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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.

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

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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.

All manufacturers, importers and brand owners of products using plastic packaging must register by 31st March 2024 with Pollution Control Board

India’s Pollution Control Board has given a final opportunity to manufacturers, importers and brand owners of products which use plastic packaging, to register with appropriate Pollution Control Board under provisions of Plastic Waste Management Rules, 2016. Such entities are required to register and discharge Extended Producer Responsibility (EPR) by buying EPR Credits from registered recyclers of plastic packaging waste.

Source: bit.ly/3PGd79b

 Central Consumer watchdog and Industry Regulators of Advertisements enter into collaboration to curb misleading advertisements

India’s Central Consumer Protection Authority (CCPA) has announced a collaboration with the industry’s self-regulatory advertisement body called Advertisements Standards Council of India (ASCI). Under the collaboration, ASCI will forward details of advertisement found to be in breach of its own misleading advertisement guidelines to the CCPA since such advertisements may also be violative of the law on misleading advertisement in India.

Source: bit.ly/3Q1U3CL

Imported devices containing foreign embedded SIM for use in M2M communication have to mandatorily shift to services provided by Indian telecom providers within six months

India’s telecommunication regulator, Telecom Regulatory Authority of India (TRAI), has issued specifications and licensure requirements for the implementation of use of embedded Sim technology in Machine-to-Machine (M2M) communication, which is seeing more and more use for remote diagnosis and monitoring in healthcare sector, since launch of 5g sim technology in the country. All communication profiles on any M2M eSIM fitted in an imported device on international roaming in India should be mandatorily converted/reconfigured into communication profiles of Indian telecom service providers (TSPs) within a period of six months from the date of activation of international roaming on such M2M e-SIM or on change of ownership of the device, whichever is earlier.

Source: bit.ly/4cyHEPZ

US FDA’s scientific authority to regulate drugs under challenge

A suit before the United States Supreme Court is challenging the decision of the United States Food and Drug Administration (FDA) in 2016 to expand scope of prescription of Mifepristone 2000, a drug that is commonly used to carry out medicated abortion procedures, and permit its prescription via telemedicine. Ex-Commissioners of US FDA have expressed concern that a decision in favour of the petitioners may lead to an environment of uncertainty where any US FDA approval granted to a drug could be challenged in future on scientific grounds even if it was approved by the US FDA.

Source: bit.ly/49dk4p2 

New reserve sample retention quantity requirements for BA and BE studies in US

The United States Federal Food and Drug Administration (US FDA) has published the final version of a guidance document that prescribes new reserve sample retention requirements for Bioavailability (BA) and Bioequivalence (BE) Studies. In the Guidance Document, US FDA has prescribed retention of 30 Single Dose, and 3 Multi Dose samples (with at least 1 unit in original container) across all sites carrying out In-Vivo studies, and 30 Single Dose, and 3 Multi Dose samples in original container for In-Vitro studies.

Source: bit.ly/3xeLrC7  

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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.

Good Distribution Practices may be implemented in India for pharmaceutical products soon
India’s Drugs Consultative Committee (DCC) has recommended that draft of revised Good Distribution Practices (GDP) guidelines for pharmaceutical products should be made mandatory soon. The DCC is of the view that there is a gap in the law which requires owners of premises such as warehouses to ensure appropriate storage condition for drugs, but no such requirement exists for transporters who transport the drugs, and this affects the quality of drugs.
Source: bit.ly/49cMPCk

TB vaccine clinical trials begins in India
A Hyderabad based biotechnology company has started Phase 3 clinical trials of tuberculosis (TB) vaccine called MTBVAC among the adults in India. The vaccine is the first live attenuated vaccine of Mycobacterium tuberculosis isolated from human strain, unlike the BCG vaccine.
Source: bit.ly/495Zuak

