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Concept Note on the 5th National Conference on “Patient Safety & Drug
Regulatory Scenario in India” on Wednesday 20th May 2015 at
Gandhi Bhawan, University of Kashmir, Hazratbal, Srinagar,
Jammu & Kashmir, 190006
INTRODUCTION: After more than 2 decades, the various stakeholders in the
healthcare delivery system in India decided to work together on the issue of
accessibility of safe medicines to the consumers in India. A partnership led by the
founder of Consumer Online Foundation decided to focus on some simple
mechanisms to tackle the menace of spurious medicines as defined under the
existing laws in India. The stakeholders intended to engage the civil society to raise
the demand for effective implementation of the laws on safety and quality standards
of medicines in India. This was the genesis of the Partnership for Safe MedicinesIndia (“PSM-India”), which started functioning from the month of September 2010.
The key objective of the PSM-India Initiative is to emphasize the need for NGO’s and
other civil society groups to take an active interest in building an effective partnership
with all the stakeholders concerned and to launch a National Campaign for
Promoting Safe Medicines. The thematic basis of the partnership is a joint initiative
between all stakeholders in an equitable manner based on trust, transparency and
accountability to each other.
It is difficult for the patients and consumers to identify look alike and substandard
medicines, which may result in severe toxic effects. This is further compounded often
by self-medication and purchase of prescription drugs over the counter from
pharmacists and the prevalence of multiple brands for the same or similar
combination of molecules forming the medication. Information made available to
consumers is too scanty and insufficient to be of any use to them. The electronic and
print media also tend to exaggerate the benefits of various medicines and drugs
without any scientific or proven backing. Therefore the partners to the initiative
advocated strongly the need for educating the consumers and creating awareness
amongst them on these aspects. Further, there was a need for physicians to be kept
contemporarily updated and that they are not influenced by medical representatives
who only highlight the merits of their own products.
The Central Drugs Standard Control Organization (CDSCO) is the Central Drug
Authority for discharging functions assigned to the Central Government under the
Drugs and Cosmetics Act. CDSCO has six zonal offices, four sub-zonal offices, 11
port offices and six laboratories under its control. Major functions of CDSCO: 1.
Regulatory control over the import of drugs, approval of new drugs and clinical trials,
meetings of Drugs Consultative Committee (DCC) and Drugs Technical Advisory
Board (DTAB), approval of certain licences as Central Licence Approving Authority is
exercised by the CDSCO headquarters. This conference intends to bring all the
stakeholders together to look at the success stories in India on Drug Regulatory
Initiatives by the State Governments and agree to a blueprint for the future to ensure
safety and quality of healthcare delivery mechanism in the interest of patients.
OBJECTIVES:
➢ To collate the success stories of the State Drug Regulatory Authorities in
terms of transparent and accountable processes to empower the consumers.
➢ To exchange ideas and look at modern information technologies (ITs)
available in India to build capacity with the State Drug Regulatory Authorities
➢ To agree on a draft blueprint on the way forward to enable all the State Drug
Regulatory Authorities to adhere to an uniform code of practices as per the
existing laws and global best practices
RATIONALE: The Indian pharmaceuticals market is third largest in terms of volume
and thirteen largest in terms of value, as per a pharmaceuticals sector analysis
report by equity master. The market is dominated majorly by branded generics which
constitute nearly 70 to 80 per cent of the market. Considered to be a highly
fragmented industry, consolidation has increasingly become an important feature of
the Indian pharmaceutical market. India has achieved an eminent global position in
pharma sector. The country also has a huge pool of scientists and engineers who
have the potential to take the industry to a very high level. The Indian pharma market
size is expected to grow to US$ 85 billion by 2020. The growth in Indian domestic
market will be on back of increasing consumer spending, rapid urbanisation, raising
healthcare insurance and so on. Going forward, better growth in domestic sales will
depend on the ability of companies to align their product portfolio towards chronic
therapies for diseases such as such as cardiovascular, anti-diabetes, antidepressants and anti-cancers are on the rise. The Government of India has unveiled
'Pharma Vision 2020' aimed at making India a global leader in end-to-end drug
manufacture. It has reduced approval time for new facilities to boost investments.
Further, the government has also put in place mechanisms such as the Drug Price
Control Order and the National Pharmaceutical Pricing Authority to address the issue
of affordability and availability of medicines. Moreover, the government has been
taking several cost effective measures in order to bring down healthcare expenses.
Thus, governments are focusing on speedy introduction of generic drugs into the
market. This too will benefit Indian pharma companies. In addition, the thrust on rural
health programmes, lifesaving drugs and preventive vaccines also augurs well for
the pharma companies. All such activities need effective regulatory mechanisms to
ensure accessibility to safe and quality healthcare, which is a RIGHT of every Indian.
EXPECTATIONS FROM THE CONFERENCE:
1. Data on the existing drug regulatory mechanisms in India and how it protects
the health and safety of the Indian Citizen.
2. An agreed plan for implementation emerging from the deliberations of the
conference and based on the inputs from experts and policy makers.
3. A detailed report of the Conference capturing the various presentations and
the recommendations made by the experts in consultation with all the
stakeholders without compromising on the Good Manufacturing and
Distribution Practices existing globally as the benchmark for improvement.