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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. The Ministry of AYUSH has proposed an amendment to the First Schedule of the Drugs and Cosmetics Act, 1940, expanding the list of authoritative books for Ayurveda, Siddha, and Unani Tibb drugs. The updated list now includes more vernacular books with details such as the author’s name and language. These drugs must be manufactured according to the formulae described in the books listed in the First Schedule, as defined by the Act.
Source: bit.ly/40UqMhL

2. The Ministry of AYUSH has proposed an amendment to update the list of poisonous substances in Ayurveda, Siddha, Sowa-Rigpa, and Unani systems under Schedule E(I) of the Drugs Rules, 1945. The draft amendment has been published for public awareness, with a 30-day period for objections or suggestions. The amendment categorizes the poisonous substances by their botanical names and includes the drugs in the respective systems of medicine that are prepared using these substances.
Source: bit.ly/3QdJ6NP

3. India’s drug pricing regulator has directed all retailers and dealers, including online pharmacies, to display the current price list of medicines on their websites. This move aims to empower consumers and ensure they are not overpaying for their medications.
Source: bit.ly/41bnhEY

4. India’s Odisha Registered Pharmacists Association (ORPhA) has expressed disagreement to government’s classification of pharmacists as paramedics, despite the Pharmacy Council of India (PCI) stating they are independent healthcare professionals. The association has urged the health minister to take steps to avoid the classification, highlighting that pharmacists are specialized healthcare professionals who play a vital role in patient care through their expertise in areas like pharmaceutical sciences, pharmacology, and medication therapy management.
Source: bit.ly/3EtSniq

5. India’s central government has imposed a ban on the export of raw human hair valued at less than $65 per kilogram, as per a notification issued by the Directorate General of Foreign Trade (DGFT). The notification stated that the export policy for raw human hair has been changed from “restricted” to “prohibited.” However, exports will still be permitted without restrictions if the Free on Board (FOB) value is $65 or more per kilogram.
Source: bit.ly/4gBVKAU

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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. The Maharashtra government plans to amend the Mumbai Nursing Home Registration Rules, 1949, following concerns from the Indian Medical Association (IMA) over the 2021 amendment, which mandated staffing and infrastructure requirements for small hospitals. The new amendments aim to align regulations with industry recommendations to improve infrastructural and staffing feasibility for healthcare providers.
Source: bit.ly/3CFx3G1

2. The European Medicines Agency has set 23rd July 2025 as the date for implementation of updated International Council for Harmonisation (ICH) guidelines on Good Clinical Practises. This latest version of the guidelines encourages the sponsors to design trials that are fit for purpose and sufficient to provide confidence in the trial’s results.
Source: bit.ly/3CG9rky

3. In the 1st half of Financial Year 2025, the National Pharmaceutical Pricing Authority’s (NPPA) overcharging demands from pharma companies dropped sharply, while the number of cases surged by over 50% compared to last year. This reflects a rise in enforcement actions but a decline in penalty amounts imposed.
Source: bit.ly/4jGCGnY

4. The amended version of European Union’s (EU) Medical Devices Regulations, 2017 introduced Section 10a to enhance transparency and availability of medical devices. It mandates early notification of supply disruptions, extends IVD transition periods, enables a gradual roll-out of Eudamed, and imposes new responsibilities on economic operators.
Source: bit.ly/414XApt

5. A Parliamentary Panel has urged the Ministry of Ayush to strengthen regulations for adverse effects reporting and ensure regular post-marketing surveillance of Ayush medicines. It has requested a detailed status report on actions taken to enhance the regulatory framework for reporting adverse effects and ensuring drug safety and efficacy.
Source: bit.ly/4gzfzZP

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 Ministry of AYUSH has notified an amendment to the Drugs Rules, 1945, inserting Schedule TB, which specifies the standards for the delivery mechanism, preservatives, and excipients that must be complied with in order to obtain a license for the manufacture of Ayurveda, Siddha, Unani, or other traditional medicines that use a nasal spray as a delivery mechanism.
Source: bit.ly/4j9pCHs

2. India’s Directorate General of Foreign Trade (DGFT) has notified the revised Schedule II (Export Policy) whereby, the terms of export have been updated in conformity with the Finance Act, 2024.
Source: bit.ly/4jss5x0

