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 The United States Food and Drug Administration (FDA) releases draft guidance for companies on addressing online misinformation about their approved medical devices and drugs. The draft guidance stipulates that US FDA won’t enforce rules restricting promotion and marketing of drugs and medical devices, whenever drug and medical device companies issue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

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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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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

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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Madras High Court Greenlights Online Sale of Drugs and Medical Devices in India

online_sale_of_drug_and _medical_devices

Introduction

The Division Bench of Madras High Court in its recent order has confirmed that online pharmacies and online marketplaces of medicines and medical devices can continue to operate under existing law i.e. Drugs and Cosmetics Act, 1940 and Rules, 1945.

In doing so, the Court reversed the order passed by a Single Judge Bench of the same Court in 2018, which had effectively ordered e-pharmacies and e-marketplaces to stop business.

In this article, we will discuss the developments leading up to the recent Court order.

Background of 2018 court order banning online sale of medicines

On 17.12.2018, The Single Judge Bench of Madras High Court surprised e-pharmacies and e-marketplaces by ordering that till the Central Government did not publish rules for regulation of e-pharmacies, “the on-line traders are bound not to proceed with their on-line business in drugs and cosmetics.”

The rationale behind such an order was that without any proper framework regulating the online sale of drugs, there may arise chances of potential misuse of health and safety. The Court felt that amendments to the Drugs Rules, 1945 were necessary before allowing the online sale of drugs. The Court also directed the state government to notify the proposed Drugs and Cosmetics Amendment Rules, 2018 in the state Gazette, latest by 31.01.2019, for online sale of drugs within the state.

However, after passing the order, at the request of e-pharmacies and e-marketplaces, the Court decided to defer the implementation of the order until 20.12.2018 so that they could prefer an appeal against the order.

Ad-interim stay of 2018 order

The e-pharmacies and e-marketplaces preferred an appeal against the order of the Single Judge, on 02.01.2019 the Division Bench temporarily stayed the operation of the Single Judge Bench.

The Bench felt that a sudden ban would disrupt access to medication for those who relied on online pharmacies, particularly for home deliveries. However, the Division Bench agreed with the Single Judge Bench on the need for appropriate regulation for the online sale of drugs and directed the Central Government to finalize a framework for the regulation of online sale of drugs.

Reversal of 2018 order

The Division Bench has now passed a final order in the appeal. It has explicitly allowed the online sale of drugs, with a condition that any online sale of drugs must be routed through licensed druggists and chemists only.

In doing so, it has endorsed the lawfulness of operation of e-pharmacies and e-marketplaces, which are currently doing business through dealers and retailers who have a license for sale or distribution of drugs under Drugs Rules, 1945.

The Court decided to dispose of the appeal primarily on the grounds that the Delhi High Court is already hearing a matter with identical issues and the Central government is in the process of preparing a new policy for the online sale of drugs.

Order from Delhi High Court

The Delhi High Court is currently hearing a batch of writ petitions in which the petitioners have challenged the legality of the online sale of drugs and medical devices. Unlike the Madras High Court, the Delhi High Court has never held that the online sale of medicines is bad in law. The Delhi High Court has always maintained a position that the online sale of medicines and medical devices by licensed retailers is not unlawful. However, the Delhi High Court has time and again expressed concerns that the Central Government is yet to finalize a framework for the regulation of online sale of drugs and medical devices, despite the fact that the draft rules for the regulation of online sale of drugs were published in 2018 for comments and the Central Government has already received comments. The Court has now given the Central Government a last opportunity to put in place a policy framework for online drug sales by July 2024.

Conclusion

The order of the Madras High Court is welcome as it removes the ambiguity that existed in relation to the legality of the online sale of drugs and medical devices. Now, the fate of e-pharmacies and online marketplaces for medicines and medical devices is inextricably linked to the outcome of the petition filed in the Delhi High Court and the decision of the Central Government to introduce (or delay the introduction of) a framework for online sale of drugs and medical devices.

