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TOP 5 HEALTH LAWS AND POLICY UPDATES

1. The Madras Court in a recent order, held that the current status-quo regarding online sale of Drugs i.e. sale being facilitated only through licensed chemists and pharmacists shall prevail, until either the Central Government frames rules or the Delhi High Court issues further orders/judgment.
Source: bit.ly/45Uxfv2

2. The Jharkhand High Court has reaffirmed precedent laid down by the Supreme Court in Martin F. D’Souza v Mohd. Ishfaq, that a private complaint against a doctor for medical negligence should only initiated by a consumer forum or criminal court, the same should be referred to a doctor/expert panel to ascertain whether there is a prima-facie case for negligence.
Source: bit.ly/3VRPooP

3. In light of recent surge in cases of dengue in Bengaluru, the Karnataka Government has issued an order to cap the price of Dengue NSI Antigen and ELISA Igm Antibody tests, conducted in Private Hospitals and Diagnostic Centres, at Rs. 250, and 300 respectively.
Source: bit.ly/3LdE1ms

4. The Delhi High Court has recently held that conversations on WhatsApp will be considered electronic record under Sec. 65B of the Act and require the necessary certificate from a person responsible for operating the computer device to generate the WhatsApp message.
Source: bit.ly/4eMwb0p

5. The head of the US’s AI task force, among others, has stepped down from his role as director at the Coalition for Health AI, the recently set up Industry Body that was aimed at guiding the US Government for setting up policy framework for regulating AI use in the Healthcare Sector.
Source: bit.ly/3VQ4zyW

 

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India’s Food Regulator FSSAI Introduces Instant License and Registration for Food Businesses with Some Exceptions

India’s Food Regulator Introduces Instant License and Registration for Food Businesses with Some Exceptions_1

India’s central food regulator, the Food Safety and Standards Authority of India (FSSAI), has made a policy decision to issue instant registrations and licenses to food businesses in India. The instant registration or license will be valid for one year and may be renewed in a regular course.

Background

All food businesses in India require either a registration or license to operate. Whether a food business will require a registration or license depends on (a) the scale of the business (b) the nature of the business and (c) the number of States in India in which the business will operate. A registration will be typically granted by the State-level Food Regulators, and license may be granted either by State-level or Central Food Regulator (FSSAI).

As per current timelines prescribed in the Food Safety and Standards (Licensing and Registration of Food Businesses) Regulations, 2011, the food regulators may take anywhere between seven days and a month to grant a registration, and up to two months to grant a license. These timelines are sometimes compounded if, during the pre-registration / pre-license inspection, the inspector directs the applicant to make improvements before the registration/license may be granted.

Tatkal (Instant) System of Food License

To improve the ease of doing business for businesses, the FSSAI has streamlined the process for granting license such that the registration/license for food businesses could be made available instantly without inspection. Of course, the registered/licensed food business will be subject to future inspection and requirements to comply with inspection related improvements.

The said ‘Tatkal’ (instant) license facility will be made available to the following categories of food businesses: importers, wholesalers, distributors, retailers, transporters, non-atmospheric-controlled storage providers, food vending agencies, direct sellers, merchant exporters, petty retailers such as snack and tea shops, and mobile food vendors (hawkers).

However, this Tatkal registration or license will not be issued to food business operators dealing in milk, meat, and fish. Also, the applicant should not have had their registration or license suspended or cancelled in the prior three months before the date of application.

Before applying, every food business should thoroughly evaluate their application. Providing incorrect information regarding the Kind of Business or failing to meet eligibility requirements can result in fines of up to Rs. 10 lakhs.

Conclusion

The decision to issue tatkal (instant) registrations and licenses is a very pragmatic step taken by the Indian Government to improve the ease of doing business for food business operators. The facility will be initially available only for individuals who own food businesses (proprietors) and be rolled out in Assam, Delhi, Gujarat, Jammu & Kashmir, and Kerala. It is expected to be eventually extended to partnerships/registered firms and be available to businesses in other States and Union Territories as well.

