Dear Reader, We are happy to share the most interesting legal and policy updates concerning health industry that we read today. We hope you enjoy reading it.
Panel of auditors to audit the promotional expenses of pharma and medical device companies will be appointed soon: Government The Secretary, Department of Pharmaceuticals, has reportedly said that the government will appoint a panel of auditors who can undertake risk-based audits from time to time, to evaluate whether the promotional expenses, especially towards conferences and workshops, have been incurred in an ethical manner as per the Uniform Code for Pharmaceutical Marketing Practices 2024. Any discrepancy will be reported to the appropriate government agency or authority. Source: bit.ly/49SNs5f
Industry welcomes the new Uniform Code for Pharmaceutical Marketing Practices The pharmaceutical industry has reportedly welcomed the new Uniform Code for Pharmaceutical Marketing Practices (UCPMP). According to news reports, the industry feels that the new code is a step ahead towards the advancement of the industry as it ensures ethical and healthy engagement between the pharmaceutical industry and medical professionals. Source: bit.ly/4a6SZWd
Nutraceutical and food supplement regulations are to be tightened further The Food Safety and Standards Authority of India (FSSAI) is in the process of tightening the regulations for nutraceuticals and health supplements. This move was prompted by the receipt of several complaints by the FSSAI about the presence of non-compliant health supplements on the market and the fact that the over-the-counter availability of nutraceuticals and health supplements is resulting in people consuming supplements along with drugs, which increases the risk of adverse effects. Source: bit.ly/3wXMsOU
A major e-commerce entity was fined Rs 25 lakh due to its inaction to remove counterfeit products from the marketplace A State Consumer Commission in India has imposed a fine of Rs. 25 lakhs on a major e-commerce entity on the grounds that the e-commerce entity failed to correct the listing of a product, which it was aware was a counterfeit product. By failing to remove the listing, the Commission held that the e-commerce entity had engaged in dark patterns and unjust enrichment. Source: bit.ly/3IBUsaH
EU to extend regulatory data protection for innovator drugs to 7.5 years The European Union is set to extend regulatory data protection for innovator drugs to 7.5 years, with one extra year of incentives if the drug meets an unmet medical need and clinical trials are conducted in the EU. There is a proposal to grant an additional 3 years of protection from generics, taking the total protection to a maximum of 11.5 years. Source: bit.ly/3IxEIWl
Dear Reader, We are happy to share the most interesting legal and policy updates concerning health industry that we read today. We hope you enjoy reading it.
State Consumer Commissions continue to dilute intermediary safe-harbour protection for e-commerce marketplace A State Consumer Commission in India has held a major e-commerce marketplace company liable for delivery of incorrect goods to customers, on the grounds that since it offered a ‘fulfilling’ service on behalf of the seller, it was not merely an intermediary but also an agent of the seller. The marketplace was made to pay punitive damages, in addition to mental harassment, on grounds that it may have unscrupulously exploited an unknown uncounted number of consumers. Source: bit.ly/49VuNW0
Kochi and Thiruvananthapuram proposed to be added to the list of airports from where drugs may be imported India’s Ministry of Health and Family Welfare has issued a draft notification that will add Kochi and Thiruvananthapuram to the list of airports from which pharmaceutical drugs may be imported into India. The Drugs Rules, 1945 specify that pharmaceutical drugs may be imported into India from a specified number of airports only. The clearance of drugs requires the approval of the Additional Drugs Controller (ADC) Customs, who is generally posted at the customs wing of the airport. Source: bit.ly/49zbUZ8
Dengue Vaccine Clinical Trials to start soon in India A major Japanese drug maker has reportedly received clearance from India’s vaccine regulator, Central Drugs Standards Control Organization, to start clinical trials of the dengue vaccine. The vaccine will be contract manufactured by a major biotech company in India. Source: bit.ly/49OyQ7b
Many medical device companies settled allegations of kickbacks given to doctors in 2023: US Department of Justice The US Department of Justice (DoJ) has issued a press release that it has recorded the highest number of settlements and judgements in its history. Some of major settlements involved allegations of unlawful kickbacks medical device companies to doctors, in form of above-fair market value supervision fees or remuneration for medical directorships and improper donation of capital equipment. Source: bit.ly/49X0H4H
Fair-use defense against copyright infringement by AI companies will be tested in new trial by media companies against Open AI In a new set of lawsuits in the US, media companies are not alleging copyright infringement by AI companies to train the algorithm, but instead alleging that before training, the AI companies removed information from the training material which established that the material was copyrighted, such as the name of the author the news. The Digital Millennium Copyright Act or DMCA, law in the US reportedly prohibits the removal of information that can help copyright holders detect infringement, including article titles, author names, and copyright dates. Source: bit.ly/3Ih1MbA
Dear Reader, We are happy to share the most interesting legal and policy updates concerning health industry that we read today. We hope you enjoy reading it.
