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. India’s Health Minister has reportedly confirmed that Central Drugs Standard Control Organization (CDSCO) will be the sole regulator of veterinary medicines in India and there is no proposals to establish a separate regulatory body for veterinary medicines in India.
Source: bit.ly/4cbgTQe

2. India’s Food regulator (FSSAI) has warned against use of unapproved non-specified ingredients, such as “Deionized apple juice concentrate,” in fruit juices.
Source: bit.ly/46swOZq

3. The State Drug Regulator (FDA) of Maharashtra is reportedly going to start an inspection drive to identify doctors and hospitals which are running an open shop for medicines without holding a valid pharmacy license.
Source: bit.ly/46rtHAZ

4. The Principal Bench and State Benches of Goods and Services Tax Appellate Tribunal (GSAT) have been established with effect from 1st September 2023.
Source: bit.ly/3A86tDM

5. The US Food & Drugs Administration (FDA) has warned a pharmaceutical company for sponsoring a celebrity paid promotion campaign on social media, in which the influencer promoted a drug but did not disclose essential risk information. The FDA found the post to be misleading.
Source: bit.ly/46rtI81

TOP 5 HEALTH LAWS AND POLICY UPDATES

1. Multinational Pharmaceutical Companies in India have reportedly sought relaxation of mandatory 50% cut in price of essential medicines after expiry of patent on ground that it hinders innovation.

Source: bit.ly/4bWhHIN

2. India’s food regulator, The Food Safety and Standards Authority of India (FSSAI), has issued directions to the effect that if any food sample is found to be unsafe in the primary lab report, it would result in an order prohibiting further distribution of such food. If the food sample is confirmed to be unsafe by a referral food lab, then the food will have to be recalled.

Source: bit.ly/3Yji2SR

3. A nutritional supplement firm was fined by District Consumer Commission for making misleading claims on the label of its protein supplement regarding the nature of protein content. According to the commission, making misleading claims on label amounts to deficiency of services.

Source: bit.ly/4dcHoWs

4. India’s Jammu and Kashmir High Court has dismissed a criminal complaint instituted against a retailer of medicines for failing to reveal details of manufacturer of a spurious drug. The High Court held that since the Drug Inspector already had the details, the non-provision of requested information did not constitute an offence under The Drugs and Cosmetics Act, 1940.

Source: bit.ly/4bSxPLd

5. India’s food regulator, The Food Safety and Standards Authority of India (FSSAI), has introduced a new license category for registration of direct sellers. Direct sellers are not permitted to sell infant milk and infant milk substitutes.

Source: bit.ly/4fdxhlZ

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

TOP 5 HEALTH LAWS AND POLICY UPDATES

1. India’s Consumer Affairs Ministry’s is proposing to amend labelling and packaging regulations for pre-packaged goods. Currently, certain large packages, like those exceeding 25 kilograms or liters, are exempt from displaying crucial information. This includes details like the maximum retail price (MRP), the date by which the product should ideally be consumed (best before date), who manufactured it, and where it came from (country of origin). Other exempt categories include cement, fertilizer, agricultural produce in 50 kg bags, and products destined for industrial or institutional use. The proposed amendment aims to close this loophole and ensure all these bulk packages are labelled clearly and consistently, just like retail products.
The proposed amendments are open for public consultation till 29th July 2024.
Source: bit.ly/4cZPiCG

2. Maharashtra state in India has reportedly announced a ban on sale of energy drinks with high caffeine content within 500-meter radius of schools. This directive aims to safeguard student health.
Source: bit.ly/467rxGj

3. India’s Karnataka Medical Council (“KMC”) has issued a show cause notice to a dermatologist alleging violation of Code of Medical Ethics, 2002 for advertising drugs/medicines on social media. The action on the part of KMC comes after it received a complaint from Indian Association of Dermatologist, Venerologists and Leprologists.
Source: bit.ly/3zLuAYY

4. India’s drugmakers are pushing the government to loosen price controls. They propose exempting all medicines under ₹5 and extending the exemption for patented drugs (currently 5 years) to 10 years. This comes amid rising costs for ingredients, prompting them to request a reduction in GST on these materials. The industry argues stricter controls stifle research and development.
Source: bit.ly/3S7oqIF

