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Healthcare and Pharma

Draft Drugs, Medical Devices and Cosmetics Bill, 2022 – Takeaways

To adapt to the recent developments and advancements, a draft of the Drugs, Medical Devices and Cosmetics Bill, 2022 (Draft Bill) has been introduced. The Draft Bill seeks to replace the existing law, the Drugs and Cosmetics Act of 1940.

#WatchNow LawWiser video on the Draft Drugs, Medical Devices and Cosmetics Bill, 2022 – takeaways with Ritika Ganju, Partner, Phoenix Legal. In this video, Ritika shares details about the

– Prime objective of the Draft Bill

– Status of the rules to the Draft Bill

– To what extent have the provisions relating to clinical trials been incorporated in the Draft Bill

– Expected impact on e-pharmacy segment

To know about all the above and more, tune into watch the full feature now!

Draft of The Drugs, Medical Devices and Cosmetics Bill, 2022 – In the video

The Ministry of Health and Family Welfare (MoHFW) introduced a draft of the Drugs, Medical Devices and Cosmetics Bill, 2022 (Draft Bill) on July 08, 2022. The Draft Bill seeks to replace the existing law i.e., the Drugs and Cosmetics Act of 1940 (Act). The suggestions, comments and objections, if any, can be forwarded to the MoHFW within 45 days from the notice of the Draft Bill.  

Some quick questions that came to our mind on the Draft Bill are discussed below.

Q. What do you see as the prime objective of the Draft Bill?  

A. The Act is a pre-independence legislation which does not conform to the technological and medical advancements and simultaneous legal developments that have occurred from time to time over a period of last few years. The primary objective of the Draft Bill seems to be to accommodate these advancements and developments. As counsels for pharma and healthcare companies, we understand that the industry has felt the need to amend and consolidate the Act to eliminate the scope of conflicts that could crop up while interpreting the Act and the rules that have been introduced over last few years specifically to regulate medical devices, clinical trials, cosmetics and the draft bill for e-pharmacies.

At the first look, one would see a definition of medical device being incorporated in the legislation, which was notified on February 11, 2020 with an intention to broaden the scope of medical devices and set the ball rolling for the registration requirement to be made applicable. Other expected definitions that can be seen include that of clinical trials, over-the-counter drugs, manufacturers, new drugs, bioavailability studies, investigational new drugs and imported spurious drugs. The Draft Bill proposes an overall structural change with introduction of provisions on manufacture, sale, distribution and clinical trial of drugs and on import, manufacture, sale, distribution and clinical investigation of medical devices. 

In short, the entire regulatory periphery governing pharma and healthcare are at an evolving stage where many aspects need to be streamlined – yes, it does look like that the Draft Bill will be a common thread running through and brining new subjects, streams and aspects of pharma and healthcare industry together. 

Q. What is the status of the rules to the Draft Bill?

A. No new set of draft rules have been made available in relation to this Draft Bill. The Draft Bill specifies that till the government formulates new rules upon the Act being repealed, the standards and the rules specified in the nineth schedule of the Draft Bill will remain in force.

Presently, the nineth schedule of the Draft Bill specifies the list of rules made under the Act namely the Drugs Rules, 1945, the Medical Devices Rules, 2017, the New Drugs and Clinical Trial Rules, 2019 and the Cosmetics Rules, 2020. 

It can be expected that when the Draft Bill becomes law, the existing rules under the Act will also be subject to an amendment for the reasons of compatibility with the proposed legislation. 

Q. To what extent have the provisions relating to clinical trials been incorporated in the Draft Bill?

A. The clinical trials never found a mention in the Act as trials were unregulated until intervention of the Supreme Court of India pursuant to a public interest litigation filed in 2013 against the unethical nature of clinical trials in the country. A writ of mandamus was sought to direct the legislature to create and implement a better regulatory framework for the same.

Until recently before introduction of the New Drugs and Clinical Trials Rules in 2019 (CT Rules), these were regulated by Schedule Y of Part XA of the Drugs Rules, 1945. In order to cut down in conflict, the CT Rules provide that in case there is any discrepancy between the CT Rules and the Drugs Rules, 1945, the CT Rules will apply. 

To ensure compliance with Schedule Y and the 2019 Rules, the MoHFW has now introduced provisions relating to clinical trials in the Draft Bill and schematised the regulatory framework around clinical trials. The Draft Bill provides for permission to conduct clinical trials and more importantly, compensation provisions are also provided for in case of injury or death related to clinical trials. Thus far there was no specific penalty prescribed for such 

Q. What is the expected impact on e-pharmacy segment?

A. As of now, the e-pharmacy segment is not regulated. The uncertainty in the regulatory framework of e-pharmacy is not conducive for the fast pace digital markets. The Draft E-pharmacy Rules were put out for comments from stakeholders by the MoFHW in 2018 (E-Pharmacy Rules). The E-Pharmacy Rules were formulated with an intent to regulate the procedure for distribution or sale of drugs through e-pharmacy and the registration requirements. These are yet to be finalised.  