Medical and Sales Representatives’ body says new Pharma Marketing Code lacks teeth
The Federation of Medical and Sales Representatives’ Associations of India (FMRAI) has criticized the newly notified Uniform Code for Pharmaceuticals Marketing Practices (UCPMP), describing it as a futile effort. It stated that the new code lacks statutory enforcement and contains no explicit penal provisions against unethical marketing by pharmaceutical and medical device companies.
Source: bit.ly/495ZAic

Fire safety in hospitals should be evaluated by Government before Summer Season: Disaster Management Body
India’s Union Health Ministry and National Disaster Management Authority (NDMA) have jointly issued an advisory to all States and Union Territories (UT’s) to take proactive measures to check fire safety compliance of all hospitals before the incoming summer season.
Source: bit.ly/4akq9Bg

No change in surrender value norms for life insurance policies: Insurance Regulator
The Insurance Regulatory and Development Authority of India (IRDAI) has decided to retain the current surrender value requirements for life insurance policies due to concerns over higher surrender value expressed by the industry. Surrender value in life insurance is an amount paid by the insurer to the policyholder when the policy is terminated prior to the policy’s maturity date.
Source: bit.ly/43zOkcL

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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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      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

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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.

      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

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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.

      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.

      Airlines have to obtain single caterer license and provide invoice containing description of license number for chargeable in-flight meals
      India’s food regulator, The Food Safety and Standards Authority of India (FSSAI), has issued an advisory to flight operators directing them to ensure that they have appropriate license for providing in-flight food. The regulator has also directed flight operators to ensure that appropriate invoice with license number is issued for sale of food, and that both ready-to-serve and pre-packaged food carries appropriate labelling declaration.
      Source: bit.ly/48NrSxN

      In medical negligence matters, exoneration by medical council will not automatically mean exoneration before consumer forum, especially if contradictory medical evidence has been furnished: Supreme Court
      India’s Supreme Court has held that a consumer commission which is deciding a complaint of medical negligence against a medical practitioner, should not solely rely on favourable report from State Medical Council especially if the complainant has submitted contradictory expert testimony from another medical practitioner.
      Source: bit.ly/3Isb30J

      Import of medicines to get boost from India’s free-trade agreement with four countries of European Free Trade Association (EFTA)
      Four European Free Trade Association states, namely, Iceland, Liechtenstein, Norway and Switzerland, have signed a Trade and Economic Partnership Agreement with India for facilitating trade and investment flows. While India has secured soft investment commitments under the Agreement, EFTA states have been given concession on import duty on pharmaceutical products exported to India and have been promised simplified customs procedure.
      Source: bit.ly/3TuP8w9

      Limits for automatic exemption in combination cases before CCI increased
      The Indian government has increased the asset and turnover thresholds for automatic exemption under India’s anti-trust regulations. For claiming the exemptions from prior approval requirement, the value of assets being acquired should be Rs. 450 crores as opposed earlier threshold of Rs. 350 crores. Similarly, the turnover should be Rs. 1250 crores as opposed earlier threshold of Rs 1000 crores.
      Source: bit.ly/3VaYle6

      Electrical appliances for hair and skin care would require Indian Standard Marks for sale in India from 4th March 2025
      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 skin and hair electrical appliances to obtain an Indian Standard Mark (IS mark) from Bureau of Indian Standards (BIS) in order to be able to sell 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.
      Source: bit.ly/4c8wSzW

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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.

      Scientific works are not protected under India’s Copyright Law: High Court
      India’s High Court of Andhra Pradesh has held that India’s copyright law only protects original literary, dramatic, musical and artistic works. It does not protect scientific works, as covered under books of Mathematics, Physics, Chemistry, Botany and Zoology used by Students. The Court clarified that mathematical equations and science subjects do not qualify as ‘original works’ because they are the matter of fact and nature.
      Source: bit.ly/432GSqc

