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Being COVID Sanguine: Some Silver Linings to the Pandemic

Given the devastating effects the COVID 19 pandemic has had on the world in general and India in particular, you’re probably wondering about the title of this blog. Don’t get me wrong- I am in no way trying to diminish the massive damage to life, livelihoods and health that the pandemic has brought upon millions of people in India and around the world. Had I seen a similar title even 4 months ago, I too would probably have experienced thoughts similar to what you felt. 

So what has changed in a matter of a few weeks? There has been a major drop in the number of cases around the country; instances of serious infections requiring ICU care have also declined. The vaccination drive is going from strength to strength, with as many as 10 million people being vaccinated across India on a single day.

But the biggest change is in my own perspective. Earlier, I always saw only the negative and the bleak, but now I am beginning to see some positives. And that’s what prompted me to write this piece. Here are five specific areas in which I see positives.

Our people exhibited phenomenal resolve and resilience

The second wave (March-June 2021) was especially brutal on India. Our healthcare infrastructure was stretched beyond breaking point. Oxygen was in short supply, as were critical drugs. Medical experts were trying to firm up treatment protocols. Although vaccinations had begun for some people, the Cowin portal was glitchy and even vaccine supply chains were far from streamlined.

But we saw hundreds of self-help groups come up on platforms like Whatsapp and Telegram. Volunteers would man them 24×7 to ensure that across India, patients and their families got access to critical resources including food, oxygen cylinders and medicines. These supplemented (and often replaced) government measures. Technology was used to the fullest, to ensure that people knew where vaccine doses were available, so they could quickly register.

The pandemic has powered a surge of innovations

Almost every day, there were/are media reports around some innovative activity in India. Some emanate from the government sector: for example, in many cities, stadia and large school buildings were converted into makeshift hospitals or Covid Care Centres.

There are many examples of innovation emerging from private enterprise too. For example, given the large quantities of PPE waste being generated, someone came up with a way to convert used PPE kits (which would otherwise have to be incinerated or buried safely in landfills) into briquettes that can be used for constructing low-cost housing.

Around the country, different teams developed prototypes of low-cost oxygenators and ventilators. This will be a source of great benefit to the country because it reduces dependence on imports. And as we have seen, geopolitical triggers or maritime issues (like the ship getting stuck in the Suez Canal) can wreak havoc with global supplies.

Recently, I read about a woman-led team in Hyderabad inventing a fabric that has anti-virus and anti-bacterial properties. Imagine the wide range of applications at home, in workplaces and public spaces for such a versatile invention.

 

Public-Private Partnership (PPP) redefined

The notion of Public-Private Partnerships too has changed in the last 18 months or so. Whether this is a direct result of the pandemic or more the outcome of policy changes is perhaps hard to separate. But India as a nation is seeing much higher levels of collaboration between government laboratories and infrastructure and the private sector. DRDO collaborating with start-ups for developing drones that can be used for vaccine delivery is one example. Another is ISRO encouraging startups and even students to design satellites. A third is ICMR collaborating with Bharat Biotec in the development of Covaxin, India’s first indigenous Covid vaccine.

Passions are changing into professions, creating employment opportunities

On the one hand, the pandemic has killed many livelihoods. But with many people looking at new, home-based business ventures- and using digital channels to market themselves and deliver their products (and in some cases, services too), one can hope that they will be able to scale and over time, some job losses can be offset. Examples include food delivery, baking, making pickles etc.  Of course, India still needs contact-based industries, such as construction and manufacturing, to pick up and get back on track.

Attempts to harness the creative talent of our youth

This may not be directly linked to the pandemic, but I believe that greater participation will result because of the restrictions imposed by it. The government is looking for innovative ideas from our youth. The Bureau of Police Research and Development (BPR&D) and The All India Council for Technical Education (AICTE) recently announced Manthan 21, a “hackathon” aimed at getting our country’s youth to come up with innovative solutions to address the challenges faced by our intelligence and security agencies. Specific areas have been identified. (more details are available here: https://manthan.mic.gov.in/about-intellithon.php).

