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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 Ministry of Textiles has further extended the timeline for the implementation of the Medical Textiles (Quality Control) Order, 2023. The new deadline is now 1st January 2025, for disposable baby diapers, sanitary napkins, reusable sanitary pads, and period panties. Earlier, the implementation date was 1st October, 2024.
Source: bit.ly/3Afz4rd

2. India’s Subject Expert Committee (SEC) has granted permission to a leading pharma company for importing and marketing the drug for a rare blood disorder, paroxysmal nocturnal hemoglobinuria (PNH), in India by waiving the requirement to conduct local clinical trials. The proposal was presented before SEC and SEC noted that the drug is approved in 35 countries including the US, European Union, Japan, and others and eventually agreed for a local clinical trial waiver.
Source: bit.ly/3BZ2MkU

3. India’s Ministry of Commerce and Industry is reportedly providing a significant boost to exporters through launch of new online portals like “Jan Sunwai” and “Enterprise Resource Planning (ERP).” These initiatives aim to reduce bureaucratic hurdles, enhance transparency, and facilitate smoother operations, ultimately leading to faster resolutions of trade issues.
Source: bit.ly/3Aeyl9N

4. The India Pharmacopoeia Commission (IPC), under the Ministry of Health and Family Welfare, attended a Joint Working Group Meeting with national regulatory authorities from Bhutan, Mauritius, Mozambique, Nepal, the Solomon Islands, and Sri Lanka. The meeting focused on strengthening pharmacopoeial cooperation and establishing an annual forum for ongoing cooperation.
Source: bit.ly/3A1eY43

5. India’s Department of Pharmaceuticals (DoP) has recently rejected the review applications from five major pharmaceutical companies, upholding the ceiling prices set for various strengths of the modified release (MR) formulations of the high blood pressure drug metoprolol. The companies argued that the pricing authority erred in its calculations by combining both the plain and modified release formulations of metoprolol 25 mg and 50 mg tablets. They pointed out that the National List of Essential Medicines (NLEM) 2022 does not include the modified release forms of metoprolol. However, the National Pharmaceutical Pricing Authority (NPPA) contended that in the absence of specific mention of any variant, these formulations can be considered alongside the conventional formulations.
Source: bit.ly/3AaMHYJ

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 Health Ministry has notified the New Drugs and Clinical Trials (Amendment) Rules, 2024 which will take effect from1st April, 2025.These amended rules outlines the requirements for registration of the Clinical Research Organizations.
Source:  https://bit.ly/4ddpX81

2. India’s Central Food Regulator (FSSAI), has issued a show cause notice to a Tamil Nadu-based company that supplied ghee for making laddoos (prasadam) at the Tirupati Balaji temple, following the detection of animal fat in the laddoos. The company is required to respond to the charges by 23rd September, 2024, failing which appropriate action will be taken against them.
Source: https://bit.ly/3BheNln

3. The Government of India is reportedly planning to adopt a risk-based approach for monitoring the quality of imported consignments of medical devices at ports. This will involve random sampling of consignments of medical devices and testing of entire cargoes in case of critical diagnostic kits.
Source: https://bit.ly/3BhePtv

4. India’s central health regulator has declared five samples of drugs to be spurious based on the physical comparison and analytical tests done by the manufacturers and on the reports from State Licensing Authorities. The actual manufacturers, as claimed on the labels, have stated that they are not the actual manufacturers of these drugs and the drugs are spurious.
Source: https://bit.ly/3XTfUjP

5. India’s Directorate General of Foreign Trade (DGFT) has amended Chapter 5 of the Handbook of Procedures (HBP) 2023 under the Export Promotion Capital Goods (EPCG) Scheme. The EPCG Scheme, which allows pharma industry to import capital goods duty-free for producing quality goods and services to boost exports, has been updated to streamline its reporting requirements. The amendment eliminates the previous requirement for annual reporting of Export Obligation (EO) fulfilment and has been replaced with a periodic reporting system.
Source: https://bit.ly/4dkMUWC

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.

