New Healthcare Bills in Parliament in Monsoon Session 2023

New Healthcare Bills in Parliament in Monsoon Session 2023

Background

The Covid Pandemic exposed some of the short comings and lacunae some of the Acts and Bills that have been enacted in India to regulate the healthcare and lifesciences industry. You may be surprised that some of these regulations pre-date the pre-independence British Era Regulations in this country. While healthcare and lifesciences products, services and professionals have progressed significantly over the last 75 years since Independence their regulations from the British Era hampered the progress. Six bills are being introduced are expected to be passed in this ongoing session of Parliament which commenced on July 20, 2023 and will be in session till August 11, 2023. These include:

  • Drugs, Medical Devices and Cosmetics Bill, 2023;
  • National Dental Commission Bill, 2023;
  • National Nursing and Midwifery Commission Bill, 2023;
  • Biological Diversity (Amendment) Bill, 2022;
  • Forest (Conservation) Amendment Bill, 2023; and
  • DNA Technology Bill (Use and Application) Bill, 2023

Let’s understand some of the Bills are being introduced directly by the Ministry of Health and Family Welfare while others are being introduced by other Ministries but have an impact on healthcare and lifesciences industry indirectly. Let’s quickly understand what these Bills are going to be enacted for.

The Drugs, Medical Devices and Cosmetics Bill 2023

This Bill seeks to regulate the import, manufacture, distribution and sale of drugs, medical devices and cosmetics. The focus of this bill is to ensure the medicine and medical devices quality, safety, efficacy, performance and clinical trials of new drugs and medical device. Beside, the Bill seeks clinical performance evaluation of new in-vitro diagnostic medical devices including Ayush medicine, medical devices and cosmetics with the objective of the highest possible regulatory standards, ensure a transparent regulatory regime and to repeal the archaic Drugs and Cosmetics Act, 1940. We do remember what was going on during the pandemic to fast track the approval of Pfizer and other companies vaccines in India without any clinical trials and data on Indians. Hopefully, this Bill will plug some of those loopholes that were being exploited by some of the multinational pharma companies to push their products into India during the Covid pandemic.

The National Dental Bill 2023

This Bill repeals the Dentists Act 1948. The proposes to set up a National Dental Commission (NMC) to regulate dental education and the profession in the country. It also seeks to make dental education affordable and raise its standards, and make quality oral healthcare accessible.  

The National Nursing and Midwifery Commission Bill 2023

This Bill seeks to set up a National Nursing and Midwifery Commission (NNMC) and to repeal the Indian Nursing Council Act 1947. The Indian Nursing Council Act, 1947 is an act of the Indian parliament that regulates the nursing profession in India and was introduced by the Ministry of Health and Family Welfare in India.

The Drugs, Medical Devices and Cosmetics Bill 2023, The National Nursing and Midwifery Commission Bill 2023 and The National Dental Bill 2023 was introduced by the current minister of Health and Family Welfare, Mansukh Mandaviya.

The National Research Foundation Bill 2023

This Bill seeks to establish a National Research Foundation and repeal the SERB which is the Science and Engineering Research Board Act, 2008. The Science and Engineering Research Board Act, 2008 is an act of the Indian parliament that provides for the constitution of a Science and Engineering Research Board to support basic research in science and engineering.

The Science and Engineering Research Board Act, 2008 falls under the Ministry of Science and Technology in India.

The Biological Diversity (Amendment) Bill 2022

This was reported by the Joint Committee was introduced on December 16, 2021. The amendment report of the joint committee was presented to both the houses of Parliament which has proposed for consideration and passing. This Bill proposes to protect some of the plant species that would enable protection and development for Ayurveda.

The Forest (Conservation) Amendment Bill 2023

The controversial bill amends the Biological Diversity Act, 2002 to simplify compliance requirements for domestic companies. It also removes research and bio-survey activities from the purview of benefit sharing requirements. The bill also decriminalises all offences under the Act. Among several criticisms of the Bill was that it promotes ‘ease of doing business’ and would exempt users of codified traditional knowledge and Ayurveda, Yoga and Naturopathy, Unani, Siddha, and Homoeopathy (AYUSH) practitioners from sharing benefits with local communities.

Environment Minister Bhupendra Yadav will be introducing the Bill.

The DNA Technology Bill (Use and Application) Regulation

In the case this Bill which was introduced in the Parliament on July 8, 2019 is seen to have an issue. This is despite the report of the standing committee on Science and Technology, Environment, Forests and Climate Change was laid on the table of Lok Sabha on February 2021 the motion proposed was for withdrawal.

The DNA Technology Bill (Use and Application) regulation is a bill that seeks to regulate the use and application of DNA technology for establishing the identity of missing persons, victims, offenders and unknown deceased persons.

The above three bills is being tabled in the Parliament by the current Minister of Science and Technology, Dr. Jitendra Singh

 

A Tale of Two Medical Systems: Revolution Ahead?

A Tale of Two Medical Systems: Revolution Ahead?

