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TOP 5 HEALTH LAWS AND POLICY UPDATES

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.

New Framework to be created to separately regulate prices of Medical Devices
In response to demands from industry associations, India’s Central Drug Price Regulator, the National Pharmaceutical Pricing Authority (NPPA), in collaboration with the Department of Pharmaceuticals is reportedly in the process of developing a special pricing framework for Medical Devices comparable to similar prevailing regulations in other jurisdictions.
Source: bit.ly/49Wh8hc

Testing Standards for stability testing of In-Vitro Diagnostic Medical Devices have been prescribed to obtain manufacturing/ import license
India’s Central Drugs Standards Regulator (CDSCO) has released a draft Guideline regarding conduct of Stability Studies for In-Vitro Diagnostic Medical Devices (IvDMD). These guidelines cover the standards and testing for determining the overall shelf life, individual component stability, stability during transportation as well as, in-use stability of IvDMD. These guidelines are applicable for all manufacturers who are in preparation of submitting a pre-market review document in pursuance of obtaining a manufacturing/ import license under the Medical Devices Rules, 2017.
Source: bit.ly/4aP4TUJ

Students pursuing courses in Indian System of medicine will have to give exit test prior to applying for Registration as a practitioner of Indian System of Medicine: Delhi HC
In a recent decision, the Delhi High Court has held that only those students that have already obtained their respective recognized qualifications (either a BAMS, or BUMS degree) would be permitted to initiate the process for registering as a practitioner of Indian Traditional Medicine. This decision was taken on the basis of Sec. 15(1) of the National Commission for Indian School of Medicine Act, 2020 which mandates a common final exit test to be cleared prior to registration with State Register.
Source: bit.ly/3JxjPLo

Government relaxes obligation of deductees to pay higher TDS for persons whose PAN remained inactive for FY 2023-2024
In pursuance of Circular No. 3 of 2023, a person whose PAN (Permanent Account Number) has become inoperative has been subject to a higher rate of TDS. The Central Board of Direct Taxes has issued a notification recently, which relaxes this obligation of persons to deduct at a higher rate of TDS, for all transactions dated till 31st March 2024 provided that the linked PAN is reactivated before 31st May 2024.
Source: bit.ly/4aR96HE

AI Taking up more of Doctors’ time since it needs more training and monitoring
In a set of recently published studies at various teaching hospitals, it was revealed that using AI to manage patient interaction and medical records to assist Doctors has in fact, lead to Doctors spending more time on the tasks delegated to the AI, since the Doctors were now required to train and supervise the AI in addition to carrying out their regular responsibilities for these tasks.
Source: bit.ly/3Wg75QU

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TOP 5 HEALTH LAWS AND POLICY UPDATES

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.

Draft GDP guidelines for pharmaceutical products published for comments
India’s Central Drugs Standard Control Organization (CDSCO) has released a draft guidance document titled “Guidelines on good distribution practices for pharmaceutical products” for comments. The Guidelines seek to eliminate the introduction of spurious, adulterated, misbranded and non-standard quality (NSQ) products into the market. It is intended to be applicable to all entities involved in any aspect of the storage and distribution of pharmaceutical products, including manufacturer as well as pharmacists and any other person dispensing medical products directly to a patient.
Source: bit.ly/4cQwypM

Agreements with Shared Workspace Providers accepted as valid proof of premises for obtaining food licenses
India’s central food regulatory authority, Food Safety and Standards Authority of India (FSSAI), has issued an advisory on the documents that may be submitted as proof of premises by importers, traders, e-commerce entities, re-labellers etc. who deal in food products and operate out of a shared workspace premises. Going forward, any legally valid agreement with workspace provider will be accepted. Such agreement may be a lease or rent agreement. However, entities who operate out of shared work-space will not be able to stock food products in shared workspace under the license.
Source: bit.ly/3JkMpzp

