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.
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 longawaited 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 worldclass 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.
On Monday, the Delhi High Court has stayed the proceedings initiated by Lokpal of India under the provisions of the Lokpal & Lokayuktas Act, 2013 against Jharkhand Mukti Morcha (JMM) Chief and Rajya Sabha MP Shibu Soren in connection with a disproportionate case of assets.
The bench comprising of Justice Yashwant Varma observed and has passed an order on Soren’s plea challenging the validity of the said proceedings, claiming that the same was ex facie bad in law and without jurisdiction.
In the present case, the proceedings were initiated by Lokpal of India pursuant to a complaint dated August 5, 2020 filed by BJP’s Nishikant Dubey. Therefore, it has been directed by the CBI to make a preliminary enquiry into the Complaint under section 20(1)(a) of the Lokpal and Lokayuktas Act, 2013. It was claimed by Soren that the said order was not served on him.
While claiming the complaint was false, frivolous and vexatious, Soren in his plea submitted that according to section 53 of the Act and there is a statutory bar against the Lokpal of India assuming jurisdiction to investigate or inquire into any Complaint made after the expiry of seven years from the offence alleged.
The plea reads that the initiation of the proceedings under the Complaint, or at the very least, continuation thereof, once it has been demonstrated by the preliminary inquiry that it pertains to alleged acquisitions prior to the 7-year period and is clearly barred by statute, without jurisdiction and the same is liable to be quashed.
Further, the petition filled submits that the maximum period of 180 days for completion of preliminary enquiry from the date of Complaint expired on February 1, 2021. In this backdrop, it has been stated that by this time, only on July 1, 2021, the comments were sought from Soren which is beyond the prescribed statutory period.
The plea adds that the final preliminary enquiry report was submitted by the CBI on 29.06.2022, about a year and a half after expiry of the 180- day period. Such purported report is void and null and non-est in the eyes of law and cannot be received or considered by the Respondent No.1.
Thus, the court took note of the order passed by Lokpal of India dated August 4, 2022 directing that proceedings under section 20(3) of the Lokpal Act be initiated to determine whether a prima facie case existed to be proceeded against Soren. It is Soren’s case that the order was passed without considering the preliminary objection on jurisdiction being raised by him.
In the said order, the court noted that all the Lokpal of India recorded was that the comments received from the petitioner were forwarded to CBI so as to examine and submit an enquiry report.
It was ordered by the court that the challenge to assumption of jurisdiction by respondent no. 1 (the Lokpal of India) has neither been answered and nor dealt with. Matters require consideration. Subsequently, there will be a stay of proceedings pending before the Lokayukta.
Accordingly, the court will now hear the matter on 14 December.
The Delhi High Court in the case Narender @ Lala v. State Of NCT Of Delhi observed and has set aside the orders of conviction for murder and sentence of life imprisonment awarded to a man in 2018 who was unrepresented by a lawyer before the Trial Court. Thus, the Delhi High Court has remanded the case back to the Trial Court for cross examination of certain prosecution witnesses.
The division bench comprising of Justice Mukta Gupta and Justice Anish Dayal observed and was of the view that there had been a grave miscarriage of justice to the man as when number of witnesses were examined, he was not represented by a counsel and that the legal aid counsel, who was present before Trial Court and was appointed on the same day and asked to cross- examine the witnesses on the same day.
On March, 2018, Narender was convicted for offence of murder punishable under section 302 of Indian Penal Code, 1860. On 4th May, 2018, he was sentenced by the Trial Court for life imprisonment and also to pay a fine of Rs. 10,000.
In the present case, the case of the prosecution was that the man had committed murder of his wife by strangulating her to death.
In a appeal, it was argued by the man that during the substantial course of trial, he was not represented by a lawyer and hence the trial in the absence of a lawyer had seriously prejudiced him. He thus sought recalling of all the prosecution witnesses and thereby ensuring a fair trial.
The Court observed that the manner in which the trial is conducted, there was a serious denial of fair trial to the appellant and the appellant is required to be given an opportunity to cross-examine the witnesses i.e., the witnesses examined in the absence of the lawyer, or the lawyer having been appointed on the same day from the legal aid and is asked to cross-examine the witnesses.
