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Medical device market & regulatory system failures, future and priorities

Poor device safety and functionality have been crucially related to legislative loopholes which make it easy for device makers to get their products in the market before proper testing.

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In the wake of reports of faulty test kits and protective gear purchased by India from China, India’s medical device industry has been in limelight again which can hamper India’s fight against COVID -19. In the past too, India has faced such failures over patient safety, quality control and efficacy of the medical devices and equipments, be it Johnson’s and Johnson’s faulty hip transplants leading to disabilities in patients or use of unapproved drug eluting cardiac stents threatening heart care in India. At the time when India has been looking at scaling up testing and surveillance due to increased diseases burden, significance of regulation, monitoring and increased domestic manufacturing of medical devices cannot be overemphasized.

Medical Devices in general means any instrument, apparatus, implement, machine, implant or other to be used for the specific medical purposes of diagnosis, prevention. monitoring, treatment or alleviation of diseases or injuries, supporting or sustaining lives control of conception , replacement, modification , support or providing information of a physiological processes. Ranging from simple thermometers, stethoscopes and tongue depressors to complex devices like pacemakers with micro chip technology, ultrasound etc., medical devices are essential for safe and effective prevention, diagnosis, treatment and rehabilitation of illness and disease.

Until recently, the healthcare stakeholders, i.e., doctor’s patients, physicians, employers, insurance companies, pharmaceutical firms and government were focused on the drugs and other pharmaceuticals. There was a limited awareness which led to free hands on the medical devices regulation. Now, India attaches great significance to medical devices as they are quintessential to healthcare. The industry is expected to grow drastically over the next several years amidst the rising demands, high incomes and growing middle class, speed innovation and technology changes, increased public health awareness and spending and government health initiatives.

Despite such widespread significance, there were fundamental and systematic issues persisting in this industry .The most common concern is the device safety and efficacy. Lack of regulatory systems with global standards has put the patient›s life at stake. Poor device safety and functionality has been crucially related to legislative loopholes which makes it easy for device makers to get their products in the market before proper testing. Lack of quality product testing in India is another hurdle which results in sub standard devices in the market. Rampant imports at low cost not only leads to poor quality equipment but a big impediment to the domestic manufacturers and the government revenue. Absence of regulatory oversight and under reporting of failure of medical devices has added to the issues surrounding this sector. Other combinations of issues include failure to work as intended/malfunction, instructions/labeling/packaging issues and use errors.

As we’ve seen, though, each of these major problems with the health care device market has captured the attention of regulators and concerned citizens, government is yet to attain a safer and more transparent industry. In such scenario, proper manufacturing, regulation, planning, assessment, acquisition, management and use of medical devices which are of good quality, safe and compatible with the settings in which they are used has become quintessential. The Indian medical devices and equipments sector with the majority of medical devices sold in India imported from other countries (Currently 75%) went unregulated so far until the notification of Medical Devices Rule, 2017. The CDSCO under the Health Ministry regulates the safety, efficacy and quality of notified medical devices under the provisions of Drugs and Cosmetics act, 1940 and the Rules made there under. The Indian Government stepped up and initiated some reforms for improving the quality of the medical device sector.

In January 2017, India’s Ministry of Health and Family Welfare released the long-awaited Medical Device Rules of 2017, which took effect on Jan. 1, 2018. Upon implementation, this regulation replaced the existing Drugs and Cosmetics Act (DCA).Prior to implementation of the Act, the medical device industry in India was largely unregulated, except for a few devices covered specifically by the DCA. The list of covered devices was limited (only 15 medical devices were included), and the DCA treated these devices as drugs rather than establishing regulations tailored to the medical device industry. The implementation of MDR 2017 attempted to establish a uniform regime for Indian medical device manufacturing and marketing, at par with the global standards. It laid down a risk based classification of medical devices. The rules notified increased number of medical devices to be regulated and separate provisions for clinical trial of medical devices to access safety, performance and effectiveness. Certifying bodies for third party assessment were also notified. Strict Registration and licensing norms and post market surveillance to ensure safety, performance and adaptability of the device were the key highlights.

The 2017 rules were a good step in right direction. However, there still existed some gaps and ambiguities. Bringing into domain larger no of medical devices was the ultimate aim with opportunities to domestic manufacturers to penetrate into the market. The pricing of the devices still remained under the market forces of demand and supply resulting into out of pocket expenditures and poverty shocks. The country still witnessed scandals, the biggest of which was the hip implants which resulted into patient disabilities. Still, outside of these “notified” device categories, manufacturers with unproven designs, little or no quality control, limited defect traceability, and inconsistent reliability could operate with relative abandon in India.