Documents which will be accepted as proof of possession of premises for food business is specified by Central Food Regulator
India’s central food regulatory authority, Food Safety and Standards Authority of India (FSSAI), has identified documents which will be accepted as proof of possession of premises by a Food Business Operator (FBO) as part of the food license application. Any food business operator, undertaking any business of food or beverage, including hotels, restaurants, food vending establishments, clubs, canteens, importers, merchant, exporters, e-commerce operators, transporters has to submit proof of possession of premise in order to obtain corresponding food license.
Source: bit.ly/3UiCgte

Waste management portals for plastic packaging and e-waste to get operational in a phase wise manner
India’s Central Pollution Control Board (CPCB) has clarified that the Extended Producer Responsibility portals for the management of Plastic Packaging waste and E-waste will get operational in a phase wise manner. For plastic packaging waste the portal is only functional for Chandigarh, Chhattisgarh, Goa & Puducherry whereas for e-waste the portal is operational for Maharashtra only. The users of the portal for other states are requested to wait till further notice.
Source: bit.ly/3JqZRBH
Source: bit.ly/3Jl1Es4

Popular protein supplements sold in India found to have lesser quantity of protein than declared on the label
A recent study has found that many popular brands of protein supplements sold in the Indian market do not have the same amount of protein as claimed on the label. In addition to the inconsistencies related to protein content, the study also found evidence of protein spiking, fungal toxins, pesticide residues, presence of heavy metals and compounds in protein supplements manufactured in India.
Source: bit.ly/3vU24CC

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TOP 5 HEALTH LAWS AND POLICY UPDATES

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.

Environmental Compensation Guidelines for Plastic Waste Published
India’s Central Pollution Control Board (CPCB) has issued guidelines for the assessment of Environmental Compensation (EC) for violation of The Plastic Waste Management Rules, 2016. The Producers, Importers, Brand Owners and Manufacturers of plastic packaging will have to pay environmental compensation (EC) for non-compliance with the marking or labelling requirements, non-registration on the Plastic Packaging Waste EPR portal, shortfall in EPR targets, non-filing of annual returns etc. EC would also be levied on the generators of waste for non-segregation of plastic packaging waste at source and littering. The environmental compensation will be higher (15 – 20%) than the EPR credit charges prevailing in the market to ensure that it acts as a deterrent. The guidelines also specify the minimum and maximum amount of environmental compensation to be levied for violations of specific provisions of the Plastic Waste Management Rules, 2016.
Source: bit.ly/3U6zhUJ

Importer of cosmetics inadvertently receives import registration for cosmetic product without applying for it
India’s Central Regulatory Body for Cosmetics, The Central Drugs Standard Control Organization (CDSCO), recently cancelled the import registration certificate of an importer of cosmetics after it realized that it had inadvertently granted registration certificate even though the importer had not applied for it. CDSCO has attributed the mistake to some technical issues.
Source: bit.ly/3vNc0xQ

Hair transplantation by doctor with M.B.B.S. degree only does not automatically result in negligence, if standard of care not compromised by doctor: National Consumer Commission
India’s National Consumer Dispute Redressal Commission (NCDRC) in Hyderabad refuse to fasten liability for medical negligence on a Doctor with M.B.B.S, who had performed a hair transplant surgery. The NCDRC observed that the M.B.B.S. course syllabus includes study of the dermis, and that a doctor with a M.B.B.S. degree has the qualifications and expertise to undertake minor surgeries of dermis such as hair transplantation.
Source: bit.ly/3PWQBZN

Indian hospitals have started using Artificial Intelligence extensively: Report
India’s major hospital chains have reportedly started using artificial intelligence (AI) for prediction, prevention, diagnosis, and personalized management. These hospital chains are also commercializing their AI solution by licensing it with smaller hospitals.
Source: bit.ly/43Ua6rF

French Government decides to impose fines on patients if they miss appointment with doctors
The French government has decided to impose a fine of five euro ($5.50) on patients who miss doctor appointments or cancel them with less than twenty-four hours’ notice. The Government homes that this initiative would free up missed appointments for other patients. It is reported that over 27 million doctor consultations go waste in France due to patient absences.
Source: bit.ly/49p7Iug

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TOP 5 HEALTH LAWS AND POLICY UPDATES

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.