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TOP 5 HEALTH LAWS AND POLICY UPDATES

Dear Reader, we are happy to share the most interesting legal and policy updates concerning health industry that we read today. We hope you enjoy reading it.

Absence of essential medicines in a hospital constitutes medical negligence
India’s National Consumer Dispute Redressal Commission (NCDRC) has held that absence of an essential injectable medicine within the hospital, resulting in administration of an alternate injection to a patient who later died, constituted medical negligence. The court ordered the Hospital to pay Rs 25 Lakh as compensation.
Source: bit.ly/3UtaJ7u

Cost of conducting clinical trial of drug published in public domain for first time
Médecins sans frontières (MSF/doctors without borders), a non-governmental organization dedicated to delivering international medical aid, has published cost of conducting clinical trial of a new drug. As per MSF, no pharmaceutical company has published actual cost of conducting clinical trials, though such costs are frequently referenced to justify high drug prices.
Source: bit.ly/3wjvo5J

Indian standards for infant formula permit addition of sugar, therefore controversy surrounding added sugar in infant food unwarranted: Industry
A popular infant formula formulation company has clarified that the sugar content in their product is within the limits prescribed by India’s food regulator, Food Safety and Standards Authority of India (FSSAI). This clarification was issued after reports that the product being sold in low-and-middle income countries has high sugar content.
Source: bit.ly/3UsnaQH

Indian medical device regulator has allowed sale of sleep apnea devices post rectification of foam degradation issue
A major manufacturer of sleep apnea therapy devices has reportedly confirmed that its devices are sold in India without the foam degradation issue, which had previously caused it to recall its devices in India and around the world. In the US, the manufacturer has agreed to provide users of affected devices with new, updated, or equivalent devices with a renewed warranty or a refund.
Source: bit.ly/3WufUXh

Revised guidance for referencing of biological products by biosimilar drugs published for comments by US FDA
The US Food and Drugs Administration (USFDA) has released a revised guidance entitled “Promotional Labeling and Advertising Considerations for Prescription Biological Reference Products, Biosimilar Products, and Interchangeable Biosimilar Products.” The guidance addresses various questions that manufacturers, packers, distributors, and their representatives/firms may have when developing FDA-regulated promotional labeling and advertisements (promotional communications) for prescription reference products, biosimilar products, and interchangeable biosimilar products licensed under the Public Health Service Act (PHS Act).
Source: bit.ly/3wudFsl

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TOP 5 HEALTH LAWS AND POLICY UPDATES

Dear Reader, we are happy to share the most interesting legal and policy updates concerning health industry that we read today. We hope you enjoy reading it.

NOC for the manufacture of unapproved drugs meant for export will be issued by the Central Drug Regulator
India’s Central Drug Regulator (CDSCO) will be the competent authority to issue the No Objection Certificate (NOC) required by pharmaceutical companies for the manufacture of unapproved, new, or banned drugs for export purposes, starting from 15th May 2024. The NOC will be issued by the zonal offices of CDSCO. The application for NOC will have to be made online. Prior to CDSCO, it was the State Licensing Authorities that issued NOCs.
Source: bit.ly/4dkZO8u

Producers of Batteries can meet EPR Targets and file Annual Returns by June 30, 2024
The deadline for meeting Extended Producer Responsibility (EPR) targets and submitting annual returns by the producers of all types of batteries has been extended to June 30, 2024.
Source: bit.ly/4a0Uynx

Private hospitals demand payment of interests from the government on delay of reimbursement for treatment under Ayushman Bharat Scheme
India’s Association of Healthcare Providers (AHPI) has raised concerns over inordinate delay in receiving reimbursement for treatment provided to Ayushman Bharat beneficiaries, which impedes cash flow and poses serious operational issues for all hospitals. The Association has urged that the government pay 1 percent interest on payments delayed beyond one month under the Ayushman Bharat scheme, which is the Central Government’s flagship universal health coverage scheme, as well as change of package rate to allow beneficiaries to avail of continued benefits from the Ayushman Bharat Scheme
Source: bit.ly/3wimXHQ