This Draft Bill proposes to regulate online mode of sale and distribution of any drug by introducing licensing and permission requirements. Under the Draft Bill, the government has the power to make rules for the manner of regulation and restriction for online sale or distribution of any drug and medical devices.   

Therefore, the provisions of the Draft Bill are reflective of the government’s intention and plans to introduce regulations governing e-pharmacy segment either simultaneously or before the Draft Bill. This can be a welcomed given the fact that e-pharmacy industry is only likely to expand.

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Draft Food Safety and Standard (Food Products Standards and Food Additives) Amendment Regulations, 2021

Recently there were two main amendments made in the Food Safety and Standard (Food Products Standards and Food Additives) Regulations. 

  1. The Food Safety and Standards Authority of India (FSSAI) has issued the Draft Food Safety and Standards (Food Products Standards and Food Additives) Amendment Regulations, 2021 on December 27, 2021. 

Authority of India

  1.  FSSAI has also issued a draft notification on Food Safety and Standard (Food Products Standards and Food Additives) Amendment Regulations, 2021. 

Watch LawWiser video on Draft Food Safety and Standard (Food Products Standards and Food Additives) Amendment Regulations, 2021 with Avani Shukla, Lawyer & Growth and collaborations at lawWiser.

Stay tuned for more such updates!

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Registrations and Compliances for healthcare MSME

It won’t be wrong to refer to this sector as the backbone of the country, one which the government has worked towards strengthening. Especially with the advent of the Atma Nirbhar Bharat Abhiyan or the Self-Reliant India Scheme of 2020 by the Government of India, there are a whole host of benefits that accrue to MSMEs once registered.  

Watch LawWiser’s video on Registrations and compliances for healthcare MSME with Sanjana Aravamudhan, Associate Consultant, Dua Consulting. She talks about the registrations and compliances that MSMEs need in order to compete in the market and avail of several benefits made available to them through various government schemes

She shares some of the advantages of MSME registrations like Banking loans with low-interest rates, tax benefits, one-time settlement fees, credit guarantee schemes, concessions and much more. 

Sanjana not only shares insights but also guides on the procedure for obtaining universal registrations that are available to the MSMEs. 

Further, she shares about the universal compliances that MSMEs must consider adhering to with a special focus on the healthcare-specific registrations and compliances.

Even though the pandemic has resulted in slowing economic growth in multiple sectors, there was a significant uptick in MSMEs engaged in primary activities like the manufacture of medical equipment and medicines due to increased demand. With the right registrations, you can avail of the significant benefits as discussed in Sanjana’s earlier video on MSMEs in a post covid world. 

Given India’s shift to being vocal for locals, MSMEs now possess a unique opportunity to engage with a whole host of stakeholders on a priority basis. This shift will provide immense financial gains to compliant MSMEs and we will explain those requirements to you in our upcoming videos. 

Watch the full video to know all about the Registrations and compliances for healthcare MSME on LawWiser.

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Engagement in a post Covid healthcare space by MSMEs

The share of MSMEs in GDP has not only remained high but has increased over the years.  But MSMEs are not only contributing to the GDP kitty, they have become big partners of India’s export growth, with a 48% share in 2018-19.

Post-covid many policies have been introduced to ensure consistent growth of MSMEs. Few policies have been introduced for MSMEs, particularly in the healthcare sector. 

Watch LawWiser video on Healthcare MSMEs in the Covid & Post Covid era with Sanjana Aravamudhan, Associate Consultant, Dua Consulting. In this video, Sanjana talk’s about the post-Covid scenario and how the MSMEs are currently placed in terms of managing what looks like a burgeoning healthcare market, but does it entirely or partially only favour MSMEs.

She also takes us through the SAFE scheme. SIDBI had launched SIDBI Assistance to Facilitate Emergency response against coronavirus (SAFE) scheme to provide financial support to all MSMEs engaged in manufacturing any product or providing any services which are related to fighting coronavirus (such as hand sanitisers, masks, bodysuits, ventilators, testing labs, etc).

She also shares about the two other key financing initiatives introduced by SIDBI to counter the adverse impact of the pandemic. They are SHWAS (SIDBI assistance to the healthcare sector) and AROG (SIDBI Assistance to MSMEs for recovery & organic growth during the COVID-19 pandemic).

She further takes us through the eligibility of the schemes, and the application process and highlights the other benefits in the pipeline for the MSMEs in the healthcare sector.

Stay tuned for more insightful content related to MSMEs. 

