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.
The Supreme Court has deferred its decision on a contempt notice issued against yoga guru Ramdev, his associate Balkrishna, and their company Patanjali Ayurved in connection with a case involving misleading advertisements. The bench, comprising Justices Hima Kohli and Ahsanuddin Amanullah, stated, “Orders on the contempt notice issued to respondents 5 to 7 (Patanjali Ayurved Ltd, Balkrishna, and Ramdev) are reserved.” The Uttarakhand State Licensing Authority (SLA) informed the court that manufacturing licenses for 14 products of Patanjali Ayurved Ltd and Divya Pharmacy have been suspended immediately. The Supreme Court noted that the counsel representing the firm had requested time to submit an affidavit detailing the actions taken to retract the advertisements of Patanjali products and to recall the medicines.
Highlighting the importance of public awareness and responsible influence, the court emphasized that Baba Ramdev wields significant influence and should employ it responsibly. It awaits an affidavit from Patanjali outlining the measures implemented to withdraw the existing misleading advertisements of the company’s products, with instructions for submission within three weeks.
During the proceedings, Indian Medical Association (IMA) President R V Asokan extended an unconditional apology to the bench for remarks made against the top court in a recent interview with news agency PTI. Justice Kohli conveyed to Asokan that public figures cannot criticize the court in media interviews. However, the court indicated its disinclination to accept the apology affidavit submitted by the IMA president at present. In an earlier hearing on May 7, the apex court had denounced Asokan’s statements as “very, very unacceptable.” The court reiterated its stance that celebrities and social media influencers are equally liable for the products they endorse, warning that if such products are found to be misleading, they could face repercussions.
The case stems from a plea filed in 2022 by the IMA alleging a smear campaign by Patanjali against the Covid-19 vaccination drive and modern medical systems. As the legal proceedings unfold, the Supreme Court continues to emphasize the importance of accountability and responsible conduct in advertising and public discourse. The case underscores the need for stringent regulations to curb misleading advertisements and ensure consumer protection. With the demand for transparency and ethical practices on the rise, the judiciary plays a pivotal role in upholding standards of integrity in commercial communications.
As the court awaits the submission of the affidavit from Patanjali, stakeholders across industries are keenly observing the developments, anticipating their implications on advertising practices and regulatory enforcement in the country.
In a courtroom battle that underscores the complex interplay between global tech giants and national regulatory frameworks, Elon Musk’s X, formerly known as Twitter, finds itself at odds with Australian law over the removal of graphic content depicting a terrorist attack.
At the heart of the dispute lies a fundamental question: to what extent should a platform like X be compelled to adhere to the laws of a specific country when it comes to content moderation? The legal showdown commenced as the eSafety Commissioner of Australia sought the removal of 65 posts showcasing a harrowing video of an Assyrian Christian bishop being stabbed during a sermon in Sydney, classified as a terrorist incident by authorities.
Tim Begbie, representing the cyber regulator, argued that while X has policies in place to remove harmful content, it cannot claim unilateral authority to decide what is acceptable under Australian law. He contended that X’s resistance to globally removing the posts challenges the notion of reasonableness within the scope of Australia’s Online Safety Act.
X’s stance, guided by its mission to uphold free speech, underscores a broader philosophical debate surrounding the jurisdictional reach of national laws in the digital realm. The company maintains that while it has blocked access to the posts for Australian users, it refuses to implement global removal, asserting that the internet should not be governed by the laws of a single nation.
However, Begbie argued that geo-blocking, the solution proposed by X, is ineffective due to the widespread use of virtual private networks (VPNs) by a significant portion of the Australian population.
Amidst the legal wrangling, X’s lawyer, Bret Walker, contended that the company had taken reasonable steps to comply with Australian laws while balancing the principles of free expression. He emphasized the importance of allowing global access to newsworthy content, cautioning against the suppression of information on a global scale. The implications of such an approach, he argued, extend beyond Australia’s borders, potentially setting a precedent for censorship on a global scale.
As the case unfolds in the Federal Court, Judge Geoffrey Kennett has issued a temporary takedown order for the posts, extending it until June 10 pending a final decision. The outcome of this legal battle is poised to have far-reaching implications, not only for the regulation of online content in Australia but also for the broader discourse surrounding internet governance and free speech in the digital age.
Beyond the legal arguments, the case underscores the evolving dynamics between tech platforms and regulatory authorities, highlighting the challenges of reconciling competing interests in an increasingly interconnected world. With the proliferation of digital platforms and the rise of social media, questions surrounding content moderation, censorship, and the balance between freedom of expression and societal harm have come to the forefront of public discourse.
