part of it, there are two initiatives, which are there in the pipeline – it’s not implemented. One is the DISHA and other is the PDP Bill. As you all know, the PDP Bill has been pending for long and the government is yet to pass it in the session of the parliament. Now the PDP Bill has the concepts of a Data Intermediary, Data Principal and Data Fiduciary. So it assigns duties to each one of them. And in this particular case, it coming onto the healthcare sector, the hospital would be the Data Fiduciary. And there are strong, stringent liabilities which are levied on the Fiduciary in case the data’s breached. Similarly, if it’s a suspicion, then, the platform through which the session has been conducted would be a Data Intermediary. And the Data Principal would be the person whose data has been given or is being processed.
In that case, the Data Fiduciary will be the doctor, the Data Principal would be the patient. And then the Data Intermediary would be the platform. Now since the PDP has not yet come into force, what is the current legal infrastructure for data protection in the healthcare sector? Surprisingly, there is NONE. The IT Act is rendered toothless because the provisions of the IT Act are very difficult to enforce. Secondly, it does not provide sufficient mechanisms to prevent the prevent breach of data. There are provisions which impose certain civil and criminal liabilities on data breach, but how far they’re being enforced is yet to see, because it does not specifically define the rules and responsibility of a Data Intermediary, Data Principal and Data Fiduciary.
Similarly, the DISHA initiative that the government plans to set up has two parts of it. Under the DISHA initiative, they’ve been National Electronic Health Authorities which would be NeHA and State Electronic Health Authorities which would be SeHA, which would provide extensive data protection to Indian subjects and also would govern the data portability. DISHA mostly prevents healthcare providers from sharing any piece of sensitive information. Also it sets up digital authorities, at both State and National level. It enforces privacy and security measures for electronic health data. But again, even though the DISHA initiative has not yet been enforced- in foreign jurisdictions, where there are robust data protection laws, healthcare to e-health is not a problem. But in India, in the absence of robust data protection mechanism, even the introduction of the telemedicine guidelines would be rendered toothless. So, first we have to go back now, get first and pass/enforce the Data Protection law, the DISHA initiative, and then you should have come up with the telemedicine guideline. But as it always happened, we first go to Step ‘B’ and then come back to Step ‘A’. So that is what has happened in this case as well.
- Albert Einstein said “The measure of intelligence is the ability to change.” The pandemic situation has caused the world to change its ways and switch to digital platform. How should India shape the Digital healthcare regulatory landscape in these pressing times?
Neha: Not just under COVID-19 times, the Indian healthcare services have already started becoming very tech enabled, as we all know. Because Digital health has a potential to expand across the diagnostics, the laboratories, the drugs, the medical insurance, point of care among the others. And now the telemedicine. The medical industry was already becoming tech enabled. The foremost thing we have to remember is that the policy has to change ,as now it is tech enabled- we have to provide the incubation and the investment possibilities in the sector. Now, majorly the global problem is affordability. It is a problem globally. In fact, even in the US and Israel, and the many countries where the healthcare is very important, it’s considered very important that the healthcare policies, which are utmost important for the government- one thing which is lacking there is the tech enabled incubation services to these start-ups and so forth. These countries are lacking from India very far behind in all these sectors. Now, what is happening is that some kind of health tech wants to do some data. They want to streamline the operations. They want to come up with a streamlined hospital setup or hospital information utility set up. So then they’re not able to start up because of the funding issue. These are the effective basically where we can go digital. With regard to digital sectors, we have to we have to make some kind of cloud based hospital information management system. Then we have to make some cloud-based insurance system and the insurance delivery system. All these facilities can be digitalized, but they haven’t been able to digitalize yet in India. So these are the few, several fields of problems that India is facing. Aditya will guide you on this, more on it.