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MSME in the Medical Devices Sector | Neeraj Dubey | LawWiser Premium

The medical devices sector has been receiving a lot of impetus for promoting its domestic manufacturing. For this, the government of India has released various schemes. Watch all the details on these schemes in #LawWiser video on MSME in the Medical Devices Sector with Neeraj Dubey, Partner, Juris Corp. 

Neeraj takes us through these critical schemes that aim to develop and promote the medical devices sector and bring them on par with global standards. He begins with the Production Linked Incentive scheme that applies only to the Greenfield projects and intends to boost domestic manufacturing and attract large investments in the sector.

Other schemes that are relevant for the sector are:

Promotion of Medical Device Parks- The central government will finance the creation of common infrastructure facilities with a grant-in-aid to 4 medical device parks which will come up in 4 different States. By this, the Government aims to attract investment in the medical device sector and provide support to the capital expenditure of the manufacturers. 

Public Procurement (Preference to Make in India) Order, this revised order issued by the DPIIT and revised guidelines issued by the Department of Pharmaceuticals aims to implement the provisions of the public procurement order relating to goods & services related to the Medical Device Sector.

Neeraj also shares insights on the Marketing Development Assistance scheme and much more.  Tune in now to watch the full video for more such insights.

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MSME in the Pharmaceutical Sector | Neeraj Dubey | LawWiser Premium

Major segments of the pharma industry in which MSMEs can make a mark are generic drugs, OTC medicines, and APIs, bulk drugs, vaccines, contract research, biosimilars and biologics. The Department of Pharmaceuticals aims to make India a leader in end-to-end drug production.

 All medical devices including Hospitals, Nursing Homes, Clinics are eligible for MSME registration under the Udyam Registration scheme that can be done online. The government has enacted multiple reforms and the production-linked incentive scheme, the PLI scheme is the most crucial of them.

Watch now #LawWiser explainer on “MSME in the Pharmaceutical Sector” featuring Neeraj Dubey, Equity Partner at Juris Corp, where he shares crucial aspects of MSME in pharma.

The Production Linked Incentive scheme for pharmaceuticals aims to enhance India’s manufacturing capabilities in two ways: increasing investment & amp; production and contributing to product diversification to high-value goods. 

The other key schemes are:

1) PLI Scheme for Promotion of Domestic Manufacturing of critical Key Starting Materials/ Drug Intermediates and APIs which provides financial incentives on sales of 41 identified products for 6 years for Fermented Based Products and Chemical Synthesis

Based Products.

The second scheme is 

2. Bulk drug parks

A scheme for promoting domestic manufacturing of critical Key Starting Materials/Drug Intermediates and APIs aimed at attracting investment to ensure sustainable domestic supply and reduce dependence on imports. How will it be done? By providing grant-in-aid to 3 Bulk Drug Parks for creation of Common Infrastructure Facilities like solvent recovery plant, distillation plant, power and steam units, common effluent treatment plant etc.

The third scheme is 

Pharmaceutical Technology Upgradation Assistance Scheme, to help SMEs upgrade their plant and machinery to WHO/Good Manufacturing Practices standards so that they could participate and compete in global markets. 

The fourth important scheme is

Pharmaceutical Promotion & Development Scheme aims at promotion, development and export promotion by extending financial support for conducting seminars, conferences, exhibitions, mounting delegations to and from India for promotion of exports as well as investments, conducting studies, etc. 

#pharmaceuticalindustry #MSME #pharmaceuticalmanufacturing #promotion #investments #medicaldevices #lawfirmmarketing #law #legalknowledge #legalnews #knowledge #legalindustry #legalcommunity 

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PLI Scheme to Benefit Pharmaceutical Sector

The Ministry of Chemicals and Fertilizers has announced that 55 pharmaceutical companies are likely to get benefitted from the Production-Linked Incentive scheme for pharmaceuticals which is part of the government’s flagship Atmanirbhar Bharat Plan. This scheme will help in enhancing India’s manufacturing capabilities and exports in ten sectors.

The financial outlay for this Production- Linked Incentive (PLI) Scheme is Rs 15,000 crore. This PLI scheme aims to enhance India’s manufacturing capabilities and also exports in ten different sectors which were approved by the Union Cabinet.

The Cabinet approved this scheme on February 24, 2021. The operational guidelines inviting applications for the pharmaceutical industries were issued on June 1, 2021. They were issued by the Department of Pharmaceuticals after consulting thoroughly with related departments, industries, and NITI Aayog. A total of 278 applications were received by 31st August on the scheme out of which 55 applicants got selected.

Watch Avani Shukla from LawWiser helps us understand different aspects related to it such as –

1. Aim of the PLI scheme

2. Invitation of applications for the PLI scheme and different categories associated with it

3. How is it going to benefit the pharma sector?

Tune into the video to learn and understand more about the scheme.