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TOP 5 HEALTH LAWS AND POLICY UPDATES

The new criminal code, Bharatiya Nyaya Sanhita (BNS) has replaced the Indian Penal Code (IPC) and introduced stricter penalties for medical negligence. Registered Medical Practitioners can now face up to two years in jail and fines for medical negligence. The new law will apply from July 1, 2024.
Source: bit.ly/3RXnx5t

The Central Pollution Control Board (CPCB) has extended the last date of filing of annual returns by the registered producers, importers, brand owners (PIBOs) and plastic waste processors for FY 2022-24 and FY 2023-24 respectively till September 2024. The earlier timeline to file the annual returns were June 30, 2024 and April 30, 2024 respectively.
Source: bit.ly/3XQtxAY

In an effort to decrease reliance on imports and to promote domestic production of medical devices, the Department of Pharmaceuticals (DoP) reportedly intends to launch a new program that will provide shared facilities for medical device parks or clusters that are formed with the exclusive financial assistance of the state governments.
Source: bit.ly/3xU6b2u

The Enforcement Directorate (ED) is investigating an alleged nationwide network of contraband dealers and has placed several pharmaceutical companies under scrutiny who are engaged in the production of drugs and opioids as a measure to prevent the creation of illicit distribution networks through fraudulent sale and supply bills.
Source: bit.ly/3VNzoEw

The United States Food and Drug Administration (USFDA) has published a draft guidance that removes the requirement of undertaking switching studies for applicants undertaking an approval for treating Biosimilars as interchangeable. The USFDA has now made switching studies optional for biosimilar approvals. Hence, persons applying for approval for Biosimilars may now use computer modelling based on the current acceptable analytical technologies to demonstrate the Biosimilars as interchangeable.
Source: bit.ly/4eQUudy

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TOP 5 HEALTH LAWS AND POLICY UPDATES

In order to procure equipment from foreign manufacturers, by floating a Global Tender Enquiry for any procurement up to INR 200 Crore, normally the concerned ministry is required to seek prior approval, and that too in exceptional circumstances. This requirement has now been exempted for certain medical devices upon request by the Ministry of Health and Family Welfare, as a result, all departments and ministries (where applicable) seeking procurement of the 161 Medical Devices listed in this Notification, shall be free to issue Global Tender Enquiries without prior approval.
Source: bit.ly/3zmmGVs

While currently Registered Medical Practitioners are encouraged to use the generic names of Drugs, they are not barred from prescribing branded Drugs, nor are they restricted to prescribe specific dosages. In this connection the Bangalore based association of Chemists and Druggists, has sought clarification regarding the obligations of registered Pharmacists, with respect to drug substitution and sale of non-standard quantity of Drugs to patients when the prescription dosage does not match the minimum pack size available from the manufacturer, along with raising concerns on the recent restriction on discount advertisement imposed by the Maharashtra Pharmacy Council.
Source: bit.ly/3LeL4Lj

In light of the recent recall of Indian manufactured spices in various countries, India’s Central food regulator, the Food Safety Standards Authority of India had conducted extensive testing of samples and has suspended licenses 111 small and medium sized exporters for not meeting standards despite the increased Minimum Residue Limits.
Source: bit.ly/4bnDQQ5
Source: bit.ly/3L4UXLP

The Rajasthan High Court has taken Suo Motu cognizance of the rising cases of food adulteration across the state, recognizing a need to plug the existing gaps in the Food Safety and Standard Act, 2006 (FSS Act, 2006). IN pursuance whereof, it passed orders to the Central and State Governments to more efficiently implement the FSS Act 2006, by identifying and targeting high-risk areas for sample collection, conducting tests with greater frequency, instituting state and district level committees for review of measures taken, and create general awareness among consumers.
Source: bit.ly/4bv1JF8

The International Medical Device Regulators Forum (IMDRF) has published guiding principles for Good Machine Learning Practice, for the use and implementation of AI and Machine Learning tools into medical devices. These guiding principles include: Leveraging multi-disciplinary expertise throughout the lifespan of the products, ensuring the training and test data-sets are separate, focusing on performance of human-AI collaborating team, and use of data-sets based on current best practices.
Source: bit.ly/4ePEmsQ