 

Experts say that the world around us has changed for ever, and there’s a “new normal” in the wake of the pandemic. There is no doubt about that. But hybrid working models or other changes visible in the organized sector (especially in larger firms and companies) are not the only changes to our world resulting from the pandemic. The impact of the less visible changes described above too will be felt by India and the world in the years ahead.

 

The second wave (March-June 2021) was especially brutal on India. But we saw hundreds of self-help groups come up on platforms like Whatsapp and Telegram. Volunteers would man them 24×7 to ensure that across India, patients and their families got access to critical resources including food, oxygen cylinders and medicines. 

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Income Tax Returns for AY 2020-21: Ready Referencer

With the extended time limit for filing of Income Tax Return (for AY 2020-21), u/s. 139(1), without late fees, for Non-Audit cases and for Non-Corporate assessees of 31st December 2020 fast approaching, given below is a quick guide for ready reference of some key changes that have been made in the respective Income tax return forms for this year.

Further, the conditions and features for eligibility of forms that are applicable for filing the correct income tax returns are also specified as follows:

Key Procedural Changes:

  • ITR 1 to ITR 4 can be filed using PAN or Aadhar by Individuals.
  • The submitted ITR forms display the ITR-V with a watermark ‘Not Verified’ until the same is verified either electronically by EVC or by sending the same via post after manual signing.
  • The unverified form ITR-V will not contain any income, deduction and tax details. The unverified form will only contain basic information, E-filing Acknowledgement Number and Verification part.
  • The unverified acknowledgement is titled as ‘INDIAN INCOME TAX RETURN VERIFICATION FORM’ & final ITR-V is titled as ‘INDIAN INCOME TAX RETURN ACKNOWLEDGEMENT’.
  • Return filed in response to notice u/s. 139(9), 142(1), 148, 153A, and 153C must have DIN.
  • There is a separate disclosure for Bank accounts in case of Non-Residents who are claiming income tax refund and not having a bank account in India.

COVID related Changes:

  • The Government had extended the time limit for claiming tax deduction u/CH VIA to 31st July 2020, and the details of the same need to be reported in Schedule DI (details of Investment).
  • The time limit for investing the proceeds or capital gains in other eligible assets, so as to claim exemptions u/s 54/ 54B/ 54F/ 54EC, had been extended to 30th September 2020.
  • Penal interest u/s. 234A @ 1% p.m., where the payments were due between 20-03-20 to 29-06-20 and such amounts were paid on or before 30-06-20, had been reduced to 75%, vide ordinance dated 31-03-20.
  • Period of forceful stay in India, beginning from quarantine date or 22-03-20 in any other case up to 31-03-20, is to be excluded, for the purpose of determining residential status in India.[1]

Consequences of Late filing of Return of Income:

  • Late Fees u/s. 234F of INR. 5,000 up to 31.12.20 and INR. 10,000 up to 31.03.21. In case of total income up to 5 Lacs, the penalty is INR. 1,000.
  • Penal Interest u/s. 234A @ 1% per month
  • Reduced to 75%. vide Ordinance dated 31.03.20, where the payments were due between 20.03.20 to 29.06.20, and such amounts were paid on or before 30.06.20.
  • Vide CBDT Notification dt 24.06.2020, no interest u/s 234A if Self-Assessment tax liability is less than 1 Lac and the same has been paid before the original due date.
  • In case of a belated return, loss under any head of Income (except unabsorbed depreciation) cannot be carried forwarded.
  • Deduction claims u/s. 10A, 10B, 80-IA, 80-IB, etc would not be allowed.

Consequences of Late filing of Return of Income:

  • Late Fees u/s. 234F of INR. 5,000 up to 31.12.20 and INR. 10,000 up to 31.03.21. In case of total income up to 5 Lacs, the penalty is INR. 1,000.
  • Penal Interest u/s. 234A @ 1% per month
  • Reduced to 75%. vide Ordinance dated 31.03.20, where the payments were due between 20.03.20 to 29.06.20, and such amounts were paid on or before 30.06.20.
  • Vide CBDT Notification dt 24.06.2020, no interest u/s 234A if Self-Assessment tax liability is less than 1 Lac and the same has been paid before the original due date.
  • In case of a belated return, loss under any head of Income (except unabsorbed depreciation) cannot be carried forwarded.
  • Deduction claims u/s. 10A, 10B, 80-IA, 80-IB, etc would not be allowed.

