PROPOSED OVERHAUL OF DRUG REGULATORY SYSTEM (INDIA)
India's Health Ministry has released a draft of the proposed
amendments to the Drugs and Cosmetics Act 1940 (Act) for public
consultation. The Act is the primary legislative instrument which
lays down the regulatory framework for drugs that are manufactured
or imported for marketing in India.
The draft proposes to vest the powers to approve the manufacture
of certain drugs in India exclusively with a single central
authority appointed by the Health Ministry of the Union Government.
Until now, the approval powers were vested with authorities
appointed by the respective State Governments. The drugs sought to
be centrally regulated include drug products comprising fixed dose
combinations, monoclonal antibodies, stem cells, gene therapeutic
products and xenografts.
The draft also lays down liabilities of sponsors and ethics
committees conducting clinical research in India and clarifies the
meaning of 'sponsor' by defining it as a person responsible
for initiation, financing and management of a clinical trial. The
draft, once finalised by the Health Ministry, is expected to be
tabled before the Indian Parliament for debate in its budget
session starting on 25 February 2015.
PHARMA MARKETING PRACTICES CODE RELEASED (INDIA)
The Department of Pharmaceuticals (DoP) has published an amended
form of the Uniform Code for Pharmaceutical Marketing Practices
(UCPMP) for adoption by the Indian pharmaceutical industry on a
voluntary basis, beginning 1 January 2015.
The UCPMP seeks to counter unethical promotional practices, with
the code as now amended, placing restrictions on:
The number of drug samples that can be handed over to
Healthcare Professionals (HCPs).
Giving of gifts for the personal benefit of HCPs.
Extending travel facilities to HCPs for attending conferences
and seminars as delegates.
Extending hospitality under any pretext to any HCP.
The UCPMP was first published in 2011 as a voluntary code.
Following the release of the amended code, the DoP will monitor
compliance with the UCPMP for six months. It will then consider
whether compliance should be made mandatory. Pharmaceutical
companies have in general indicated an intent to comply with the
NOVARTIS OBTAINS INTERIM INJUNCTION AGAINST CIPLA FOR PATENT
Novartis has successfully obtained a temporary injunction
against Cipla, restraining Cipla from selling its generic
equivalent (Unibrez) of Novartis' patented drug (Onbrez). The
order will remain in force until the parties enter into a licence
agreement or until Cipla is able to procure a compulsory licence
from the Indian Controller of Patents.
Cipla announced the launch of its generic drug in October 2014.
It had also filed an application before the Indian Department of
Industrial Policy & Promotion to revoke Novartis' patent
for Onbrez. The application was filed under Section 66 of the
Patents Act 1970, which permits revocation of a patent if the
patent is prejudicial to public interest.
In December 2014, Novartis filed a patent infringement action
against Cipla before the Delhi High Court, together with a separate
urgent application for interim relief. On 9 January 2015, Novartis
was granted the interim relief. The case is important as it
showcases the urgency and seriousness with which the courts in
India have started treating patent infringement cases.
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