Supreme Court clarifies when a patient’s negligence may be reduced due to pre-existing conditions
TOP 5 HEALTH LAWS AND POLICY UPDATES
Supreme Court clarifies when a patient’s negligence may be reduced due to pre-existing conditions
India’s Supreme Court extends scope of misleading advertisement review to multinational and domestic FMCG manufacturers, doctors
In a proceeding against a major Ayurvedic products manufacturer for publication of misleading advertisements, India’s Supreme Court has clarified that the decisions and orders made in the ongoing case is not limited to the a particular manufacturer, rather is directed to all FMCG companies who are publishing misleading advertisements and doctors who are endorsing medicines to public after accepting consideration from pharmaceutical companies.
Source: bit.ly/44b832P
Indian Government to scrutinize organ transplants closely after receiving reports of foreign nationals involvement in organ donation
India’s Union Health Ministry, through the office of Director General of Health Services (DGHS), has ordered state authorities to compulsorily create a NOTTO (National Organ and Tissue Transplantation Organization) ID maximum within 2 days for the donor and recipient for both living-donor and deceased-donor transplants, citing reports of purported commercial dealings in organ transplants involving foreign nationals.
Source: bit.ly/3WcUKgk
New Telehealth Accreditation Program introduced in US
It has been reported that leading not-for-profit agencies in the US such as Joint Commission and National Committee for Quality Assurance (NCQA) will begin offering accreditation for telehealth services to qualified hospitals, ambulatory care centres, and behavioural health organizations in 2024. The accreditation is aimed at filling the gap of legally enforceable telehealth standards in the US.
Source: bit.ly/3W8MKgg
Employee non-compete clauses may soon be illegal in the US
The US Federal Trade Commission (FTC) has issued a final rule to promote competition by banning non-compete clauses in employee contracts nationwide. As per FTC, non-compete covenants in contracts prevent workers from taking a new job or starting a new business, which in turn harms competition.
Source: bit.ly/3UtDRg2
French Government to turn down bid from foreign pharmaceutical companies to buy domestic generic company
The Government of France is reportedly going to block foreign bidders including two Indian pharmaceutical companies from attempting to purchase a domestic generic pharmaceutical manufacturer. As per the French government, this decision has been taken in the national interest to safeguard the supply chain of medicines.
Source: bit.ly/3W8MIFa
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Guidance for making regulatory applications for biological and biotechnology products such vaccines may be revised soon
India’s central drug regulator, Central Drugs Standards Control Organization (CDSCO), has issued draft of revised guidance which seeks to align the online regulatory application process with applicable law i.e. The New Drugs and Clinical Trial Rules, 2019. Recently, the CDSCO has started accepting regulatory applications through NSWS portal. All stakeholders have time until April 25, 2024 to submit their suggestions/comments.
Source: bit.ly/3JlwIrU
Indian Pharma industry has sought clarity from Government on ethics of sponsoring foreign trips of doctors to attend scientific and training programs outside India.
An industry group representing multinational pharma companies has reportedly approached the Indian Government for seeking clarity on the issue of Indian doctors being sponsored by pharma companies for attending medical events outside India. A recent guidance issued by Department of Pharmaceuticals called Uniform Code for Pharmaceutical Marketing Practices, 2024 (UCPMP) has stated that pharma companies will not sponsor travel and hospitality of Doctors unless they are speaking in medical events.
Source: bit.ly/3JklqnG
New Guidance document for generation and transfer of EPR Certificate under E-Waste Management Rules issued
India’s Central Pollution Control Board has issued a guidance document which explains steps to be taken by recyclers, recycling facilities under the E-Waste (Management) Rules, 2022 for generation of EPR Certificate. It has been clarified that EPR Certificate will have validity of 2 years. All importers and manufacturers of electric and electronic equipment including medical devices are required to procure EPR Certificates from registered recyclers to discharge their respective Extended Producer Responsibility obligations.
Source: bit.ly/44242Oc
Nestle wins class action suit filed by Government in the infamous Maggie Noodles case
The National Consumer Disputes Redressal Commission (NCDRC) has dismissed the Indian government’s 2015 complaint against Nestlé India over the safety of its Maggi noodle products. The Indian government had accused Nestlé of engaging in unfair trade practices by adding a ‘No added MSG’ label and claimed that the instant noodle product contained impermissible lead levels. However, NCDRC has noted in its order that the lead content in the tested instant noodle products was within permissible limits and that the Food Regulator itself had permitted brands to carry No Added MSG label if MSG was not deliberately added by manufacturer during the manufacturing process.
