The government of India will
soon reveal the results of the
world’s largest ever study
taken up to test the quality of
more than 47,000 medical
products taken up in 2015.
The results will be revealed
in August 2015, said Mr K L
Sharma, joint secretary in
the Ministry of Health and
Family Welfare while
speaking at a pharmaceutical conference in Cambridge, USA organized
by the USA-India Chamber of Commerce (USAIC).
The drug samples were collected by a mammoth exercise coordinated by
the central drugs regulators through the National Institute of Biological
and Indian Statistical Institute among other institutions. This is believed
to be the largest exercise of its kind in the world.
INDIA'S STEMPEUCEL BECOMES 5TH OFF-THESHELF APPROVED STEM CELL PRODUCT IN THE
WORLD
Stempeutics Research
recently announced that the
Drugs Controller General
(India) has granted limited
approval for manufacturing
and marketing of its stem cell
based biological product
Stempeucel for the treatment
of Buerger’s disease.
Stempeutics is a group
company of Manipal Education and Medical Group in a joint venture
with Cipla Group.
Commenting on the approval of DCGI on May 30th, Mr B N Manohar,
CEO of Stempeutics mentioned, "Obtaining DCGI approval for
Stempeucel is an important and historic milestone for Stempeutics. We
are the FIRST Company in India to achieve such approval. It took
almost 9 years to develop Stempeucel for the treatment of Buerger’s
Disease. European Medicinal Agency has classified Stempeucel as an
Advanced Therapeutic Medicinal Product (ATMP) and designated it as
an Orphan Drug (ODD) for the treatment of Buerger’s Disease. Our goal
is to globalize Stempeucel for Buerger’s Disease and the market size is
approx. US$ 1.5 Billion worldwide”.
Buerger's Disease is a rare and severe disease affecting the blood vessels
of the legs. It is characterized by inflammation and occlusion of the
vessels of extremities resulting in reduced blood flow to these areas, thus
leading to severe pain and ulcers or necrosis, which finally may
require amputation.
JUBILANT LEVERAGES ITS EPIGENETICS EDGE
THROUGH $180 MILLION DEAL WITH
CHECKPOINT THERAPEUTICS
Jubilant Biosys, a subsidiary of Jubilant Life Sciences, and Checkpoint
Therapeutics, Inc a subsidiary of US based Fortress Biotech, has
announced the signing of an exclusive, worldwide license agreement for
compounds having
potential to halt cancer
growth.
Under the agreement
signed on May 27th,
Jubilant Biosys will outlicense to Checkpoint a
family of patents
covering compounds
that inhibit BRD4, a
member of the BET
(Bromodomain and Extra Terminal) domain for cancer treatment.
The deal includes an upfront payment of US $2 million and contingent
preclinical, clinical and regulatory payments including commercial
milestones totalling up to US $180 million. Jubilant Biosys will also
receive research funding and royalty payments on successful
commercialization of the compounds. Checkpoint will assume all further
preclinical, clinical development and commercialization
responsibilities.
The field of epigenetics as a treatment for cancer is a rapidly
evolving area of focus for the pharmaceutical and biotech
industry. Both parties believe that by working together to
further develop these compounds, they will better be able to
move towards bringing a product to market that will greatly
improve the lives of patients.
biotech
WORLD'S LARGEST DRUGS QUALITY TEST STUDY
HELD IT INDIA, RESULTS TO BE OUT SOON
TIME UP FOR BRITISH-ERA DRUG
REGULATIONS AS GOVT GOES FOR FRESH
RELOOK
India will soon overhaul its 76-year old Drugs and Cosmetics
Act 1940 and bring in a new, modern legislation to regulate
production and consumption pharmaceuticals and other related
products.
As a precursor to this, the government is bringing in a separate
legislation to regulate a wide range of Medical Devices first and
based on its success and acceptance by industry and other
stakeholders, the drugs regulation Act will follow, said Mr K L Sharma,
joint secretary, Ministry of Health and Family Welfare in Government of
India, while delivering a Key Note address at the 10thAnnual US India
BioPharma and Healthcare Summit 2016 at Cambridge, Massachusetts,
organized by the USA-India Chamber of Commerce.
Mr Sharma said these decisions were taken by the Union Cabinet
headed by Prime Minister, Mr Narendra Modi, while discussing the
amendments proposed to the omnibus 1940 Drugs Act to make it more
contemporary. The Cabinet asked for scrapping of the British-era Act
and bring in separate legislations to regulate various areas covered by
the Act. The Drugs and Cosmetics Act 1940 was last amended in 2003
with more guidelines. The Modi government wants a total fresh look to
this Act.
The government has started an ambitious exercise in August 2015 to
equip the drug regulatory set up in India’s 36 states and union
territories and the central government set up by equipment
modernization, hiring of hundreds of regulatory experts, multiple
training programmes for existing staff with help from regulators from
US and Europe and overall skill upgradation of human resources in the
system, Mr Sharma said.
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