Aditya: I think the answer to this question has already been answered by me in the last question because of what is the status of the current health regulatory landscape. The status is that we have introduced the telemedicine guidelines and we have DISHA, which is there, there are number of state policies that have been adopted in the telemedicine infrastructure. But what we lack is PDP and sufficient data protection law, and also authorities. I think the implementation of law is most important. So are the authorities equipped to deal with, to implement the provisions of the existing laws. The answer is No because as we see, even in the cyber offenses, the police stations, the cybercrime cells are understaffed & ill-equipped and they have very less knowledge as to how to trace a particular cybercrime. So I think first of all, we need to train, we need to train, we need to inculcate, we need to involve, we need to hire, individuals who are working in the digital regulatory interface at the first place. But, a lot of time, and they have second order experience and expertise in the sector. Secondly, we need to make sure that we adopt a robust mechanism by taking into picture the stakeholder participation because the stakeholders and industrial experts are the ones who know that what are the problems that they face on a daily basis. So, the Parliament should make sure that stakeholder participation is there before framing any law because these are sectors which require huge amount of technical expertise. So I think stakeholder participation is very important.
Neha: Well, there are some other measures which are required on urgent footing. And the foremost among them is that we have to create a robust IP mechanism for the healthcare sector. We have to make some favorable IP laws for the drugs, the pharmaceuticals, and especially the biotechnology. Because there we have to grant favorable IP to the stakeholders. Then one more thing is that we have to invest more in the R & D (Research and development) and innovation because India is launching many kinds of biotechnologies in this process. For example, India is one of the biggest manufacturers of the vaccines. There we are a bit ahead , why they are being able to register and file ,why they have not been able to market themselves because of the lack in the R & D and the innovation. And then again, lack of the favorable IP laws and these things are also majorly connected with the digital healthcare ecosystem in our country.
- Recently, the Madras High Court has ordered Patanjali Ayurved to stop using ‘Coronil’ branding for its ‘immunity-boosting’ products in a trademark infringement case filed by Chennai-based Ardura Engineering Pvt proceedings against Patanjali .
In view of the pandemic, all Pharma Companies are trying to come up with vaccine and cure for COVID. What are the things they need to be mindful of legally (licensing, patent, trademark, compliances) when coming up with the Drug/Vaccine?
Aditya: The question has 2 parts to it. I we’ll be talking about the factual aspects of the case and what was the finding which was given by the court. And Neha would throw some light upon what should the pharma companies keep in mind with regard to licensing, patent, trademark and other compliances before introducing a vaccine.
What happened in this case was, we need to understand one thing that the plaintiffs who filed the suit before the Madras High Court, he was the proprietor of 2 marks- “Coronil-92 B and
Coronil-213 SPL” under Class 1 of the industrial chemicals. Now the defendant i.e. Patanjali Ayurveda launched – Coronil for curing Coronavirus and upon objection by AYUSH Ministry they stated that it won’t cure coronavirus but it was merely an immunity booster. The plaintiff filed a suit against the defendant and sued him for relying on Section 29(4) stating that it had a reputation in Indian & abroad. “Coronil-92 B and Coronil-213 SPL” had an existing reputation in Indian and abroad. It also took a very interesting argument that the use of the mark by the defendant would dilute the plaintiff’s reputation due to the perceived inefficacy of the product and the accompanying negative press of the defendant. The defence taken was predictably on the ground of the products being fully different, and there be no possibility of confusion. So Patanjali contended that the products were totally different since “Coronil-92 B and Coronil-213 SPL” was an industrial chemical for rust free surface and so on and so forth. And it was an industrial chemicals registered on the class one, whereas the Patanjali Ayurveda’s Coronil was registered in Class 5. So the purpose was totally different. Hence, it didn’t infringe the trademark of the plaintiff.
Interestingly, there were two things which are relied upon by the court. Two sections of the Trademarks Act which were discussed which were Section 29 (1) and Section 29(4). Section 29 (1) of the Trademarks Act says when identical mark is used for similar class of goods which are similar to the same class for which the registration has been affected whereas according to Section 29(4) of the Trademarks Act, protection is granted even when the offending Mark is used for a different class of goods. The precondition for Section 29(4) is that the plaintiff’s mark should have a reputation in India.