Star-rating for energy efficiency on white goods to be under stricter government regulation

Indian Government may reportedly introduce rules for non-branded products to validate star rating for energy efficiency on white goods. White goods refer to household appliances of daily use such as air conditioners, refrigerators, television sets, etc. The National Test House (NTH), along with Bureau of Energy Efficiency (BEE), will conduct testing to help improve the quality of products and put a check on substandard products with a view to save energy.
Source: bit.ly/3TAWopa  

US FDA to train Indian drug regulators on cGMP inspection

The US FDA has invited drug regulators of the State of Gujarat, Telangana, Goa, and Karnataka to act as observers during checks and inspections of drug facilities in India, so that they develop a greater understanding of the US FDA inspection protocol.
Source: bit.ly/43FfvD9

GST officials should refrain from doing fishing inquiries: Government

The Directorate General of GST Intelligence (DGGI) has reportedly issued a new guideline for GST officials stating that they should refrain from “fishing inquiries” to check evasion of goods and service tax (GST). The Guidelines state that tax officers should clearly state the nature of the investigation in formal letters to designated company officials and avoid using ambiguous language in letters and summons. Terms like “GST enquiry,” “evasion of GST,” or “GST evasion,” among others, should not be used in a letter sent to an ordinary taxpayer.
Source: bit.ly/3IZO9Og  

Indian Courts will be slow to intervene in enforcement of foreign arbitral awards on grounds of bias: Supreme Court 

India’s Supreme Court has held that intervention in enforcement of a foreign arbitral award on the grounds of bias should be discouraged. Indian courts will be permitted to entertain a claim for arbitral bias in an enforcement proceeding only after the ground has been raised before the arbitral tribunal. In order to assess arbitral bias, the Courts will have to prioritize international standards above domestic ones, even while it permits the execution of a foreign arbitral award. 
Source: bit.ly/3J48bqR  

Chemicals used to decaffeinate coffee beans may be banned in US 

Consumer Health Groups have petitioned US Food and Drug Administration to ban methylene chloride, a chemical which is used as additive to decaffeinate coffee beans, because it has been proven to cause cancer in rodents.
Source: bit.ly/3vx2n6a

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TOP 5 HEALTH LAWS AND POLICY UPDATES

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.

Hospitals and pharma companies in India bought electoral bonds worth 9 billion Rupees
Indian hospitals and pharma companies have reportedly bought electoral bonds for approximately Rs. 900 crore. Electoral bonds bought by businesses are later encashed by political parties, and until recently, the identity of businesses that bought electoral bonds was kept confidential.
Source: bit.ly/43qtXyz

New portal for filing consumer complaints to be introduced
India’s Central Consumer Protection Authority (CCPA) will reportedly launch a dedicated online complaint portal for consumers to file complaints against misleading advertisements and unfair trade practices. The timing of the launch of the portal is intended to coincide with World Consumer Rights Day (March 15).
Source: bit.ly/3ViSKCP

New guidelines that will differentiate brand extension and surrogate advertisements to be notified soon
India’s Central Consumer Protection Authority (CCPA) has reportedly formed a committee to deal with the issue of differentiation of genuine brand extensions from surrogate advertisements. Brand extensions are advertisements by companies that extend existing brands into new product categories. For example, advertisements by alcohol companies to sell music CDs, glasses, soda, etc. under the same brand name. However, if the products covered brand extensions are not available for sale in the open market, then such advertisements become surrogate advertisements.
Source: bit.ly/3Tll3hn

EU may soon adopt a single compulsory license regime for medicines in crisis situations
The European Union Parliament is reportedly going to consider a proposal to allow manufacturers of critical medicines to manufacture them for all member states without the consent of the patent holder in crisis situations. Under the current law, even if one State of the EU grants a compulsory license to a manufacturer to manufacture a critical medicine in a crisis situation, the medicine cannot be exported or sold in other EU states unless the concerned State also grants some kind of immunity against the import of such medicine into that State.
Source: bit.ly/3Vp0Iud

