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.

1. In its recent annual Budget announcement, the central government has proposed to waive customs tariffs on three additional drugs, used in treatment of cancer.
Source: bit.ly/4dinoSC

2. The Bombay High Court held a Director of a chemical manufacturer criminally liable for export of controlled substances from the country, holding that all officers of companies should keep themselves abreast of the latest regulations, and being ignorant of new notified compliance cannot excuse liability.
Source: bit.ly/46iRp22

3. The Madras High Court stayed a suspension order issued against a branch of a major fast food chain, holding that suspension cannot be ordered without giving an opportunity to improve its practices in pursuance of an Improvement Notice issued under Sec. 32(1) of the Food Safety Standards Act, 2006.
Source: bit.ly/3LFGne4

4. The Ethics and Medical Registration Board of the National Medical Commission of India, the country’s premier regulator of the medical profession has recently issued a decision proposing to expand the scope of qualified Doctors that may now be permitted to undertake spinal surgery. While previously only neurology specialists were permitted to operate on the spine, orthopedic specialists may also undertake the same with existing qualifications.
Source: bit.ly/46s1oCn

5. An appeals courts of the United States has rejected the petition of several US states against the reclassification of contraceptive medication, holding that no grounds were established to prove actual harm suffered by the State governments. as claimed.
Source: bit.ly/3zZpdFC

TOP 5 HEALTH LAWS AND POLICY UPDATES

1. India’s Central Food Regulator the Food Safety Standards Authority, has introduced registration process for direct sellers to differentiate from Retailers, and make it easier to preserve exemption granted from regulation to direct sellers.

Source: bit.ly/4feuedl

 

2. The Kerala High Court in following with a recent decision of the Punjab High Court has held that the newly enforced Criminal Procedure (The Bharatiya Nagrik Suraksha Sanhita, 2024) will apply to all criminal appeals filed on or after 1st July 2024, the day of enforcement of the  new law. The court held that while the substantial right to appeal is preserved under the repealed statute, the procedural right will transfer over as per Sec. 531 of the new Code.

Source: bit.ly/4bQpMi4

 

3. Exports of Drugs and Pharmaceuticals have reportedly increased by 9.5% in the first quarter of FY 2024-25 year-on-year.

Source: bit.ly/4d3x3Nb

 

4. In response to recent reports that India has the 2nd highest number of unvaccinated children, the Indian government has clarified in a press release that, this statistic is misleading as such children only constitute a minute 0.11% of the nation’s population of children.

Source: bit.ly/3zQzFPw

 

5. The United States Food and Drug Administration has published Guidance for Human radiolabeled mass balanced studies, prescribing the information that sponsors need to submit, most notably now requiring a minimum of 6 participants for such studies as against the accepted variance between 4-6 participants.

Source: bit.ly/3y2UEy8

Medical Fitness Certificate for Food Handlers: How to ensure compliance with this Mandatory License Condition?

All Food Business Operators (FBOs) in India must maintain a record of annual medical examination of all food handler(s) engaged by the FBO. This is a mandatory condition of the food license. The Food Safety Officer checks the record of medical examination at the time of inspection, and any shortcoming in the record-keeping may result in suspension or cancellation of license.

In this article, we will discuss key considerations for ensuring full compliance with the requirement of maintaining records of medical examinations of food handlers.

Who is a food handler?

A food handler is any person who directly handles packaged or unpackaged food, food equipment, utensils, or food contact surfaces, and is therefore expected to comply with food hygiene requirements.

Personal hygiene and sanitary requirements applicable to FBOs

In addition to the requirement of a medical examination of food handlers, all FBOs have to ensure that no person, whether handling food or not, who may be suffering from any disease or illness that is likely to be transmitted through food is allowed to enter any area where the food is handled, i.e., where the food is packaged or unpackaged, where food equipment and utensils are stored, where food contact surfaces exist, or where food is cooked or manufactured.

In addition to the above general requirement, FBOs who are involved in high-risk food businesses such as meat and dairy have additional personal hygiene and cleanliness requirements, which are discussed below.

Meat

FBOs who deal in meat must ensure that any person who comes into contact with meat in the course of his or her work must be medically examined prior to such person being engaged. FBOs who run meat shops must ensure that any person who handles meat is medically examined annually, and the medical examination includes an examination of the sputum and chest X-ray for tuberculosis. The medical examination should also include stool tests for parasitic infections (protozoal and helminthic) transmitted through ingestion, as well as for enteropathogenic bacteria such as Escherichia coli, Salmonella, Shigella species, and Vibrio cholera.

Dairy

FBOs who manufacture, process, store, or sell milk and milk products are required to ensure that the persons employed for handling raw materials or dairy products have, before joining, submitted a medical certificate that states that there is no medical impediment to working in the specific capacity or role that the person is going to be employed by the FBO.