Further, the court remanded the back to Trial Court for cross-examination of ten prosecution witnesses. Also, the court directed the Trial Court Judge to follow due process of law and also to record the statement of the man under Section 313 CrPC and permit leading the defence evidence if so required.
The Court ordered that the case be listed before the learned Trial Court on 26th September, when Superintendent Tihar Jail will product the appellant before the learned Trial Court and the learned Trial Court is requested to expedite the trial and conclude the same preferably within four months.
The Supreme Court in the case Dr. B.R. Ambedkar Educational And Cultural Trust v. Hon’ble High Court Jharkhand And Ors. observed and has refused to entertain a plea challenging the non-inclusion of reservation for Scheduled Castes, Scheduled Tribes and Other Backward Classes communities in the process of appointment of District Judges in pursuant to an advertisement issued in March, 2022 by the High Court of Jharkhand. The present petition claimed that the exclusion of reservation violates Jharkhand State Reservation Policy and constitutional guarantee under Article 16(4). Apart from this, it is also in derogation of a resolution being passed by the High Court vouching to implement reservation in the Jharkhand Superior Judicial Service.
The bench comprising of Justice D.Y. Chandrachud and the Justice Hima Kohli observed and has granted liberty to the petitioner to file a petition under Article 226 of the Constitution before the Jharkhand High Court.
The court while considering that the process of appointment as per the concerned notification is underway, Justice Chandrachud asked the petitioner to approach the High Court with respect to future appointments.
It stated that “For the future you can file a petition before the High Court… We will give you liberty to approach the High Court under Article 226 of the Constitution.”
The bench of Justice Chandrachud observed that the Decisions of the Administrative side of the High Court can be challenged before the judicial side of the High Court. You can move the High Court.
In the present case, a writ petition challenging a similar notification was filed in 2017 before the High Court, which was eventually dismissed. It was observed by the High Court that there is no duty vested in the authorities to reserve seats for all posts, more particularly in higher judiciary. Moreover, it had already initiated the appointment process, the High Court opined that it cannot alter the rules midway. Thus, the appeal filed before the Apex Court was also dismissed.
However, in 2018 the Full Court of the Jharkhand High Court had agreed in principle to grant reservation in the recruitment for Jharkhand Superior Judicial Service. The advocates belonging to the SC/ST/OBC communities in 2021 had made representations to the Chief Justice of the High Court requesting for the implementation of the Reservation policy in appointment of District Judges (direct entry from Bar)/ superior judicial service. The impugned notification was issued without incorporating reservation for SC/ST/OBC communities in March 2022.
Mr. Arvind Gupta, Advocate on Record has filled the present petition.
The Supreme Court in the case Vishwanath Pratap Singh vs Election Commission of India observed that the right to contest an election is not a fundamental right but only a right conferred by a statute.
The bench comprising of Justice Hemant Gupta and the Justice Sudhanshu Dhulia observed while dismissing a Special Leave Petition filed by Vishwanath Pratap Singh that an individual cannot claim that he has a right to contest election and the said stipulation violates his fundamental right, so as is required under the Act, to file his nomination without any proposer.
Also, the court imposed a cost of Rupees one lakh on Singh.
In the present case, Singh had first approached the Delhi High Court challenging a notification issued by Election Commission of India for election to Rajya Sabha after he was not allowed to file his nomination without a proper proposer being proposing his name. His contentions were rejected by the High Court that his fundamental right of free speech and expression and right to personal liberty has been infringed.
While dismissing the SLP, the Apex Court observed that the writ petition before the High Court was entirely misconceived.
The bench observed while referring to earlier judgments viz Javed v. State of Haryana, (2003) 8 SCC 369 and Rajbala v. State of Haryana (2016) 2 SCC 445 wherein it was stated that the right to contest an election is neither a fundamental right nor a common law right. It is a right conferred by a statute.
