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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.

Body massagers cannot be ‘sex toys’ just because they can have alternative use: High Court

In a recent ruling, the Bombay High Court has held that body massagers cannot be treated as ‘sex toys’ merely because they can be used for alternative purposes. While coming to this conclusion, the Court observed that it would be incorrect to classify massagers
as items of objectionable description or as obscene figures in the absence of any substantial justification.

Source: bit.ly/3Vvxp9k

Homeopathy practitioners cannot present themselves as gynaecologist; amounts to medical negligence and deficiency in service: State Consumer Commission

The State Consumer Disputes Redressal Commission, Lucknow (SCDRC) has taken the view that cross-practicing of medicine by doctors trained in branches other than allopathy constitutes medical negligence and a deficiency in service. SCDRC imposed a compensation of Rs. 30 Lakhs on a city-based private nursing home and a homeopathy practitioner for medical negligence. The practitioner misrepresented herself as a gynaecologist, and prescribed allopathic medicines. The SCDRC held both the practitioner and the nursing home liable for their negligence and deficiency in service.

Source: bit.ly/3xavblG

A leading ayurvedic Indian FMCG company has tendered an unconditional apology for its misleading advertisement to Supreme Court

Following a contempt notice on misleading advertisements and the issue of summons, the co-founders of a major ayurvedic FMCG company have tendered an unconditional apology for the company’s misleading advertising practices. The Supreme Court had directed that the co-founders of the company appear personally before the Court on the date of the next hearing. 

Source: bit.ly/43vV5wj 

Government proposes ban on 23 dangerous dog breeds in India

The Indian Government proposed a ban on 23 dog breeds in the country that are deemed “dangerous for human life” in an effort to address the growing number of dog attack cases. Additionally, the government has urged state governments to desist from granting licenses or permits for the sale and breeding of these dog breeds. 

Source: bit.ly/43xEjgi 

Draft Resolution introduced by the UN General Assembly on Artificial Intelligence

The UN General Assembly adopted its first resolution on artificial intelligence (AI) to ensure the technology benefits all nations while respecting human rights and ensuring safety.
Co-sponsored by 123 states, the resolution was adopted by consensus without a vote. Recently, the European Parliament has also taken steps to adopt the Artificial Intelligence Act, considered the world’s first comprehensive legal framework for AI.

Source: bit.ly/490W88s

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STATUS OF REGULATION OF AI IN INDIA: IMPACT OF NEW ADVISORY

The Ministry of Electronics and Information Technology (MeitY) issued a new advisory on Artificial Intelligence (“AI”) on March 15, 2024 (“New Advisory”), scrapping the earlier version issued on March 1, 2024. The New Advisory has diluted the strict position taken by MeiTY in its earlier advisory.

1. CHANGES

    Though, the New Advisory has retained majorly all clauses of the earlier version, there are few changes brought out in terms of the regulatory framework. These changes have been summarized below:   

    A. No More Prior Government Approval

      Previously, intermediaries and platforms were required to ensure that a proper government approval was in place prior to making under-testing/ unreliable AI tools available to Indian public.

      The New Advisory scraps the previous approval mechanism which was loaded with ambiguities.  Specifically, there was a lack of clarity on definitions for “unreliable” models and the process for obtaining approval.

      B. Focus on Labelling

      The New Advisory underscores the significance of user awareness regarding AI-generated content. Intermediaries and platforms are required to ensure appropriate labelling of AI, particularly which is under-tested/ unreliable, regarding the fallibility of outputs.

      Intermediaries and platforms have to ensure user awareness regarding fallibility of AI tools/systems and their outputs. User awareness should be created using consent popup or any other relevant mechanism. 

      This transparency empowers users to critically evaluate the information they encounter online and mitigates the potential for manipulation through AI-powered misinformation campaigns. AI-generated content, especially those vulnerable to misuse like deepfakes, must be clearly labelled for user awareness.

      C. No Reporting

      Under the previous advisory intermediaries and platforms were also mandated to submit an Action Taken-cum-Status Report (“ATS Report”) to MeitY within a 15-day timeframe. The New Advisory has removed the reporting requirement. 

      2. ISSUES  

      Even though the New Advisory states that it is applicable to Platforms, it does not clarify which entities are covered by the expression ‘Platforms’ leaving a question mark on scope of its applicability to non-intermediaries using or making available AI tools.

      Further, the is no clear guidance about testing of AI tools/systems. The government has not clarified any standards for testing the AI tools. Intermediaries and platforms have been asked to ensure labelling of under-tested/ unreliable AI tools without any clear prescription on standards of testing AI tools or clarity about authority which will certify testing and reliability of AI tools.   