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TOP 5 HEALTH LAWS AND POLICY UPDATES

The Department of Pharmaceuticals (DoP) has extended the deadline for filing a self-declaration under the Uniform Code for Pharmaceutical Marketing Practices, 2024 (UCPMP) to July 31st, 2024. The prior date for filing the self-declaration was June 30th, 2024.
Source: bit.ly/4coX09h

The Central Drugs Standard Control Organization (CDSCO is considering making the international nomenclature of cosmetic ingredients (INCI) mandatory on all cosmetic product labels to improve transparency and identification. The unified INCI method will help customers understand product compositions while assisting dermatologists and regulators in monitoring component safety. The move is intended to avoid confusion, improve compliance, and increase the marketability of safe products.
Source: bit.ly/3L6jz6J

A Super Speciality Hospital and one of its doctors were ordered by the State Consumer Disputes Redressal Commission (SCDRC) to compensate its patients for medical negligence. The reason for the directive was that the specialist doctor had given his responsibility to a junior and neglected to attend to the patient, which led to an incorrect diagnosis and treatment, which constituted medical misconduct.
Source: bit.ly/3zrpKQn

The Central Drugs Standard Control Organization has ordered the closure of more than 36% of the 400 drug manufacturing facilities located throughout India after an increase in inspection following deaths associated with substandard cough syrups.
Source: bit.ly/4eKMs5Y

In an effort to regulate false and misleading nutritional claims and health claims made by e-commerce platforms, the Food Safety and Standards Authority of India (FSSAI) is planning to impose stricter controls on advertisement and sale of protein supplements and shakes in India.
Source: bit.ly/45KzjpF

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TOP 5 HEALTH LAWS AND POLICY UPDATES

The Central Drugs Standard Control Organization (CDSCO) may initiate the process of developing a guidance document that will outline methods for the safe disposal, collection, storage, and transportation of unused and expired drugs in accordance with various international recommendations. This follows a recent modification to Schedule M of the Drug Rules, which outlines standards for producers to store waste material properly and safely until disposal.
Source: bit.ly/4cEM07z

The Madras High Court’s division bench has overturned a 2018 single-judge order prohibiting online pharmacies from digital trade, providing a significant boost to the sector. This ruling is expected to influence ongoing cases, where the government may finalizing policies for regulating online drug sales.
Source: bit.ly/3RGccqb

In an instance of medical negligence, the National Consumer Dispute Redressal Commission ordered hospital officials to pay Rs. 200,000 in compensation for failing to show the patient the pacemaker as part of proper procedures and consultation, resulting in a deficiency in services.
Source: bit.ly/4brby74

The Study highlighting issues with self-regulation of UK pharma industry was released presenting patterns of company misconduct, recidivism, and complaint resolution delays within the European context.
Source: bit.ly/45MTZ03

The Ministry of Health and Family Welfare has suspended the mandatory linking of Central Government Health Services (CGHS) beneficiary ID with Ayushman Bharat Health Account (ABHA) ID, making it optional until further notice, due to practical issues and data privacy concerns.
Source: bit.ly/4buGLGM

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TOP 5 HEALTH LAWS AND POLICY UPDATES

India’s Central Pollution Control Board has issued final warning to all Producers, Importers, Brand Owners and Plastic Waste Processors, to complete Extended Producer Responsibility (EPR) registration on dedicated EPR portal latest by June 30, 2024, or face punishment.
Source: bit.ly/4cgRsxK

India’s Health Ministry has published Guidelines for Ethical Use of Leftover De-identified/ Anonymous Samples for commercial purposes.
Source: bit.ly/3RIc0XE

The Committee on Energy and Commerce in Congress of the United States of America has sought reply from US Food and Drugs Administration (US FDA) about institutional weaknesses in US FDA’s foreign inspection program over variations in inspection outcomes from India and China.
Source: bit.ly/3RF3xEH

