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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 Indian Pharmacopoeia Commission (IPC), traditionally responsible for preparing standards for medicines, is now reportedly expanding its role to prepare standards for medical devices in collaboration with the Bureau of Indian Standards (BIS). It has also begun auditing medical device companies and is developing monographs which will outline standards and specifications for medical equipment. This initiative aims to enhance India’s credibility in medical device manufacturing and support export growth.
Source: short-url.org/1c9pE

2. The Telangana High Court set aside a blanket injunction order in a trade secret dispute, holding that confidential information and trade secrets must be clearly identified and proven. It ruled that the trial court erred by granting a blanket restraint and directed a fresh hearing in accordance with law.
Source: short-url.org/1gQnE

3. The Indian government has amended the export policy for rice (both Basmati and non-Basmati) to non-EU European countries, removing the requirement for Export Inspection Council (EIC) certification until April 2, 2026. The EIC certification will, however, remain mandatory for exports to the EU, the UK, Iceland, Liechtenstein, Norway, and Switzerland.
Source: short-url.org/1gQlT

4. The Pharmaceuticals Export Promotion Council (Pharmexcil) has asked pharma exporters to submit cases of delayed or non-payment by overseas buyers to help frame a Standard Operating Procedure (SOP). This SOP aims to streamline the process of addressing payment-related grievances and Pharmexcil’s timely intervention.
Source: short-url.org/1c9p-

5. Tamil Nadu Food and Drugs Administration (FDA) is investigating the license of a local cough syrup manufacturer following child deaths in Madhya Pradesh linked to contaminated cough syrup produced by the company. The scrutiny in Tamil Nadu began after a formal request from the Madhya Pradesh Drugs Control Authority and the state drug regulator. In response to these incidents, India’s Union Health Ministry has issued an advisory urging the rational use of pediatric cough syrups banning them for children under two years, advising caution for older children, and promoting rest and hydration as preferred treatments.
Source: short-url.org/1gQng
Source: short-url.org/1c9qC

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 plans to discontinue the doorstep delivery of certain medicines that were permitted during the COVID-19 pandemic to prevent misuse by online platforms currently offering doorstep medicine delivery services. The earlier provision allowed licensed retailers of Drugs to deliver medicines on the doorstep based on original prescriptions during the pandemic.
Source: bit.ly/4izvgkG

2. India’s Health Ministry is considering a proposal to include the name of the person responsible (authorised person) for batch release in all drug manufacturing licenses. This aims to enhance accountability, as batch release ensures the safety and quality of medicines.
Source: bit.ly/4izvgkG

3. The Bureau of Indian Standards (BIS) has recently raided a facility supplying sanitary pads without the mandatory ISI mark and seized around 30,000 pads in Hyderabad. As per the Quality Control Order, BIS certification for sanitary pads is compulsory, and violations are strictly punishable.
Source: bit.ly/3S2bIdM

4. The Indian Council of Medical Research has recommended banning the drug ‘Nimesulide’ for individuals under 18 and above 60, and in all formulations above 100 mg due to risks of liver damage and gastrointestinal issues. ICMR also advises a black box warning on labels and cautions against use in women trying to conceive.
Source: bit.ly/42pwQ3Q
Source: bit.ly/4izvgkG

5. Indian government has defined ‘proof of origin’ for trade to enhance ease of doing business and prevent misuse of trade pacts. Importers must submit a certificate of origin to claim duty concessions under Free Trade Agreements (FTAs). The move aims to simplify procedures and ensure transparency.
Source: bit.ly/42rED11

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.

India’s Central Food Regulator (FSSAI) has published draft of the certificate required to be procured by importer of vegan food, from regulatory authority of exporting authority, in order to import vegan food into India. Objections may be submitted by 30th April 2025.
Source: bit.ly/4hbimbQ

2. Karnataka State Government is reportedly working on a Not of Standard Quality (NSQ) drug recall policy. In addition to recall, if a batch of medicines is found spurious or NSQ, the manufacturing and distribution license may get suspended until corrective actions are taken.
Source: bit.ly/4ioKGc0

3. India’s Environment Ministry (MoEFCC) has issued an SOP which clarifies that white-category industries can be exempted from obtaining consent to establish (CTE) only when they submit a self-declaration of compliance with applicable environmental laws. White category industries are least polluting industries.
Source: bit.ly/43mS433

4. India’s Central Pollution Control Board (CPCB) has discovered major non-compliances during audit of plastic packaging waste recyclers such as the absence of production capacity relative to Extended Producer Responsibility (EPR) certificates issued and the absence of GST invoices for sales transactions. Brand owners should not buy EPR certificates from such recyclers.
Source: bit.ly/43fNDXY

5. India’s Supreme Court has clarified that for an activity to be construed as “manufacturing” process requiring license under Factories Act 1948, the activity need not transform goods or necessarily produce an entirely new product that is commercially recognized as different.
Source: bit.ly/43fNQdI

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