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TOP 5 HEALTH LAWS AND POLICY UPDATES

Dear Readers, 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 Central Drug Regulator (CDSCO) is set to develop guidelines for the safe disposal of pharmaceutical waste which are expired and unused drugs and medicines, to curb antimicrobial resistance (AMR).
Source: bit.ly/3yOlfPY

2. The Indian Health Ministry has reportedly stated that 156 fixed dose combination (FDC) drugs recently banned were licensed by the State Licensing Authorities (SLA) without prior approval from the Drug Controller General of India (DCGI).
Source: bit.ly/3Xl6Xj7

3. Bureau of Indian Standards (BIS) certification will be mandatory for medical textile products covered by Quality Control Order from 1st October 2024. The products that will require certification and BIS mark are sanitary napkins, reusable sanitary pads/sanitary napkins, period panties, baby diapers, hospital bed linens, pillow covers, dental bibs and shoe covers intended for medical use.
Source: bit.ly/4e3FI1U

4. India’s major pharma companies have requested the Delhi High Court to quash the government’s recent notification banning 156 fixed-dose combination (FDC) drugs. They have also sought interim relief in their petitions to exhaust the stock that was manufactured before the notification came into effect, prohibiting any coercive measures against retailers and stockists until the stock is exhausted.
Source: bit.ly/3yUZFcw

5. India’s Central Pollution Control Board has issued a show cause notice to producers, importers, and brand owners (PIBOs) of plastic packaging, requiring them to file annual reports and fulfill Extended Producer Responsibility (EPR) obligations for the financial year 2022-2023 by September 1, 2024. Failure to comply will result in the imposition of environmental compensation (EC) and additional penalties.
Source: bit.ly/3XmQ5bF
Source: bit.ly/3XmQc75
Source: bit.ly/3yUZAWg

Posted on

TOP 5 HEALTH LAWS AND POLICY UPDATES

Dear Readers, 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 central food regulator, Food Safety and Standards Authority of India (FSSAI) has said that it is misleading to differentiate milk and milk products on whether they are made from A1 milk or A2 milk. All manufacturers and marketers and e-commerce entities have been directed to stop claims of A1 and A2 proteins present in the milk. All manufacturers have been given six months to exhaust all of the pre-printed labels containing claims about A1 and A2 proteins.
Source: bit.ly/4dz5awA

2. The Central Pollution Control Board (CPCB) has released updated guidelines for assessing environmental compensation to be levied on entities that violate the Plastic Waste Management Rules, 2016, including Extended Producer Responsibility (EPR) obligations.
Source: bit.ly/46Uh9lX

3. India’s Ministry of Health has banned the 156 fixed-dose combination (FDC) medications, commonly known as “cocktail drugs,” which include multivitamins, antibiotics, and painkillers. The ministry’s rationale is that these drugs have no there is no therapeutic justification and pose a risk to human health, even though there are safer alternatives available.
Source: bit.ly/3XfRVeq

4. The US Food and Drug Administration (FDA) has issued a draft guidance on pre-determined change control plans (PCCPs). The guidelines offer manufacturers a way to specify prospective modifications to a device and apply for premarket authorization for those changes in a marketing submission for the device. This eliminates the need for them to obtain FDA approval for each major change before it is implemented. The draft guidance is open to receiving comments from industry stakeholders till November 20, 2024.
Source: bit.ly/3AtTY5B

5. The Medicines and Healthcare products Regulatory Agency (MHRA), an agency of the Department of Health and Social Care in the United Kingdom, has ruled that a biopharmaceutical company has violated the country’s drug regulations by using a LinkedIn post to advertise prescription-only medicines to the general public.
Source: bit.ly/4fSmKgt

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. The number of cosmetic products which can be added to a single application for the import registration certificate of cosmetics has been limited to fifty (50) products from 16th August 2024.
Source: bit.ly/4dbUnrX

 2. The Central government has reportedly prepared a draft of the Standard Veterinary Treatment Guidelines (SVTG) covering 274 diseases across 12 major livestock species with an aim to create uniform treatment protocols, lessen variation in prescription practices, and improve compliance among veterinarians and other prescribers.
Source: bit.ly/3SNEnnU

3. The Supreme Court of India has given a deadline of 12th October 2024 to implement the law for regulation of allied healthcare practitioners.
Source: bit.ly/3SNqR3L

4. The Madras High Court has reportedly directed the Indian Council of Medical Research (ICMR) to opine whether there were vested interests involved in the ban on pioglitazone, an antidiabetic drug, which was later revoked.
Source: bit.ly/3SLbmcm

