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 Drugs Standard Control Organization (CDSCO) is in the process of initiating license withdrawal procedures for unapproved fixed-dose combinations (FDCs) of antibiotics. This action follows the failure of state drug licensing authorities to submit critical data. The move is aimed at curbing irrational antibiotic use and combating antimicrobial resistance.
Source: bit.ly/4j6zhxs

2. India’s government plans to mandate QR codes on vaccines, antimicrobials, narcotics, and cancer drugs to enhance traceability and combat counterfeiting. The move also includes adding excipient details on labels for certain medicines, aiming to improve drug authenticity, safety, and public health protection across the supply chain.
Source: bit.ly/4jflqFa

3. An Indian industry group has urged the government to scrap the mandatory testing of cough syrups at government-approved laboratories before export. The group argues that this costly process delays shipments and places a heavy burden on small manufacturers. The requirement was introduced following reports linking India-made syrups to fatalities in Gambia.
Source: bit.ly/437zHNO

4. The United States Food and Drug Administration (US FDA) has issued a warning to an Indian drug manufacturer for significant violations of Current Good Manufacturing Practices (CGMP) at its production facility. The violations include unsanitary conditions, inadequate equipment cleaning, poor documentation, and unverified raw material, raising serious global concerns about product quality, safety, and regulatory compliance.
Source: bit.ly/4mjGJIg

5. The EU’s Scientific Committee on Consumer Safety (SCCS) has concluded that butylparaben at 0.14% is unsafe for children aged 0.5–10 years when used in multiple cosmetic products. However, it is considered safe in single-use dermal and oral products, excluding body lotions.
Source: bit.ly/3H8EmYu

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. Export samples of “Cough Syrup” under HSN code 3004 has been exempted from testing by the Directorate General of Foreign Trade (DGFT) provided they are being exported to or are manufactured at a plant/section which is approved by the regulatory agencies of USA, UK, Canada, European Union, Japan, Australia, Singapore, Republic of Korea and Switzerland.
Source: bit.ly/3YeH6tI

2. India’s Department of Pharmaceuticals (DoP) has recently rejected the review application of a leading pharmaceutical company and upheld the action of NPPA in fixing the ceiling price of the subject formulation. DoP stated that all modified release formulations of a drug that were mentioned in National List of Essential Medicine (NLEM) 2011 – Schedule I of Drugs Price Control Order, 2013 (DPCO, will be included in the NLEM 2015 – Schedule I of DPCO even though not specifically mentioned in NLEM 2015. It may be worth noting that, NLEM 2022 unlike NLEM 2015 specifically mentions that all modified release formulations of drugs specified in the NLEM list of 2022 will be regulated as scheduled formulations.
Source: bit.ly/3NzW73a

3. Goods and Service Tax (GST) on life and health insurance premiums by senior citizens may reportedly be exempted from GST irrespective of the coverage amount. Group of Ministers (GOM) to submit its report on the GST rates on life and health insurance premiums to the GST Council by October end of this year and final decision will be taken by the GST Council.
Source: bit.ly/3Nxr1cr

4. India’s pharmaceutical exporters are waiting for a government response to their request for an exemption from the onerous payment conditions prescribed under Section 43B (h) of the Income Tax (IT) Act, 1961. They are advocating for a minimum 60-day credit period, which is in line with global market standards where credit terms frequently extend up to 120 days. According to section 43B (h), payments for goods or services must be cleared within 45 days of acceptance. Failure to comply within this period creates financial burden and prevents businesses from claiming these payments as tax deductions.
Source: bit.ly/3Nx3dFD

5. To streamline and modernize pharmaceutical export-related procedures, the Directorate General of Foreign Trade (DGFT) has implemented an electronic Appendix 4H certificate filing system. The certificates which record the consumption and stock of duty-free imported or locally sourced raw materials under the Advance Authorization (AA) and Duty-Free Import Authorization (DFIA) schemes, are fully digitalized, as highlighted in Trade Notice No. 21/2024-25. Digital submission of these certificates is now mandatory for all pharma exporters.
Source: bit.ly/3YvCbES
Source: bit.ly/48fPe0g

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 Union Health Ministry of India has been allocated a budget of Rs 90,958.63 crore for the financial year 2024-2025 in the Parliament’s interim Union Budget 2024 session. This budget is 12.96% higher than the budget that was allocated for the financial year 2023-24.
Source: bit.ly/3YnHCWu

2. The Union Health Ministry of India has announced a revision in the basic customs duties (BCD) with an aim to align with domestic capacity expansion for medical equipment such as X-ray tubes, flat panel detectors, including scintillators that will be used in the manufacture of medical X-ray machines for medical, surgical, dental, or veterinary use. The custom duty will be reduced from 15% to 5% until 31st May 2025.
Source: bit.ly/4fgx6GI

3. India’s Environment Ministry has issued a draft guidelines relating to the Uniform Consent Fee and the Grant, Refusal, or Cancellation of Consent to Establish & Consent to Operate. These guidelines aim to streamline the consent mechanism under the provisions of the Water Act and Air Act, enhance ease of doing business, minimize the compliance burden on industries, and reduce duplication of work concerning the issuance of consents.
Source: bit.ly/4cQs6af

4. India’s Environment Ministry has notified an Public Liability Insurance (Amendment) Rules, 2024. This amendment aims to increase scope of public liability insurance to environmental damage that may be caused by industrial accidents.
Source: bit.ly/3YihHjg

5. The India’s Central Drug Regulator (CDSCO) is reportedly planning to exempt the need for testing Cough Syrups intended for export to the US, UK, Canada, the European Union, Japan, Australia, Singapore, Korea, and Switzerland at prescribed laboratories.
Source: bit.ly/4df0ZFz