So in this case, the court observed that the plaintiff’s Mark already had a reputation in India, and the reputation does not mean that it should be really well known mark. Reputation means the overall conduct after product is launched in the market. So that would amount to reputation. So the court held that it was a well-known Mark. It had a reputation in India and even though the Patanjali product was from a different class, still it amounted to trademark violation, and it heavily penalized the defendant in this case. So it is an interesting judgment given by the Madras High Court wherein the court has held that even for different class of words, if there’s a particular reputation and there’s harm to that reputation by introducing a particular product, then that defendant is liable to be penalized.In this particular case, the court also took note of the fact that the defendants product launched in the market is very ineffective and not good. The court specifically stated that because the defendant earlier conduct was contradictory and confusing. Court noted the conduct of the defendant and held it liable.
I think it’s a good judgment. It actually goes both leaps and bounds and reliance has been placed on a lot of judgments of the UK and US Courts. Also the licensing aspect was also kept in mind for imposing a penalty on the defendant. I think upon the compliance, the licensing aspects which are required by the corporates before they introduce a particular product in the market, Neha will put some light on this.
Neha: The question is very specific that when the Pharma Companies are trying to come up with the vaccine and the cure for COVID, so what all they have to be mindful of the legal provisions and when they’re coming up with a drug. I would like to tell you all that, firstly, that a vaccine is basically a drug because it is a preventive drug, which is for the immunization purposes.
India has a national vaccine policy and India is one of the largest manufacturers of the vaccine in the world, we have a 100 billion dollar industry of vaccine production. Mostly the vaccines are marketed outside also. We all know that in 2014-India, as it is known worldwide that India became Polio free. So this was a whole long 20- 30 years of the vaccine immunization program. So in terms of vaccine production,India is doing very, very fine, but the major loopholes are in the regulation of the vaccine. So let me tell you, some of the vaccine regulations. Vaccine is regulated by the National Regulatory Authority under the Immunization and the Vaccine Program of India. So this is the apex regulatory authority and is regulated under The Drugs and Cosmetic Act, because it is a drug.
But before a vaccine is finally marketed into, there many kind of procedural and the production regulations, which we have to oversee. And the first of them is the clinical trial oversight, when the product is in the R & D stage. We have to try the vaccines onto some animals, then comes the human trial of the vaccines. These are all part of the clinical trials, , which are regulated in India and worldwide. And along with the Indian regulations, we have to comply with WHO regulations also.
Second is the marketing authorization, which Aditya was also talking about and the marketing authorization and the IP laws, which a manufacturer has to take into consideration before bringing his vaccine into the market. Then come to vigilance. Vigilance also is at the time of the production, and manufacturing only. Coming to the Laboratory access – where the vaccine is being produced, the Laboratory access given to certain organizations, for example, the CDSCC or the Central Drug Standard Control Organization, where they have to oversee that in what environment and in what kind of regulatory framework, the manufacturing is going on.
These are standard guidelines when vaccines are being produced.These are just few of them. There are other number of things. For example, the licensing of the premises where the manufacturing of vaccine is being done. That is also done separately. Then there’s a market surveillance and control. Here, the analytics come into form that initially what trial we have to do and what will be, what prevention is it addressing, let’s take a picture of example, for COVID-19 drug / vaccine, firstly market surveillance is being done so as to know how to target, vaccine is required for how many people to start mass production. Initially, in vaccine production, that is for handful of people for trial purposes. Then comes the mass production after the human trials are concluded and their efficacy is proven. Then there’s some regulatory inspection. And lastly, the quality control inspection. From the quality control inspection, after the human trial – they see whether they are efficacious, efficacy is proved or not. Then only they can start the mass production. So all these regulations are being taken care of before a vaccine is actually marketed and it’s mass production in country has started
So as of now, no mass production has started worldwide for the COVID-19. This is one major factor that needs to be told to people In India as well only human trials are going on for the COVID-19 vaccine.
- Medical Devices forms a quintessential aspect of Healthcare industry. Do you think the present regulations effectively govern the Medical Devices sector or the regulatory system needs an overhaul in view of the increasing importance of Healthcare industry?