5. The US Food & Drug Administration (FDA) has reportedly rejected a proposal to approve psychedelic – MDMA as a treatment for post-traumatic stress disorder (PTSD) citing safety and efficacy concerns.
Source: bit.ly/3YDYqJf

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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

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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TOP 5 HEALTH LAWS AND POLICY UPDATES

India’s Central Consumer Protection Regulator has issued draft Guidelines for Prevention and Regulation of Unsolicited and Unwarranted Business Communication, 2024 for public consultation and suggestions till 21st July, 2024
Source:  bit.ly/4cdCxV0

India’s Consumer Protection Regulator is in discussion with electronic manufacturers to change the warranty period of electronic appliances from purchase date to installation date to address the issue of shortfall in warranty period.
Source:  bit.ly/3zbR7xM

India’s COVID-19 manufacturer adds Indian Council of Medical Research as a co-owner in the patent for the vaccine.
Source:  bit.ly/4cd3esZ

According to a report by an investment banking firm, Indian market has 388 generic pharmaceutical brands with sales of over 100 crores, up from just 21 brands fifteen years ago.
Source:  bit.ly/3XymBrN

The Arbitration Bar of India and Indian Arbitration Forum have expressed their concerns over the Office Memorandum issued by Ministry of Finance providing guidelines for arbitration and mediation in Contracts of Domestic Public Procurement.
Source:  bit.ly/3XymDzV

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.

New Framework to be created to separately regulate prices of Medical Devices
In response to demands from industry associations, India’s Central Drug Price Regulator, the National Pharmaceutical Pricing Authority (NPPA), in collaboration with the Department of Pharmaceuticals is reportedly in the process of developing a special pricing framework for Medical Devices comparable to similar prevailing regulations in other jurisdictions.
Source: bit.ly/49Wh8hc

Testing Standards for stability testing of In-Vitro Diagnostic Medical Devices have been prescribed to obtain manufacturing/ import license
India’s Central Drugs Standards Regulator (CDSCO) has released a draft Guideline regarding conduct of Stability Studies for In-Vitro Diagnostic Medical Devices (IvDMD). These guidelines cover the standards and testing for determining the overall shelf life, individual component stability, stability during transportation as well as, in-use stability of IvDMD. These guidelines are applicable for all manufacturers who are in preparation of submitting a pre-market review document in pursuance of obtaining a manufacturing/ import license under the Medical Devices Rules, 2017.
Source: bit.ly/4aP4TUJ

Students pursuing courses in Indian System of medicine will have to give exit test prior to applying for Registration as a practitioner of Indian System of Medicine: Delhi HC
In a recent decision, the Delhi High Court has held that only those students that have already obtained their respective recognized qualifications (either a BAMS, or BUMS degree) would be permitted to initiate the process for registering as a practitioner of Indian Traditional Medicine. This decision was taken on the basis of Sec. 15(1) of the National Commission for Indian School of Medicine Act, 2020 which mandates a common final exit test to be cleared prior to registration with State Register.
Source: bit.ly/3JxjPLo

Government relaxes obligation of deductees to pay higher TDS for persons whose PAN remained inactive for FY 2023-2024
In pursuance of Circular No. 3 of 2023, a person whose PAN (Permanent Account Number) has become inoperative has been subject to a higher rate of TDS. The Central Board of Direct Taxes has issued a notification recently, which relaxes this obligation of persons to deduct at a higher rate of TDS, for all transactions dated till 31st March 2024 provided that the linked PAN is reactivated before 31st May 2024.
Source: bit.ly/4aR96HE

AI Taking up more of Doctors’ time since it needs more training and monitoring
In a set of recently published studies at various teaching hospitals, it was revealed that using AI to manage patient interaction and medical records to assist Doctors has in fact, lead to Doctors spending more time on the tasks delegated to the AI, since the Doctors were now required to train and supervise the AI in addition to carrying out their regular responsibilities for these tasks.
Source: bit.ly/3Wg75QU

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.