Vide CBDT Notification dt 24.06.2020, no interest u/s 234A if Self-Assessment tax liability is less than 1 Lac and the same has been paid before the original due date.

  1. Section 5A: Apportionment of income between spouses governed by the Portuguese Civil Code.
  2.  115BBDA: Tax on dividend from companies exceeding Rs. 10 Lakhs; 115BBE: Tax on unexplained credits, investment, money, etc. u/s. 68 or 69 or 69A or 69B or 69C or 69D.
  3. Inserted in sec 139(1) by Act No. 23 of 2019, w.e.f. 1-4-2020:

Provided also that a person referred to in clause (b), who is not required to furnish a return under this sub-section, and who during the previous year:

  • has deposited an amount or aggregate of the amounts exceeding one crore rupees in one or more current accounts maintained with a banking company or a co-operative bank; or
  • has incurred expenditure of an amount or aggregate of the amounts exceeding two lakh rupees for himself or any other person for travel to a foreign country; or
  • has incurred expenditure of an amount or aggregate of the amounts exceeding one lakh rupees towards consumption of electricity; or
  • fulfils such other conditions as may be prescribed,

Shall furnish a return of his income on or before the due date in such form and verified in such manner and setting forth such other particulars, as may be prescribed.

4. Section 57: Deduction against income chargeable under the head “Income from other sources”.

5. Schedule DI: Investment eligible for deduction against income (Ch VIA deductions) to be bifurcated between paid in F.Y.19-20 and during the period 01-04-20 to 31-07-20.

6.High-value Transaction: Annual Cash deposit exceeding Rs. 1 crore or Foreign travel expenditure exceeding Rs. 2 Lakhs, Annual electricity expenditure exceeding Rs. 1 Lakh.
7.Schedule 112A: From the sale of equity share in a company or unit of equity- oriented fund or unit of a business trust on which STT is paid under Section 112A.

8. 115AD(1)(iii) proviso: for Non-Residents – from the sale of equity share in a company or unit of equity-oriented fund or unit of a business trust on which STT is paid under Section 112A.
9. Section 40(ba): any payment of interest, salary, bonus, commission or remuneration paid to a member in case of Association of Person (AOP) or Body of Individual (BOI).

10. Section 90 & 90A: Foreign tax credit in cases where there is a bilateral agreement; Section 91: Foreign tax credit in cases of no agreement between the countries.

[1] Circular No 11 of 2020 dated 08th May 2020.

References

Image Credits: Photo by Markus Winkler from Pexels

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Junk food ban- Legal responsibilities of School Authorities

According to the World Health Organization (WHO), 38 million children under the age of 5 were overweight or obese in 2019 and over 340 million children and adolescents aged 5-19 were overweight or obese in 2016. The statistics are alarming because obesity is just one of the myriads of health problems that result from continuous consumption of a poor-quality diet high in junk food. Plus, obesity is an external manifestation of the problem, but the harmful effects of these zero-nutrition foods fester within the body and cause permanent damage. The repercussions are far worse when the habit is inculcated at a tender age. Junk food can cause memory and learning problems as well as fatigue and weakness among children. Further, advertisement specifically designed to influence young minds into making unhealthy choices is another grave cause of concern.

Since schools are the temples of learning and the place where children spend most of their waking hours, initiating a healthy eating environment in and around the school premises was crucial. Towards this end, regulations have been passed by the Government to ensure that children are exposed to wholesome meals and proper guidance that instill good eating habits.

Background

A Public Interest Litigation (PIL) was filed by an NGO in 2010 seeking a direction banning the sale of junk food and aerated drinks in and around schools (Uday Foundation for congenital defects and rare blood groups Vs. Union of India & Ors.). Pursuant to the PIL, the Hon’ble High Court of Delhi issued a direction to the Central Government to draft detailed guidelines to regulate the sale of junk food and aerated drinks in and around school premises in the country.  