Supreme Court clarifies when a patient’s negligence may be reduced due to pre-existing conditions
India’s Supreme Court has laid down the situations in which a patient’s claim for compensation due to medical negligence may be reduced on the grounds of pre-existing conditions. These are: First, when a latent condition of the patient has been unearthed; Second, when the negligence on the part of the wrongdoer re-activates a patient’s pre-existing condition that had subsided due to treatment; Third, wrongdoer’s actions aggravate known, pre-existing conditions, that have not yet received medical attention; and Fourth, when the wrongdoer’s actions accelerate an inevitable disability or loss of life due to a condition possessed by the patient even when the eventuality would have occurred with time, in the absence of the wrongdoer’s actions. This rule is commonly referred to as the ‘egg-shell skull’ rule.
Revised penalty will apply, even if the offence took place before the penalty is revised: Supreme Court
India’s Supreme Court has held that a repealed provision will cease to operate from the date of repeal and the substituted provision will commence to operate from the date of its substitution. The Court was dealing with a matter involving the determination of penalty for loss of liquor in transit. The unamended rule, which existed at the time when the breach happened, provided for a penalty of four times the duty payable on liquor.  The amended rule provided for a penalty equal to the duty payable on liquor. Since no additional guidance for the application of the amended rule was prescribed, the Supreme Court held that the amended penalty provision would apply.
Proceedings related to alcohol content in drugs under excise laws and drug laws can run concurrently: High Court
India’s Gujarat High Court has clarified that action under the Drugs & Cosmetics Act does not exempt an individual from prosecution if a case is made out under the Gujarat Prohibition Act, 1949. In this case, a pharmaceutical manufacturer had allegedly violated the State’s prohibition law by selling intoxicating substances as ayurvedic medicine and, therefore, was facing action against the excise laws as well as drug laws.
Limits on the import of Isopropyl alcohol relaxed
India’s Directorate General of Foreign Trade (DGFT) has notified the discontinuation of safeguard measures on the import of isopropyl alcohol (IPA) through a trade notice. Earlier, country-wise quantitative restrictions (QR) were imposed on the import of IPA into India.
Used imported medical devices with a minimum shelf life of 5 years are not waste: Tribunal
India’s Hyderabad Bench of Customs, Excise, and Service Tax Appellate Tribunal (CESTAT) has held that used medical devices with a minimum residual life of 5 years or more are not e-waste or hazardous waste. In this matter, a hospital had imported used medical equipment for internal use but the Customs had seized the capital equipment on grounds that the used medical equipment qualified as hazardous waste under the Hazardous and Other Wastes (Management and Transboundary Movement) Rules, 2016
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.

Airlines have to obtain single caterer license and provide invoice containing description of license number for chargeable in-flight meals
India’s food regulator, The Food Safety and Standards Authority of India (FSSAI), has issued an advisory to flight operators directing them to ensure that they have appropriate license for providing in-flight food. The regulator has also directed flight operators to ensure that appropriate invoice with license number is issued for sale of food, and that both ready-to-serve and pre-packaged food carries appropriate labelling declaration.
Source: bit.ly/48NrSxN

In medical negligence matters, exoneration by medical council will not automatically mean exoneration before consumer forum, especially if contradictory medical evidence has been furnished: Supreme Court
India’s Supreme Court has held that a consumer commission which is deciding a complaint of medical negligence against a medical practitioner, should not solely rely on favourable report from State Medical Council especially if the complainant has submitted contradictory expert testimony from another medical practitioner.
Source: bit.ly/3Isb30J

Import of medicines to get boost from India’s free-trade agreement with four countries of European Free Trade Association (EFTA)
Four European Free Trade Association states, namely, Iceland, Liechtenstein, Norway and Switzerland, have signed a Trade and Economic Partnership Agreement with India for facilitating trade and investment flows. While India has secured soft investment commitments under the Agreement, EFTA states have been given concession on import duty on pharmaceutical products exported to India and have been promised simplified customs procedure.
Source: bit.ly/3TuP8w9

Limits for automatic exemption in combination cases before CCI increased
The Indian government has increased the asset and turnover thresholds for automatic exemption under India’s anti-trust regulations. For claiming the exemptions from prior approval requirement, the value of assets being acquired should be Rs. 450 crores as opposed earlier threshold of Rs. 350 crores. Similarly, the turnover should be Rs. 1250 crores as opposed earlier threshold of Rs 1000 crores.
Source: bit.ly/3VaYle6

Electrical appliances for hair and skin care would require Indian Standard Marks for sale in India from 4th March 2025
The Department for Promotion and Industry and Internal Trade has published a Quality Control Order (QCO) which makes it mandatory for importers and manufacturers of skin and hair electrical appliances to obtain an Indian Standard Mark (IS mark) from Bureau of Indian Standards (BIS) in order to be able to sell in India. BIS grants rights to use IS Mark after testing and inspection of products and manufacturing facilities, both in India and abroad, and charges a fee on the products sold.
Source: bit.ly/4c8wSzW