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

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. India’s Environment Ministry is planning to exempt white category industries i.e., low environment risk industries from the requirement to obtain consent before establishing and operating an Industry provided the industry makes a self-declaration to the concerned pollution control board.
Source: https://bit.ly/3LygA7t
Source: https://bit.ly/4d7nqNv

2. India’s environment ministry is planning to exempt industries who have already obtained Environmental Clearance (EC) from obtaining environmental consent to establish the industry.
Source: https://bit.ly/3LygA7t
Source: https://bit.ly/4d7nqNv

3. After Odisha and West Bengal, other states in India are reportedly considering to allow online sale and home delivery of alcoholic beverages.
Source: https://bit.ly/3WiXAyu

4. Indian Pharmacopoeia Commission (IPC) has waived off the Target Animal Batch Safety Test (TABST), which involved administering vaccine overdoses to animals to test each batch of vaccine for safety of a specific species starting from 1st July 2024.
Source: https://bit.ly/3WAR8U3
Source: https://bit.ly/4fgy3is

5. EU antitrust regulators have officially accepted a pharmaceutical giant’s pledge not to disparage its competitor’s iron deficiency treatment medicine.
Source: https://bit.ly/3zSqMFn

Posted on

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

Posted on

TOP 5 HEALTH LAWS AND POLICY UPDATES

1. India’s drug regulator will implement the mandate of printing of QR codes to curb counterfeiting. The top-selling brands have reportedly said that they have already started integrated QR codes and bar codes for tracking and compliance checks.
Source: bit.ly/4d80PzG

2. Indian Health Ministry has issued draft rules under the Drugs and Cosmetics Act, 1940 relating to compounding of minor offences and violations. The draft rules establish a system for companies to settle minor violations of the Act, like manufacturing drugs without proper procedures, outside of court. Companies can apply to a designated compounding authority with relevant documents, and if approved, avoid prosecution. This aims to resolve issues efficiently without lengthy court cases, but serious offenses like selling adulterated drugs are not eligible for compounding.
Source: bit.ly/3zLSKlT

3. India’s Drug Control Officers collective proposal to Indian Government for changing the name of the Drugs and Cosmetics Act, 1940 to ‘Bharatiya Aushadhi awam Chikitsa Upakaran Adhiniyam’ has received mixed responses from the industry and various stakeholders. While some have reasoned that change of name of the Act is the need of the hour and should be done as early as possible, others have questioned the need and purpose of the exercise.
Source: bit.ly/4d9IsdV

4. India’s Pharmacy Regulator, the Pharmacy Council of India (“PCI”) has extended the deadline for submission of statutory documents till 31st July, 2024 by new institutions and existing institutions that have applied for introduction of new course. PCI stated that the documents should be submitted on its compliance portal only. No other mode other than the PCI Compliance portal will be entertained for submission of documents.
Source: bit.ly/3y0YeZE

5. Indian Health Minister stresses on India’s need for world class regulatory framework for Pharma and Medical Device Industry to ensure better quality of products. The Minister also stated the importance of transparency in India’s apex drug regulator the Central Drugs Standard Control Organisation (CDSCO). The Union Health Minister stated that it is important for CDSCO to be in continuous dialogue with the drugs and medical devices industry to understand their issues and support them to fulfill the quality expectations and standards of CDSCO.
Source: bit.ly/4d5XuBd

Posted on

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

Posted on

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

Posted on

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

Posted on

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

Posted on

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

 

Posted on

TOP 5 HEALTH LAWS AND POLICY UPDATES

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

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

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

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

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