In light of the directions, the Food Safety and Standards Authority of India (FSSAI) has notified the Food Safety and Standards (Safe food and balanced diets for children in school) Regulations, 2020 (“the Regulations”) that prohibits the sale, marketing and promotion of junk food within the school premises and the surrounding vicinity. The said Regulations apply to –

  1. Schools (pre-primary, primary, elementary, secondary, day-care) that provide food within the campus.
  2. Shops/stalls or food outlets which sell food products within fifty meters of the school gate in any direction.
  3. Food Business Operator (FBO)* /Food caterers who supply mid-day meals.

This Regulations inter-alia outlines the roles and responsibilities of the School Authority to ensure safe food and balanced diets on school premises.   

Licensing requirements

  • The School Authority shall get registered as an FBO to sell/provide catering of school meals by itself on the school campus.
  • The School Authority shall mandatorily enter into a contract or transaction with the registered or licensed FBOs under the provisions of the Food Safety and Standards Act, 2006 (“The Act”).
  • The Central or State Department of School Education shall ensure that FBOs contracted by it for the operation of the mid-day meal scheme are registered or licensed under the provisions of the Act.
  • The provisions of Regulations shall be duly complied by FBOs with effect from 01st July 2021.

By registering under the Act, the School Authority shall be liable for the compliance of provisions of the Act and the Rules and Regulations made thereunder. Any violations or non-compliance by the school authority under the Act shall attract penal provisions and penalties including imprisonment.

Prohibition of Junk Food 

  • The School Authority shall ensure that no person shall sell or offer for sale including free sale, or permit sale, of food products high in saturated fat or trans-fat or added sugar or sodium [High in Fat, Salt and Sugar (HFSS) ** or Junk food] in school premises or campus.
  • The School Authority shall ensure that there shall not be any advertisement, banner or wallpaper or direct/indirect promotion of Junk food in school premises or campus.
  • The School Authority has to display a board containing the warning “Do not sell, including free sale or market, or advertise Junk food within school premises or campus” at the entrance gate or gates of the school.
  • No person shall directly or indirectly advertise or market or sell or offer for sale including free sale, or permit sale, of Junk food products in the school campus or to school children in an area within fifty meters from the school gate in any direction.

The School Authorities are made responsible to ensure the sale, advertisement, and promotion of Junk food do not take place even by a third party.  Shops/stalls and food outlets which are running within school premises or within fifty meters of the school gate in any direction shall stop selling all kinds of Junk food products. The Regulations with respect to prohibiting and promoting of junk foods in and around school premises shall come into force only from such date as the Food Authority may, by notification in the Official Gazette, appoint.

Sanitary and hygienic practices

  • The School Authorities shall encourage to adopt a comprehensive program for promoting safe food and balanced diets amongst school children and meet specified benchmarks to convert school campus into ‘Eat Right Campus’ and also follow guidance from “Dietary guidelines for Indians – A Manual” issued by the National Institute of Nutrition and other expert institutions or authorities.
  • The School Authority shall ensure that the FBOs supplying prepared school meals in the school premises are identified and selected food that can be served or sold on the basis of the broad guidelines given in the Schedule to Regulations and as per the directions, issued by the Food Authority or the Commissioner of Food Safety of the State. The School Authority may appoint a Health and Wellness Ambassador or Health and Wellness team, who shall act as the nodal persons to monitor the availability of safe, balanced, and hygienic food.
  • The School Authority may engage with nutritionists, dietitians, nutrition associations or seek parental support to assist in the drafting of the menu for the children, periodically.
  • The crèches or day-cares for infants or children up to the age of twenty-four months old are also expected to serve safe and balanced diets to them. 