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Biotechnology and Patents |Biotech Patent| #QuickBytes

Patent applications in biotechnology are growing more than ever! Biotechnology involves technical applications of different kinds of biological processes in microorganisms, animals, and plants which can be harnessed for several useful applications. Due to the pandemic, the patent applications in biotechnology have increased by 6.3% and are still on the rise. In this video, Avani Shukla of LawWiser talks about when does a biotechnological invention can get patented and what are the exceptions. She takes us through the Legislative framework and policies for the protection of biotechnology and further discusses the need to balance out ethical and legal issues related to it.

Biotechnology is simply a technology based on biology. It uses cellular and biomolecular processes to create technologies and products that help us live better lives and improve the health of our planet. For almost 6,000 years, we’ve relied on the biological processes of microorganisms to create valuable food products like bread and cheese, as well as to preserve dairy products.

 

Biotechnology and Patents

 

In 1856, India passed the Patent Act. Since then, it has been amended multiple times, the most recent being in 1970, when it was updated to meet international patentability standards for novelty, inventive step, and industrial applicability. However, there was nothing particular about biotechnology creation and protection in this iteration. At the same time, as the number of biotech inventions and patent applications increased in the US and EU, the need for a modification to the Indian Patent Act to allow for biotech patentability grew louder in India. In 2002, an amendment was made to include biochemical, biotechnological, and microbiological processes in the scope of potentially patentable processes.

 

Biotechnology and Patents in India

 

Biotechnology inventions are given patents in India if they meet the patent eligibility criteria of novelty, inventive step, and industrial applicability. Biotechnology inventions are a broad field of biology that uses living organisms and systems to create or develop products, as well as any other technological application that uses living organisms, biological systems, or derivatives thereof to modify or create products or processes for specific uses.

Biotechnology and patents in India are currently booming, as seen by the data.

India, which is ranked third in the Asia Pacific, is one of the top 12 biotechnology destinations in the world. 1 By 2025, the biotech business in India is expected to be worth $100 billion. 2 Because the biotechnology business relies largely on research and development, it is critical for biotech companies to grasp the legal protections available to safeguard their ideas through patent rights.

Types of Biotechnology Patents

 

In most every field of research, there are two basic types of Biotechnology patents:

  • Product patents.
  • Process patents.

This holds true for biotechnology as well. An inventor can patent a product or a new procedure that they have developed. Because of the nature of biotechnology, there are some limitations on what can be patented and what cannot. To put it another way, inventions are patentable, but discoveries aren’t.

Biotechnology discoveries are natural items or processes that are basically held by nature, hence they cannot be “owned” by a single individual through a patent. However, if you develop a product or technique that involves the utilisation of natural, living objects, you should consider filing a patent for it. When trying to patent a biotechnology invention, this can lead to some complex situations.

 

Conclusion

Biotechnology and patents in India have significantly grown as shown by the data itself. However, some inflexible laws have to be constructed to potentially grow in this industry.

 

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Mental Health Stigma in Legal Profession | #LetsGetReal

Watch now LawWiser’s panel discussion – Mental Health Stigma in the Legal Profession. Our speakers include – Chris Parsons, Chairman, India Practice and Mental Wellbeing Champion at Herbert Smith Freehills; Dr. Milind Antani, Leader – Pharma, Healthcare, and Digital Health at Nishith Desai Associates; and Seb Jauslin, Founder of SebJauslin.com, Lawyer turned Therapist.

Moderated by Jigyasa Tandon – Mental health educator and counseling psychologist, this discussion helps us understand mental health within the context of the legal profession. Chris and Seb share personal experiences of burnout, stigma, and socio-cultural factors.

Dr. Antani further talks about the steps taken within NDA towards the mental well-being of its people.

The speakers cover different aspects such as:

– The stigma surrounding mental health in the legal profession

– The relationship between law and mental health

– Helpful ways in which people can take care of themselves in mental health distress

A big thank you to Nishith Desai Associates for supporting our belief that this dialogue around mental health is important to initiate.

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Registration of Medical Devices (DCGI) – In A Minute | Ritika Ganju

Recently the Registration of Medical Devices is introduced with licensing through simple e-based process. It will also increase the ambit of medical devices which come under regulatory control.

This will further affect the implications and procedure related to licensing and Registration of Medical Devices. The Registration is optional till October this year and after that it will become mandatory. The regulation will be under control of – Central Drug Standards Control Organization (CDSCO), The Drug Controller General of India (DCGI), India’s Drugs & Cosmetic Act and Rules (DCA)

Watch this LawWiser In A Minute Video powered by Phoenix Legal, where Ritika Ganju, Partner, Phoenix Legal, takes us through key highlights of this requirements. She also shares objectives and implications of new medical devices regulations.

To get featured in more such conversations, write us on [email protected]

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