Source: bit.ly/3vIR1MJ
US based telehealth companies penalised for selling personal information
The United States Federal Trade Commission has reportedly taken action against an alcohol addiction telehealth company, for sharing health information to third parties including some major social media companies and search engines. A proposed order to settle the allegations will prevent the company from disclosing sensitive data for advertising purposes, among other penalties.
Source: bit.ly/43ZfoCi
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.
Manufacturers of tobacco products required to register their packing machine(s) with tax authorities
India’s Central Board of Indirect Taxes and Customs (CBIC) has postponed the timeline for manufacturers of tobacco products such as pan-masala, chewing tobacco, smoking mixtures, etc. to report their production capacity. CBIC had in January this year announced that producers must register their filling and packing machines and report these details. The measure was set to be implemented from 1st April 2024. However, the new effective date for implementation of the timeline is now 15th May 2024.
Source: bit.ly/3xz7400
NPPA releases draft ceiling price calculation sheets of seven scheduled formulations
The National Pharmaceutical Pricing Authority (NPPA) has published a preliminary calculation of ceiling prices for seven drug and vaccine formulations, inviting feedback from stakeholders within a ten-day period. These ceiling prices have been adjusted to reflect the minimum and maximum market prices of the products, in accordance with the updated Schedule I of the Drugs (Prices Control) Order, 2013, aligning with the National List of Essential Medicines (NLEM), 2022. The move shall be affecting major pharmaceutical giants in the business of ORS, vaccines and more.
Source: bit.ly/3UhjK4J
High Courts should interfere only when the case in lower court was decided by fraud or collusion: Supreme Court of India
While deciding an appeal against the order of the High Court, the Supreme Court of India observed that the High Court should apply care and caution while entertaining the petitions under Article 226 of the Constitution. The Court further explained that, in case of an already available alternative statutory remedy, the High Court should interfere in the matter only when the case is decided by fraud or collusion, otherwise an order in the same matter by the High Court will mean reopening the issues that have achieved finality.
Source: bit.ly/4cNGwIJ
Goa FDA to get the status of “US FDA observer” amid surge in increase in retail and wholesale licenses
The Goa Food and Drug Administration (FDA) has been extended the invitation to participate as “FDA observer” for inspections conducted by the USFDA India Office. This development came as a result of increase in retail and wholesale licenses issued by Goa FDA and their familiarity with the US FDA’s inspection process.
Source: bit.ly/3UfqIHq
Rejecting apology of the Directors of a Company for misleading advertisements, the Supreme Court sets caution for FMCG companies
Observing caution for fast-moving consumer good (FMCG) companies, the Supreme Court of India has refused to accept an apology from a major Indian Ayurvedic medicine manufacturer for misleading advertisements regarding its products in contravention of an undertaking provided to the Court. The Supreme Court stated that misleading advertisements by FMCG companies result in deceiving innocent consumers and play with public health.
Source: bit.ly/3PYqoKq
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Delay condonation should be evaluated based on reasons provided and not merits of case: Supreme Court
In a recent decision, the Supreme Court held that in condoning delay for a filing for which limitation period has been stipulated under the Limitation Act, 1963, a Court should not base its decision on whether such delay has been condoned in a similar matter, evaluating delay on merits of the fact situation, but rather each delay should be evaluated on the grounds pleaded in the application for its condonation.
Source: bit.ly/49MllnH
Central Government to take strict action against non-compliance with quality maintenance in manufacture of fire-resistant fabrics raw material
The Indian Central Government is intending to take stringent action against violators of the Bureau of Indian Standards (BIS) Quality Control Order for raw material used to manufacture fire-resistant fabric used in upholstery used in commercial spaces such as cinema halls, conference halls etc. Pursuant to issue of this Quality Control Order, only those raw material that have been certified by the BIS may be used in manufacture of commercial space upholstery. However, this Quality Control Order does not apply to upholstery used in households or those manufactured for export.
Source: bit.ly/4cKT4R3
Indian Government partners with Quality Council of India to improve services at Central Government run hospitals
India’s Central Ministry of Health and Family Welfare has entered into a Memorandum of Understanding with the Quality Council of India, to help improve quality standards for healthcare delivery at government run hospitals and help the hospitals get accredited by the National Accreditation Body for Hospitals/ Laboratories.