Implementation, Monitoring, and surveillance

  • The School Authority/ State Food Authority/ Any public authority like Municipal Corporation or any other local body or Panchayat in an area shall have a system of regular or periodic inspection of school premises to ensure that safe, balanced and hygienic food is served to children.
  • The State Level Advisory Committee (SLAC) constituted under the Food Safety and Standards (Licensing and Registration of Food Businesses) Regulations, 2011 shall create a subcommittee consisting of representatives from the Department of School Education, and public health professionals in the field of food and nutrition to monitor the implementation of these regulations and to ensure availability of safe and wholesome food to school children.
  • Implementation of these Regulations is achieved by action or complaint of the School Authorities to concerned Food Safety Authorities.  

PROS:

CONS:

Undoubtedly, Junk food is addictive by nature and spoils children’s physical and mental health at an early age. Objectives of the prohibition of unhealthy Junk food and also monitoring hygienic/nutritious food for children are well appreciated. The Regulations also encourage schools to implement and monitor a balanced food menu for children. Junk food manufactures may change/restrict ingredient limits/compositions of saturated fat or trans-fat or added sugar or sodium in their products to escape from the labeling of their products as Junk food. The Regulations will address all serious problems arising from undernutrition and malnutrition in children who are living in rural areas.

Implementation and enforcement of the Regulations is not easy unless School Authorities create awareness among children about the side effects of eating Junk food and the necessity of nutritious food. It is not easy to label food as Junk food and it requires a regular monitoring system. Some parents will provide Junk food in lunch boxes and the same will defeat the purpose of the Regulations. Majority of shops and outlets near schools sell Junk food to attract children. Small vendors and shopkeepers who keep and sell Junk products would be badly affected by the regulations. Small businesses/manufacturers of food products such as fried chips, bakery items, chocolate bars, candies, chocolates, peppermints, sweet gums, wrapped sweets that cannot be sold near the school would face losses and may also result in closure.  

 Conclusion

The FSSAI has notified and implemented the Regulations after conducting various surveys, research, and consultation with the public, nutritionists, various organizations, and medical experts. Now, the Regulations must be implemented and followed by the School Authorities in letter and spirit without any further delay. 

Manufacturing and Best Before dates to be mandatorily displayed on sweet packages

The FSSAI has also issued Orders on 25th & 30th September 2020 for mandating the compulsory display of Manufacturing date and Best Before date on non-packaged and loose sweets containers/packages/tray holding sweets at the outlet sale.

Image Credits:  Photo by Fábio Alves on Unsplash

The FSSAI has notified and implemented the Regulations after conducting various surveys, research and consultation with the public, nutritionists, various organisations and medical experts. Now, the Regulations must be implemented and followed by the School Authorities in letter and spirit without any further delay.

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Telemedicine in India: Doctor’s Consultation is just a Phone call away!

India is making some major headway towards providing universal health coverage. However, a significant challenge is the limited number of qualified doctors and other healthcare professionals available in our country. Telemedicine is a solution to this limitation as it allows consultation, diagnosis, and treatment by healthcare professionals from remote locations with the help of technology

The requirement of telemedicine was starkly visible during the current COVID-19 pandemic and the resultant lockdown. It significantly helped in reducing hospital visits, waiting periods, and long travel to and from the hospital. Other benefits of telemedicine include timely and faster access to healthcare services, convenience, cost-saving, and adequate documentation of health records. Until recently, there was no legislation or guidelines on how telemedicine could be practiced in India. In view of the current pandemic, the Government of India has timely come up with the Telemedicine Practice Guidelines on 25th March 2020.  This guideline forms a part of the Indian Medical Council (Professional Conduct, Etiquette and Ethics) Regulations, 2002, and is numbered Appendix-5. With this, there is now some legitimacy attached to the service and the guidelines would pave the way for statutory legislation on the same lines in the future.

Evolution of Telemedicine in India

From the constitution of a Telemedicine Taskforce in the year 2005 by the Ministry of Health and Family Welfare, India has gradually progressed in telemedicine by budgeting for it, setting up various institutions, connecting Regional Cancer Centers with peripheral centers across India through the ONCO-NET India Project and networking of states and district headquarters and premier institutes as part of Integrated Disease Surveillance Project (IDSP).  The Government has further facilitated it through the establishment of the National Rural Telemedicine Network, mother, and child tracking system (MCTS), the establishment of National Telemedicine Network, National and Regional Resource Centers etc. Various indigenous software has also been developed to provide telemedicine solutions.