Guidelines to differentiate brand extension from surrogate advertising issued In a meeting with stakeholders, the Department of Consumer Affairs (DoCA) has clarified the difference between brand extension advertisements which are permitted, and surrogate advertisements which are not permitted. A brand extension advertisement should not contain direct or indirect references to prohibited products. It should also not use colour, layout, or presentations associated with the prohibited products. Source: bit.ly/42PKVGk
Draft Pharmacovigilance Guidance Document published for comments A draft of the revised Pharmacovigilance Guidance Document for Marketing Authorization Holders (MAHs) of Pharmaceutical Products has been published for comments. The last date for providing comments is March 23, 2024. This guidance document facilitates MAHs to setup & implementation of uniform Pharmacovigilance System for pharmaceutical products in the Indian market in the post-licensure period. Source: bit.ly/3SSrfgw
Many small and medium pharmaceutical manufacturing units have been ordered shut down after increased surveillance India’s central drug regulator, Central Drugs and Standards Control Organization (CDSCO), and state-level drug licensing authorities have reportedly issued show-cause notices to several drug small and medium manufacturers in the State of Punjab and Himachal Pradesh on grounds of poor quality control, and have also directed some of them to stop manufacturing. Source: bit.ly/3I88UqP
Pharma MNCs exit domestic market due to regulatory headwinds Many multinational pharmaceutical companies are reportedly cutting back on operations and manufacturing in India as part of a global strategic review due to regulatory headwinds on account of price control, rising costs, competition, and unfavourable intellectual property climate. Source: bit.ly/42PaWW9
Frozen embryos should be treated as children: US Court The Alabama State Supreme Court has ruled that frozen embryos in test tubes should be treated as ‘children’. This ruling has forced in vitro fertilization (IVF) providers in Alabama to stop treating patients, raising questions about the procedure’s continued availability in the state. Source: bit.ly/3I8T4vR
Dear Reader, We are happy to share the most interesting legal and policy updates concerning health industry that we read today. We hope you enjoy reading it.
Indian Government tacitly endorses use of AI in screening patients India has started a pilot telemedicine project called “Aarogya-Doctor on Wheels”. The unique aspect of the pilot project is that it is leveraging Artificial Intelligence (AI) for screening patients. The patient narrates his illness or complaint in his native language and the AI understands the language and responds to the patient in the same language. Once the patient has been screened, he is referred to a specialist doctor for teleconsultation. Source: bit.ly/3SISGt8
Code for regulation of marketing practices of medical devices industry will continue to remain in a draft form for some time The Department related Standing Committee on Chemicals and Fertilizers has stated that draft Uniform Code for Pharmaceutical/Medical Device Marketing Practices (“UCMPMD”) will be finalized once the Supreme Court adjudicates a related writ petition, in which it has been prayed that code for regulation of pharmaceutical marketing practices (UCPMP) be given the status of law. Source: bit.ly/49J8Mdb
Home based care models should be developed specifically for elderly population: Government Policy Think Tank Taking note of the fact that there are more than 100 million elderly people in India, India’s apex government think-tank, NITI Ayog, has made case for development of Comprehensive and Integrated Senior Care Package. The package will include all aspects of senior care such as home-based care models, R&D in geriatric care, palliative and end-of-life services, Capacity building healthcare professionals and caregivers, development of assistive devices such as Mobility aids, Personal emergency response systems, Medication reminders, Smart home technology and Hearing and visual aids. Source: bit.ly/3T5XYjP
Courts should be slow in granting anticipatory bail in narcotic matters, if the quantity is large: Supreme Court India’s Supreme Court has held that in bail matters pertaining to dealing in illegal Narcotics Drugs and Psychotropic Substances, the Courts should first satisfy itself that accused may not be guilty of the offence alleged and that accused is not likely to commit any offence while on bail. Source: bit.ly/3uGeCx2
Promotion of prescription drugs by Social Media Influencers in US a cause of concern, but US FDA may not have jurisdiction to regulate them The US Food and Drug Administration (US FDA) is under scrutiny for its inability to regulate social media influencers engaged in marketing of prescription drugs without providing warnings about risks associated with their use. US FDA is reportedly unsure whether it can or cannot regulate such actions of social media influencers. Source: bit.ly/3OMCYfj
Dear Reader, We are happy to share the most interesting legal and policy updates concerning health industry that we read today. We hope you enjoy reading it.