Neha: Looking into the history that how these medical devices came into the picture. And recently there has been a new law for the medical devices, which has been announced in January or February, 2020 only. So what happened was initially under the Drugs and Cosmetics Act, both the drug and the medical devices were being regulated simultaneously. Now, what was the ill-effect of this was that the drugs were more and the medical devices were less as obviously we can think about it. And what happened was there were only a handful of medical devices which could be regulated or which could be controlled under this Drugs and Cosmetics Act. The new medical devices, which were coming into the picture due to newer technologies and newer diagnostic technologies or imaging technologies coming up. They were not being able to come into the picture of the drugs and cosmetics side, because nobody knew that how to control them, how to prove their efficacy, because these were not being manufactured by India.The problem came here was because they were being imported.
So in 2017, the Government came up with the Medical Devices regulations, which came into attached with the Drugs and Cosmetics Act itself. Now what happened is that from around 15 devices, which were regulated before in the Drugs and Cosmetics Act were increased to 30, then 40. But again, there was a need felt. For medical devices, we have to proceed to four to five things, which are very important. That is, we have to see that how these medical devices are being manufactured, where these are manufactured, to prove where to prove the efficacy of the medical device. We have to see for the patient safety also in this. So efficacy of the medical devices is the foremost problem and then came the quality control. If we are importing these devices, and if they are being sold into the Indian market, the regulation and the quality controlling power comes into the hands of the Indian suppliers. So can we control the quality of the imported medical devices.
Third thing which came up is what if the medical devices, which are being produced are imported- they become faulty, then whose fault it is? Is it the manufacturers fault or the device fault? There are other additional issues which were like the labeling and the packaging issues of the medical devices. And there were many sort of medical devices controversy which came into the Indian market. For example, the stents, the pricing of the stents were a major issue. There was some preliminary steps which were pointed and still they were being impacted, or they were being inserted into the human body. Then the Johnson and Johnson hip implants. And there were many kind of medical device controversy which have come to the market. For all these, the government felt that there’s a need to separate the regulation and the control of drugs from the devices. And that’s why now they have come up with the Medical Devices Rules in 2017. What these rules are doing, is that they are classifying the devices according to the risk- the A, B, C, D are the four categories and the medical devices are divided according to this classification.
Now, what are the Risks?
The Category A devices has the most risk, the Category B device has a lesser list, the Category C devices has more lesser risk and the Category D device are the ones which don’t have such risks. So, there are separate regulations and quality control procedures for all these kinds of devices.
Aditya: Adding to what Neha said, the Medical Devices (Amendment) Rules, 2020 makes the registration of the medical devices compulsory.So the manufacturer or importer of medical device has to compulsively register the medical device with the Drug Controller General of India (DCGI) through an online portal called online system of Medical Devices established by CDSCO. This is a welcome change.
The 37 categories of medical devices which are specified under the 8th Schedule of the Medical Devices Regulations of 2017 will not be affected by this amendment and will not require a registration but the new devices introduced in the market- whether imported or manufactured- they have to be registered.
Similarly, moving forward, there is an important question with respect to how far we have travelled and how far we need to go. What we need to do is to assign the roles and responsibilities of each authority very carefully and very clearly. At each stage, we need to make sure that technically qualified scientists are there at each stage of licensing. Generally what happens is that the departments such as the Drug Technical Advisory Board, or the CDSCO or the NPPA (National Pharmaceutical Pricing Authority) are manned by personnel who at some level are not qualified to deal with technical questions and queries. As a result, we see that there are cases of faulty implants and spurious devices are being imported from China.
Now, how do we overcome that? We can overcome that by ensuring that there are checks and balances at each level of trial, manufacturing, importing and licensing. Secondly, we also have to make sure that the departments or the infrastructure we have i.e. the NLEM (National List of Essential Medicines)- it has to be made more comprehensive. Subsequent to a judgement passed by the Delhi High Court the with respect to NLEM, coronary stents were included in the NLEM which is a welcome change. That was a very huge leap. The Court had to intervene because the departments were not taking any action and were not concerned about including these devices in NLEM. Similarly, the Madras HC judgement recently penalised Patanjali. Such judicial intervention is required from time to time to make sure that even the medical devices and drugs sector is kept in check.
