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.

Delay condonation should be evaluated based on reasons provided and not merits of case: Supreme Court
In a recent decision, the Supreme Court held that in condoning delay for a filing for which limitation period has been stipulated under the Limitation Act, 1963, a Court should not base its decision on whether such delay has been condoned in a similar matter, evaluating delay on merits of the fact situation, but rather each delay should be evaluated on the grounds pleaded in the application for its condonation.
Source: bit.ly/49MllnH

Central Government to take strict action against non-compliance with quality maintenance in manufacture of fire-resistant fabrics raw material
The Indian Central Government is intending to take stringent action against violators of the Bureau of Indian Standards (BIS) Quality Control Order for raw material used to manufacture fire-resistant fabric used in upholstery used in commercial spaces such as cinema halls, conference halls etc. Pursuant to issue of this Quality Control Order, only those raw material that have been certified by the BIS may be used in manufacture of commercial space upholstery. However, this Quality Control Order does not apply to upholstery used in households or those manufactured for export.
Source: bit.ly/4cKT4R3

Indian Government partners with Quality Council of India to improve services at Central Government run hospitals
India’s Central Ministry of Health and Family Welfare has entered into a Memorandum of Understanding with the Quality Council of India, to help improve quality standards for healthcare delivery at government run hospitals and help the hospitals get accredited by the National Accreditation Body for Hospitals/ Laboratories.
Source: bit.ly/3Ub0ful

Prices of imported Active Pharmaceutical Ingredient see sharp decline due to action against cartelized manufacturers
Despite an increase in demand in the Indian domestic pharmaceutical manufacturing sector for Active Pharmaceutical Ingredients (APIs), indicated by a 39% increase in year-on-year imports, the price of APIs being imported from China and other countries has reduced significantly to pre-COVID levels. This reduction is suspected to be caused by breaking-down of manufacturing cartels. This reduction in prices of API signifies an increase in profit margins for Indian firms which have traditionally been depended on Chinese imports.
Source: bit.ly/43Qlo0d

ECHR holds that inaction against climate change may be considered violation of human rights
The European Court of Human Rights has issued an award in favour of several Switzerland based petitioners who brought claims against their Government. The Court held that the European Convention on Human Rights envisages citizens right to be protected by their government against adverse effects of climate change. The petitioners had claimed that the inaction of the Swiss government and insufficient mitigation measures had caused a violation of the petitioners’ human rights, since such inaction by the government has increased their likelihood of dying of heat stroke.
Source: bit.ly/3JbMLZ6

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.

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

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.

Indian Government may soon have to explain why traditional medicines are outside the scope of its flagship Universal Health Coverage scheme, or include it

India’s Delhi High Court has directed the Indian Government to provide reasons for excluding ayurveda, yoga, and naturopathy treatments are not covered by its Universal Health Coverage scheme (Ayushman Bharat) or if there is a plan to include it, then describe the steps for including them. The direction was issued in response to a Public Interest Litigation (PIL) Petition.
Source: bit.ly/43R0pdJ

Applications invited from private medical device testing laboratories to enable them to test medical devices on behalf of manufacturers
In a first of its kind development, India’s central medical device regulator, Central Drugs Standards Control Organization (CDSCO), has published a notice on its website inviting private medical devices testing laboratories to submit applications for obtaining licenses to test medical devices on behalf of manufacturers. Medical devices cannot be sold after manufacturing without testing by an in-house or external lab, and micro and small-scale manufacturers of medical devices are finding it a challenge to get their medical devices tested due to shortage of private medical testing laboratories.
Source: bit.ly/3TNyMNV

Right against adverse effects of climate change is now a fundamental right of Indians
The Supreme Court of India has interpreted Article 21 of the Indian Constitution, which recognizes the right to life and personal liberty, to include right against adverse effect of climate change. The Supreme Court’s interpretation came in a controversial litigation where the Court had to balance the need to take urgent steps to conserve Great Indian Bustard (GIB) with the need to use land inhabited by GIB for use to generate renewal solar and wind energy.
Source: bit.ly/3vHjIJU