In the digital era, where information knows no borders and online platforms wield immense influence over public discourse, the case of X versus Australian law serves as a microcosm of the broader tensions between technology, governance, and individual rights. As societies grapple with the complexities of the digital age, the need for robust legal frameworks, ethical guidelines, and international cooperation becomes ever more apparent.
As the legal battle between X and Australian authorities unfolds, it underscores the intricate relationship between technology, law, and societal norms in the digital age. At stake is not just the removal of graphic content depicting a heinous act but also the broader principles of free speech, censorship, and the jurisdictional reach of national regulations in a globalized world.
The outcome of this case carries significant implications for the future of online content moderation and regulation. On one hand, proponents of free speech argue that platforms like X should have the autonomy to determine their content policies without being unduly influenced by the laws of individual countries. They contend that a global approach to content moderation ensures consistency and prevents the fragmentation of the internet along national lines.
On the other hand, proponents of regulation argue that national laws play a crucial role in safeguarding citizens from harmful content and upholding community standards. They assert that while platforms may operate globally, they must abide by the laws of the countries in which they operate, particularly when it comes to content that poses a threat to public safety or incites violence.
Amidst these competing interests, the case highlights the need for a nuanced approach to content moderation that balances the principles of free speech with the protection of users from harm. It also underscores the importance of international cooperation and dialogue in addressing cross-border challenges in the digital realm.
Beyond the legal realm, the case has broader implications for the future of internet governance and the regulation of online platforms. As technology continues to evolve at a rapid pace, policymakers around the world face the daunting task of crafting regulations that are effective, enforceable, and adaptable to the ever-changing digital landscape.
Moreover, the case raises important questions about the role of tech companies in shaping public discourse and influencing democratic processes. With social media platforms serving as key channels for information dissemination and political engagement, the decisions made by companies like X have far-reaching consequences for the functioning of democratic societies.
Ultimately, the resolution of this case will have significant implications not only for X and its users but also for the broader digital ecosystem. It will shape the future trajectory of online content moderation, influence regulatory approaches to technology platforms, and set precedents for how governments and tech companies interact in the digital age.
As the legal proceedings continue, stakeholders from across sectors will closely monitor developments, recognizing that the outcome of this case has the potential to reshape the digital landscape for years to come. Whether it leads to greater clarity in content moderation policies, a re-evaluation of regulatory frameworks, or a deeper understanding of the complexities of governing the internet, the case of X versus Australian law represents a pivotal moment in the ongoing debate over the future of online governance and free speech in the digital age.
The Supreme Court in the case Arun Muthuvel v. Union of India has elucidated the issues it will consider in a batch of petitions challenging provisions of the Surrogacy Regulation Act, 2021 and the Surrogacy Regulation Rules, 2022. The bench comprising of Justice BV Nagarathna and Justice AG Masih passed the order recording the following issues:
Whether the prohibition of commercial surrogacy as stated under Section 4(ii)(b) and Section 4(ii)(c) of the Surrogacy (Regulation) Act, 2021 is constitutional?
Whether the right of a couple to avail surrogacy being restricted to married couples between the age of 23 to 50 years and in case of female and between 26 to 55 years in case of male as it is being provided as stated under Section 4(iii)(c)(I) read with Section 2(1)(h) of the Surrogacy (Regulation) Act, is constitutional?
Whether the right of a single woman to avail surrogacy being restricted to only widows or divorcees between the ages of 35 to 45 years as it is provided being under Section 2(1)(s) of the Surrogacy, the Regulation Act 2021, is constitutional?
Whether the right of an intending couple to avail surrogacy being restricted to only those couples who do not have a surviving child as provided as stated under Section 4(iii)(c)(II) of the Surrogacy (Regulation) Act 2021, is constitutional?
Whether individuals who initiated the process of availing surrogacy which being prior to the enactment of the Surrogacy, the Regulation Act, 2021 have any right to avail surrogacy in a manner which being beyond the scope of the Surrogacy (Regulation) Act, 2021, save for cases falling within the ambit of Section 53 of the Act?
The petitioner in the plea highlighted an additional issue which relates to exclusion of single men from the purview of Surrogacy Regulation Act.
Therefore, the lead petition in the matter has been filed by an infertility specialist from Chennai, Dr. Arun Muthuvel, through Advocate Mohini Priya and Advocate Ameyavikrama Thanvi.
Therefore, while highlighting various contradictions in the Surrogacy Regulation Act and the Assisted Reproductive Technology (Regulation) Act, 2021, thus, the petitioner in the plea points out that the twin legislations inaugurated a legal regime that was discriminatory and was violative of the constitutional rights of privacy and reproductive autonomy.
The Supreme Court in the case observed and has agreed to hear the petition wherein it challenges against the two Acts. In September last year, several other petitions and applications were filed wherein similar questions were raised, such as whether it was constitutional to exclude unmarried women from the ambit of the Surrogacy Act, or whether limiting the number of donations made by an oocyte donor under the ART Act would amount to unscientific and irrational restrictions.