      All rare disease drugs imported into India will be exempted from requirement to pay customs duty: High Court
      India’s Delhi High Court has issued an order exempting drugs and medicines used in therapy for rare diseases from requirement of payment of customs duty. Prior to the order, the exemptions from payment of customs duty was limited to drugs used for treatment of Spinal Muscular Atrophy (SMA) or Duchenne Muscular Dystrophy (DMD). Earlier the Court had directed the National Rare Diseases Committee to hold deliberations with manufacturing and marketing companies to explore the possibility of procuring the medicines at a reasonable price.
      Source: bit.ly/3T1H2JN

      Flow of counterfeit products into Indian market to be checked through a new surveillance system
      India’s Ministry of Consumer Affairs is planning to develop a new surveillance system to identify counterfeit products sold in the retail market. The Ministry proposes to collect samples soon after they enter the retail market and test them under new laboratories which will be set-up specifically for the purposes.
      Source: bit.ly/3T5EKta

      Online gaming guidelines to prevent compulsive gaming in India to be published
      India’s Department of Consumer Affairs (DoCA) is planning to commission a research on the disruptive impulse control behavioural patterns of digital consumption that may cause vulnerabilities. The initial part of the research will be focused on online gaming addiction. The research would later be expanded to identify the underlying factors of excessive consumption of online content. The findings of the research would be used to provide policy inputs for framing of the Guidelines for protecting the interests of the consumers.
      Source: bit.ly/3T1hXPb

      US BioSecure Act to impact Indian biotechnology companies providing services or manufacturing products for US market
      The BIOSECURE Act which has been introduced in the US House of Representatives prohibits US federal agencies from entering into contract with any entity that uses biotechnology equipment or services from a biotechnology company of concern to perform a federal contract. Some Chinese companies have been identified as biotechnology company of concern, and the list may be expanded to include companies from Russia, Iran and North Korea as well.
      Source: bit.ly/3V5yQeq

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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.

      India takes baby steps in regulation of Artificial Intelligence, puts in place prior consent requirement before deployment of AI
      India’s Ministry of Electronic & Information Technology has reportedly advised platforms and intermediaries which employ artificial intelligence (“AI”) models or generative AI software, algorithms to mandatorily obtain government approval before offering their services. Additionally, platforms or intermediaries using unreliable AI models or algorithms should label themselves as “under testing” and take explicit consent from users, making them aware of potential errors in the technology.
      Source: bit.ly/430rwT8

      Indian Government to hold discussions with private hospitals on capping of medical treatment rates
      India’s Ministry of Health and Family Welfare is reportedly in discussion with major corporate hospitals on the possibility of capping of medical treatment rates. India’s Supreme Court last week had directed the Ministry to exercise its powers under Clinical Establishment Rules for prescribing ceiling prices of medical treatments, and threatened that if it did not do so, the Court will itself direct the Ministry to notify Central Government Health Scheme (CGHS) rates as ceiling prices for medical treatments across the country.
      Source: bit.ly/3wGw6di

      Eye drops in India may soon have to be sold in transparent bottles to detect contamination
      India’s central drug regulator, the Drugs Controller General of India, has called a meeting with pharmaceutical manufacturer associations to propose the use of transparent bottles in packaging eye drops. It is expected that use of transparent bottles will help detect contamination and particulate matter, so that any damage to the eye due to contaminated or spurious eye drops may be avoided. Most eye drops are currently sold in opaque bottles.
      Source: bit.ly/3UX4Lxv

      Yogurt makers may lawfully claim that it can reduce the risk of type 2 diabetes: US FDA
      The U.S. Food and Drug Administration has reportedly allowed dairy-based yogurt makers to claim that Yogurt may reduce the risk of type 2 diabetes. However, the US FDA has recommended that the claim may be used carefully in yogurts that contain high levels of added sugar.
      Source: bit.ly/3STFDF2

      Legal validity of US Medicare drug price negotiation program upheld
      A federal judge in Delaware in US has upheld the legal validity of U.S government’s condition that manufacturers of Top 10 drugs which are used in Medicare health insurance program will have to reduce prices or stop supplying to the program. This is the third positive court ruling in favour of US Government in the last few weeks on the subject of price negotiations.
      Source: bit.ly/4bZbOM8