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. In the most recent 91st Meeting of the Drugs Technical Advisory Board (DTAB) which advises the central government on drug regulatory policy matters, the DTAB has recommended the use of QR code to identify genuine anti-cancer medication, in recognition of recent cases of spurious drugs sale coming to light.
Source: bit.ly/3zP609I

2. The DTAB, has provided rationale for its decision to reject waiver of Clinical Performance Evaluation for IN-Vitro Devices (IVDs) which are already approved internationally. The DTAB expressed its opinion that the performance of IVDs are variable based on the population, and their performance and effectiveness cannot be taken for granted across demographic lines.
Source: bit.ly/3ZV6hT7

3. The Indian Ministry of Environment Forest and Climate Change has notified the new Ecomark Rules, aimed at replacing the erstwhile Ecomark Scheme, 1991. These rules specify criteria for approving ecomark for a product including: recyclability, reduction in pollution and use of non-recyclable resources, and sustainability of production process.
Source: bit.ly/3TXRP9a

4. The Bombay High Court clarified that any seized sample would have to be separated and the individual components of the Cannabis plant identified, because Ganja is defined under the Narcotic Drugs and Psychotropic Substances, Act 1985 only as the “flowering tops” of the Cannabis plant, and for that reason the seeds and leaves cannot be counted towards identifying whether an accused was carrying “commercial quantity” of Ganja.
Source: bit.ly/3NgyD2P

5. In a departure from government policy, the Drugs Consultative Commission (DCC) decided that including the International Nomenclature of Cosmetics Ingredients would be difficult to accommodate, and for that reason all cosmetics manufacturers should continue to adhere to the applicable standards set by the Bureau of Indian Standards (BIS) for their ingredients.
Source: bit.ly/3NduBbB

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. To combat antimicrobial-resistance the Drugs Consultative Committee, which advises the Central and State Governments on conduct of Drug regulation in the country, has, in its 64th meeting recommended amendment to the Drug Rules to regulate sale of antibiotic Drugs to manufacturers who may not have a license under the Drug regulations.
Source: bit.ly/4evHfhA

2. The Punjab and Haryana High Court upheld the position that under the Narcotic Drugs and Psychotropic Substances Act, 1985, upon seizure, the entirety of the bulk of the seized substance need not be sent to the Forensic Laboratory, rather merely a select homogenized sample thereof would be sufficient.
Source: bit.ly/4gx15uL

3. The Supreme Court has ordered the Central Government Ministry of Health and Family welfare, and the Government of Kerala to file counter-affidavits explaining the delayed action in setting up a special committee to study the effectiveness of the Rabies vaccine.
Source: bit.ly/3MXwwAE

4. The High Court of Bombay has struck down the insertion of Rule 3 of Information Technology (Intermediary Guidelines and Digital Media Ethics Code) Amendment Rules, 2023, which empowered the government to set up fact-check units on the ground that this violated the fundamental right to equality and to carry on trade and business.
Source: bit.ly/4diYthg

5. The United States Federal Trade Commission has formally initiated litigation against Pharmacy Benefit Managers which act as middlemen between Drug Companies and Insurers, for deliberately driving the price of insulin higher for consumers and receiving rebates from manufacturers in the process.
Source: bit.ly/3zrNfcq

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.

E-Commerce websites instructed to avoid marketing Milk/ cereal/ malt based drinks as “Energy Drinks”
India’s Food Standards Regulator (the Food Safety Standards Authority of India) has issued an advisory to e-commerce websites, requiring them to ensure that proprietary foods, i.e. foods that are not categorized under the Food Standards Regulations, specifically those currently registered as analogues to milk/ cereal/ malt based beverage, should not be advertised as “Health Drink”/ “Energy Drink”, as only carbonated/ non-carbonated water-based flavoured drinks are regulated as “Health Drink” and “Energy Drink”.
Source: bit.ly/3xlfzvD

Drug Price Regulator may examine prevalent drug substitution and discounting prices offered by major drug retail stores in India
The Indian Central Drugs Regulator (CDSCO) has reportedly requested the Central Drugs Price Regulatory Body (NPPA) to investigate drug substitution and discounting practices of a major pharmacy chain on the basis a complaint raised by State Chemists and Druggists’ Association of the State of Karnataka (KCDA). In its complaint, the KCDA has alleged that the major pharmacy chain has been deliberately undercutting prices, sustained by substitution of prescribed drugs with other cheaper but identical formulations and unreasonably increasing its profit margins, which is currently violative of regulations applicable to pharmacists, as well as pricing norms of drugs.
Source: bit.ly/4cJSJOg

Vaccine manufacturers may have to provide manufacturing and sales data to government soon
The advisory body to India’s Central Drugs Regulator, the Drugs Consultative Committee, has requested various State-level Drug Licensing Authorities to ensure submission of details of the manufacture and sale of vaccines within the states to the Central Drugs regulator (Central Drugs Standards Control Organization), for the purpose of meeting obligation for the Global Benchmarking of Vaccines of the World Health Organization.
Source: bit.ly/3PJkAEw

Major Ayurvedic Medicine manufacturer may be on hook for contempt of court after Supreme Court rejects its apology for publishing misleading advertisements
In its ongoing proceedings against a major Ayurvedic medicine manufacturer for publication of misleading advertisements in contravention of undertaking given by it to the Supreme Court, the Court has refused to accept the apology which was tendered by the manufacturer, and rejected submissions of the manufacturer that: (1) The restriction on advertisement under the Drugs and Magic Remedies (Objectionable Advertisements) Act, 1954 is archaic and may be relaxed since the manufacturer now has scientific data to back its claims, and (2) that the manufacturer should not be held liable for an advertisement issued by an independent marketing department.
Source: bit.ly/4akJen5

Australia updates Medical Device Recall Procedure
The Australian Therapeutics Goods Administration, which regulates medical devices at the central level in the country, has published a revised version of the Uniform Recall Procedure for Therapeutic Goods (URPTG), which relaxes regulatory burden of importers and manufacturers of medical devices. The revised URPTG provides additional clarity on procedure for immediate recall, clarifying timing of release of recall information by the regulator, modifying Customer Response Forms, and eases the filing requirements under the law by making all templates for recall action publicly available on the website of regulator.
Source: bit.ly/3TAZJEo