      3. IMPACT

      The changes brought out in the New Advisory mark a shift in India’s regulatory approach; from zero regulation to a more measured stance on AI regulation. The New Advisory has addressed the concern raised about implementation of prior approval mechanism by removing that requirement.

      Despite the removal of approval mechanism, intermediaries and platforms still face significant risk due to lack of clarity and ambiguity in standards of testing unreliable AI systems. While the New Advisory might reduce compliance costs for intermediaries and platforms, it might inadvertently increase their chances of losing legal immunity (safe harbor) under Indian law.

      As of now, intermediaries and platforms are required ensure compliances which were enlisted in the earlier advisory except seeking government approval for using under-testing/unreliable AI tools and submitting ATS Report. We have summarized the compliances mentioned under the advisory issued on March 1, 2024, you can read it here: https://shorturl.at/JKQ13  

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      UCPMP 2024 – Highlights and Summary of Key Differences from UCPMP 2015

      India’s Department of Pharmaceuticals (DoP) has published The Uniform Code For Pharmaceutical Marketing Practices, 2024 (UCPMP 2024). The UCPMP is a code that governs the interaction between the industry and healthcare practitioners (HCPs/doctors) in India. The UCPMP 2024 replaces the UCPMP 2015, and is applicable to both pharma and medical device companies.

      In the paragraphs below, we have summarized the business-critical changes between UCPMP 2024 and UCPMP 2015.  The expression ‘company’ refers to both pharma and medical device companies, unless the context suggests otherwise.

      Enforceability: The UCPMP 2024 is ‘kind of’ ‘somewhat’ mandatory. The text of UCPMP 2024 does not carry the word ‘voluntary’ as UCPMP 2015 did, but at the same time, it also does not have any statutory backing. It appears that the DoP is planning to enforce it through ‘audit’ mechanism. Under UCPMP 2024, DoP has the power to order an audit of any company upon receipt of a complaint of violation of UCPMP 2024 against the company. In case the audit proves a breach, the DoP may ‘recommend’ appropriate government agencies (such as the Income Tax Department and the National Pharmaceutical Pricing Authority) to take action against the company. An appellate body, which is headed by the Secretary, DoP, also has the power to ‘prescribe’ penalties to defaulting companies. Separately, the CEO of the company has to give an undertaking that the company shall abide by UCPMP 2024 will extend all assistance to ‘authorities’ for its enforcement.

      Medical Education and Training: Companies can sponsor or organize conferences, workshops and trainings for doctors by themselves without having to necessarily collaborate with another entity, such as an association of doctors. Such conferences, workshops and trainings cannot be held outside India. The details of such events and expenses incurred by the company will have to be published on the company’s website. The record of these expenses may be audited by auditors appointed by the DoP. If the DoP auditors find discrepancies in the records, they will bring them to the attention of appropriate government agencies and authorities.

      Hospitality and travel: During conferences and workshops, all doctors including delegates may be served modest meals. However, delegates cannot be offered travel facilities. Speakers may be offered both hospitality and travel facility.

      Brand reminders: A company may supply doctors with informational and educational materials such as e-journals and dummy device models as brand reminders, provided that the total worth of each item does not exceed Rs. 1000. There is no cap on how many brand reminders can be given to the doctor. However, a brand reminder should not have an independent commercial value for the doctor.

      Engagement of HCPs as a Consultant: Companies can continue to engage doctors as consultants for research, but the research has to be ‘bona fide’. The DoP is expected to provide more clarity on this issue.

      Monetary grants: Companies cannot offer monetary grants under any pretext now, including for educational purposes to doctors who are pursuing training, residency, or fellowship.

      Sample packs: A company may offer a doctor up to 12 sample packs of medicines each year. However, these sample packages should be properly marked as ‘not for sale.’ The monetary value of samples distributed by a company should not exceed 2% of its domestic sales.

      Further changes to UCPMP 2024: The DoP has reserved powers to modify or limit the scope of UCPMP by issuing standing orders from time to time.

      It is important that industry takes cognizance of the changes because any non-compliance with UCPMP 2024 may negatively impact a company’s industry standing and perception amongst doctors.  India’s tax department has also been disallowing any expenses which have been incurred in contravention of UCPMP, so a mistake may prove very expensive.

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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.