India’s Karnataka High Court has formed a sub-committee to draft rules for establishing Intellectual Property Division (IPD) in Karnataka High Court. IPD benches are established with specialised judges to cater to Intellectual Property Disputes.
Source: bit.ly/4bmOVR8

India’s Kerala High Court, in a recent case, has framed guidelines for prosecuting guardian of a minor, or the owner of a vehicle driven by a minor, for offences involving vehicle driven by the minor.
Source: bit.ly/3RHALDn

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TOP 5 HEALTH LAWS AND POLICY UPDATES

The US Food and Drug Administration (FDA) has finalized guidance on circumstances that constitute delaying, denying, limiting, or refusing a drug or device inspection. The latest guidance extends the US FDA’s existing inspection standards for drug manufacturing companies to include device manufacturing companies as well.
Source: bit.ly/3XCVD2s

The Department of Pharmaceuticals (DoP) expanded its committee on drug and medical device pricing reform and added key public stakeholders to the committee as special invitees. This special invitees include patient advocacy groups, healthcare providers, and the medical community.
Source: bit.ly/3XDmJ9z

Indian government has formed a committee to assess the feasibility of allowing nutraceutical production within existing drug manufacturing facilities. This follows the recent update to Schedule M of Drugs Rules, 1945, which mandates separate production areas for nutraceuticals and pharmaceuticals.
Source: bit.ly/45JefzF

India’s Drugs Technical Advisory Board (DTAB) is evaluating a ban on chloramphenicol and nitrofuran antibiotics in animal feed due to misuse concerns in poultry and livestock.
Source: bit.ly/3zleFAo

New guidelines on the withdrawal of life support from terminally sick patients have been released by the Ministry of Health and Family Welfare (MOHFW) for healthcare providers and are to remain open for public comments for one month. The guidelines emphasize patient’s autonomy and their right to decline life-sustaining treatment (LST), even if doing so results in death.
Source: bit.ly/3RH4D2P

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TOP 5 HEALTH LAWS AND POLICY UPDATES

India’s Central Consumer Protection Regulator has issued draft Guidelines for Prevention and Regulation of Unsolicited and Unwarranted Business Communication, 2024 for public consultation and suggestions till 21st July, 2024
Source:  bit.ly/4cdCxV0

India’s Consumer Protection Regulator is in discussion with electronic manufacturers to change the warranty period of electronic appliances from purchase date to installation date to address the issue of shortfall in warranty period.
Source:  bit.ly/3zbR7xM

India’s COVID-19 manufacturer adds Indian Council of Medical Research as a co-owner in the patent for the vaccine.
Source:  bit.ly/4cd3esZ

According to a report by an investment banking firm, Indian market has 388 generic pharmaceutical brands with sales of over 100 crores, up from just 21 brands fifteen years ago.
Source:  bit.ly/3XymBrN

The Arbitration Bar of India and Indian Arbitration Forum have expressed their concerns over the Office Memorandum issued by Ministry of Finance providing guidelines for arbitration and mediation in Contracts of Domestic Public Procurement.
Source:  bit.ly/3XymDzV

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Mandatory undertaking before advertising food and health products and services on the internet, TV and print media in India

India’s Supreme Court has exercised its inherent constitutional powers and issued directions that, before an advertisement concerning food and health products or services is displayed/ aired/ printed/, the concerned advertiser / advertising agency will have to issue a self-declaration to the concerned electronic media / T.V. Channel / broadcaster / printer/ publisher/ electronic media stating that the “the advertisement does not make misleading claims and complies will all relevant regulatory guidelines”. A breach of these directions may result in contempt of the Supreme Court and be punishable under the Contempt of Courts Act, 1971. It may also result in breach of relevant sectoral laws, for example, in case of TV advertisements, it may result in breach of Cable Television Network Act, 1995. This has been clarified by Ministry of Information and Broadcasting in its circulars (1, 2).