Source: bit.ly/3Ub0ful
Prices of imported Active Pharmaceutical Ingredient see sharp decline due to action against cartelized manufacturers
Despite an increase in demand in the Indian domestic pharmaceutical manufacturing sector for Active Pharmaceutical Ingredients (APIs), indicated by a 39% increase in year-on-year imports, the price of APIs being imported from China and other countries has reduced significantly to pre-COVID levels. This reduction is suspected to be caused by breaking-down of manufacturing cartels. This reduction in prices of API signifies an increase in profit margins for Indian firms which have traditionally been depended on Chinese imports.
Source: bit.ly/43Qlo0d
ECHR holds that inaction against climate change may be considered violation of human rights
The European Court of Human Rights has issued an award in favour of several Switzerland based petitioners who brought claims against their Government. The Court held that the European Convention on Human Rights envisages citizens right to be protected by their government against adverse effects of climate change. The petitioners had claimed that the inaction of the Swiss government and insufficient mitigation measures had caused a violation of the petitioners’ human rights, since such inaction by the government has increased their likelihood of dying of heat stroke.
Source: bit.ly/3JbMLZ6
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 may soon have to explain why traditional medicines are outside the scope of its flagship Universal Health Coverage scheme, or include it
India’s Delhi High Court has directed the Indian Government to provide reasons for excluding ayurveda, yoga, and naturopathy treatments are not covered by its Universal Health Coverage scheme (Ayushman Bharat) or if there is a plan to include it, then describe the steps for including them. The direction was issued in response to a Public Interest Litigation (PIL) Petition.
Source: bit.ly/43R0pdJ
Applications invited from private medical device testing laboratories to enable them to test medical devices on behalf of manufacturers
In a first of its kind development, India’s central medical device regulator, Central Drugs Standards Control Organization (CDSCO), has published a notice on its website inviting private medical devices testing laboratories to submit applications for obtaining licenses to test medical devices on behalf of manufacturers. Medical devices cannot be sold after manufacturing without testing by an in-house or external lab, and micro and small-scale manufacturers of medical devices are finding it a challenge to get their medical devices tested due to shortage of private medical testing laboratories.
Source: bit.ly/3TNyMNV
Right against adverse effects of climate change is now a fundamental right of Indians
The Supreme Court of India has interpreted Article 21 of the Indian Constitution, which recognizes the right to life and personal liberty, to include right against adverse effect of climate change. The Supreme Court’s interpretation came in a controversial litigation where the Court had to balance the need to take urgent steps to conserve Great Indian Bustard (GIB) with the need to use land inhabited by GIB for use to generate renewal solar and wind energy.
Source: bit.ly/3vHjIJU
Extension granted to foreign manufacturers of high-risk food products such as nutraceuticals, infant food, milk products for registration with Indian food authority till 31st August, 2024
India’s central food regulator, Food Safety and Standards Authority of India (FSSAI), has extended the timeline for registration of foreign facilities which manufacture high risk food products, until 31st August, 2024. The high-risk food products are nutraceuticals, infant food, milk and milk products, meat and meat products (including poultry, fish and their products) and egg powder.
Source: bit.ly/3U8vEOd
Study indicates that more than half of cancer drugs which receive accelerated approval do not demonstrate clinical benefit in confirmatory trials
A study published in the Journal of the American Medical Association indicated only 43% of cancer drugs which were granted accelerated approval have demonstrated a clinical benefit in terms of patient survival or quality of life in confirmatory trials conducted in US. Accelerated approvals or early approvals are marketing approvals granted by Regulatory Authorities to drugs which show promising initial results for treating debilitating or fatal diseases.
Source: bit.ly/3U5XGd8
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.
E-Commerce websites instructed to avoid marketing Milk/ cereal/ malt based drinks as “Energy Drinks”
India’s Food Standards Regulator (the Food Safety Standards Authority of India) has issued an advisory to e-commerce websites, requiring them to ensure that proprietary foods, i.e. foods that are not categorized under the Food Standards Regulations, specifically those currently registered as analogues to milk/ cereal/ malt based beverage, should not be advertised as “Health Drink”/ “Energy Drink”, as only carbonated/ non-carbonated water-based flavoured drinks are regulated as “Health Drink” and “Energy Drink”.
Source: bit.ly/3xlfzvD
Drug Price Regulator may examine prevalent drug substitution and discounting prices offered by major drug retail stores in India
The Indian Central Drugs Regulator (CDSCO) has reportedly requested the Central Drugs Price Regulatory Body (NPPA) to investigate drug substitution and discounting practices of a major pharmacy chain on the basis a complaint raised by State Chemists and Druggists’ Association of the State of Karnataka (KCDA). In its complaint, the KCDA has alleged that the major pharmacy chain has been deliberately undercutting prices, sustained by substitution of prescribed drugs with other cheaper but identical formulations and unreasonably increasing its profit margins, which is currently violative of regulations applicable to pharmacists, as well as pricing norms of drugs.
