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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. Supreme Court Calls Unethical Clinical Trials a Critical and Serious Issue, Orders Detailed Report from Government. The Supreme Court of India recently heard a Public Interest Litigation (PIL) filed by a public health rights NGO, highlighting unethical clinical trials causing serious adverse effects and deaths of the participants. The Court directed the Central Government to submit a detailed report within four weeks addressing concerns such as transparency, accountability, provisions for criminal actions against sponsors/investigators and other points raised by the petitioners.
Source:  bit.ly/4bW7QEB

2. Group of therapists have approached the Bombay High Court, alleging police harassment under the Immoral Traffic (Prevention) Act, violating their trade and dignity rights. The Maharashtra government informed the Court about a 12-member committee drafting guidelines for regulating spa and massage centers. The guidelines will cover important aspects such as licensing procedures, operational standards, and the regulation of cross-gender massages.
Source: bit.ly/4c4hG7s

3. India’s Health Department of Karnataka has clarified that Essential Narcotic Drugs (END) in the state will now be regulated under the Central Narcotic Drugs and Psychotropic Substances (NDPS) Rules, replacing the previous state regulations. As a result, hospitals and medical institutions recognized as RMIs by the state drug regulator no longer need state-level permission to stock these drugs. However, other narcotic drugs in Karnataka will continue to be regulated according to state NDPS Rules.
Source: bit.ly/4l1XDdY

4. The list of drugs taking a shift from prescription-only to over-the-counter (OTC) is reportedly to be released soon. A sub-committee is drafting guidelines, which may categorize OTC drugs for sale in pharmacies or in general stores, similar to practices in Western countries.
Source: bit.ly/4hJjCDB

5. MedTech Europe has released a report outlining the administrative burdens caused by the non-harmonized authorization process for IVD performance studies & the increased post-market and clinical reporting requirements for medical devices under the new medtech regulations. The report also proposes several solutions, including streamlining approvals for multinational studies, digitalizing processes, and allowing manufacturers to consolidate key reports.
Source: bit.ly/42jN4dJ

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.

Strict quality checks to be done by the food regulatory authority of powdered spices in India
Food Safety and Standards Authority of India (FSSAI) has announced plans to conduct comprehensive quality checks of different brands of powdered spices following an import ban by Hong Kong and Singapore on certain packaged powdered spices manufactured two popular Indian brands. The ban was ordered due to alleged discovery of a cancer-causing pesticide, ethylene oxide, which is also prohibited for use in food products by FSSAI in India.
Source: bit.ly/4b8aiWU

India too may soon allow sale of drugs without license
A Committee chaired by India’s Directorate General of Health Services will reportedly publish a list of drugs which can be sold over the counter (OTC) at retail stores, which are not druggists and chemists store. Unlike other countries like US, UK or China, India does not currently have any rule that allows sale of drugs over the counter.
Source: bit.ly/3UellH0

New voluntary standards for allopathic clinics to be implemented from June
India’s National Accreditation Board for Hospitals & Healthcare Providers (NABH) has published Accreditation Standards for Allopathic Clinics (2nd Edition). NABH will start issuing accreditations as per this standard from 1st July, 2024. New applications or renewal applications as per the 1st Edition Standards will not be accepted after 30th June, 2024.
Source: bit.ly/3xKLMwx

Indian Pharma Companies need to implement differential pricing strategies to leverage patent cliff: DOP study
A study conducted by India’s Department of Pharmaceuticals (DOP) states that pharmaceutical companies should come up with competitive pricing strategies and investigate differential pricing models based on regional economic factors and healthcare systems to ensure affordability and improve accessibility to capitalize on patent cliff opportunities. The report states that over 20 drugs with a combined sales value of $251 billion are expected to go off-patent in the current decade.
Source: bit.ly/4dbsCAg

World Health Organization outlines ten fundamental patients’ rights in its Patient Safety Rights Charter
The World Health Organization has launched the Patient Safety Rights Charter. This first-ever charter identifies ten fundamental patients’ rights in the context of safety and provides healthcare workers, leaders, and governments with the tools they need to build patient-centered healthcare systems, enhancing patient safety and lowering the risk of harm. WHO has recognized increasing patient safety through systemic and systematic action as a global priority.
Source: bit.ly/3WcsnPg