Mandatory vaccination of workers working in food factory    

If the FBO is a manufacturer, processor, and packer who operates a factory, then all workers working in the factory ought to be compulsorily vaccinated against an enteric group of diseases as per the recommended schedule of vaccination. Enteric groups of disease are infections caused by viruses and bacteria that enter the body through the mouth or intestinal system, primarily as a result of eating, drinking, and digesting contaminated food or liquids. Cholera, typhoid fever, Salmonella, or E. coli are some common enteric diseases. A record of the vaccination of all factory workers is required to be maintained, which may be inspected at the time of inspection. The decision regarding the scope of vaccination, i.e., which enteric diseases are to be covered by vaccination, is taken by the registered medical practitioner according to the list declared by the concerned municipal corporation of the area.

Format of Medical Fitness Certificate 

After the medical examination of food handlers, a medical fitness certificate in the prescribed format must be issued by a registered medical practitioner. It must contain the signature and seal of the registered medical practitioner. The medical fitness certificate should indicate that the registered medical practitioner has undertaken a physical examination, an eye test, and a skin examination, as well as any other tests required to confirm any communicable or infectious disease that the person is suspected to be suffering as observed during the clinical examination, if applicable. It should also indicate that “based on the medical examination, he/she is found free from any infectious or communicable diseases, and the person is fit to work in the food establishment.”

Discretionary Powers of Food Safety Officer vis-à-vis ordering medical examination of workers

If a Food Safety Officer, during an inspection, believes that the food handler is suffering from any infectious disease, he may ask for a medical examination of that person, and on such examination, if he finds out that person is suffering from an infectious disease, he has the authority to prohibit employees suffering from infectious diseases from participating in food handling activities and ensure strict adherence to health and safety.

Penalty for non-compliance

Failure to comply with these regulations can result in penalties of up to two lakh rupees and potential license cancellation under Section 58 of the Food Safety and Standards Act, 2006.

Conclusion 

All FBOs should sensitize themselves to the legal requirements of annual medical examination of staff, mandatory vaccination of workers working in food factories, and general hygiene and sanitary requirements applicable to all persons handling food or operating in an area where food is handled. Failure to meet these requirements of food laws may result in a heavy monetary fine and suspension or cancellation of the license.

TOP 5 HEALTH LAWS AND POLICY UPDATES

1. The Central Government is mulling including non-prescription Neutraceuticals currently regulated by the Central government food regulator the Food Safety Standards Authority of India, under the price control regime similar to Drug price regulation under the Drugs (Prices control) Order, 2013.
Source: bit.ly/4cRZVb7

2. The Supreme Court in continuation of prior orders issued acknowledging the concerns raised in a petition seeking to address the shortage of life saving Antiretroviral Drugs in the country, has granted the request of the petitioner to discuss the access of quality Antiretroviral Drugs to persons dealing with HIV.
Source: bit.ly/4cAATg9

3. The Central Government has issued a Draft Notification proposing amendment to the Drugs Rules, 1945, mainly intending to introduce restriction on advertising Drugs listed in Schedule G of the Rules.
Source: bit.ly/3Whm0Ke
Source: bit.ly/3VZZ0Or

4. Then United States Federal Trade Commission is set to take action against Drug supply middlemen and major pharmacy chains for use of anticompetitive tactics in negotiating Drug prices.
Source: bit.ly/3WgtAom

5. The World Health Organization has issued a new and updated list of pathogens, to reorient the prioritization in combating Antimicrobial Resistance.
Source: bit.ly/4czZdiw

TOP 5 HEALTH LAWS AND POLICY UPDATES

1. India’s central food regulator has approved a proposed Amendment to the Food Safety Standards (Labelling and Display) Regulations, 2020, to now indicate the per-serving Recommended Dietary Allowances, sugar, salt and sodium content in larger font.
Source: bit.ly/4bB3IYw

2. Association of Indian Medical Device Industry has requested the Ministry of Finance to increase the import tariffs on Medical Devices, correct the inverted duty structure, and to introduce new cap on trade margin in a bid to encourage the development of indigenous industry and competition.
Source: bit.ly/3VWQSOP

3. The Ministry of Consumer Affairs has set up a meeting with Automobile manufacturers operating India, and various Automobile manufactures Associations in an effort to onboard these companies on the Right-to-Repair portal maintained by the Ministry, and which has already onboarded several consumer electronics companies.
Source: bit.ly/4coI0bD

4. The Supreme Court, in the course of ongoing proceedings, has granted the Central Government an additional period of 8 weeks to frame a National Policy on Distribution of Menstrual Products (to adolescent children).
Source: bit.ly/4cTgvGV

5. The European Commission’s Medical Device Coordination Group has issued a new guidance amending the Guidance on “Classification Rules for in vitro Diagnostic Medical Devices under Regulation (EU) 2017/746” regarding the classification of In-Vitro Medical Devices at the pre-market introduction stage. The new amendment provides differential Conformity Assessment for the Devices based on their classification; The guidance has also provided an annex differentiating an In-Vitro Medical Device and a Companion Diagnosis.
Source: bit.ly/3Y2Ffbs

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.