Taking cue from the above, on February 11, 2020, the Ministry of Health and Family Welfare (Mo H&FW) issued two notifications in the Indian Gazette – a new definition of medical devices and The Medical Devices (Amendment) Rules, 2020, the latter amends the Medical Devices Rules, 2017, and has been effective from April 1, 2020. This will bring all medical devices under single regulatory framework. Under the new Medical Devices (Safety, Effectiveness and Innovation) Bill, the government has also proposed an improved regulatory framework which is said to improve the ease of doing business by providing a sound environment for innovation and approval of medical devices in the country. The new proposed regulatory framework is said to focus on safety, efficiency and quality of medical devices, and will be operating under Central Drugs Standard Control Organization (CDSCO), which will be enhancing its expertise to regulate safety and efficacy of medical devices. The ministry of health and family welfare (Mo H&FW) in partnership with Niti Aayog has established a separate regulatory body for medical devices sold in the Indian markets. Also, the government plans to include the country’s top technical institutes such as the Indian Institute of Technology (IIT), Indian Institute of Science (IISc) and others, thereby utilising their world-class laboratories, to help set benchmarks and safety guidelines for providing certifications to medical devices.

The Medical Device Rules, 2017 and the amendment Rules of 2020 have many attractive features that encourage the medical device sector in India. By introducing a single online portal, the registration process has been streamlined. An audit by the notified bodies will further increase the manufacturing quality of devices. A change in clinical trial requirements will encourage the innovation of new medical devices. The regulations will thus encourage domestic manufacturing and increased scrutiny of import license documents. However, there still remains certain grey areas with changes in the industry dynamics. They include looking for regional prospects and providing market opportunities, increasing competition, bringing down costs and reducing imports, separate FDI Framework for medical device industry that is independent of regulations governing the pharmaceutical sector, penalising frauds exclusively for medical devices. Mere control through licensing, testing and certification lead to red-tapism, bureaucratic hurdles and delays.

With the shifting market dynamics caused by Covid-19, pretty much everything is in overhaul mode. Within the burgeoning health technology ecosystem, the medical devices market is also witnessing a dramatic shift as policies are being changed to accommodate the high demand. The Covid-19 pandemic has just highlighted the importance of medical devices more than ever. A lot of startups, researchers and medical device manufacturers are currently focusing on improving the quality of care and also developing affordable devices, including ventilators, contactless wearable devices, UV sterilising chambers, testing kits, PPE among others. At the same time, the Indian government has been supportive in this context and is easing the regulatory process for mass testing and production, where they are pushing startups and SMEs to develop medical devices that help India tackle the pandemic and other lifestyle and chronic diseases.

Financial incentives are also underway to boost local manufacturing of medical devices over five years through a comprehensive production linked incentive (PLI). Central government through Department of Pharmaceuticals notification (DoP) lays out plan to incentivise Indian players with at least Rs.3,420 crore, over a period of five years. This incentive would be provided if they were to invest in their set-ups to produce key medical devices. According to a data compiled by DoP, India’s medical device market stood at Rs.50,026 crore for 2018-19 and is skewed in the favour imports which were to the tune of  Rs.43,365 crore, while exports were Rs.16,300 crore. While both exports and imports grew at 25. 2 and 23.8 per cent as compared to 2017-19, and it is expected to touch  Rs.86,840 crore in 2021-22, officials said that there is a lack of level playing field in India versus the competing economies. Lack of adequate infrastructure, domestic supply chains, logistics, high cost of finance, limited availability of quality power supply, limited design capabilities, low focus on R&D, and skill development are the main roadblocks.

Today the India’s medical device industry market is still in the nascent stage and many companies are facing closures since they cannot compete with China and imports from other countries, including the US, Singapore and Germany and others. The industry is surviving a regulatory vacuum & regular patient safety concerns. The recent J&J hip implant frauds and most recent ban on Trans-vaginal Pelvic Mesh by USFDA made the Indian regulators seriously think to look medical devices as a different sector altogether. It has become imperative to have a separate law as devices are engineering items and not medicine, continued attempts to regulate them as drugs is irrational. A separate legislation for the same would be a welcome step.

Neha Gyamlani is an Advocate at Rajasthan High Court and Partner at J&G Advocates. Aditya Jain is an Advocate on Record at Supreme Court of India and Partner at J&G Advocates.  

India’s medical device market stood at Rs 50,026 crore for 2018-19 and is skewed in the favour of imports which were to the tune of  Rs 43,365 crore, while exports were Rs 16,300 crore. While both exports and imports grew at 25. 2 and 23.8 per cent as compared to 2017-19, and it is expected to touch  Rs 86,840 crore in 2021-22, officials said that there is a lack of level playing field in India versus the competing economies.

