Try GOLD - Free
Centre to amend Rules to licensing of stem cell, gene therapy products
Chronicle Pharmabiz
|October 23, 2025
THe Union ministry of health and family welfare has issued a draft amendment of Drugs Rules, 1945 to enable industry to apply for manufacturing license of stem cell derived products, gene therapeutic products, among others.
The draft amendment proposes to amend the forms, already used to grant manufacturing permission for vaccines and r-DNA products, to include these products, so that the industry can apply with the State Licensing Authorities (SLA) and Central Licences Approval Authority (CLAA) for manufacturing licenses for these products.
It proposes to add cell or "Stem Cell derived products, Gene therapeutic products or Xenografts, etc," to the sub-rule (3) of rule 75, forms of application for licence to manufacture for sale or distribution of drugs specified in certain Schedules.
This story is from the October 23, 2025 edition of Chronicle Pharmabiz.
Subscribe to Magzter GOLD to access thousands of curated premium stories, and 10,000+ magazines and newspapers.
Already a subscriber? Sign In
MORE STORIES FROM Chronicle Pharmabiz
Chronicle Pharmabiz
Home-grown CAR-T cell therapies gaining ground
INDIAN biotech and pharmaceutical companies are actively working on innovative solutions to make CART cell therapy both accessible and cost-effective.
4 mins
November 27, 2025
Chronicle Pharmabiz
NPPA extends price fixation on orthopaedic implants for 1 year
IN a move that will disappoint the industry, the National Pharmaceutical Pricing Authority (NPPA) has extended the ceiling price fixation it imposed on orthopaedic knee implants for knee replacement system for one more year.
1 mins
November 27, 2025
Chronicle Pharmabiz
FICCI envisages it's Smart AAMs to boost healthcare
In line with the Central Government's vision of comprehensive primary healthcare, FICCI Swasth Bharat Task Force has undertaken a transformative initiative titled 'Smart Ayushman Arogya Mandirs-AAMs' (earlier called Health & Wellness Centres) aimed at strengthening the primary healthcare delivery system across India.
1 min
November 27, 2025
Chronicle Pharmabiz
DoP asked to bring policy for affordable drug pricing
THE Parliamentary Panel on Chemicals and Fertilisers has recommended to the Department of Pharmaceutical (DoP) to take steps to come out with a pharmaceutical policy with thrust to provide both scheduled and nonscheduled formulations at affordable prices.
1 mins
November 27, 2025
Chronicle Pharmabiz
Ramaiah emphasises need for bone health and osteoporosis diagnosis
RAMAIAH Memorial Hospital (RMH), a multi-superspecialty quaternary care hospitals emphasises on bone health and osteoporosis diagnosis. It calls for timely screening and diagnosis through the new and advanced DXA scanner with superior and accurate test results.
2 mins
November 27, 2025
Chronicle Pharmabiz
Nathealth calls for action in 2026-27 Union Budget
NATHEALTH has submitted its budget 2026-27 recommendations to the Union government, outlining a roadmap to strengthen healthcare delivery, foster innovation, and expand insurance and preventive coverage.
1 mins
November 27, 2025
Chronicle Pharmabiz
Hotspots & growth opportunities in biomanufacturing
THE Indian bioeconomy has grown from US$ 10 billion in 2014 to US$ 165.7 billion in 2024, and is likely reach US$ 300 billion by 2030.
3 mins
November 27, 2025
Chronicle Pharmabiz
Omega Hospitals acquires Cytecare Hospitals
Morgan Stanley PE backed Hyderabad-based Omega Hospitals has acquired Cytecare Hospitals, a leading cancer care hospital in Bengaluru.
2 mins
November 27, 2025
Chronicle Pharmabiz
Devices sector hails withdrawal of QCOs
THE medical devices manufacturers industry in the country has welcomed the Central government's decision to withdraw multiple Quality Control Orders (QCOs) imposed on essential raw materials across various industries, including the medical devices sector.
1 min
November 27, 2025
Chronicle Pharmabiz
'There is urgent need for tech-focused regulatory approach for med devices'
THE Indian healthcare industry has evolved at a breakneck pace, but its regulatory framework has struggled to keep up to its speed of development.
2 mins
November 27, 2025
Listen
Translate
Change font size