However, the Supreme Court in Javed (supra) had made the following observations: Right to contest an election is neither a fundamental right nor a common law right and it is a right conferred by a statute. At the most, in view of Part IX having been added in the Constitution of India that a right to contest election for an office in Panchayat may be said to be a constitutional right and a right originating in the Constitution and given shape by a statute. But even if, it cannot be equated with a fundamental right. It is stated that there is nothing wrong in the same statute which confers the right to contest an election also to provide for the necessary qualifications without which a person cannot offer his candidature for an elective office and also to provide for disqualifications which would disable a person from contesting for, or from holding, an elective statutory office.
It was held in Rajbala (supra) that the right to contest for a seat in either of the two bodies is subject to certain constitutional restrictions and could be restricted further only by a law which the parliament made.
Further, the court added that Singh did not have any right to contest election to the Rajya Sabha in terms of the law made by the Parliament.
The Court stated while dismissing the SLP that the Representation of People Act, 1950 read with the Conduct of Elections Rules, 1961 has contemplated the name of a candidate to be proposed while filling the nomination form. However, it cannot be claimed by an individual that he has a right to contest election and the said stipulation violates his fundamental right, so as to file his nomination without any proposer as is required under the Act.
The Himachal Pradesh High Court in the case Shri Kantu Ram v Shri Beer Singh recently observed that a court, while exercising powers under Section 147 of the Negotiable Instruments Act and can proceed to compound the offences even after recording of conviction by the courts below.
The bench comprising of Justice Sandeep Sharma observed in a case where the revision Petitioner, who was convicted under Section 138 of the NI Act by the Magistrate Court and was aggrieved by subsequent dismissal of appeal by the Sessions Court and had agreed to pay the amount due and settle the matter.
Thus, the petitioner had sought compounding of offences.
In the present case, the respondent admitted the factum with regard to receipt of the amount due from the accused and expressed that the prayer made on behalf of accused for compounding of offence can be accepted.
However, the High Court allowed the prayer and the offence committed by the Petitioner under Section 138 NI Act was ordered to be compounded.
The Court observed that the Reliance was placed on Damodar S. Prabhu V. Sayed Babalal H. (2010) 5 SCC 663, wherein the Apex Court has categorically held that court, while exercising power under Section 147 of the NI Act and can proceed to compound the offence even after recording of the conviction by the courts below.
The Jammu and Kashmir and Ladakh High Court in the case Bashir Ahmad Wani v Jammu and Kashmir Grameen Bank and Another recently observed and stated that an employee who is removed from service for misconduct is not at par with those who is being retired on superannuation.
The bench comprising of Justice Sanjeev Kumar observed while dismissing the pension claim made by a former employee of the J&K Grameen Bank, who was removed from service in 2011.
In the present case, the petitioner had sought benefit of the J&K Grameen Bank (Employees) Pension Regulations, 2018 whereby provision was made for terminal benefits.
However, the court disallowed the claims on two grounds:
Firstly, that at the time of removal of the petitioner from service when there were no norms, rules or regulations providing for the benefit of pension to the employees of the respondent-Bank.
In the year 2011, the employees of the respondent-Bank were governed by the J&K Grameen Bank ( the Officers and Employees) Service Regulations, 2010… it is abundantly clear that it does not prescribe imposition of a penalty of removal along with the pensionary benefits.
Secondly, it was opined by the court that though the 2018 Regulations had been made applicable to those employees who were in service between 1st day of September, 1987 and 31st day of March, 2010 and the employees retired from the services of the Bank before 31st day of March, 2018, however, this leeway cannot come to aid of the Petitioner.
The Curt observed that the reason for finding that the Petitioner was not an employee who had “retired” on superannuation from the bank. Rather, he was “removed” for misconduct.
The Court stated that the regulations apply to those employees who retired from the service of the Bank before 31.03.2018 and not the employees who were terminated for misconduct. Viewed thus, the order of removal of the petitioner dated 02.09.2011 holding the petitioner entitled to terminable benefits and cannot, by any stretch of reasoning, be construed to be an order of removal with the benefit of the pension. Neither, the petitioner, at the time of his removal from service, nor with the promulgation of Pension Regulations of 2018, is entitled to the benefit of pension.