Scope of the Telemedicine Practice Guidelines, 2020

The Telemedicine Practice Guidelines introduced on 25th March 2020 provide norms and protocols pertaining to physician-patient relationship; issues of liability and negligence; evaluation, management, and treatment as well as informed consent. The provisions also deal with continuity of care; referrals for emergency services; medical records; privacy and security of the patient records and exchange of information; prescription; health education and counseling. These guidelines also provide information on technology platforms and telemedicine tools available to medical practitioners and how to integrate them into these technologies.

Guidelines for Registered Medical Practitioner

  • Information Exchange: A Registered Medical Practitioner (“Doctor”) is empowered by these guidelines to provide telemedicine consultation to patients from any part of India, and the same professional norms, ethics, and standards apply. All physical examinations cannot be done via video/audio/text messages. Therefore, it is left to the Doctor’s professional judgment as to whether he/she can provide a technology-based consultation or an in-patient consultation. In addition, doctors are restrained from providing telemedicine when the physical examination is critical for consultation. Doctors are also mandated to uphold the same standard of care as in-patient consultation. Both Doctors and patients are required to provide their identification to the other as may be deemed appropriate.   Since prescriptions are based on the age of the patient, a Doctor is required to explicitly ask for the age, and if necessary, seek proof thereof.  In the case of a minor, teleconsultation can only be done when the minor is accompanied by an adult whose identity is also required to be verified.
  • Informed Consent: Patient consent is mandatorily required for a telemedicine consultation. Consent is implied when telemedicine is initiated by the patients themselves. If it is initiated by a health worker, another Doctor, or caregiver, explicit consent of the patient must be procured and recorded.  Health education, counseling, and prescription of medicines can be done through telemedicine. If a caregiver is not present with the patient and does not have authorization, Doctors cannot provide telemedicine consultation. In the case of a health worker, he/she should have obtained informed consent from the patient to obtain consultation from Doctor.
  • Prescription of Drugs: The guidelines categorize drugs into four lists, List O (over the counter medications), List A (can be prescribed during the first consultation and has relatively low potential of abuse), List B (when an in-patient consultation is already done, and drugs have to be prescribed in follow up consultation), Prohibited Drugs (high potential for abuse). Doctors cannot prescribe prohibited drugs. Doctors can only prescribe List A drugs if the consultation is done through video as it involves the first consultation. If the gap between two successive consultations is more than 6 months or if the consultation is for a different health condition, it would be construed as a first consultation. Signed prescription or e-prescription can be sent to the patient digitally (or to the pharmacist after the explicit consent of the patient).
  • Confidentiality, Privacy and Data Protection: Doctors are required to abide by their professional conduct regulations, IT Act, Data protection and privacy laws in India, and other applicable rules. The guidelines specify a certain inclusive list of actions constituting misconduct by Doctors such as insisting on telemedicine when a patient is willing to travel, misusing patient data, prescription of medicine from the restricted list, and solicitation of telemedicine. Further, doctors will not be held responsible for breach of confidentiality if there is a piece of reasonable evidence to believe that patient’s privacy and confidentiality has been compromised by a technology breach or by a person other than the Doctor. However, doctors should ensure that a reasonable degree of care is undertaken during hiring such services. Penalties for violation would be as per the IMC Act, ethics, and other prevailing laws.
  • Documentation: Doctors are required to maintain digital trails and documentation of the telemedicine consultation such as logs of telemedicine interaction; patient records, reports, diagnostic data, etc., utilized during telemedicine consultation, and prescriptions for such period prescribed from time to time. Fees for telemedicine consultation should be treated in the same way as in-patient consultation, and a fee receipt should be provided to the patient.

