The government may give drug companies just 45 days to comply
with the upcoming pricing regime that promises cheaper essential
medicines, making it mandatory for companies to conform to revised
rates irrespective of the date of manufacture. The intent is to
cater to the consumer's interest by not allowing the
manufacturers to sell the previous batches at non-revised price.
The industry officials, on the other hand, have criticised this
step claiming that the directive could lead to chaos and even
shortage of essential drugs in the short term. As per them, the
task of recalling batches "from every nook and corner" is
a logistic nightmare which could lead to losses on account of
price-cut, labelling and additional freight movement. Factoring
this, the government intends to allow pharma companies to send a
supplementary price list of revised prices that the retailers will
have to display in their premises.
PSA view - The pharma companies had ample time
to implement the price policy which was notified on December 7,
2012 and thus avert the possibility of these potential losses. The
time line at present is speculative and the pharma companies could
be given an extension for implementation. However, regardless of
whether an extension is granted, the companies should make changes
to the drug price as this is a reality which is to be implemented
sooner rather than later.
Government to introduce ART Bill in next session of
The Union Health Ministry is formulating the ART Bill to be
presented in the next session of the parliament. The ART Bill aims
to provide a national framework for regulating and supervising the
mushrooming business of infertility clinics and surrogacy in India.
Many technologies relating to fertility require enormous technical
expertise and infrastructure and, hence, the government is looking
to regulate the same. The ART Bill has been drafted with the
assistance of the Indian Council of Medical Research and has gone
through almost 4 years of government and public discussions. The
ART Bill looks to establish strict parameters for the establishment
of an infertility clinic and also, defines the minimum requirement
regarding staff in an infertility clinic and minimal physical
requirements for a clinic.
PSA view - The step taken by the government to
introduce the ART Bill is in the right direction. However, the ART
Bill still has certain lacunae. For example, the ART Bill legalizes
surrogacy without really describing the rights of surrogates.The
Health Ministry should provide a strong legislation which covers
all aspects relating to assisted birth and surrogacy.
Ayush Department issues GCP guidelines
With a view to facilitate researchers and institutions in
adopting standards for good clinical practices for conducting
clinical trials in ASU medicine, the Ayush Department has issued
GCP Guidelines. These Guidelines are addressed to investigators and
all interested parties involved at various stages of conducting
clinical trials and provide guidance for designing, conducting,
auditing, reporting, documenting and terminating studies related to
new ASU drugs on humans. This 114 page Guidelines is a step to
encourage clinical trials in alternative medicines and maintain the
sanctity and clinical efficacy.
PSA view - The announcement of the Guidelines
is well timed, especially in view of the focus on scientific
validation of ASU cures which are meant for voluntary use, not
linked with any provisions of Drugs & Cosmetics Act, 1940, and
the rules thereunder. The Guidelines shall prove significant in
validating the fact that ASU drugs have minimal side effects by
providing for a means of validation of safety and efficacy using
scientific and evidence-based methodologies. These are needed for
universal acceptability, gaining confidence of practitioners in ASU
medicines and cures.
WHO approved Indian vaccine standards
Earlier this month, the vaccine industry received a much desired
relief when the WHO team of international experts from eight
countries approved India's vaccine regulatory system for
maintaining international standards. The team had conducted
comprehensive tests in December 2012 and found that the Indian body
- National Regulatory Authority of India and its affiliated
institutions meet the WHO standards and the efficacy indicators for
a functional vaccine regulatory system.
PSA view - This approval shall open new vistas
for easy export of vaccines produced in India. Currently, the
Indian vaccine industry is MINR 190,000 strong and is expected to
grow further as it is a major vaccine producer that has 12 major
vaccine manufacturing facilities. India currently exports 16
prequalified vaccines through United Nations agencies and this
number is all set to increase now.
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