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. Regulatory reforms under the Biological Diversity Amendment Act, 2023 are driving increased intellectual property filings linked to India’s biological resources. Streamlined procedures and mandatory prior registration with the National Biodiversity Authority have enhanced compliance, improved processing efficiency, and strengthened alignment between innovation, conservation priorities, and equitable benefit sharing frameworks
Source: shortlink.uk/1nbX2

2. The Jammu & Kashmir and Ladakh High Court has ruled that merely holding the position of Director or Managing Director does not automatically attract liability under the Drugs and Cosmetics Act, 1940. Liability arises only if specific allegations prove the individual was responsible for the company’s conduct or involved in the offence.
Source: shortlink.uk/1sqvC

3. The Drugs Consultative Committee(DCC) has approved a proposal to develop a real-time digital portal for tracking manufacture, import, export, sale, and stock of pharmaceutical products regulated under the Narcotic Drugs and Psychotropic Substances Act. The portal is aimed at strengthening surveillance, with potential integration involving CDSCO, State Authorities, and the Central Bureau of Narcotics.
Source: shortlink.uk/1nbXc

4. The Department of Pharmaceuticals has liberalised the RPTUAS guidelines to allow shortlisted applicants to claim the first instalment of subsidy upon submission of either a Revised Schedule M or WHO-GMP certificate. The remaining certificate may be furnished at the time of claiming the second instalment, thereby providing greater flexibility in meeting compliance requirements.
Source: shortlink.uk/1nb-y

5. India’s Directorate General of Foreign Trade expanded the mandatory Halal certification requirement under the India Conformity Assessment Scheme (I CAS) Halal to 20 additional countries, including Egypt, Kenya, Morocco, and Maldives. Exporters must obtain certification from NABCB-accredited bodies, with compliance effective within two weeks (six months for Egypt).
Source: shortlink.uk/1sqvW

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. The Supreme Court of India has urged the Union Government to enact a comprehensive law governing passive euthanasia and end of life care in India. The Court noted that the absence of legislation has repeatedly required judicial guidelines, while permitting withdrawal of life sustaining treatment for a patient in a prolonged vegetative state.
Source: short-url.org/1qSHk

2. The Drugs Technical Advisory Board (DTAB) has recommended amending entry no. 33 of Schedule K to permit only unflavoured nicotine gums (2 mg) under sale license exemptions. Nicotine lozenges (2 mg) are excluded. Sale to minors is prohibited, online access closely monitored, and marketing by the tobacco industry restricted.
Source: short-url.org/1qSHq

3. A Mumbai Sessions Court has set aside criminal proceedings against directors of an e-commerce platform in a case concerning alleged online sale of abortion pills. The court held that the company operates as an intermediary marketplace and cannot be held directly liable for products listed by third-party sellers, highlighting limits on platform liability in e-commerce
Source: short-url.org/1lJ8-

4. The Drugs Technical Advisory Board (DTAB) has recommended introducing a separate form for wholesale bulk drug licences to capture details of wholesalers dealing with NDPS substances. Qualification criteria for competent persons and adequate transition time for existing wholesaler licensees to obtain the new licence is also proposed by DTAB
Source: short-url.org/1lJ9e

5. The Central Drugs Standard Control Organization (CDSCO) has issued an advisory warning manufacturers, importers and marketing authorisation holders against direct or indirect promotion of prescription medicines, including GLP-1 receptor agonists. The regulator noted that surrogate advertising, misleading efficacy claims and promotional campaigns increasing product visibility may constitute misleading marketing practices.
Source: short-url.org/1lJ9i

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. In its recent annual Budget announcement, the central government has proposed to waive customs tariffs on three additional drugs, used in treatment of cancer.
Source: bit.ly/4dinoSC

2. The Bombay High Court held a Director of a chemical manufacturer criminally liable for export of controlled substances from the country, holding that all officers of companies should keep themselves abreast of the latest regulations, and being ignorant of new notified compliance cannot excuse liability.
Source: bit.ly/46iRp22

3. The Madras High Court stayed a suspension order issued against a branch of a major fast food chain, holding that suspension cannot be ordered without giving an opportunity to improve its practices in pursuance of an Improvement Notice issued under Sec. 32(1) of the Food Safety Standards Act, 2006.
Source: bit.ly/3LFGne4

4. The Ethics and Medical Registration Board of the National Medical Commission of India, the country’s premier regulator of the medical profession has recently issued a decision proposing to expand the scope of qualified Doctors that may now be permitted to undertake spinal surgery. While previously only neurology specialists were permitted to operate on the spine, orthopedic specialists may also undertake the same with existing qualifications.
Source: bit.ly/46s1oCn

5. An appeals courts of the United States has rejected the petition of several US states against the reclassification of contraceptive medication, holding that no grounds were established to prove actual harm suffered by the State governments. as claimed.
Source: bit.ly/3zZpdFC