Brand owners now responsible for collection of any plastic packaging waste
The Ministry of Environment has amended the Plastic Waste Management (Amendment) Rules, 2024. All brand owners who use plastic packaging on the product package are obligated to collect plastic packaging waste. However, if the brand owners have met the Extended Producer Responsibility targets by contracting with a registered recycler, then physical collection of plastic packaging waste may not be required.
Source: bit.ly/3PrvG0L

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TOP 5 HEALTH LAWS AND POLICY UPDATES

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

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TOP 5 HEALTH LAWS AND POLICY UPDATES

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.

Greenwashing Regulations Published for Comments
India’s Ministry of Consumer Affairs has published the Draft Guidelines for the Prevention and Regulation of Greenwashing, 2024, which seek to regulate the advertisement of false or misleading environment claims, and/or the downplaying of harmful environmental effects of any product or service by any advertiser or producer. Industry may submit its comment on the draft of the Guidelines until 21st of March 2024.
Source: bit.ly/4bLPO7u

India’s Supreme Court puts controversial amendment of India’s forest law on hold
The Supreme Court of India has put on hold the application of The Forest Conservation (Amendment) Act, 2023 which diluted the scope of forests to only those lands which were either notified as forests or identified as forests in government records. However, the Supreme Court had ordered the Government to follow the dictionary definition of forest until consolidated record of forest lands are prepared by all State Governments.
Source: bit.ly/4bCE6vI

Details of Liaison Officers of Social Media Companies not matter of public record, and so need not be revealed to public: High Court
India’s Delhi High Court has rejected a Public Interest Litigation (PIL), that sought information about persons appointed by major Social Media Companies to handle directions from Government , on the ground that the sole purpose of a Liaison Officer is to co-ordinate and interact with Central Government, and not with the public. Social Media Companies have separately appointed a Grievance Officer to resolve grievances of the public, and the details of Grievance Officer are publicly available.
Source: bit.ly/3ONb5Uk

Couples cannot adopt a healthy child, if they have two or more children: High Court
The High Court at Delhi has issued an order upholding the retrospective validity of a government notification that limited couples with 2 or more children to adopt only special needs children, holding that the right of adoption of a parent is not a protected Fundamental Right under Article 21 of the Indian Constitution, and therefore cannot be prioritized above the right of a child.
Source: bit.ly/3T4VCS9

WHO Urges heightened regulation of Tobacco products and e-cigarettes
Highlighting that the region (South East Asia) has nearly 77% of the global smokeless tobacco consumers, the World Health Organization is calling on governments in South East Asia to intensify efforts and take initiative to control use of tobacco, tobacco products, and e-cigarettes.
Source: bit.ly/3OPT87N

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TOP 5 HEALTH LAWS & POLICY UPDATES

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.

Human Rights body to probe sale of drugs with identical brand names in India
The National Human Rights Commission (NHRC) in India has taken suo motu cognizance of a newspaper report which stated that many drugs in India were being sold with identical brand names for treating different medical conditions. NHRC has issued notice to Secretary, Ministry of Health and Family Welfare and Central Drugs Regulator, asking for detailed report within four (04) weeks.
Source: bit.ly/3SB8WfB

India’s Environment Regulator to take action against unregistered recyclers and refurbisher of battery waste
India’s Central Pollution Control Board (CPCB) has issued direction to all State Pollution Control Board (SPCB) and Pollution Control Committees (PCCs) to ensure compliance with Battery Waste Management Rules, 2022 by recyclers and refurbishers of battery waste. CPCB has directed SPCB/PCC to carry out drives identifying informal / illegal battery waste recyclers, and physically verify facilities of existing waste recyclers. All battery waste recyclers and refurbishers are obligated to register under Battery Waste Management Rules, 2022.
Source: bit.ly/3OGJTGI