5. Indian Supreme Court has rejected Doctor’s plea for improved security, which is filed by a Delhi Medical Association. The apex court was hearing the DMA’s petition which also sought directions to the authorities to ensure adequate security at hospitals and medical centres to prevent attacks on doctors and healthcare workers by patients’ relatives and others. The Apex Court stated that currently laws exist to deal with such instances.
Source: bit.ly/3Ln9Fh9

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. The Indian Government has informed the Delhi High Court that it has been unable to notify rules for regulation of online sale of medicines. The Delhi High Court will now proceed to decide the legality of online sale of medicines in India.

Source: bit.ly/4cZRrOJ

 

2. A Swiss Biotech MNC has successfully obtained an interim injunction against an Indian Biosimilar Manufacturer which will prevent the manufacturer from launching the Biosimilar of Perjeta (Pertuzumab) on ground that it deliberately withheld information about receipt of regulatory marketing approval from the High Court.

Source: bit.ly/3zLi9Ms

 

3. India’s apex investigation agency, the Central Bureau of Investigation, has filed a charge sheet alleging violation of India’s bribery laws against a cardiologist, senior employees of a medical equipment MNC, and some distributors of medical equipment. The cardiologist was an employee of prominent government hospital and the complaint revolves around the collection of bribes by the cardiologist from medical equipment and stent suppliers for recommending their products to patients.

Source: bit.ly/3zy0PdM

 

4. India’s Delhi High Court has upheld the regulation which mandates pan masala companies to display statutory health warnings about the harmful effects of pan masala on 50% space on the front side of the packaging of such products. The Court ruled that the regulation brought in by the government gives effect to the legislative intent of safeguarding the larger public interest, which is paramount, and does not disproportionately impact the rights of the Petitioners.

Source: bit.ly/4cWwPHa

 

5. The United States Food and Drug Administration (FDA) releases draft guidance for companies on addressing online misinformation about their approved medical devices and drugs. The draft guidance stipulates that US FDA won’t enforce rules restricting promotion and marketing of drugs and medical devices, whenever drug and medical device companies issue specific communications to correct online misinformation about their approved drugs/devices or relevant therapeutic category.

Source: bit.ly/4deP3DZ

TOP 5 HEALTH LAWS AND POLICY UPDATES

1. India’s Supreme Court has reportedly asked the Ministry of Information and Broadcasting to appropriately modify the self-declaration requirement imposed by the Supreme Court on all advertisements, such that the consumers remain protected against misleading advertisement, but the industry is not overly inconvenienced in the process of complying with the self-declaration requirement.
Source: bit.ly/3xYqk7C

2. The Supreme Court has ruled that not disclosing critical or material information about safety at the time of promotion of the product amounts to unfair trade practices.
Source: bit.ly/460Duxr

3. Central Drugs Standard Control Organization (CDSCO), India’s drug regulatory authority, is reportedly planning to take action against pharmaceutical companies that fail to implement barcodes or QR codes on the top 300 medicine brands identified by the National Pharmaceutical Pricing Authority (NPPA).
Source: bit.ly/3zJllrU

4. MeDevIS (Medical Devices Information System) online portal, the first worldwide open access clearing house for information on medical devices, was launched by the World Health Organization (WHO). It is intended to assist governments, regulators, and users in making decisions about the selection, procurement, and use of medical devices for diagnosing, testing, and treating diseases and health conditions. MeDevIS refers to two international naming systems for medical devices: the European Medical Device Nomenclature (EMDN) and the Global Medical Device Nomenclature (GMDN), which attempt to maintain data uniformity across borders.
Source: bit.ly/3zJQIm9

5. The U.S. Federal Trade Commission recently stated that a pharmacy benefit managers (PBM), who operate as middlemen between pharmaceutical firms and customers, have an excessive amount of influence over prescription drug costs due to the years-long dealmaking which has ultimately resulted in the consolidation of pharmacies and health insurance companies.
Source: bit.ly/3W0Mhee

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.