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 Drug Manufacturers will have to put in place prompt and effective recall procedure soon
At a meeting called by India’s Health Ministry with drug manufacturers, the Ministry has reportedly reminded all drug manufacturers that they will have to put in place a prompt and effective drug recall system. Such a drug recall system is a mandatory requirement of revised Schedule M of Drugs Rules, 1945, which is scheduled to come into effect on 27th June 2024 for large enterprises, and on 27th December 2024 for small and medium scale enterprises.
Source: bit.ly/3wbgKgZ

India’s central food regulator to conduct own testing and investigation into pre-packed spices manufactured in India
India’s Central Food Regulator (FSSAI) has recently issued a statement declaring that it is currently in the process of collecting samples of fruit and vegetables, fish products and spices and culinary herbs, as part of its scheduled surveillance for salmonella and other contaminants. This statement has come in light of the recent ban by Governments of Hong Kong and Singapore on certain brands of Indian spices, on the basis that the products contained Ethylene Oxide, a known carcinogen that can cause breast cancer and lymphoma.
Source: bit.ly/3UFCXgH

Supreme Court seeks explanation from Central Government on proposal to fix prices for ophthalmologic procedures
The Supreme Court has issued a Notice to the Central Government, seeking response on the nature of power and viability of regulations that permit government to uniformly fix the prices across private hospitals for Ophthalmologic procedures. The Court has clubbed this matter along with a pending case, where the Central Government has been directed by the Supreme Court to determine a policy to fix uniform prices for procedures done at private hospitals.
Source: bit.ly/4bzRdx9

If husband is unable to contribute gamete, then wife is not barred from seeking gamete from a donor for IVF: High Court
In a recent decision, the Calcutta High Court has held that, under India’s current regulatory regime surrounding In-Vitro Fertilization (IVF), there is no restriction that requires that either the egg or the sperm must come from the couple seeking the IVF themselves. A married woman may seek to obtain sperm from a third party donor.
Source: bit.ly/3Uocq68

Excessive prescription and use of Antibacterial medicine in treatment of COVID-19 has increased global Antimicrobial Resistance: WHO
The World Health Organization has recently posted findings from its Global Clinical Platform for COVID-19, which are an anonymized repository of worldwide treatment data. These findings have revealed that there has been rampant over-prescription and use of antibiotics worldwide, in the course of treating COVID-19, which has contributed to the globally rising Antimicrobial Resistance problem.
Source: bit.ly/4dnzWcb

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.

Insurance Regulator Removes Barrier to offering Insurance Policy to Senior Citizens among other underserved demographics
India’s Central level Insurance regulator the IRDAI has recently issued the Insurance Regulatory and Development Authority of India (Insurance Products) Regulations, 2024, where it has removed the barrier to insurance for persons over the age of 65 years. Previously, persons defined as “Senior Citizens” were not catered to, in terms of fresh insurance policy offerings.
Source: bit.ly/3JsNLIj

Pharmacists who were not personally dispensing medication at pharmacy penalized by Karnataka Pharmacy Council
The Executive Committee of the Pharmacy Council of the Indian State of Karnataka, by exercise of powers under Section 36 of the Pharmacists Act, 1948 has decided to take disciplinary action against certain Pharmacists for violation under Section 42 whereby only Pharmacists are permitted to dispense medication. It was found that several Pharmacists in the state were absent from their posts and had only been registered with their pharmacies for namesake.
Source: bit.ly/3QB2jtJ

Consumer Affairs Ministry has urged FSSAI to initiate Action against major food manufacturer for high sugar content in infant formula
India’s Central Consumer Affairs Secretary, in a recent letter to the Central Food Regulator (FSSAI), has urged it to initiate action against a major food product manufacturer, in light of the recent serious allegations regarding the heightened sugar content in the infant formula the company has been marketing in India.
Source: bit.ly/3xUo0Ox

India’s Central Bank has published Draft Circular regulating Point-of-Sale Payment Aggregators: Requiring compliance with Guidelines for online Payment Aggregators
India’s Central Bank, the Reserve Bank of India, has issued a Draft Circular for regulation of Payment Aggregators providing point-of-sale services, whereby, within 3 months of publication of final version of this Notification, all entities that are currently providing such services will be mandated to adapt and comply with all requirements concerning Guidelines on governance, merchant on-boarding, customer grievance redressal and dispute management framework, baseline technology recommendations, security, fraud prevention and risk management framework, as provided in a prior Notification on Regulation of Payment Aggregators and Gateways published in 2020.
Source: bit.ly/3U7NwY7
Source: bit.ly/3w55rHa

EU may revise categorization of Personal vs Commercial Confidential Data in Marketing Authorization Process
The European Union Regulator has begun consultation regarding an update to the current regulation surrounding what constitutes Personal data vs Commercial Confidential data in respect of protecting business secrets in marketing authorization applications submitted by pharmaceutical and medical devices companies.
Source: bit.ly/3JvpCRA

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