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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.

1. A Public Interest Petition has been filed in the Delhi High Court, highlighting the need to require the use of verifiable Digital Signature on medical records and prescriptions to prevent fraud, misuse and fabrication of patient data.
Source: bit.ly/46qn6GP

2. The Indian Council of Medical Research has recently published Volume IV of the Standard Treatment Workflows which introduces new treatment methods for 32 common health conditions.
Source: bit.ly/3WCUqXO

3. The Indian government is set to launch a universal platform to track vaccination, U-Win which is reportedly based on the erstwhile Co-Win platform which had been maintained to track COVID-19 vaccinations,
Source: bit.ly/3SMCnfN

4. The West Bengal Clinical Establishment Regulatory Commission, the State level regulator of hospitals, clinics and healthcare centres, is set to issue an advisory mandating hospitals to pro-actively update the kin of patients on continued developments in health conditions to improve quality of counselling.
Source: bit.ly/4djmOUo

5. The United States Food and Drug Administration has finalized guidelines on the manner of use of Real World Data from Electronic Health Records, for the purpose of selecting and analysis of study data, as well as specifying limitation on the kind of data that can be used for clinical studies and regulatory decision making.
Source: bit.ly/3YfnV3i

Posted on

TOP 5 HEALTH LAWS AND POLICY UPDATES

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

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

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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

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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

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TOP 5 HEALTH LAWS AND POLICY UPDATES

1. The Supreme Court has issued its decision in a matter concerning the legality of exercise of powers by the National Pharmaceutical Pricing Authority (NPPA) in levying overcharging fees against an entity that claimed not to be a “distributor” or a “dealer” as defined under the Drugs (Prices Control) Order, 1995, since it had a dual role. The Court held that there is no mutual exclusivity between a dealer and a distributor, and dismissed the appeal.
Source: bit.ly/3xPkgP1

2. The National Medical Commission, has mandated the presence and maintenance of a Tobacco Cessation Centre at all hospitals attached to Medical Colleges across the country.
Source: bit.ly/3WdIjzk

3. To curb rise in misleading advertisements, the Central Government may soon introduce regulation to restrict the advertisement of Diabetes, Sex Hormone and Oncology medication, and may require approval and permission to make claims of efficacy for these Drugs.
Source: bit.ly/46nCjst

4. The Ministry of Health and Family Welfare has published Draft Drugs (Amendment) Rules, 2024 whereby it intends to amend Rule 96 requiring inclusion of details of Drug excipients on retail labels of Drugs.
Source: bit.ly/463YZO9

5. The European Commission has published and adopted the Artificial Intelligence Act, which will regulate the inclusion and integration of AI into Medical Devices and In-Vitro Devices. This Act is set to come into force on the 2nd August 2024.
Source: bit.ly/3Y5qCUV

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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

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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

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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. 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

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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