 

Guidelines for Technology Platforms

It is the responsibility of technology platforms such as websites, mobile apps, etc., assisting in telemedicine services to:

  1. Ensure that the telecommunication is with a Doctor who is duly registered with the national or state medical councils.
  2. Conduct Due Diligence before listing Doctors in online portals. The technology platform should provide the name, qualification, registration number, and contact details of every Doctor.
  3. Report any non-compliance to the Board of Governors of MCI.
  4. Ensure that Artificial intelligence or machine learning is not utilized to counsel patients. However, such technologies can be used to assist Doctors in inpatient evaluation, diagnosis, management, and prescription.
  5. Ensure that the technology platform has a proper mechanism to address the queries and grievances of patients.

Any violation by the Technology Platform would lead to blacklisting of them by the Board of Governors or MCI, and thereafter, no Doctor shall use such a platform to provide telemedicine services.

Conclusion

In the wake of the coronavirus pandemic and the heavy toll it is taking on the healthcare sector across the world, the telemedicine guidelines had to be brought in to limit hospital visits and avoid the transmission of diseases significantly. The guidelines are designed to regulate unauthorized use and assist Registered Medical Practitioners to provide their services in an uninterrupted manner and to remote locations.  The provision for blacklisting technology platforms that do not abide by these guidelines is a welcome step to ensure due care from their end and was necessary to inculcate faith in these platforms. However, it is unjust on the part of the Government of India to only empower doctors who practice modern medicine to provide telemedicine services and not bring practitioners of Indian Medicine under its ambit.  As the definition of Registered Medical Practitioner in the guidelines state, it is only for doctors enrolled in the State Medical Register or Indian Medical Register as per the Indian Medical Council Act 1956.  Practitioners of Ashtang Ayurveda, homeopathy, Siddha, Unani, Tibb, or Sowa-Rigpa who are registered under other enactments have been overlooked.

That said, several initiatives by the Government of India on providing greater bandwidth connectivity, optical fiber connectivity, and National Knowledge Network connecting more than 800 institutions including medical institutions would encourage Telemedicine and Telehealth significantly. With people across the country in isolation and quarantine, Telemedicine is a viable alternative for patients to get immediate medical attention for minor health issues. With the assistance of technologies like fitness trackers, smartwatches, and plasters that are capable of monitoring heart rate, breathing rate, body temperatures, and generating ECG reports, it is time to harness Telemedicine for faster and timely access to healthcare services.

 

Image Credits: Photo by National Cancer Institute on Unsplash

In the wake of the coronavirus pandemic and the heavy toll it is taking on the healthcare sector across the world, the telemedicine guidelines had to be brought in to limit hospital visits and avoid the transmission of diseases significantly. The guidelines are designed to regulate unauthorized use and assist Registered Medical Practitioners to provide their services in an uninterrupted manner and to remote locations.  The provision for blacklisting technology platforms that do not abide by these guidelines is a welcome step to ensure due care from their end and was necessary to inculcate faith in these platforms.

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The Orphan Treatment of Orphan Drugs

“Orphan drugs” are pharmaceutical products used for the diagnosis, prevention or treatment of rare diseases. The definition of rare diseases varies from country to country. e.g. in the United States, a rare disease is defined as a condition that affects fewer than 200,000 people whereas in Europe it is less than one person per 2,000. Nevertheless, it is generally accepted that a disease having fewer than 100 patients per 100,000 population is a rare disease. It is assessed that internationally, around 6000 to 8000 rare diseases are in existence with new ones being discovered quite regularly. Moreover, it is estimated that there are approx. 4000-5000 rare diseases for which there are no treatments available.

In India, the rare disease and disorder population is between 72 to 96 million and up to 450 rare diseases have been recognized[i]. Because rare diseases affect a very small population of individuals and the profit potential is poor, pharmaceutical companies often do not take much interest in developing molecules for the treatment of these diseases. The shelving of these molecules and ignorance of the small patient pool gave rise to the concept of ‘pharmaceutical orphans.’