Source: bit.ly/4cJSJOg
Vaccine manufacturers may have to provide manufacturing and sales data to government soon
The advisory body to India’s Central Drugs Regulator, the Drugs Consultative Committee, has requested various State-level Drug Licensing Authorities to ensure submission of details of the manufacture and sale of vaccines within the states to the Central Drugs regulator (Central Drugs Standards Control Organization), for the purpose of meeting obligation for the Global Benchmarking of Vaccines of the World Health Organization.
Source: bit.ly/3PJkAEw
Major Ayurvedic Medicine manufacturer may be on hook for contempt of court after Supreme Court rejects its apology for publishing misleading advertisements
In its ongoing proceedings against a major Ayurvedic medicine manufacturer for publication of misleading advertisements in contravention of undertaking given by it to the Supreme Court, the Court has refused to accept the apology which was tendered by the manufacturer, and rejected submissions of the manufacturer that: (1) The restriction on advertisement under the Drugs and Magic Remedies (Objectionable Advertisements) Act, 1954 is archaic and may be relaxed since the manufacturer now has scientific data to back its claims, and (2) that the manufacturer should not be held liable for an advertisement issued by an independent marketing department.
Source: bit.ly/4akJen5
Australia updates Medical Device Recall Procedure
The Australian Therapeutics Goods Administration, which regulates medical devices at the central level in the country, has published a revised version of the Uniform Recall Procedure for Therapeutic Goods (URPTG), which relaxes regulatory burden of importers and manufacturers of medical devices. The revised URPTG provides additional clarity on procedure for immediate recall, clarifying timing of release of recall information by the regulator, modifying Customer Response Forms, and eases the filing requirements under the law by making all templates for recall action publicly available on the website of regulator.
Source: bit.ly/3TAZJEo
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.
Supreme Court of India pulls up State Licensing Authority for failing to take action against misleading advertisements by leading ayurvedic manufacturer
India’s Central Ayush Ministry recently filed an affidavit in the Supreme Court of India to explain the steps it has taken against a leading manufacturer of Ayurvedic products after receiving several complaints against the manufacturer for making false and derogatory claims against modern medicine. The affidavit states that no action has been taken in the past two years by the State Licensing Authority, despite several orders from the Supreme Court, Right to Information (RTI’s), and directives from the Prime Minister’s Office (PMO). The Supreme Court has now asked the State Licensing Authority to issue its reply.
Source: bit.ly/4aDTxmc
Relaxation of penalties for certain offences involving drugs, medical devices and cosmetics to take effect from December 31, 2024
The Indian Government has decided to relax the penalties for offences relating to drugs, medical devices and cosmetics that are of the nature of violation of conditions of license or failure to label in the prescribed manner. These offences typically invited punishment of imprisonment and fine, but may now be compounded by the payment of a penalty both before or after institution of prosecution. The decision was notified under the Jan Vishwas (Amendment of Provisions) Act, 2023. The Government has now notified the date of coming into effect of the relaxation as December 31, 2024.
Source: bit.ly/3U0yhS4
Source: bit.ly/3THGUjd
Major technology company admits to collecting information from private browsing, agrees to destroy data as part of the settlement
A major technology company, known for operating a popular internet search engine, has agreed to destroy billions of data records to settle a lawsuit. The suit claimed that the search engine company was secretly tracking the internet use of people who thought that they were browsing privately. Under the settlement, the search engine will update disclosures about what it collects in “private” browsing and will also let the users block third party cookies for five years.
Source: bit.ly/3vIwHL9
Industry demands that US FDA should give prior notice before conducting remote regulatory assessments
The US Food and Drug Administration’s (USFDA’s) revised guidance for conducting remote regulatory assessments (RRAs) has received comments from the industry. A clear demand from the industry is that the US FDA should provide advance notice for mandatory assessments and discuss observations before taking any regulatory action.
Source: bit.ly/3xieXXJ
Written patient consent required for sensitive examinations on anesthetized patients in US
The United States Department of Health and Human Services has recently released a new guidance as per which hospitals have to mandatorily obtain written informed consent from anesthetized patients for breast, pelvic, prostate, and rectal exams performed on them for educational and training purposes. If hospitals do not obtain the explicit consent and violate the patient privacy rights, they may become ineligible for participation in the Medicare and Medicaid programs, as well as become liable for fines and investigations.