Background

The current spat between the Indian Medical Association (IMA) and Baba Ramdev of Patanjali is like a modern version of Charles Dickens’ famous novel A Tale of Two Cities, that led to the French Revolution. The Federation of Resident Doctors’ Association (FORDA) has decided to execute a Black Day on the 1st of June against the controversial statements made by Baba Ramdev against Allopathy and the video shared by him on Twitter. These activities by the allopaths are only goes on to strengthen the value proposition of Alternative Therapies and Indian Traditional Medicine in the minds of the consumer and view IMA and the Allopaths with suspect. The louder the decibel in media the faster would be the Medical Revolution against Allopathy.

Having led the world’s first Integrative Medicine Partnership at the Institute of Ayurveda and Integrative Medicine (IAIM) and served their Advisory Board, I would like to request both sides to set aside their differences and work towards delivering innovative integrative solutions between the two systems for the consumers before it is too late that the consumers bring about a Medical Systems Revolution. Here are some of the points and issues that I would like to lay down for the jury of the consumers to judge and adjudicate.

Investor Perspective: Larger Flow of Investments in Indian Alternative Therapies

Investors and companies invest in opportunities where they see money and value proposition for the consumer’s needs. Let’s understand from the consumers point of view the world over which is becoming more and more skeptic of the allopathic system and their preference towards Indian Traditional Medicine or Alternative Therapies and Medicine for treatment and wellness. Our annual Healthcare and Sciences Heatmap 2021 Investment Heat Map | Kapil Khandelwal (KK) every year is measuring the investment in different sectors including Alternative Therapies. Our conclusion is that Indian Alternative Therapies and Medicine have been gaining wider consumer acceptance and affirmation leading to increased investment activities. Apart from the shift from Allopathy towards Some of the key drivers for investment in this sector are:

  • Economic growth and rising incomes
  • Rising per capita expenditures on healthcare products
  • Low cost of production
  • Improvements in the distribution network
  • Increase in accessibility in both urban and rural regions
  • Awareness programs and subsidies
  • Rise in non-communicable and chronic diseases

It’s not Baba alone who is the key enemy of the allopaths As per our analysis over 60 corporate groups, pharma and consumer companies, including Multinational Companies (MNCs) have diversified into Indian Alternative Therapies and Medicines with an overall investment of over INR 80000 crores. Moreover, as a boost to this sector, the government recently introduced an economic stimulus package under the Atmanirbhar Bharat and has allotted INR 4,000 crore to the sector for promotion of herbal cultivation. The move aims to cover 10 lakh hectares (24.7 lakh acres) under herbal cultivation over a period of two years

Defamations Cannot Muffle Consumer’s Choice

Nearly 75 per cent of Indian households already use some form of Ayurveda to treat a variety of problems. The writing is on the wall for Allopathy during the current Covid Pandemic, when those who were the forbearers of medical treatment had no answers to treat Covid and the consumers themselves had to search for home made solutions to build immunity and treat mild forms of the infections themselves. Rather than take the prescribed Allopath Doctor’s prescription of artificial vitamins, zinc and tablets, etc. consumers preferred gilroy, kali mirchi, methi, nimbu pani, turmeric, kada, etc. Where was IMA hiding in 2020 with a mass campaign to debunk all these stuff that the consumers were ingesting based on Indian Alternative Therapies and Medicines. I am sure with the current spat between the Baba and IMA allopaths, pharmaceutical companies, doctors and others seem to fear that their dominance is at stake is very apparent.

Indian Alternative Therapies and Medicine are Learning from The Chinese Traditional Medicine

Indian Traditional Medicine and Chinese Traditional Medicine are equally older than Allopathy. However, Chinese export over 5 times more in value their traditional medicines to the world than the Indians. The Chinese were able to lead this sector globally by publishing and sponsoring enough research on quality, effectiveness and safety of their traditional medicine. Moreover they were able to invest aggressively in research in combining their traditional medicine with western medicines into integrative medicine. Why is there no spat between Chinese and the large pharma companies of the West?

India is learning from the Chinese catching up by investing heavily on:

  • Product innovation is the core to the healthcare solutions that consumers are seeking against allopathic medicine
  • Study Ayurveda and Alternative Therapies by using the methods and means of western medicine. (As a side note: I know for sure that the same Baba recruited one of my ex-colleagues who was from allopathic drug discovery having worked in US and India to set this up at his Patanjali Research. I am sure he has some aces up his sleeve when he is challenging IMA in the courts rather than just tendering an apology.)
  • Innovate the basic theory of Indian Alternative Therapies. Different from the western medicine which starts from the molecular biology, Ayurveda is researched and developed based on systematic biology of Kafa, Wada, Pitta. Clinical trials and research is strengthening this potential
  • Big Data solutions into health informatics to empirically proving where Allopathy stops and Ayurveda starts. At IAIM, there is a large initiative to collect data to prove what limits Allopathy and where Ayurveda benefits the consumer.
  • Integrating genetics with the systematic biology of Ayurveda leveraging the big data. Apart from the phenotype, genotype and other information is strengthening innovation in the products.

So, my concluding comment on this is spat between Ayurveda and Allopathy is that it’s a lose-lose for both not just in India but internationally giving the Chinese Traditional Medicine a chance to grow its pie internationally. The win-win solution for both the sides is not to prove who is right or wrong on their claims and counter claims and defame both the systems of Medicine in India but to work out an integrative medicine solution between the two. Else we are heading down to the wire on a medical revolution like the Tale of Two Cities dictated by the consumers choice and preferences.