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AN ASSOCIATION OF CORPORATE BODIES CAN ESTABLISH A CAPTIVE POWER PLANT PRIMARILY FOR THEIR OWN USE UNDER THE ELECTRICITY ACT: SUPREME COURT

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The Supreme Court in the case Chhattisgarh State Power Distribution Company Ltd. vs Chhattisgarh State Electricity Regulatory Commission observed that a captive power plant primarily for their own use can be established by an association of corporate bodies.

The requirement would be that the consumption of SBIPL and SBMPL together should not be less than 51% of the power generated. Admittedly, the joint consumption by SBIPL and SBMPL is more than 51% and under the provisions of the said Act, the use of electricity by it would be for captive use only even an association of corporate bodies can establish a power plant. Since SBMPL holds 27.6% of the ownership, the requirement of not less than 26% of shares is fulfilled by SBMPL as SBMPL holds 27.6% equity shares in SBPIL.

The fourth proviso to sub­section (2) of Section 42 of the said Act would also reveal that surcharge would not be leviable in case open access is provided to a person who has established a captive generating plant for carrying the electricity to the destination of his own use and under Section 9 of the said Act, could be an individual or a body corporate or association or body of individuals, whether incorporated or not, it is clear that the person will get benefit even an association of corporate bodies can establish a captive power plant it has been seen. The definition of “person” is wide enough to include any company or body corporate or association or body of individuals, whether incorporated or not, or artificial juridical person it should be primarily for the use of the members of such co­operative society or association is the requirement, the Bench observed while referring to the provisions of the Electricity Act.

The BPIL, the respondent contended and supported the impugned judgment that no permission is required from the Commission for supply of electricity for its own use. Thereafter the appellant Company contended that unless SBPIL consumes 51% of the aggregate electricity generated by it, it will not be entitled to get the benefit under Section 9 of the said Act, in an appeal filled before the Apex Court.

An appeal was dismissed by the Appellate Tribunal for Electricity filed by the Company further The Commission held that SBPIL was entitled to supply electricity to its sister concern SBMPL and the same would qualify to be treating as own consumption and within the ambit of Section 9 read with Section 2(8) of the Electricity Act, 2003 and Rule 3 of the Electricity Rules, 2005 SBPIL submitted a petition for providing open access and wheeling of power through the transmission system of the Chhattisgarh State Power Distribution Company Ltd (Company) for captive use by SBMPL to the Chhattisgarh State Electricity Regulatory Commission, the commission. A Captive Generation Plant is established by SBPIL, and is a sister concern of SBPIL Shri Bajrang Power and I spat Ltd and Shri Bajrang Metallics and Power Ltd, SBMPL.

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Where the crime was committed the remission or premature release policy of the state has to be considered: Supreme Court

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The Supreme Court in the case Radheshyam Bhagwandas Shah, Lala Vakil vs State of Gujarat observed that where the crime was committed has to be considered in the remission or pre­mature release in terms of the policy which is applicable in the State.

While allowing the writ petition the court observed and contended that Once the crime was committed in the State of Gujarat, after the trial been concluded and judgment of conviction came to be passed, all further proceedings have to be 6 considered including remission or pre­mature release in terms of the policy which is applicable in the State of Gujarat where the crime was committed and not the State where the trial stands transferred and concluded for exceptional reasons under the orders of this Court, as the case may be. The court further stated that under Section 432(7) CrPC the appropriate Government can be either the Central or the State Government but there cannot be a concurrent jurisdiction of two State Governments.

the appropriate Government in the ordinary course would be the State of Gujarat. But the case was transferred in exceptional circumstances by this Court for limited purpose for trial and disposal to the neighboring State i.e., the State of Maharashtra by an order dated 06.08.2004. ordinarily, the trial was to be concluded in the same State and in terms of Section 432(7) CrPC as the crime in the instant case was admittedly committed in the State of Gujarat, observed by the Apex Court.

he application for pre­mature release has to be filed in the State of Maharashtra and not in the State of Gujarat, as prayed by the petitioner by judgment impugned dated 17.07.2009 As His petition filed in the High Court of Gujarat was dismissed taking note of Section 432(7) CrPC on the premise that since the trial has been concluded in the State of Maharashtra. Thereafter He had filed his petition for pre­mature release under Sections 433 and 433A of the Code of Criminal Procedure, 1973 stating that he had undergone more than 15 years 4 months of custody.