The key thing to note is that the legal obligation has been cast on the owners and operators of electronic media (Google, Facebook, Instagram, YouTube etc), T.V. Channels, Radio Stations, Print and Digital News Websites etc. to ensure that the prescribed self-declaration is in place before the advertisement is accepted and published.

In order to ascertain the genuineness of the self-declaration, the Ministry of Information and Broadcasting and Press Council of India have respectively created dedicated portals where the self-declaration issued by advertisers/advertising agencies can be accessed and verified.

How to make self-declaration for advertisement over internet and print medium?

An advertiser who wishes to make any advertisement in relation to food or health products (health supplements, drugs, medical devices, dental products, nutraceuticals, food for special medical purposes, cosmetics, condoms etc.) or health services (telemedicine, physiotherapy, dental consultation etc.) over the internet or print medium should take the following steps:

Step 1 – Sign up on the dedicated portal: https://cbcindia.gov.in/cbc/advt-login

Step 2 – Fill the required details, and upload the Letter of Authorization in prescribed format

Step 3 – Generate Self-Declaration by providing mandatory details the following mandatory details:

  1. Product / Service Name
  2. Brief Description of Advertisement Content
  3. Title of Advertisement
  4. Nature of Advertisement (Internet Video, Internet Static, Print)

Step 4 – The Form of Self-Declaration will be automatically generated. It should be downloaded for signatures.

Step 5 – The signed Self-Declaration (which will be autogenerated) should be uploaded. Once uploaded, it should be directly accessible for download by Advertiser as well as general public.

How to make self-declaration for advertisement over TV and Radio.

An advertiser who wishes to make any advertisement in relation to food or health products (health supplements, drugs, medical devices, dental products, nutraceuticals, food for special medical purposes, cosmetics, condoms etc.) or health services (telemedicine, physiotherapy, dental consultation etc.) over the T.V. Channels or Radio Stations should take the following steps:

Step 1 – Sign up on the dedicated portal: bit.ly/3RZh3D5

Step 2 – Fill the required details, and upload the Letter of Authorization in prescribed format

Step 3 – Submit the following mandatory details:

  1. Product / Service Name
  2. Title of Advertisement
  3. Advertisement URL
  4. Date of First Release of Advertisement
  5. Nature of Advertisement (Internet Video, Internet Static, Print)

Step 4 – Upload the Letter of Authorization Form (template provided here: bit.ly/4bBk43E

Step 5- Upload Self-Declaration Certificate (template autogenerated)

Step 6- Submit the Form with details as described above, after uploading the Letter of Authorization and Self-Declaration Certificate.

Once submitted, it should be directly accessible for download by Advertiser as well as general public.

How to verify self-declaration made by advertisers

Owners and operators of electronic media, and print and digital publications, may visit the following link to verify if the self-declaration of advertiser is genuine or not: https://cbcindia.gov.in/cbc/advt-public-list

Owners and operators of T.V. Channels and Radio Stations may visit the following link to verify if the self-declaration of advertiser is genuine or not: bit.ly/4bBk43E

How to ensure that advertisement does not make misleading claims and complies with all relevant laws?

The Indian law surrounding misleading claims is scattered across various statutes, and has been shaped by Courts to keep pace with changing times. The key legislations which apply to food and health products and services are: Consumer Protection Act, 2019, The Guidelines for Prevention of Misleading Advertisements and Endorsements for Misleading Advertisements, 2022, The Food Safety and Standards Act, 2006, The Food Safety and Standards (Advertising and Claims) Regulations, 2018, The Drugs and Magic Remedies (Objectionable Advertisements) Act, 1954) and Rules, 1955, The Drugs and Cosmetics Act, 1940, and Drugs Rules, 1945, The Medical Devices Rules, 2017 and The Cosmetics Rules, 2020, The Legal Metrology Act, 2009 and Legal Metrology (Packaged Commodities) Rules, 2011.

Conclusion

Considering the Supreme Court order and Circulars of the Ministry of Information and Broadcasting, all advertisers, broadcasters and publishers (both print and digital, video and static medium) must now ensure compliance with the requirement of self-declaration and familiarize themselves with misleading advertisement laws.