- The Medical and Healthcare laws are the most ignored area in law schools despite the plethora of legislations, rules and regulation they encompasses within themselves. Could you tell us various concomitant of this area of practise.
As you rightly said that this is the most ignored section of law. Even we ourselves didn’t study in our curriculum the medical and healthcare laws of the country. Various concomitants of this area of practise would be:
- First would be the laws governing the qualification/practice and conduct of professionals which will be The Indian Medical Council Act 1956, Indian Medical Council (Professional Conduct, Etiquette, and Ethics )Regulations 2002,The Dentist’s Act 1948,The Pharmacy Act 1948, AICTE Rules for Technicians 1987 etc. which guide the practise and the conduct of the Professionals involved in the Medical Sector.
- Second is with respect to those laws which are governing the business aspect i.e. The Clinical Establishment (Registration and Regulation) Act 2010 etc. Then comes the Contract Act, Sales of Goods Act 1930, Information Technology Act, 2000,Cable Television Network Act 1995 etc.
- Then comes the IP laws- the Trademarks Act, Patents Act and Copyrights Act etc. We have to understand these Acts with respect to the business aspect of the Medical Sector.
- Next would be Drugs and Cosmetics Act 1940, Narcotics and Psychotropic Substances Act, 1985, Drugs and Magic Remedies (Objectionable) Advertisement Act where some kind of black magic is dealt with.
We have to understand the legislations with respect of the Medical and Healthcare sector. All of these would be encompassed within this practise area.
- Tell us about an interesting experience of yours while working in the Healthcare Sector?What would be your advice to someone who has an interest/ inclination towards this area of practise?
Aditya: We do come across various challenges while practicing in the healthcare sector and it is an interesting area of practise. This specialized area of law like energy, healthcare, solar power etc., and these requires specialized knowledge of the industry as well because there are various stakeholders involved. We have been working in this sector for quite a long now, but before delving into this sector, it was very important for us to know that what are the various stakeholders involved and what are the various duties and responsibilities under this particular sector. We ourselves studied the various legislation in depth before having stepped into this practise area.
Interestingly, we have filed a Public Interest Litigation recently in which we have challenged the appointment of Drug Controller of the State because we came to know that he does not possess the qualifications which are required to be appointed as a drug controller which is shocking! Now, since this matter has come to our light, we have already filed a PIL and let’s see how the Court would intervene. But this is very shocking that one of the highest post i.e. Drug Controller of State is being occupied by a person which is not qualified.
Secondly, one other experience which we had while working in this sector was with regard to the licensing permission which are required. Most of these are being undertaken by Brokers. Every sector has brokers, even this sector has them. There are certain responsibilities that have been given to the department to overview the entire sector, to check the functioning of the key stakeholders. But that is not being done. That is being done to give unfair and undue advantage to these brokers. Also the impact of Stockiest’, one of the cases that is decided by CCI where the Federation had approached the CCI against the association with regard to the duty of the Stockiest.There are stockiest in this sector which stock a particular product/ device and they make sure that only that particular product/ device is distributed in the market which is very unfair I would say. Also the pharmacists have tie ups with certain pharmas, medical practitioners and doctors and they are assigned to give only certain medicines which the doctors prescribe. All these mafias are operated in the sector which is very shocking.The primary aim of the Government is to regulate this sector because this sector concerns the Health of the people which is of primary importance.Now, we see such stakeholders in the market which are not penalized. As lawyers, it is our duty to make sure that they comply with the law.
Now, Neha can give some insights into what interesting experiences she has had while working in this sector.
Neha: As commoners, we always face some kind of problems. Speaking from my experiences, when I was in college, I was buying some medicine outside a hospital. I went to the Hospital Pharmacy with an online prescription to get medicine for my friend-and the Pharmacist said that didn’t had the medicine that was mentioned in the prescription and only had one particular medicine with respect to that disease. I asked that why they didn’t keep it there as it was a general drug and it should be available.To my surprise, they told me that they were required to keep stocks of only those medicines which the doctors are getting in samples from the big Pharma Companies. I was shocked to see that Doctors are prescribing and pharmacies are selling only those medicines which they are getting in sample from the big Pharma Companies.