The bench comprising of Justice Ajay Rastogi and the justice Vikram Nath observed and noted that under Section 432(7) CrPC can be either the Central or the State Government but there cannot be a concurrent jurisdiction of two State Governments of the appropriate Government.

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Adopt roster based reservation for preferential candidates as followed by JIPMER: Supreme Court directs all AIIMS institutes

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The Supreme Court in the case Students Association AIIMS Bhopal And Or’s. v. AllMS and Or’s observed and directed all AIIMS Institutes to adopt roster-based reservation followed by Jawaharlal Institute of Postgraduate Medical Education and Research, Pondicherry (JIPMER) as a plea was filled in the Court seeking direction to AIIMS to have a defined criteria for arriving at seat matrix for institutional preference candidates in INI-CET examination.

the order of the Apex Court in the case AIIMS Students’ Union v. AIIMS And Or’s, would not be applicable if It emphasized that if the roster-based system is implemented the actual roster points for AIIMS would be different from JIPMER as the same would depend on the percentage of seats decided to be allocated to the preferential candidates but It stated that the reservation would be similar to the one adopted by JIPMER AIIMS New Delhi was willing to provide a roster-point based reservation for its institutional preference candidates, by way of an affidavit 20th January 2022 the Bench was apprised that pursuant to a meeting held on 28th June 2020 as prescribed the relevancy:

It shall not be too wide with the one for the general category candidate, that the margin of difference between the qualifying marks for the Institute’s candidate.

The one who has secured marks at the common entrance PG test less than the one secured by any other candidate belonging to reserved category enjoying constitutional protection such as SC, ST etc. cannot be the AIMS graduate the last student to qualify for admission.

appearing on behalf of AIIMS, Advocate, Mr. Dushyant Parashar, New Delhi was asked to get instructions from AIIMS, Bhubaneswar and Jodhpur so that the Court can pass appropriate orders on the next date of hearing. As that apart from AIIMS, Bhubaneswar and AIIMS, Jodhpur, all other AIIMS before the Apex Court has agreed to implement the roster-based reservation system followed by JIPMER Puducherry for their institutional preference candidates, the Court was informed at the last date of hearing.

the petition had been filed seeking direction to AIIMS to disclose how the seats for institutional preference candidates are to be allotted in the view of the same the petitioners claim that in the INI-CET examination conducted in July, 2021, only 4 seats (1.87%) in AIIMS, New Delhi were allotted to institutional preference candidates. Rivetingly, the petitioners note that no seats were allocated to any other AIIMS for admission of institutional preference candidates.

the Bench comprising of Justice L. Nageswara Rao and the justice A.S. Bopanna observed and noted that to record in the order that the roaster system would be applicable from this year. Mr. Parashar informed it that since new software is to be put in place for counselling, it might cause some delay. The bench further stated that the court will order it to apply this year but in case of delay AIMS can come later.

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‘The crime committed has to be considered in the remission or premature policy of the state’

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The Supreme Court in the case Radheshyam Bhagwandas Shah, Lala Vakil vs State of Gujarat observed that where the crime was committed has to be considered in the remission which is applicable in the State and the pre­mature release in terms of the policy

The Court noted while hearing the writ petition that in terms of the policy which is applicable in the State of Gujarat where the crime was committed and not the State where the trial stands transferred and concluded for exceptional reasons under the orders of this Court once the crime was committed in the State of Gujarat, after the trial been concluded and judgment of conviction came to be passed, all further proceedings have to be 6 considered including remission or pre­mature release, as the case may be, in the instance case. under Section 432(7) CrPC, there cannot be a concurrent jurisdiction of two State Governments, can be either the Central or the State Government of the appropriate government.

in terms of Section 432(7) CrPC, the trial was to be concluded in the same State and ordinarily in the State of Gujrat the crime in the instant case was admittedly committed. by an order 06.08.2004., the case was transferred in exceptional circumstances by this Court for limited purpose for trial and disposal to the neighbouring State i.e., the State of Maharashtra, observed by the bench of Apex Court.

As mentioned by the petitioner in the plea that by judgment impugned dated 17.07.2019., the application for pre­mature release has to be filed in the State of Maharashtra and not in the State of Gujarat and His petition filed in the High Court of Gujarat was dismissed taking note of Section 432(7) CrPC on the premise that since the trial has been concluded in the State of Maharashtra. under Sections 433 and 433A of the Code of Criminal Procedure, 1973, the petition was filled by the petitioner for premature release further the petitioner stated that that he had undergone under the custody of more than 15 years 4 months.

Section 302, 376(2) (e) (g) and reading it with Section 149 IPC, Shah was found guilty for the offence, the offence committed by him in the State of Gujrat.