Difference of manufacturing process will not take away ability of manufacturer of product manufacturer to enforce product patent, if the product is covered by Product-by-Process Patent: High Court
The Delhi High Court of India has held that a product-by-process patent would be enforceable even if the alleged infringement relates to manufacturing of a product using process which is different than the one claimed in patent. The High Court was dealing with a matter relating to manufacture of a compound called Ferric Carboxymaltose (FCM) which was patented by the Innovator. The defendants had raised an argument that they are not covered by the patent because they were following a different process to manufacture FCM. However, the argument was rejected by the High Court.
Source: bit.ly/3OGtr9C

Manufacturers of medical devices who do not wish to disclose name and address of manufacturing facility, may apply for neutral code on central portal
The Indian medical devices regulator, Central Drugs Standard Control Organization (CDSCO) has direct all the manufacturers of medical devices for export purposes to submit the applications for neutral code through online system of medical devices portal only. If a neutral code is declared on the label of package, it does not have to bear the name and address of the manufacturer. The online portal is now functional to accept the applications.
Source: bit.ly/3SWgTxn

Recommendations for COVID legislation received from Law Commission of India
The Law Commission of India has submitted its report titled “A Comprehensive Review of the Epidemic Diseases Act, 1897″ to the Government of India. The commission has recommended either to amend the existing law or enact the new legislation to address the underlying gaps in the Epidemic Diseases Act, 1897. The 1897 was relied on by the Government of India to introduce various controls during the COVID pandemic, including lock downs.
Source: bit.ly/3SWMdMm

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Daily Health News Wrap – 01 Feb 2024

01 Feb 2024

Important clarifications issued by Central Pollution Control Board w.r.t. Extended Producer Responsibility (EPR) compliances under E-waste Management Rules, 2022.
India’s Central Pollution Control Board (CPCB) has released certain notices and guidance document under E-Waste (Management) Rules, 2022 which have a significant impact on EPR obligations.
Sources: –
FAQ for E-waste: bit.ly/3HHuiCU
Fee Structure for registration for Recyclers: bit.ly/3SpMBkS
Notice for Producers:  bit.ly/48XXFwK
Notice for Recyclers: bit.ly/48XhbJK
Important clarification issued by India’s Central Pollution Control Board (CPCB) under E-waste Management Rules, 2022 (EWM) for the importers of Electrical and Electronic Equipment (EEE) who are not required to comply with Extended Producer Responsibility (EPR) requirements
India’s Central Pollution Control Board has issued a clarification under E-waste Management Rules, 2022 (EWM Rules) identifying importers of Electrical and Electronic Equipment (EEE) who are not required to be registered as Producers under EWM Rules and therefore do not need to fulfil Extended Producer Responsibility (EPR) obligations. Such producers are required to submit certain documents to Customs/Port authorities as a proof of submission of those documents to CPCB.
Source: bit.ly/42kj9Bq
Indian Government extends the deadline for application of quality control order for certain drugs
Indian Central Government has extended the dates of applicability of Quality Control Orders (QCO) of Morpholine, Acetic Acid, Methanol and Aniline to 1st August 2024, 3rd August 2024, 3rd August 2024 and 3rd August 2024 respectively.
Source: bit.ly/48XokK3
Indian Government extends timelines for submission of application under Production Linked Incentive (PLI) scheme
The Department of Pharmaceutical under the Indian Ministry of Chemicals and Fertilizers has extended the timeline for medical device manufacturing companies to submit the application under the Production Linked Incentive (PLI) Scheme till the end of February 2024. The PLI scheme aims to promote domestic manufacturing of class B medical devices.
Source: bit.ly/47Y4UDx
New Guidelines for effective performance of Environment Regulators issued by Supreme Court of India
The Supreme Court of India has recently issued stringent guidelines which ensure the efficient functioning of environmental protection authorities and the enforcement of environmental regulations across the country. The court also upheld the reconstitution of the Central Empowered Committee (CEC), which is tasked with compliance with judicial orders pertaining to environmental conservation.
Source: bit.ly/3SFwscs