Orphan drugs and policies in India

In India, almost all orphan drugs are imported. The primary reason being lack of infrastructure, high cost and time, no cost of return, and no clear policy on orphan drugs and rare diseases. Although the disquiet around the development of orphan drugs resulted in an Orphan Drugs Act as early as 1983 in the United States, India has lagged behind for decades with the first ‘National Policy on Treatment of Rare Diseases’ coming out as late as 2017. Further, there are no epidemiological data, no figures on the burden of rare diseases and morbidity and mortality associated with them. In fact, until last year, India did not even have a definition of ‘orphan drugs.’ The new Drugs & Clinical Trial Rules 2019 finally defined it as “a drug intended to treat a condition which affects not more than five lakh persons in India”.

Drugs and Clinical Trials Rules, 2019:

In March 2019 Central Drugs Standard Control Organization (CDSCO) released New Drugs and Clinical Trials Rules, 2019. As per these new guidelines, local clinical trials (data) may not be required for orphan drugs permitted to be imported for sale or distribution. Further, the Expeditious Review Process could be sought for approval of a new drug after clinical development (applicable for Orphan Drugs). Furthermore, no fee shall be chargeable in respect of an application for conduct of clinical trial for orphan drugs.

New Drug Exemption Rule, 2019:

Further encouragement for orphan drug development could be seen in the New Drug Exemption rule released in January 2019. Under this rule, all new drugs patented in India were to be exempted from price control for five years. The five-year window starts from the date when the manufacturer starts commercial marketing in India. The Government has also exempted such drugs from price control that are used for the treatment of a disease that qualifies as Orphan Disease in the opinion of the Ministry of Health and Family Welfare (“Orphan Drug Exemption”). However, these rules are not devoid of shortcomings which may bring about issues during implementation. The requirement of the use of the exemption for five years from the “date of commencement of commercial marketing by the manufacturer in the country” is ambiguous as there is no legal definition of what amounts to ‘commercial or business marketing’ in India. The second issue that needs clarification is the exemption from price control available to ‘manufacturers’ of the patented new drug rather than the ‘drug’ itself. As a result, multiple manufacturers, importers, marketers of the same drug would seek to benefit from the exemption which could pose a challenge when the date of commercial marketing of different manufacturers would vary from each other. The third most important issue with absolute market exclusivity is that cost of orphan drugs per treatment episode could be extremely high.

Rare diseases as a public health issue

When a person contracts a rare disease, it not only puts an emotional strain on him/her, it also puts a heavy financial strain on his family. In addition to this, the unavailability of proper treatment remains a big challenge. Internationally, there are very few pharmaceutical companies, which are actively working on orphan drugs or rare diseases. And in India, the problem is more worrisome because there are hardly any pharmaceutical companies engaged in the development of these drugs. In addition, lack of awareness among the medical fraternity, lack of epidemiological data, lack of dedicated healthcare policies, schemes, and diagnostic facilities are some of the major hurdles that Indian pharmaceutical companies have to deal with.

The new drug exemption policy along with the CDSCO released new Drugs and Clinical Trials Rules, 2019 could provide the necessary impetus to the research and development of orphan drugs in India. However, there are still major strides that could be taken in line with other international governments which provide incentives ranging from tax credits to priority review vouchers in addition to fast track approvals by regulatory agencies, market exclusivity, fee reductions for regulatory approvals. Nevertheless, incentives should be balanced so as not to encourage pharmaceutical companies to exploit them to manufacture drugs for sub-categories of existing diseases to maximize profits by making existing drugs outrageously costly and inaccessible.

Hence, a more robust policy is imperative to devise a multipronged and multisectoral approach to build India’s capacity to tackle rare diseases comprehensively. Particularly, in areas of – obtaining requisite funding, creation of an extensive database, for cost estimation of the treatment; research and development for the treatment and diagnostic modalities, including through international/regional collaborations; training of health care providers; awareness generation; creating a conducive environment for drug development and measures for ensuring affordability of treatment, etc. With the necessary government action, hopefully, the orphan treatment of orphan drugs will minimize to give some respite to the patients.

A more robust policy is imperative to devise a multipronged and multisectoral approach to build India’s capacity to tackle rare diseases comprehensively. 

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