Extension granted to foreign manufacturers of high-risk food products such as nutraceuticals, infant food, milk products for registration with Indian food authority till 31st August, 2024 
India’s central food regulator, Food Safety and Standards Authority of India (FSSAI), has extended the timeline for registration of foreign facilities which manufacture high risk food products, until 31st August, 2024. The high-risk food products are nutraceuticals, infant food, milk and milk products, meat and meat products (including poultry, fish and their products) and egg powder.
Source: bit.ly/3U8vEOd

Study indicates that more than half of cancer drugs which receive accelerated approval do not demonstrate clinical benefit in confirmatory trials
A study published in the Journal of the American Medical Association indicated only 43% of cancer drugs which were granted accelerated approval have demonstrated a clinical benefit in terms of patient survival or quality of life in confirmatory trials conducted in US. Accelerated approvals or early approvals are marketing approvals granted by Regulatory Authorities to drugs which show promising initial results for treating debilitating or fatal diseases.
Source: bit.ly/3U5XGd8

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.

No significant hike in prices of essential medicines: Indian Government
India’s Ministry of Health and Family Welfare has issued a clarification in response to reports about the significant increase in medicine prices by an increase in the Wholesale Price Index (WPI) of 0.00551% for the FY 2023-2024. It has been clarified that the increase is a miniscule increase and will not have any substantial increase in the prices of medicines. WPI increase is the maximum increase permissible and the manufacturers may or may not avail this increase in price for the medicines.
Source: bit.ly/43I1OmR

Foreign medical graduates should receive same internship stipend as medical graduates who have completed education in India: Supreme Court
The Supreme Court of India has directed medical colleges to treat foreign medical graduates on par with Indian medical graduates in terms of stipends paid by the medical colleges during internship, on grounds of fairness and equity. The Court has also warned medical colleges of strict action if they discriminate against foreign medical graduates.
Source: bit.ly/3J3gAuX

Digital database for organ donation to be rolled out soon by Indian Government
India’s National Health Authority (NHA) and the Ministry of Health and Family Welfare are likely to roll out a National Digital Organ Donor Register which is aimed at building a comprehensive database of prospective organ donors to meet increasing demand for organ transplant and to regulate organ donation in the country. The digital register will reportedly maintain records of prospective donors and patients waiting for organ transplant in a confidential manner.
Source: bit.ly/3TGWrQh

Export of fresh fruit and vegetable to receive a boost from Indian Government
India’s Commerce Ministry is reportedly seeking to facilitate export of agricultural products, including fresh fruits and vegetables, to new markets such as US, European Union and African countries with an aim to double India’s agricultural exports, bring foreign exchange, and address the existing export-import imbalance due to ban on export of wheat and rice.
Source: bit.ly/43MOrSv

China relaxes regulations on Cross Border Data Transfer
The Cyberspace Administration of China (CAC) has introduced revised cross-border data transfer regulations. The revised regulations have reportedly eased compliance burdens on companies, which should facilitate more cross-border flow of data.
Source: bit.ly/3PMdlvq

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.

E-Commerce websites instructed to avoid marketing Milk/ cereal/ malt based drinks as “Energy Drinks”
India’s Food Standards Regulator (the Food Safety Standards Authority of India) has issued an advisory to e-commerce websites, requiring them to ensure that proprietary foods, i.e. foods that are not categorized under the Food Standards Regulations, specifically those currently registered as analogues to milk/ cereal/ malt based beverage, should not be advertised as “Health Drink”/ “Energy Drink”, as only carbonated/ non-carbonated water-based flavoured drinks are regulated as “Health Drink” and “Energy Drink”.
Source: bit.ly/3xlfzvD

Drug Price Regulator may examine prevalent drug substitution and discounting prices offered by major drug retail stores in India
The Indian Central Drugs Regulator (CDSCO) has reportedly requested the Central Drugs Price Regulatory Body (NPPA) to investigate drug substitution and discounting practices of a major pharmacy chain on the basis a complaint raised by State Chemists and Druggists’ Association of the State of Karnataka (KCDA). In its complaint, the KCDA has alleged that the major pharmacy chain has been deliberately undercutting prices, sustained by substitution of prescribed drugs with other cheaper but identical formulations and unreasonably increasing its profit margins, which is currently violative of regulations applicable to pharmacists, as well as pricing norms of drugs.
Source: bit.ly/4cJSJOg