The bench in the case observed and has expressed reservations about hearing the challenges to both the Acts simultaneously, as the linkage between the provisions of the two Acts could not be ascertained in the present matter. Further, the said court decided that issues wrt the Surrogacy Regulation Act will be heard first, followed by those which relate to the ART Act.
The court asked the parties to file written submissions on the foregoing issues. It has also been clarified by the said court that the petitioners need not restrict their submissions to the issues recorded by the court. Any ‘related’ issue may also be raised during the proceedings.
Accordingly, the court listed the matter for further consideration on July 30, 2024.
The Supreme Court’s decision to reject the government’s application seeking clarification on administrative allocation of spectrum for non-mobile services is not expected to impact the allocation of satellite spectrum as outlined in the Telecom Bill, according to highly placed sources. In February 2012, the Supreme Court had upheld that auctions were the preferred method for allocating scarce public resources like telecom spectrum.
The Centre had filed a miscellaneous application in December last year seeking a clarification on the matter of administrative allocation of spectrum, which was mentioned in court last week. However, the SC registrar refused to accept the plea, arguing that it was seeking a review of the 2012 order and that there was no ‘reasonable cause’ to entertain it.
Government sources emphasized that this decision would not change the existing laws governing spectrum allocations for satellite communications, as clearly stated in the Telecom Bill. Sources clarified that the application did not seek to amend the 2012 judgment on 2G spectrum allotment nor did it seek permission for administratively allocating spectrum. Spectrum will continue to be auctioned for mobile services, while for the 19 specific use cases cited in the Telecom Bill, it will be allocated administratively.
The government had filed the miscellaneous application at the Supreme Court to explain its intentions before tabling the bill in Parliament, emphasizing that it was not seeking any permission from the court. The application aimed to seek appropriate clarifications from the court regarding the CPIL judgment in 2012, to establish a spectrum assignment framework that includes methods of assignment other than auction in suitable cases, to best serve the common good. In 2012, the SC had criticized the ‘first-come, first served’ method for spectrum allocation, known as the CPIL judgment, and had quashed the 2G spectrum allotted by the United Progressive Alliance government.
Since then, the government has been issuing spectrum administratively in certain cases where auctions are not technically or economically preferred or optimal. The Telecom Bill’s First Schedule lists satellite spectrum and 18 other sectors where administrative allocations will be compulsory, including law enforcement, public broadcasting, in-flight and maritime connectivity, the Indian Army and Coast Guard, and radio backhaul for telecom services. Government sources noted that all stakeholders were consulted on the issue, and the government was confident of its legal standing as outlined in the Telecommunications Act.
The SC, in a presidential reference, did not specify that all spectrum should be auctioned, only that for mobile services. The Supreme Court’s decision not to accept the government’s application seeking clarification on spectrum allocation for non-mobile services does not alter the framework outlined in the Telecom Bill. While auctions remain the preferred method for mobile services, administrative allocations will continue for specific use cases, including satellite spectrum, as delineated in the bill.
The rejection of the application underscores the importance of adherence to established legal procedures and the judiciary’s role in upholding regulatory frameworks. Moving forward, the government remains committed to transparent and efficient spectrum allocation, balancing the imperatives of economic efficiency and public interest in the telecommunications sector.
A legal dispute has unfolded involving B2B fashion startup Zilingo, with former CEO Ankiti Bose on one side, and co-founder Dhruv Kapoor and former COO Aadi Vaidya on the opposing side.
A recent court decision in Delhi has brought focus to a legal dispute involving Ankiti Bose, the former CEO of Zilingo, a prominent technology platform. The court issued an ex parte order in Bose’s favor, instructing certain parties, including Zilingo co-founder Dhruv Kapoor and former COO Aadi Vaidya, to refrain from making defamatory statements against Bose. This decision underscores the importance of protecting reputational rights against unfair reporting.
The court’s ruling cited a prima facie case in Bose’s favor, acknowledging her legal right to safeguard her reputation from damaging remarks. It emphasized that failure to act promptly could lead to irreparable harm to Bose’s reputation. The order specifically bars Kapoor and Vaidya from making any further defamatory postings against the former CEO.
This legal action stems from a broader conflict within Zilingo, a B2B fashion startup that has faced financial struggles since its inception in 2015. Bose’s departure from the company was contentious, marked by allegations of misconduct and underperformance. She subsequently filed a First Information Report (FIR) accusing Kapoor and Vaidya of sexual harassment and business irregularities. In response, the accused have dismissed these claims as retaliatory, asserting that Bose’s actions were prompted by her dismissal from the company.