      Indian government may reconsider its decision of prohibiting manufacture of drugs and nutraceuticals, health supplements in same facility
      The Indian government is reportedly reconsidering its decision to act against pharmaceutical companies who are manufacturing nutraceuticals, health supplements and drugs in the same facility, due to objections raised by small scale manufacturers. The previous Good Manufacturing Practices (Schedule M) for drugs gave some concession to manufacturers of drugs to manufacture nutraceuticals and health supplements in the same facility. However, no such concession exists under revised Good Manufacturing Practices (Schedule M) published in December 2023.
      Source: bit.ly/3x59lQo

      Exporters of Indian farm produce are facing phytosanitary challenges
      Indian agricultural exports, including fruits and vegetables, are reportedly finding it difficult to enter regions like Europe, Australia, and the US due to tough phytosanitary requirements and thresholds such as high pesticide content. In response, India’s Commerce Ministry is reportedly creating a data set on export consignments of agricultural exports that were refused by European countries and other nations on grounds of phytosanitary non-compliances, resulting in significant trade hurdles regardless of duty relaxations. A phytosanitary certificate is required for the export of agricultural products to ensure that the produce is pest-free, disease-free, and meets other health requirements such as traceability at the farm level.
      Source: bit.ly/4ctvxnB

      Indian government has established Fact Check Units to check spread of fake news
      The Indian Ministry of Electronics and Information Technology has appointed the Press Information Bureau of the Ministry of Information and Broadcasting as Fact Check Unit to address fake and misleading news against Central Government. The fact check unit of the central government is expected to vet all the online content related to the business of the central government. Any content identified as fake by the unit will be taken down from the internet.
      Source: bit.ly/3Px3Yj8

      The Centre gives more time to states to establish Allied Healthcare Councils
      India’s Ministry of Health and Family Welfare has extended the timeline for states to establish state allied and healthcare councils by six months. State Governments have to setup State Councils for Allied Healthcare by November 2024. The National Commission for Allied and Healthcare Professions Act 2021, which regulates quality of allied and other healthcare professionals in India, will be operationalized once the State Councils have been established.
      Sourve : bit.ly/3PxeZ4d

      Integrated Veterinary Health Certificates (VHC) mandatory after 30th June,2024 for import of milk and milk products into India
      The Food Safety and Standards Authority of India (FSSAI) has extended the deadline for implementing its decision to require imported food consignment of milk and milk products to be supported by an integrated veterinary health certificate. The requirement will take effect on July 1, 2024. From that date, only those milk and milk products that are supported by integrated veterinary health certificates will be allowed importation into India. The Integrated Veterinary Health Certificate must demonstrate that imported milk and milk products meet both the FSSAI’s food safety standards and the Department of Animal Husbandry and Dairying’s (DAHD) sanitary criteria.
      Source: bit.ly/3TIh53F

      Posted on

      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.

      Periodic Safety Update Reports for Medical Devices to be filed only through online portal of CDSCO
      The Central Medical Devices Regulator of India (Central Drugs Standards Control Organization) has issued a circular, stating that starting on 1st April 2024 it will require and restrict all manufacturers of Medical Devices/ In-vitro Devices to make submission of Periodic Safety Update Reports, only on the online portal and that offline mode of submission of application will not be accepted going forward.
      Source: bit.ly/3TEO74B

      Absence of Regulation of Second-Hand Medical Devices being Imported into India flagged by Parliamentary Panel
      The Department-related Parliamentary Standing Committee on Chemicals and Fertilisers, in a recent report, has highlighted that currently India’s Central Medical Device Regulations (Medical Devices Rules, 2017) do not regulate second-hand medical devices. The Committee has recommended framing policy to ensure its quality and safety, as well as introducing possible restrictions on import of second-hand or refurbished Medical Devices into India.
      Source: bit.ly/3VsdCaQ

      Supreme Court Orders Director of Company as well as Endorser of offending Advertisement to be present for Contempt Proceedings relating to misleading advertisements
      As part of the ongoing action being taken against a major Indian Ayurvedic Medicine manufacturer for publication of misleading advertisements regarding its products in contravention of an undertaking provided to the Court, the Supreme Court, in pursuance of determining whether to pursue contempt proceedings against the manufacturer, has issued an order requiring the physical presence of the Director of the entity as well as a prominent Ayurvedic Yoga practitioner who had given his endorsement to the claims made in the offending advertisements of the Company.
      Source: bit.ly/3vu45VQ

      Delhi High Court orders suspension of accounts accused of impersonation of prominent investment group despite objection that no evidence of involvement is provided.
      In pursuance of ongoing action against certain anonymous persons impersonating a prominent Investment group and misleading the general public, the Delhi High Court has issued a further order to messaging platform WhatsApp to take action to remove/ block access to certain accounts/ messaging groups, despite objection from the platform that the account/ messaging groups have been prove to neither violate T&Cs of WhatsApp, nor having carried out any illegal activity.
      Source: bit.ly/3vkn7hu

      EU Parliamentary Committee votes to present amendment to increase exclusivity period for orphan drugs and introduce extended regulatory data-protection period.
      The European Parliamentary Committee on Environment, Public Health and Food Safety has voted in favour of introducing several amendments to the current EU Pharmaceutical Directive, including a controversial proposal to increase the exclusivity period for Orphan Drugs from 10 to 11 years, as well as an extended regulatory data-protection period of 9 years; both decisions that industry experts believe may have adverse consequences for competition in the EU Pharmaceutical Market.
      Source: bit.ly/3Vr9zeK

      Posted on

      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.