3. India’s indirect tax regulator has issued a circular clarifying the conditions for eligibility for the interest waiver scheme introduced by the GST Council late last year. In addition to submitting applications and filing Forms GST SPL-01 and GST SPL-02, applicants are also required to withdraw any appeal application filed against demand orders, notices, or statements for which the interest waiver is being sought.
Source: bit.ly/40ohfzs

4. India’s Parliamentary Standing Committee on Chemicals and Fertilizers, in its most recent report, has expressed concern that the low number of IVD manufacturers selected under the PLI incentive scheme may not be sufficient to meet the country’s domestic requirements
Source: bit.ly/42a7zuM

5. The United States Federal Trade Commission (US FTC) has alleged that several of the country’s largest insurance companies entered into vertical arrangements with benefit managers to mark up the prices of common and essential prescription medicines, totalling USD 7.3 billion between 2017 and 2022.
Source: bit.ly/4fXStMi

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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 Bombay High Court’s Division Bench has stayed an order penalizing a leading AYUSH drug manufacturer for violation of an injunction order on the selling of camphor products thereby infringing another company’s organics’ trademark. Earlier the drug manufacturing company was imposed with a penalty for contempt of court after observing continued violations of the restraining order since 2023.
Source: bit.ly/3ZF02RK

2. India’s Delhi High Court has directed online platforms, including Telegram, to block accounts linked to an anonymous user threatening to leak an insurance company’s confidential customer data. The court emphasized that misuse of such data could lead to identity theft, fraud, and privacy violations and restrained the unidentified entity from sharing the data and ordered intermediaries to disclose its details.
Source: bit.ly/3VKUjbT

3. India’s Karnataka government has reportedly merged the Department of Food Safety and Standards with the Drug Control Department, renaming it as the Food Safety and Drug Administration (FDA). The move aims to streamline operations and enhance service delivery under a unified Commissioner. Officers and staff will now function under the FDA’s administrative control, with steps being taken to restructure rules and regulations. The decision follows similar mergers in states like Maharashtra, Gujarat, and Tamil Nadu.
Source: bit.ly/4flpL7B

4. The Union Ministry of AYUSH (MOA) will reportedly launch a national portal, ‘Trinetra’, for pharmacovigilance in Indian Systems of Medicine (ISM) to curb misleading advertisements. Announced at the World Ayurveda Congress in Dehradun, the portal will ensure quicker reporting of misleading advertisements thereby improving consumer safety. Experts emphasized the need to protect Ayurveda’s reputation and address false claims of “magic cures” and “side-effect-free” treatments.
Source: bit.ly/4gC7y6O

5. India’s Supreme Court has criticized the Delhi government for failing to provide data on daily solid waste generation, calling it a “shocking state of affairs.” Despite an order dated November 18, 2024, the data remains pending, prompting the Court to warn of contempt proceedings if an affidavit is not submitted by December 18, 2024. The Chief Secretary has been directed to appear before the Court on December 19. The Court expressed concern over untreated solid waste, linking it to public health risks and landfill fires.
Source: bit.ly/3ZZyXtK

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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. A Public Interest Litigation before the Bombay High Court is being opposed by the Association of Oral and Maxillofacial Surgeons of India, arguing on the basis of a notification of the Dental Council of India dated 6th December 2021, that specialized Oral and Maxillofacial Surgeons registered with State Dental Councils should be permitted to carry on hair transplant surgeries.
Source: bit.ly/49yFtLx

2. The Central AYUSH Minister (Ayurveda, Unani, Siddha and Homeopathy) has stated in response to query in the Indian Parliament, that the ministry has followed a policy of co-location of AYUSH facilities at primary healthcare centres to encourage patients to make choice of treatment.
Source: bit.ly/41ssp8c

3. A lawsuit has been filed in the United States against the manufacturers of consumer food products, alleging that the products manufactured by the companies are “ultra-processed” and prone to causing chronic diseases among consumers.
Source: bit.ly/4goMQXO

4. The Union Health Ministry of India has reportedly urged states to classify snakebites as a notifiable disease, meaning it must be reported to the government by hospitals. This follows the launch of the National Action Plan for Prevention and Control of Snakebite Envenoming (NAPSE), which aims to reduce snakebite deaths by 50% by 2030. One of NAPSE’s recommendations is that snakebites be made a notifiable disease to better track and address the issue.
Source: bit.ly/4gxDPvG