While buying medicines for myself, I have observed about the availability of medicines. Some drugs are not particularly available in a State. The whole industry is being regulated by the big “mafias” which are controlling the prices and controlling what medicines are to be sold in the market, what drugs are to be secured for high section of society. This is not done. It is unjust. So what the legal professionals who want to practice in this particular sector have to come up front with these issues and have to ensure that these kinds of practices are not happening in the market. These are anti-competitive practices which are happening in this industry and needs to be stopped.
Addressing to the question that what advice we would like to give to someone who is inclined in the medical and healthcare sector would be to identify the problems which are prevailing in this industry. Identifying problems which are in the digital landscape, identifying the pricing issues, problems relating to the medical devices and drugs would be helpful. These are the issues which are coming up and no one is focusing on them. So the plethora of litigation that would be coming up in this sector would go to different forums and tribunals. The CCI looks into the aspect of the excessive pricing and anti-competitive practices of drugs but hardly 1 or 2 drugs come up every year or very few of such problems are being brought forward by the NGOs etc. Actually, the prices are being regulated arbitrarily and not according to the demand and supply in the market. The new professionals should identify such problems and bring them into the limelight.
Aditya: Answering the question that what advice we would like to give to someone who is inclined in the medical and healthcare sector The answer to this question would be in two parts.
First would be to identify the problems which are there in the sector from each stakeholders perspective. Be it a seller, be it a manufacturer, be it an importer, be it a patient or be it a doctor. These are the key stakeholders which are there in the sector. So, we should identify the problem that each stakeholders faces and what are the reasons for this. For example, a doctor is facing certain problem in conducting his session or in getting recognized- the problem lies in the affiliation council or the disciplinary authority. The patient is having problem in identifying a trustworthy doctor- that is because there is no transparent and free information available on the web or portals which the Government provides. One problem that manufacturers’ face is that they are not aware of the law scenario part of the compliance and what are the safety precautions they have to take before starting the trials. From point of view of the lawyer, you have to talk from an industry perspective and to be able to talk from an industry perspective, you need to have knowledge and research scientist in place. There have to be participative way to resolve issues.The medical sector in India has huge potential. This is a good area of practise where students should focus upon keeping themselves updated with the on-going medical things in the sector and with sufficient and sufficient awareness, they can also develop specialization be it in medical devices,pharmaceuticals, telemedicine etc.
- A message for the Readers
Aditya: All those who are interested in the Medical and Healthcare Sector should ensure that they read more about the sector and attend and listen to more informative webinars and interviews and keep themselves abreast with all the developments in the sector. They also need to make sure that they have keen interest in this practise area because as a lawyer, talking from a legal perspective; we primarily gained interest in the medical sector because it affects us all. It is one sector where there is a huge vacuum of good lawyers and practitioners. It is one sector like energy and housing which is essential. Healthcare is a thing which everyone adopts and which everyone takes and we often see the Doctors’ prescribes medicines which are not really required and there are pharmacists that give out the same. There are devices which lack the same amount of efficacy. So why this is always happening is because of the lack of knowledge of the consumer or the patient. The consumer and the patients’ needs to possess the basic knowledge so as to ensure that they are not befooled.
Neha: The basic and the most precise advice for the lawyers who want to practise here is that be aware of what laws are applicable in the Healthcare sector, what laws can be applied to where, what are the tribunals, what are the places of justice where we can go, whether we can go to the Consumer Court, whether we can go to the competition commission; where we can go to seek remedy of a particular problem or dispute. Most importantly, be aware of the laws. Firstly one needs to be aware of the laws and the problems which are persisting in the industry. There are many problems which are persisting in the industry. And definitely, it is the duty of the lawyer to identify those. So my advice would be – Be aware and informed.
*Picture credits: IMA eVarsity