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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 National Pharmaceutical Pricing Authority (NPPA) has directed drug manufacturers to reduce the maximum retail price (MRP) of three crucial cancer drugs i.e., Trastuzumab Deruxtecan, Osimertinib, and Durvalumab. This is in line with reduction of customs duty and GST rates on these medications.
Source: bit.ly/4fBQ3Dd

2. Delhi High Court has granted a permanent injunction against a pharma company which had imitated the design and presentation of a drug manufactured by another pharma company. This ruling highlights the requirement for pharma companies to ensure a distinctive packaging to avoid copyright Infringement claims.
Source: bit.ly/40AprhH

3. The All India Organization of Chemists and Druggists (AIOCD) has urged the Drug Controller General of India (DCGI) to restrict a partnership between a rapid delivery platform and an e-pharmacy, citing concerns over regulatory and quality compliance issues that could potentially jeopardize patient safety.
Source: bit.ly/4fDJEqS

4. The Himachal Pradesh High Court has directed the state government to implement a QR code system to assess the quality of medicines in the state. This QR code will provide consumers with key information about the medicine, including production and expiry dates, unit details, batch numbers, and component specifics in order to enhance consumer awareness and transparency in medicine quality.
Source: bit.ly/3YE20Bw

5. UK government is set to launch ‘World-First’ Genomics-Led pandemic warning system. The system will utilize the technology to flag and monitor potential outbreaks of bacterial or viral diseases.
Source: bit.ly/4fBdyw6

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

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TOP 5 HEALTH LAWS AND POLICY UPDATES

1. India’s drug regulator will implement the mandate of printing of QR codes to curb counterfeiting. The top-selling brands have reportedly said that they have already started integrated QR codes and bar codes for tracking and compliance checks.
Source: bit.ly/4d80PzG

2. Indian Health Ministry has issued draft rules under the Drugs and Cosmetics Act, 1940 relating to compounding of minor offences and violations. The draft rules establish a system for companies to settle minor violations of the Act, like manufacturing drugs without proper procedures, outside of court. Companies can apply to a designated compounding authority with relevant documents, and if approved, avoid prosecution. This aims to resolve issues efficiently without lengthy court cases, but serious offenses like selling adulterated drugs are not eligible for compounding.
Source: bit.ly/3zLSKlT

3. India’s Drug Control Officers collective proposal to Indian Government for changing the name of the Drugs and Cosmetics Act, 1940 to ‘Bharatiya Aushadhi awam Chikitsa Upakaran Adhiniyam’ has received mixed responses from the industry and various stakeholders. While some have reasoned that change of name of the Act is the need of the hour and should be done as early as possible, others have questioned the need and purpose of the exercise.
Source: bit.ly/4d9IsdV

4. India’s Pharmacy Regulator, the Pharmacy Council of India (“PCI”) has extended the deadline for submission of statutory documents till 31st July, 2024 by new institutions and existing institutions that have applied for introduction of new course. PCI stated that the documents should be submitted on its compliance portal only. No other mode other than the PCI Compliance portal will be entertained for submission of documents.
Source: bit.ly/3y0YeZE

5. Indian Health Minister stresses on India’s need for world class regulatory framework for Pharma and Medical Device Industry to ensure better quality of products. The Minister also stated the importance of transparency in India’s apex drug regulator the Central Drugs Standard Control Organisation (CDSCO). The Union Health Minister stated that it is important for CDSCO to be in continuous dialogue with the drugs and medical devices industry to understand their issues and support them to fulfill the quality expectations and standards of CDSCO.
Source: bit.ly/4d5XuBd

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TOP 5 HEALTH LAWS AND POLICY UPDATES

1. The Central Government is mulling including non-prescription Neutraceuticals currently regulated by the Central government food regulator the Food Safety Standards Authority of India, under the price control regime similar to Drug price regulation under the Drugs (Prices control) Order, 2013.
Source: bit.ly/4cRZVb7

2. The Supreme Court in continuation of prior orders issued acknowledging the concerns raised in a petition seeking to address the shortage of life saving Antiretroviral Drugs in the country, has granted the request of the petitioner to discuss the access of quality Antiretroviral Drugs to persons dealing with HIV.
Source: bit.ly/4cAATg9

3. The Central Government has issued a Draft Notification proposing amendment to the Drugs Rules, 1945, mainly intending to introduce restriction on advertising Drugs listed in Schedule G of the Rules.
Source: bit.ly/3Whm0Ke
Source: bit.ly/3VZZ0Or

4. Then United States Federal Trade Commission is set to take action against Drug supply middlemen and major pharmacy chains for use of anticompetitive tactics in negotiating Drug prices.
Source: bit.ly/3WgtAom

5. The World Health Organization has issued a new and updated list of pathogens, to reorient the prioritization in combating Antimicrobial Resistance.
Source: bit.ly/4czZdiw