The litigation highlights the complexities of corporate disputes and the broader implications for individuals and businesses. Beyond the legalities, it reflects the challenges faced by startups navigating internal strife amidst financial difficulties. Zilingo’s trajectory, from inception to liquidation, encapsulates the turbulent landscape of the tech industry and underscores the importance of legal protections for individuals like Bose seeking to safeguard their professional standing amidst controversy. The court’s intervention serves as a reminder of the gravity of reputational issues in the modern corporate environment, particularly amidst the complexities of startup dynamics and leadership disputes.
The Supreme Court in the case Indian Medical Association v. Union Of India observed and has clarified against Patanjali over publication of misleading advertisements that it was not dealing with Patanjali as a standalone entity; rather, the Court’s concern, in public interest, extended to all those Fast Moving Consumer Goods, FMCGs or drugs companies which take consumers of their products for a ride through misleading advertisements. The bench comprising of Justice Hima Kohli and Justice Ahsanuddin Amanullah in its order stated that, this court must clarify that we are not here to gun for a particular party, or a particular agency or a particular authority.
This being the absolute Public Interest Litigation, PIL since it is in the larger interest of the consumers, the public to know which way they are going and how and why they can be misled and how […] is acting to prevent that misuse. Thus, at the end, this is also as we said a part of the process of rule of law. If that is violated, then it affects […].
The court in the case observed that the implementation of laws regulating misleading ads in relation to medicines require deeper examination, as the products are used for babies, school going children and senior citizens based on the ads: Further, the court stated that this court is of the opinion that the issue which relates to implementation of the relevant provisions of the Drugs and Magic Remedies Act and the Rules, the Drugs and Cosmetic Act and the Rules, and the Consumers Act and the relevant Rules needs closer examination in the light of the grievances raised by the petitioner…not just limited to the respondents before this court but to all similarly situated or placed FMCGs who have […] misleading advertisements, and taking the public for a ride…affecting the health of babies, school going children and senior citizens who have been consuming products on the basis of the said misrepresentation.
The court while taking into account the misleading ads issued in electronic media impleaded the Ministry of Information and Broadcasting, Ministry of Information Technology, and Ministry of Consumer Affairs. Therefore, the same was being done with a view to examine the steps taken by these Ministries to prevent abuse of Drugs and Magic Remedies (Objectionable Advertisements) Act 1954 (and the Rules), the Drugs and Cosmetic Act 1940 (and Rules) and the Consumer Protection Act. Accordingly, the court listed the matter for further consideration on May 07, 2024.
Background Of The Case:
The Court raps Uttarakhand authorities The said court also came down heavily on the State of Uttarakhand for the failure of its licensing authorities to take legal action against Patanjali and its subsidiary Divya Pharmacy. The bench also asked why it should not think that the authorities were ‘hand in glove’ with Patanjali or Divya Pharmacy.
The court in its order stated that it was ‘appalled’ to note that apart from ‘pushing the file’, the State Licensing Authorities did nothing and were merely trying to ‘pass on the buck’ to ‘somehow delay the matter.’ The court stated that the State Licensing Authority is “equally complicit” due to its inaction against Divya Pharmacy despite having information about t heir advertisements violating the Drugs and Magic Remedies (Objectionable Advertisements) Act.
Further, the court stated that it was refraining from issuing contempt notices to other officers. Further, the court directed that all officers holding the post of Joint Director of the State Licensing Authority, Haridwar between 2018 till date shall also file affidavits explaining inaction on their part.
Background of the Case:
The contempt case was initiated wherein the petition is filed by the Indian Medical Association against Patanjali’s advertisements attacking allopathy and making claims about curing certain diseases. On the Supreme Court reprimand, the Patanjali on last November had assured that it would refrain from such advertisements. The court in the case noted that the misleading advertisements continued, thus, the Court had issued contempt notice to Patanjali and its MD in February.
The court in march considering that reply to the contempt notice was not filed, the personal appearance of the Patanjali MD as well as Baba Ramdev, who featured in the press conferences and advertisements published after the undertaking, was ordered by the said Court. Therefore, the Patanjali MD filed an affidavit wherein it is stated that the impugned advertisements were meant to contain only general statements but inadvertently included offending sentences. Further, the court stated that the advertisements were bona-fide and that Patanjali’s media personnel was not ‘cognizant’ of the November order (wherein the undertaking was given before the Supreme Court).
The affidavit filed also contained an averment that the Drugs and Magic Remedies Act was in an “archaic state” as it was enacted at a time when scientific evidence regarding Ayurvedic medicines was lacking. On the last date of hearing, both Baba Ramdev and MD Balkrishna were physically present in Court. The court expressed its reservations about MD Balkrishna’s affidavit, calling it “perfunctory” and “mere lip service”. The court gave last opportunity to the alleged contemnors for filing a proper affidavit.