Source: bit.ly/3U1M8aX
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Corporate hospitals may soon have to comply with advertisement norms applicable to doctors
India’s National Medical Commission (NMC), which regulates the conduct of medical practitioners (doctors), has endorsed the position that all hospitals should comply with the same standards of ethics as are applicable to doctors under the NMC Registered Medical Practitioner (Professional Conduct) Regulations, 2023. The operation of 2023 Regulations is currently under suspension.
Source: bit.ly/3vpJ7aV
High Court imposes damages of 244 crores in Standard Essential Patents case
India’s Delhi High Court has reportedly imposed damages amounting to INR 244 Crores on an Indian smartphone manufacturer. The Court found smartphone manufacturer guilty of infringing seven patents on 2G, EDGE, and 3G technology granted to a global telecom company. The order is expected to be out soon.
Source: bit.ly/3TxOXyI
Drug Manufacturers will have to upload all product details on Government portal soon
The Drugs Consultative Committee (DCC), a committee comprising State-level Drug Regulators, has recommended that the Central Drugs Regulator, Central Drugs Standard Control Organization (CDSCO), should set a deadline for manufacturers of drugs to upload list of drugs manufactured on an online portal called SUGAM.
Source: bit.ly/3TxP0uo
Ban on trade of ferocious dog breeds has been stayed in various States in India
India’s Kerala High Court, Karnataka High Court and Kolkata High Court has stayed a controversial circular of the Central Government which prohibited import, trading and selling of 23 breeds of dogs identified as ferocious in the circular. The circular also mandated sterilization of dogs from further breeding as pets. The circular has been challenged on the ground that it is unscientific, not based on evidence and has been issued without consultation with relevant stakeholders.
Source: bit.ly/3TVZcyi
European Medicines Agency urges sponsors of clinical trials to register on new portal before January 2025 deadline
The European Medicines Agency (EMA) has strongly advised sponsors of clinical trials that have been approved before 31 January 2023 to submit application to move the clinical trials to the new Clinical Trials Information System (CTIS) as soon as possible, considering it will take EMA up to three months to review and authorize the application. As of now, only 20% of clinical trials have been moved to the new platform.
Source: bit.ly/3TZRzHl
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Criminal prosecution for drug related offences can start only on the basis of a drug inspector’s complaint: Supreme Court
India’s Supreme Court has confirmed that only a drug inspector, and not the police, is authorized to file a First Information Report (FIR) or a complaint for offence related to drugs under the Drugs and Cosmetics Act, 1940.
Source: bit.ly/3PGkEVL
Drug prices may increase slightly due to increase in Wholesale Price Index
India’s drug price regulator, the National Pharmaceutical Pricing Authority of India, has communicated to the pharmaceutical industry that annual change in the Wholesale Price Index (WPI) in 2023 compared to 2022 was (+)0.00551%. Accordingly, manufacturers of drugs whose price are capped may increase their price by (+)0.00551% in the month of April without government approval.
Source: bit.ly/3xgzbRC
Drug labels may have to mention excipients which cause hypersensitivity soon
India’s top drug policy advisory body, the Drugs Advisory Board (DTAB), has directed India’s Central Drug Regulator, The Central Drugs Standards Control Organization, to prepare a list of excipients that cause hypersensitivity, with the intent that such excipients should be disclosed label of medicine. Other excipients will not have to be mentioned on the labels of medicine. Currently, the law does not require manufacturers to include to disclose information about excipients on the label of drugs.
Source: bit.ly/43E3M7D
Source: bit.ly/3vv1j2N
India low on Biopharma Innovation: Leading Industry Analyst
A leading industry analyst firm has written an open letter to Prime Minister of India that India seems to be ceding ground to its Asian peers in biopharma innovation and manufacturing. The firm has highlighted that India needs to encourage investment in biopharma manufacturing capacity, increase public health expenditure, and extend insurance coverage for the novel drugs, in order to promote innovation in biopharma space.
Source: bit.ly/3PHcD2N
High time to implement essential diagnostic guidelines to standardize diagnostic practices: Expert
Healthcare industry expert in India has emphasized the urgent need for the implementation of national essential diagnostic guidelines to standardize practices, improve patient care, streamline diagnostic processes, guide clinical decision-making, optimize resource utilization, and reduce healthcare disparities across India. In 2019, the Indian Council of Medical Research (ICMR) had issued the National Essential Diagnostic List (NEDL) to ensure consistency and quality in diagnostic procedures.
Source: bit.ly/3vyESd5