Draft GDP guidelines for pharmaceutical products published for comments
India’s Central Drugs Standard Control Organization (CDSCO) has released a draft guidance document titled “Guidelines on good distribution practices for pharmaceutical products” for comments. The Guidelines seek to eliminate the introduction of spurious, adulterated, misbranded and non-standard quality (NSQ) products into the market. It is intended to be applicable to all entities involved in any aspect of the storage and distribution of pharmaceutical products, including manufacturer as well as pharmacists and any other person dispensing medical products directly to a patient.
Source: bit.ly/4cQwypM

Agreements with Shared Workspace Providers accepted as valid proof of premises for obtaining food licenses
India’s central food regulatory authority, Food Safety and Standards Authority of India (FSSAI), has issued an advisory on the documents that may be submitted as proof of premises by importers, traders, e-commerce entities, re-labellers etc. who deal in food products and operate out of a shared workspace premises. Going forward, any legally valid agreement with workspace provider will be accepted. Such agreement may be a lease or rent agreement. However, entities who operate out of shared work-space will not be able to stock food products in shared workspace under the license.
Source: bit.ly/3JkMpzp

Documents which will be accepted as proof of possession of premises for food business is specified by Central Food Regulator
India’s central food regulatory authority, Food Safety and Standards Authority of India (FSSAI), has identified documents which will be accepted as proof of possession of premises by a Food Business Operator (FBO) as part of the food license application. Any food business operator, undertaking any business of food or beverage, including hotels, restaurants, food vending establishments, clubs, canteens, importers, merchant, exporters, e-commerce operators, transporters has to submit proof of possession of premise in order to obtain corresponding food license.
Source: bit.ly/3UiCgte

Waste management portals for plastic packaging and e-waste to get operational in a phase wise manner
India’s Central Pollution Control Board (CPCB) has clarified that the Extended Producer Responsibility portals for the management of Plastic Packaging waste and E-waste will get operational in a phase wise manner. For plastic packaging waste the portal is only functional for Chandigarh, Chhattisgarh, Goa & Puducherry whereas for e-waste the portal is operational for Maharashtra only. The users of the portal for other states are requested to wait till further notice.
Source: bit.ly/3JqZRBH
Source: bit.ly/3Jl1Es4

Popular protein supplements sold in India found to have lesser quantity of protein than declared on the label
A recent study has found that many popular brands of protein supplements sold in the Indian market do not have the same amount of protein as claimed on the label. In addition to the inconsistencies related to protein content, the study also found evidence of protein spiking, fungal toxins, pesticide residues, presence of heavy metals and compounds in protein supplements manufactured in India.
Source: bit.ly/3vU24CC

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.

Environmental Compensation Guidelines for Plastic Waste Published
India’s Central Pollution Control Board (CPCB) has issued guidelines for the assessment of Environmental Compensation (EC) for violation of The Plastic Waste Management Rules, 2016. The Producers, Importers, Brand Owners and Manufacturers of plastic packaging will have to pay environmental compensation (EC) for non-compliance with the marking or labelling requirements, non-registration on the Plastic Packaging Waste EPR portal, shortfall in EPR targets, non-filing of annual returns etc. EC would also be levied on the generators of waste for non-segregation of plastic packaging waste at source and littering. The environmental compensation will be higher (15 – 20%) than the EPR credit charges prevailing in the market to ensure that it acts as a deterrent. The guidelines also specify the minimum and maximum amount of environmental compensation to be levied for violations of specific provisions of the Plastic Waste Management Rules, 2016.
Source: bit.ly/3U6zhUJ

Importer of cosmetics inadvertently receives import registration for cosmetic product without applying for it
India’s Central Regulatory Body for Cosmetics, The Central Drugs Standard Control Organization (CDSCO), recently cancelled the import registration certificate of an importer of cosmetics after it realized that it had inadvertently granted registration certificate even though the importer had not applied for it. CDSCO has attributed the mistake to some technical issues.
Source: bit.ly/3vNc0xQ

Hair transplantation by doctor with M.B.B.S. degree only does not automatically result in negligence, if standard of care not compromised by doctor: National Consumer Commission
India’s National Consumer Dispute Redressal Commission (NCDRC) in Hyderabad refuse to fasten liability for medical negligence on a Doctor with M.B.B.S, who had performed a hair transplant surgery. The NCDRC observed that the M.B.B.S. course syllabus includes study of the dermis, and that a doctor with a M.B.B.S. degree has the qualifications and expertise to undertake minor surgeries of dermis such as hair transplantation.
Source: bit.ly/3PWQBZN

Indian hospitals have started using Artificial Intelligence extensively: Report
India’s major hospital chains have reportedly started using artificial intelligence (AI) for prediction, prevention, diagnosis, and personalized management. These hospital chains are also commercializing their AI solution by licensing it with smaller hospitals.
Source: bit.ly/43Ua6rF

French Government decides to impose fines on patients if they miss appointment with doctors
The French government has decided to impose a fine of five euro ($5.50) on patients who miss doctor appointments or cancel them with less than twenty-four hours’ notice. The Government homes that this initiative would free up missed appointments for other patients. It is reported that over 27 million doctor consultations go waste in France due to patient absences.
Source: bit.ly/49p7Iug