Vaccine manufacturers may have to provide manufacturing and sales data to government soon
The advisory body to India’s Central Drugs Regulator, the Drugs Consultative Committee, has requested various State-level Drug Licensing Authorities to ensure submission of details of the manufacture and sale of vaccines within the states to the Central Drugs regulator (Central Drugs Standards Control Organization), for the purpose of meeting obligation for the Global Benchmarking of Vaccines of the World Health Organization.
Source: bit.ly/3PJkAEw

Major Ayurvedic Medicine manufacturer may be on hook for contempt of court after Supreme Court rejects its apology for publishing misleading advertisements
In its ongoing proceedings against a major Ayurvedic medicine manufacturer for publication of misleading advertisements in contravention of undertaking given by it to the Supreme Court, the Court has refused to accept the apology which was tendered by the manufacturer, and rejected submissions of the manufacturer that: (1) The restriction on advertisement under the Drugs and Magic Remedies (Objectionable Advertisements) Act, 1954 is archaic and may be relaxed since the manufacturer now has scientific data to back its claims, and (2) that the manufacturer should not be held liable for an advertisement issued by an independent marketing department.
Source: bit.ly/4akJen5

Australia updates Medical Device Recall Procedure
The Australian Therapeutics Goods Administration, which regulates medical devices at the central level in the country, has published a revised version of the Uniform Recall Procedure for Therapeutic Goods (URPTG), which relaxes regulatory burden of importers and manufacturers of medical devices. The revised URPTG provides additional clarity on procedure for immediate recall, clarifying timing of release of recall information by the regulator, modifying Customer Response Forms, and eases the filing requirements under the law by making all templates for recall action publicly available on the website of regulator.
Source: bit.ly/3TAZJEo

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.

Corporate hospitals may soon have to comply with advertisement norms applicable to doctors

India’s National Medical Commission (NMC), which regulates the conduct of medical practitioners (doctors), has endorsed the position that all hospitals should comply with the same standards of ethics as are applicable to doctors under the NMC Registered Medical Practitioner (Professional Conduct) Regulations, 2023. The operation of 2023 Regulations is currently under suspension.
Source: bit.ly/3vpJ7aV

High Court imposes damages of 244 crores in Standard Essential Patents case

India’s Delhi High Court has reportedly imposed damages amounting to INR 244 Crores on an Indian smartphone manufacturer. The Court found smartphone manufacturer guilty of infringing seven patents on 2G, EDGE, and 3G technology granted to a global telecom company. The order is expected to be out soon.
Source: bit.ly/3TxOXyI

Drug Manufacturers will have to upload all product details on Government portal soon

The Drugs Consultative Committee (DCC), a committee comprising State-level Drug Regulators, has recommended that the Central Drugs Regulator, Central Drugs Standard Control Organization (CDSCO), should set a deadline for manufacturers of drugs to upload list of drugs manufactured on an online portal called SUGAM.
Source: bit.ly/3TxP0uo

Ban on trade of ferocious dog breeds has been stayed in various States in India

India’s Kerala High Court, Karnataka High Court and Kolkata High Court has stayed a controversial circular of the Central Government which prohibited import, trading and selling of 23 breeds of dogs identified as ferocious in the circular. The circular also mandated sterilization of dogs from further breeding as pets. The circular has been challenged on the ground that it is unscientific, not based on evidence and has been issued without consultation with relevant stakeholders.
Source: bit.ly/3TVZcyi

European Medicines Agency urges sponsors of clinical trials to register on new portal before January 2025 deadline

The European Medicines Agency (EMA) has strongly advised sponsors of clinical trials that have been approved before 31 January 2023 to submit application to move the clinical trials to the new Clinical Trials Information System (CTIS) as soon as possible, considering it will take EMA up to three months to review and authorize the application. As of now, only 20% of clinical trials have been moved to the new platform.
Source: bit.ly/3TZRzHl

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.

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

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.

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  

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.

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

Posted on

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