5. The Ministry of Health and Family Welfare has stated that data on disciplinary actions against Registered Medical Practitioners (RMPs) over the past five years is not centrally maintained. It has advised states to promote the prescription of generic drugs and conduct prescription audits in public health facilities. The Indian Medical Council’s 2002 regulations mandate that physicians prescribe drugs by their generic names, legibly and preferably in capital letters, ensuring rational and appropriate use.
Source: bit.ly/3ZRLujb

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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 Environment, Forest, and Climate Change has released draft rules under the Environment Protection Act, 1986, proposing Extended Producer Responsibility (EPR) for managing post-consumer waste from paper, glass and metal packaging along with sanitary products. These Rules aim to promote recycling, reuse, and waste-to-energy initiatives. Producers, importers, and brand owners must register and meet EPR targets from April 2026.
Source: bit.ly/49w0GFK

2. India’s Central Pollution Control Board (CPCB) has regulated the micro and small importers, producers, sellers and manufacturers of plastic raw materials and have mandated their registration on the EPR Plastic Portal. Filing of annual returns and compliance with all other EPR obligations is also outlined in the guidance issued by CPCB.
Source: bit.ly/49CJo9Z

3. India’s Supreme Court has reiterated that Ayurvedic/AYUSH doctors cannot claim parity with allopathic doctors, citing differences in academic qualifications and the standards of their respective courses. The court dismissed a petition by AYUSH doctors in Kerala, referring to past judgments that clarified the distinction in responsibilities and remuneration between allopathic and AYUSH practitioners.
Source: bit.ly/4iqyYhN

4. India’s Delhi District Consumer Commission has fined a leading FMCG company with a fine of ₹15 lakh for misleading advertisements about its “Fair and Handsome” cream, which claimed to provide fairness within three weeks without proper evidence. The Commission found the claims deceptive and an unfair trade practice, ordering the company to withdraw all misleading ads and packaging.
Source: bit.ly/3OPcMjE

5. India’s Central Drugs Standard Control Organization (CDSCO) has issued a circular thereby directing all State and Union Territory Drugs Controllers to ensure the approval of drugs and medical devices for rare diseases within 90 days of receiving applications to expedite the regulatory process and support faster access to treatment for rare diseases.
Source: bit.ly/3VvSFLl

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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. An interministerial committee constituted by the Department of Pharmaceuticals has proposed that health-supplements and nutraceuticals should be regulated as “Drugs” to ensure better quality control and to streamline insurance regulation as well.
Source: bit.ly/40QCmfk

2. In its recent meeting, the Ayurveda Siddha and Unani Drugs Technical Advisory Board (ASUDTAB) has proposed to amend the Drugs Rules and regulate the retail sale of AYUSH medicine, which would empower drug inspectors to inspect these premises and collect and examine samples.
Source: bit.ly/3Cve0xR

3. The CDSCO is set to hold a round-table meeting for all Cosmetics industry stakeholders, including manufacturers and marketers to discuss issues including expansion of permission for cosmetics manufacturers to manufacture topical products.
Source: bit.ly/4ey6nDX

4. The Supreme Court dismissed a Special Leave Petition filed in response to the decision of the Delhi High Court seeking Order to mandate Doctors to explain side-effects to patients, holding that since there is no obvious issue highlighted with the side-effect information legally required to be presented by manufacturers, it is not necessary to require Doctors to do the same.
Source: bit.ly/48WLP70
Source: bit.ly/3UV5MoM

5. In a recent decision, the Supreme Court held that when examining petitions concerning procedural irregularities under the Arbitration and Conciliation Act, 1996, Courts should limit their examination to merely determining whether a valid arbitration agreement is existing and whether there is a preliminary dispute regarding appointment of Arbitrators.
Source: bit.ly/4ezdTP6

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. The government has expanded the definition of Homeopathic medicine, to include all drugs except those drugs “which is administered by injectable route”.
Source: bit.ly/48C6E7n

2. The government has given more powers to Adjudicating Officers under the food laws. In addition to existing power, they have now been granted the additional power to investigate cases of supply of false information as well as unlicensed operation of food business.
Source: bit.ly/3NPfCVw