Innovator Pharma Company questions biosimilar trial on ground of non-procurement of comparator drug from authorized sources A multinational pharmaceutical company has questioned the veracity of a biosimilar drug trial before India’s clinical trial regulator, The Drugs Controller General of India (DCGI), on grounds that the comparator drug, a biologic, was not procured from authorized sources, thereby putting clinical trial subjects at risk and casting shadow over appropriateness of the clinical trial. Source: bit.ly/49tJmjj
Indian IPR regime well-equipped to handle AI generated works and there is no proposal to amend the law in context of AI generated content: Ministry of Commerce & Industry India’s Minister of Commerce & Industry, while replying to a question in India’s parliament, has clarified that user of Generative AI should obtain permissions of owner of original copyrighted work processed by Generative AI technology before using the AI generated content for commercial purposes. The Minister further clarified that there is neither any proposal to create any separate right nor to amend the law in the context of AI-generated content. Source: bit.ly/48cK4R8
Guidelines to distinguish nutraceuticals and drugs which have same or similar composition soon The Indian Government has reportedly formed a high-level committee to address complaints that products which have identical or similar compositions are being approved as nutraceuticals, drugs or ayurvedic formulations, depending on the regulatory pathway chosen by the manufacturer. Under the current law, nutraceuticals are not permitted to make claims of treatment or cure on the label, however there are reports of non-compliance with this requirement. Source: bit.ly/49bvaMb
Preparing a list of unvaccinated employees does not amount to violation of privacy: Madras High Court India’s Madras High Court has held that the action of preparation of list of employees who have not received COVID-19 vaccinations and subsequent circulation of such list amongst employees of company would not amount to violation of privacy. The High Court was hearing a criminal complaint filed by an employee of the Company under Information Technology Act, 2000 on grounds that the Company had breached the said law sharing his personal information as part of list of unvaccinated employees. Source: bit.ly/42yExmP
Couples seeking surrogacy on medical grounds are able to use donor sperm or egg, in spite of law to the contrary, by approaching a High Court Following the precedent set by Supreme Court, the Bombay High Court has permitted two couples to use donor eggs for surrogacy owing to medical issues faced by the Couple. The development is important because The Surrogacy (Regulation) Rules, 2022 explicitly prohibits the use of donor gametes for surrogacy. In the past, Karnataka High Court has also granted similar reliefs to a couple facing medical challenges to conceive using own gametes while seeking a surrogate to deliver the baby. Source:bit.ly/42yczHP
From September 16, 2019, all research conducted in
India which focuses on human diseases or conditions in the context of a drug,
medical device or cosmetics will have to be reviewed and overseen by a
non-governmental body known as Ethics Committee.
More specifically, from that date, the Drugs and
Cosmetics Act, 1940 (DCA) will begin to apply to “biomedical and health
research”, which is defined as “research including studies on
basic, applied and operational research or clinical research, designed
primarily to increase scientific knowledge about diseases and conditions (physical
or socio-behavioral); their detection and cause; and evolving strategies for
health promotion, prevention, or amelioration of disease and
rehabilitation”. The New Drugs and Clinical Trials Rules, 2019
(NDCTR), notified under the DCA, will make it mandatory for any person, company
or institution involved in biomedical and health research regulated by NDCTR to
ensure that a registered Ethics Committee reviews and oversees the conduct of
the research.
Background
Prior to notification of
NDCTR on March 19, 2019, there was no
law as such that regulated biomedical and health research carried out on human
participants other than such clinical research which involved a ‘new drug’. The
Indian Council of Medical Research, India’s apex medical research and
scientific body, had published The National
Ethical Guidelines for Biomedical and Health Research on Human Subjects but there was no law that could enforce these
guidelines on sponsors, professionals and institutions involved in the research.
This lacuna in the law has been addressed by NDCTR. The provisions in NDCTR that relate to
biomedical and health research were to take effect after 180 days from March 19,
2019 (i.e. the date of its notification). This time was sought, perhaps, to put
the administrative machinery in place, such as the National Ethics Committee
Registry for Biomedical and Health Research.
Who will be impacted
Any legal person, whether an individual or company, undertaking any biomedical or health research regulated by NDCTR for academic or business purposes, will have to approach a registered Ethics Committee for approval of the research proposal.
A laundry list of those who may be impacted the most
is described below for convenience –
Pharma Companies – Pharma companies usually undertake non-interventional research to evaluate patient behaviour, adoption and outcomes. Pharma companies also undertake non-mandatory post-marketing surveillance of pharmaceutical drugs. To the extent that such research concerns the health of the patient, it would have to be approved and overseen by a registered Ethics Committee.
Medical Device Companies – Like pharma companies, medical device companies undertake non-interventional research to evaluate patient behaviour, adoption and outcomes. Medical device companies also commission research to analyse secondary health data in patient registries. Such research would have to be approved and overseen by a registered ethics committee.