The bench comprising of Justice Ajay Rastogi and the justice Vikram Nath observed that under Section 432(7) CrPC can be either the Central or the State Government but there cannot be a concurrent jurisdiction of two State Governments of that appropriate government.

The bench comprising of Justice Ajay Rastogi and the justice Vikram Nath observed that under Section 432(7) CrPC can be either the Central or the State Government but there cannot be a concurrent jurisdiction of two State Governments of that appropriate government.

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Seeking reduction of qualifying the percentile for admission in ayurveda course: A plea in Supreme Court

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The Supreme Court in the Case Amit Kumar v UOI & Or’s observed in Ayurveda course in view of large number of vacancies and for seeking reduction of qualifying percentile for admission, an ayurveda aspirant who appeared in NEET 2021 has approached the Court.

the court had observed that lowering the minimum marks and reducing the percentile for admission to first year BDS Course would not amount to lowing the standards of Education and further the Court directed to lower the percentile mark by 10 percentiles for admission in first year of BDS Course for academic year 2020-2021, with regards to substantive the contentions made by the petitioner by referring the judgement passed in the case in Harshit Agarwal & Or’s v Union of India.

the percentile may also be reduced for Ayurveda programme enabling the Petitioner to take admissions then If percentile is being reduced/considered for reduction for BDS course was further stated by the petitioner in the plea, while referring to an order dated 04.29.2022. Thereafter the top Court had asked Centre to consider lowering the percentile for BDS Courses.

Seeking the Centre’s response in a plea by filing a counter affidavit, noted by the Top Court specifying the above-mentioned information:

after deducting the admission granted for MBBS Courses (BDS Courses), the total number of Candidates.

in All India Quota and State Quota, the totals number of vacant seats.

in government colleges on one hand & private/deemed colleges on the other hand, the number of seats which are remaining.

the petition was filed through AOR Neeraj Shekhar and for the petitioner Advocate Shivam Singh appeared.

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Bank case rejected by Supreme Court against farmer

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The Supreme Court in the case Bank of Maharashtra & Or’s v Mohanlal Patidar observed an order given by the High Courts of directing the bank the OTS proposal given by a farmer who had availed a loan from the bank, the court further pulled up the Bank of Maharashtra for challenging the order.

The Bank shall complete remaining formalities and provide all consequential benefits flowing therefrom to the petitioners, the court further stated that it is needless to emphasize The OTS proposal given by the petitioners in both the cases shall be accepted by the Bank and ‘sanction letters’ be issued forthwith, the court allowed the petitioner plea.

The petitioner not only promptly challenged the said order, it is noteworthy that petitioner never acceded to the unilateral decision dated 25th August 2021 and even otherwise the letter dated 25th August 2021 is held to be illegal by us, clause-7 of policy cannot take away the fruits of OTS benefits, within two months from the date of issuance of order dated 22th September 2021, the petitioner filled the instant petition and further the court directed we are unable to give stamp of approval to the impugned orders and action of the Bank, observed by the bench comprising of Justice Sujoy Paul and the justice Dwarka Dhish Bansal while setting aside the impugned orders of the bank.

In an order dated 03.09.2021 it was stated and it showed that the petitioner was required to pay minimum 10% of the OTS amount within stipulated time and that he had deposited Rs.35,00,000/- out of Rs.36,50,000/- within the stipulated time, it was argued before the court by the counsel.

As full and final settlement of the dues, he will be required to deposit Rs.50.50 lakhs as he was informed by the Asset Recovery Branch of the Bank.

Whole law comes into place when a matter of farmers come as the down payment were also accepted and it was further stated by the bench in an oral remark You don’t file cases against the ones who loot 1000s of crores.

The respondent had obtained a loan and intended to pay it in terms of a One Time Settlement which was quantified as Rs 3650000/-. in furtherance thereof the respondent had deposited Rs 35,00,000 with the bank, in the above-mentioned matter.

The bank had miserably failed to accept the same and on the contrary, decided to enhance the compromise amount to Rs.50.50 lakhs unilaterally which was contrary to the OTS scheme, contended by the counsel further the counsel stated that the bank had miserably failed to accept the same and on the contrary, decided to enhance the compromise amount to Rs.50.50 lakhs unilaterally which was contrary to the OTS scheme.

The bench comprising of Justice DY Chandrachud and the justice Surya Kant observed and remarked while dismissing the plea assailing Madhya Pradesh High Court’s order dated 02.21.2022 Such a litigation in Supreme Court will spoil the families of farmers financially, Go after bigger fish.

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