3. India’s drug price regulator the National Pharmaceutical Pricing Authority (NPPA) has issued a price-control notification requiring a proportional reduction in price of the drugs resulting from the reduction in the Customs Duty and GST.
Source: bit.ly/3YPz7Du

4. The Indian Medical Association has taken objection to the proposal of the Central Government to introducing category of “Geriatric Nursing Practitioners”, and the designation of these nurses as Medical Practitioners, stating that this conflicts with qualification requirements under the National Medical Council Guidelines.
Source: bit.ly/4fu2IrI

5. Several industry associations representing the Homeopathic industry in the United States, have filed a lawsuit challenging the power of the United States Food and Drug Administration’s (US FDA) power to require New-Drug Approvals, and further the USFDA power to prosecute and penalize violations.
Source: bit.ly/3YuZxJz

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. The Union AYUSH Ministry has prohibited to advertise Ayurveda, Siddha, Unani, and Homeopathy drugs with claims of “miraculous or supernatural effects” in order to prevent misleading advertisements with unverified claims. The ministry instructed that such drugs should contain a caution to be taken under medical supervision on its label. Additionally, the ministry issued a public notice clarifying that it does not certify, grants license or approves any company for making ayurvedic drugs.
Source: bit.ly/4eXXjsL
2. India’s central drug regulator (CDSCO) is actively investigating social media influencers who promote false claims, quick fixes and misleading medical content.
Source: bit.ly/4eGfqDC 

3. The Pune division of the Food and Drug Administration (FDA) has taken action against three drug firms for violating the Drugs and Magic Remedies (Objectionable Advertisements) Act, 1954. The firms were found selling Ayurvedic medicines with misleading claims to cure diabetes, arthritis, and kidney ailments, leading to the seizure of products.
Source: bit.ly/3XUC5Fe

4. The Delhi High Court ruled that a mere fraction of a cause of action occurring in a jurisdiction is insufficient to invoke the court’s territorial jurisdiction. The decision of the court said that in order to raise the territorial jurisdiction of a specific court, there must be a significant link of the matter to the specified territory, reinforcing the standards for filing cases in the court.
Source: bit.ly/3ZXxPr1

5. The Medicines and Healthcare products Regulatory Agency (MHRA) in UK has unveiled its 2024/25 business plan, which prioritizes enhancing access to innovative healthcare technologies while optimizing service delivery. Key initiatives of the plan include the implementation of new IT systems and a commitment to public engagement and diversity in regulatory processes, aimed at reinforcing the UK’s position in life sciences and improving pandemic preparedness.
Source: bit.ly/3BES5Ux

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. The Drugs Technical Advisory Body, in its 91st meeting, has recommended the exemption of several chemical contraceptives at specific dosage values, from the labelling requirements under Schedule H which would have limited sale by prescription only.
Source: bit.ly/3ZWiqqU

2. The Directorate General of Foreign Trade has amended the export policy for cough Syrup, amending an earlier notification, exempting the requirement for pre-export testing for jurisdictions including the USA, EU, and South Korea which may already have granted approval.
Source: bit.ly/3YfvOVP
Source: bit.ly/3YeH6tI

3. The Ministry of Environment Forest and Climate change has notified the Liquid Waste Management Rules, 2024 set to come into force from 1st October; which govern the treatment and management of liquid effluents arising from domestic and industrial activities including treatment of wastewater, sludge generated during treatment of wastewater and reuse/reutilization of any wastewater or sludge generated.
Source: bit.ly/3YhCpzl

4. In a recent public notice, the Central Government Ministry of Ayurveda, Yoga and Naturopathy, Unani, Siddha and Homeopathy (AYUSH) has clarified that it does not license or ratify any AYUSH products or medicines, and warned against the advertising of AYUSH products as “Miracle Cures”. This comes in the light of the Ministry of AYUSH having repealed Rule 170 of the Drugs Rules, 1945, which regulated AYSUH advertising.
Source: bit.ly/4dzToBi
Source: bit.ly/3XXf9Fi

5. The European Commission’s Medical Device Coordination Group (MDCG) has issued a voluntary document to supplement its earlier Designation, re-assessment and notification of conformity assessment bodies and notified bodies, which is intended to guide notified bodies to impose corrective and preventative action.
Source: bit.ly/4eYr4JJ