Cosmetics Companies – Cosmetics companies commission health-related studies from time to time. For example, cosmetic companies pay market research companies to assess the impact of the product from a psychological perspective (e.g. increase in confidence, reduction in stigma related to pimples or scars etc.). Such studies would henceforth be required to be approved and overseen by a registered Ethics Committee.
Diagnostic Companies – Diagnostic companies, especially those operating in the field of precision diagnostics, commission studies on existence and determination of various biological markers that aid in the diagnosis of diseases and conditions prevalent in the Indian market. Such studies would henceforth be required to be overseen by a registered Ethics Committee.
Technology Companies – Some technology companies, such as IBM, offer products and services that help clinicians in making better decisions with respect to the choice of medicines by analyzing a database of patient records (e.g. IBM Watson). Such technology companies, before deploying their products and services that analyze patient data with reference to pharmaceutical drugs, notified medical devices or cosmetics, would require the approval of a registered Ethics Committee.
Contract Research Organizations – There are numerous contract research organizations that undertake comparative Bio-availability and Bio-equivalence studies in India for pharmaceutical drugs that have been in the market for some time (i.e. drugs other than new drugs). Such comparative studies would henceforth be required to be approved and overseen by a registered Ethics Committee.
Market Research Organizations – Many market research organizations collect health data or undertake health-related primary research (e.g. patient interviews) and secondary research (e.g. prescription analysis) to reach certain conclusions for its clients (e.g. distinctive health-related product claims). Such marketing research organization would also have to submit their research to a registered Ethics Committee for review and approval.
Who will not be impacted
Companies undertaking health research on traditional medicinal products (Ayurvedic, homoeopathic medicines etc.) – The NDCTR have been framed under powers that the Central Government has with respect to pharmaceutical drugs, notified medical devices and cosmetics. Therefore, logically, it does not apply to all other categories of drugs such as ayurvedic medicines and homoeopathic medicines. Since the obligations with respect to biomedical and health research are provided under the NDCTR, these logically cannot apply such other category of drugs due to the inherent limitations of NDCTR.
Companies undertaking health research on non-notified medical devices – The DCA applies to a very small number of notified medical devices at present. Any bio-medical and health research that concerns non-notified medical devices should not be covered by NDCTR.
Food & Beverage companies – The DCA does not apply to food or beverages. A separate legislation, called Food Safety and Standards Act, 2006 (FSSA), regulates the quality of food and beverages sold in India. There is no requirement to obtain an Ethics Committee permission to undertake biomedical and health research related to food products under FSSA.
Educational institutions – Students, academicians and professionals in numerous educational institutions undertake epidemiological research i.e. biomedical and health research that is related to diseases and conditions in general and not related to any particular medicine, notified medical device or cosmetics. Such research should not fall in the scope of NDCTR.
Challenges
Shortage of registered ethics committees – Almost all major research institutions in India have a registered ethics committee that they have formed themselves. Some research institutions who don’t have a registered ‘institutional’ ethics committee of their own seek services of a registered ‘independent’ ethics committee. These ethics committees are registered to review clinical trials on new drugs and investigational notified medical devices. The challenge, however, is that a separate registration is required for ethics committees which will review biomedical and health research proposals. In fact, the authority which will grant such registration to ethics committees was designated only a few days ago by the government (i.e. on September 12, 2019). Therefore, at the time of commissioning biomedical and health research, the sponsor of such must carefully evaluate the ‘registered’ status of the ethics committee who has offered its services.
Lack of clarity in definition – The definition of “biomedical and health research” is very broad, so much that it could arguably extend to research on how a medicine “tastes” or a medical device “feels”. Further, the definition by itself does not restrict the application of NDCTR to research that involves medicines, notified medical device and cosmetics only. It is broad enough to cover “basic research” as well, which is not connected any medicine, medical device or cosmetic but instead concerns research on human body and its constituents. Such expansive interpretation of the scope of the definition is not correct, because the parent law to NDCTR, that is the DCA, is applicable only to drugs, notified medical devices and cosmetics. Therefore, rules made under it, cannot go beyond the scope of DCA.
Conclusion
In light of the application of NDCTR to biomedical and
health research, sponsors of any research that concerns human participants and
involves a pharmaceutical drug, notified medical device or cosmetic must be
careful to not inadvertently violate NDCTR. A good practice would be to refer
all such studies for approval of a duly registered Ethics Committee who may,
after review of the study design, itself come to a conclusion that it is within
the scope of NDCTR or not. Needless to say, all eligible biomedical and health
research should under undertaken after review, and under supervision, of a duly
registered Ethics Committee only.
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