US government likely to ease restrictions on regulation of Marijuana
The U.S. Drug Enforcement Administration (DEA) is likely to reclassify marijuana as a less dangerous drug by moving it from a tightly regulated class to a less tightly regulated class. Although the DEA’s proposal would highlight the medical benefits of cannabis, it would not allow its use for recreational purposes. The White House Office of Management and Budget is reportedly still in the process of reviewing the idea.
Source: bit.ly/4a2osrm

Form 483 notice need not to be responded by manufacturers of medical devices within 15 days: US Medical device experts
According to US Food and Drug Administration (FDA) officials, a medical device manufacturing company is not required to respond to a Form 483 notice (Notice of Inspectional Observations) within 15 days. The 15-day deadline for response applies to warning letters and not to Form 483 notices, though the FDA advises that if the manufacturer wishes to respond to a Form 483 notice, then it should do so within 15 days of the notice.
Source: bit.ly/44FHVxn

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TOP 5 HEALTH LAWS AND POLICY UPDATES

Dear Reader, we are happy to share the most interesting legal and policy updates concerning health industry that we read today. We hope you enjoy reading it.

Indian 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

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TOP 5 HEALTH LAWS AND POLICY UPDATES

Dear Reader, we are happy to share the most interesting legal and policy updates concerning health industry that we read today. We hope you enjoy reading it.

Manufacturers of Ayurvedic Drugs cannot claim “Certified by” or “Approved by”: Ministry of AYUSH
India’s AYUSH Ministry has reportedly issued a warning to all ayurveda, siddha, unani and homeopathic drug makers, against the use of any misleading, unsubstantiated claims and false advertisements such as a green logo or false statements like “the product is approved or certified by the ministry”. The Ministry also clarified that it has no role in issuing manufacturing licences or approvals. This warning comes in the backdrop of a misleading advertisements case against a major Ayurvedic drugs and products manufacturer in the Supreme Court of India.
Source: bit.ly/3UF32fP

After Hong Kong, US Food Regulator is probing Indian spices due to reports of contamination
The US Food and Drug Administration has reportedly initiated a probe against two Indian spice manufacturers for their spice mixes which allegedly contain hazardous cancer-causing pesticides. The two manufacturers who are facing similar controversies in Hong Kong and Singapore have refuted the allegations. India’s spice regulator, the Spice Board of India, has taken cognizance of matter and is working closely with the two manufacturers to ascertain the root cause of such allegations.
Source: bit.ly/3UB8q3r

India extends the approval for use of drones for spraying approved pesticides till April 18, 2025
India’s Agriculture Ministry has extended its interim approval by one year, i.e., until April 18, 2025, for drone-based application of already approved pesticides formulations including insecticides, fungicides and plant growth regulators which were earlier permitted to be only sprayed manually by knapsack sprayers. The earlier approval was valid till April 18, 2024.
Source: bit.ly/4bf9MX7

Indian FMCG companies are reclassifying popular health drinks as functional nutritional drinks to comply with the recent government directions
Days after India’s Ministry of Commerce and Industry issued a directive to all e-commerce sites instructing not to list malt drink mixes and other similar products under the category of health drinks, Indian manufacturers have started reclassifying their products. A major manufacturer of food products has classified its malt drink mix as “Functional Nutritional Drink”. India’s food regulator had clarified earlier this month that there is no category called “health drink” under which it grants manufacturing license.
Source: bit.ly/4dbOpb7

India’s Madras High Court denies relief to doctors for violating bond conditions; directs them to undertake Bond Service in Government Medical College and Hospitals
India’s Madras High Court has upheld the validity of bond service conditions based on bond agreements signed by doctors. The instant case related to temporary appointment of three doctors to the post of Assistant Surgeon in compliance with bond agreement. The doctors claimed that they had served during COVID-19 pandemic period and urged their service be calculated basis two years of service as stipulated in the bond. The High Court stated that the period of COVID duty done by Medical Officers after completion of their PG courses alone will be treated as Bond Service and services rendered by the Postgraduates during their courses would be considered as study period only.
Source: bit.ly/44opFYX