      Drinks or beverages should not be sold as “health drinks” for children: NCPCR
      The National Commission for Protection of Child Rights (NCPCR) in India has sent a recommendation to the Consumer Affairs Department that no drinks or beverages including a popular drink for children and other similar products should be sold under the category of health drinks in stores or shops. It has sent a recommendation to Ministry of Commerce and Industry to issue directions to all e-commerce entities to remove these drinks and beverages from the category of health drinks on their websites.
      Source: bit.ly/4aksQTe

      Cookware, Utensils and Cans for foods and beverages will require Indian Standard Marks for sale in India
      The Department for Promotion and Industry and Internal Trade has published a Quality Control Order (QCO) which makes it mandatory for importers and manufacturers of Cookware, Utensils and Cans for foods and beverages to obtain an Indian Standard Mark (IS mark) from Bureau of Indian Standards (BIS) for sale of products in India. BIS grants rights to use IS mark after testing and inspection of products and manufacturing facilities, both in India and abroad, and charges a fee on the products sold. The QCO will take effect from September 1, 2024 for large scale manufacturers.
      Source: bit.ly/49WwzXf

      Restriction on package size of tablets or capsules relaxed in India
      India’s Ministry of Health and Family Welfare has issued an amendment in Drugs Rules, 1945 for the sale of multipacks (more than 10) of Tablets (coated or uncoated) or Capsules (hard or soft gelatin). From now onwards, packet of more that 10 tablets can be sold in the multiples of 5 or 7. Earlier, it could only be sold in the multiples of 5.
      Source: bit.ly/3VjpDPJ

      Strict implementation of new Pharma and Medical Device Promotion Code 2024 on cards as government reaches out to industry.
      India’s Department of Pharmaceuticals will reportedly be holding a spree of meetings with the stakeholders from the pharma and medical device industry to ensure strict implementation of Uniform Code of Pharmaceutical Marketing Practices (UCPMP) 2024. The UCPMP 2024 has replaced UCPMP 2015, and will govern interaction of pharma and medical device industry with doctors going forward.
      Source: bit.ly/3Tminjw

      India’s Plastic Waste Management (PWM) Rules, 2016 have been overhauled
      India’s Indian Ministry of Environment Forest and Climate Change has introduced major amendments to the PWM Rules, 2016. A summary of the major amendments is described below:

      1. Extension in date of filing of annual returns for FY 2022-2023: The Producers, Importers, Brand Owners (PIBO’s) and Recyclers of Plastic Packaging Waste will have to file the annual returns for the FY 2022-2023 by 31st March 2024. This extension is granted only for the FY 2022-2023.
      2. Dates to file annual return by PIBO’s and recyclers: The annual return filing date for PIBO’s is 30th June and for Recyclers is 30th April of next financial year to which the return relates.
      3. Definitions of Importer, Manufacturer and Producer has been amended:
        • “Importer” means a person who imports for commercial use, any plastic packaging or any commodity with plastic packaging or carry bags or plastic sheets or like material, or plastic raw material including in the form of resin or pellets, or intermediate material to be used for manufacturing plastic packaging such as films or preforms.
        • “Manufacturer” means and includes a person engaged in production of plastic raw material, including compostable plastics and biodegradable plastics.
        • “Producer” means a person engaged in manufacturing of plastic packaging; and, includes a person engaged in manufacture of intermediate material to be used for manufacturing plastic packaging, and also the person engaged in contract manufacturing of products using plastic packaging or through other similar arrangements for a brand owners.
        Source:  bit.ly/4cnitjy

      Posted on

      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.

      Prior Government approval not necessary for using unreliable or untested artificial intelligence (AI) in India
      India’s Ministry of Electronics and Information Technology (MeitY) has revised its controversial advisory on use of AI, and has done away the requirement of permission from Indian Government prior to use of under-testing/unreliable AI products. However, the requirement to label under-testing/unreliable AI products prior to making them available to users, and to obtain informed consent prior to use of such products by users continues.
      Source: bit.ly/3VlHOUI

      Indian Patent Rules have been amended significantly
      The Patent (Amendment) Rules, 2024 notified by India’s Ministry of Commerce and Industry have introduced several key changes to patent framework. The time-limits for foreign applications, notice of pre-grant oppositions and request for examinations has been revised. Additionally, the revised rules now require permit a patentee or a licensee to furnish a statement of working of patent only once every three years, as opposed to once every year.
      Source: bit.ly/49TDwZl

      India’s Food Regulator confirms that there is no specific food standards for seeds of fruits and plants
      India’s Food regulator, Food Safety and Standards Authority of India (FSSAI), has confirmed that there are no specific food standards for edible dried seeds obtained from fruits and vegetables as of now. Importers and manufacturers can follow the current standards and obtain license under the parent category of dried fruits and dried vegetables till such time specific standard is notified by FSSAI.
      Source: bit.ly/3VnSNNI

      India’s New Code on Interaction between Industry and Doctors may not be enforceable
      India’s Department of Pharmaceuticals (DoP) published Uniform Code of Pharmaceutical Marketing Practices (UCPMP) 2024 to regulate the interaction between doctors and pharma and medical device companies. The DoP has not described UCPMP 2024 as voluntary, which it had done in for UCPMP 2015. This implies that the UCPMP may be mandatory. However, concerns are being raised by experts on the enforceability of UCPMP 2024 due to absence of statutory backing.
      Source: bit.ly/3vj0JoH

      India’s antitrust regulator to examine in-app billing practices of Google
      The Competition Commission of India (CCI) has initiated an investigation against Google for abusing its dominant position through its new user Choice Biling System. CCI has taken a prima facie view, based on information received by multiple stakeholders, that Google’s new policy skews and disrupts market competition in the downstream app markets and continues to favour Google’s apps while cementing its position in the payment processing market as well.
      Source: bit.ly/3THykCh

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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

      Posted on

      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.

      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

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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 marketing code for pharmaceutical companies notified; Pharmaceutical Associations to set up dedicated portal for handling complaints of violations
      The Department of Pharmaceuticals has notified Uniform Code for Pharmaceutical Marketing Practices (UCPMP) 2024. In order to ensure strict compliance with UCPMP, all pharmaceutical associations are required to establish an Ethics Committee for Pharmaceutical Marketing Practices (ECPMP) and set up a dedicated UCPMP portal on their websites. Unlike the previous iteration of the code, the 2024 iteration has explicitly permitted pharma and medical device companies to provide brand reminders up to Rs. 1000 per item, and has also allowed another informational and educational items to be included in the category of brand reminders.
      Source: bit.ly/3IClT44

      New law for regulation of prices of Drugs and Medical Devices soon; Indian Government constitutes a high level committee
      India’s Department of Pharmaceuticals has constituted a committee which has been tasked to draft a new Drugs and Medical Devices (Control) Order. The committee will also examine pricing regulation for drugs and medical devices with focus on balancing price availability for essential medicines and price moderation for medical devices without hindering growth of industry.
      Source: bit.ly/3v8Nff5

      Government can give precedence to quality over price in tenders of life saving medical devices: High Court
      The High Court of Jharkhand in India, while deciding on the validity of decision rendered by Tender Committee for medical devices, has stressed that pricing cannot be the sole criteria for awarding tender, and the Tender Committee was within its right to consider quality of the medical devices in addition to pricing. The Court observed that judgments made by expert committees must not be subject to scrutiny by courts and in cases involving tenders, the focus should solely be on the decision-making process rather than the perceived validity of the decision itself.
      Source: bit.ly/3ICmNOi

      Export of human blood and human blood components samples will require NOC from Drugs Regulator or Indian Council of Medical Research
      India’s Ministry of Commerce has amended its export policy put restrictions on export of samples of human blood and biologicals such as anti-sera made from human blood. If the purpose of export of sample relates to its use in development of a drug, then a NOC from Central Drugs Control Organization (CDSCO) will be required. In all other cases, a NOC from Indian Council of Medical Research (ICMR) will be required.
      Source: bit.ly/3VbtuhG

      Anti-trust Committee recommends law to regulate conduct of large digital enterprises
      The Committee of Digital Competition Law has recommended that the Indian Government should proactively regulate behaviour of large digital enterprises, and that the Competition Commission of India (CCI) should intervene before instances of anti-competitive conduct transpire. At present, CCI has powers to intervene after anti-competitive conduct has been committed. Large digital enterprises are enterprises which have significant presence and financial strength, and provide core digital services.
      Source: bit.ly/3PokH8j