Disaster Management in
Pharmaceuticals Industry:
Some First Ideas
Raghu Babu
German Technical Cooperation
Indo-German Environment Programme
March 27, 2009
Pharmaceuticals Industry
in India (1)
10,563 pharma
units in India;
77.4% formulation,
22.6% mfg.
Figures as of 2007
»
»
»
»
Manufacturing medical and biological products
Processing botanical drugs and herbs
Isolating active medical principles;
Manufacturing pharmaceutical products intended for internal and external consumption in
such forms as tablets, capsules, ointments, powders and solutions
Pharmaceuticals Industry
in India (2)
» Industry site: A site owned and operated by a single
company. All the activities on the site are conducted directly by
this company or are carried out by third parties exclusively for
the company.
» Chemical park: A site accommodating several chemical
companies which are legally separate entities. The
infrastructure and a variable range of services are provided by
the largest chemical company on the site (the major user) or by
one (or more) independent infrastructure companies.
» Industrial park: Similar to the chemical park, but is (also or
more heavily) used by companies from other sectors.
Hazard Categories in
Pharmaceuticals Industry
» Ecotoxic - damage is caused to the environment.
» Carcinogenic - contribute to the causation of cancer.
» Persistent - remain dangerous for a long time.
» Bio-accumulative – accumulates as it makes its way up
the food chain.
» Disastrous due to a catastrophe, mishap, calamity or
grave occurrence in any area.
Sources of Hazards in
Pharmaceuticals Industry (1)
» Manufacturing and formulation installations.
» Handling and storage of hazardous chemicals including warehouses,
godowns, tank forms in ports/fuel depots/docks.
» Transportation (road, rail, air, water, pipelines).
» Emission of pollutants – the air pollutants include carbon monoxide
(CO), nitrogen dioxide (NO2), particulate matter of 10 microns or less
(PM10), total suspended particulate matter (SPM), sulphur dioxide (SO2),
and volatile organic compounds (VOCs). The most common VOCs
include methanol, dichloromethane, toluene, ethylene glycol, N,NDimethylformamide, and acetonitrile.
» Effluents - effluent releases could go directly to streams, rivers, lakes,
oceans, or other bodies of water. The releases due to runoff, including
storm water runoff, could also be a potential hazard.
Sources of Hazards in
Pharmaceuticals Industry (2)
» Hazardous wastes – these are in the form of liquids, solids,
contained gases or sludges. As a general measure, about 200kg
of waste is generated per metric ton of active ingredient
manufactured by the pharmaceutical industry. This waste,
containing spent solvents and other toxic organics in significant
concentrations, requires treatment before it can be disposed off
safely.
» Toxic releases - these include on-site discharge of a toxic
chemical to the environment including emissions to the air,
discharges to bodies of water, releases at the facility to land, as
well as contained disposal into underground injection wells.
» Use of a hazardous technology.
» Natural hazard events such as flood, cyclone, earthquake,
tsunami.
What is Disaster ?
“Disaster" means a catastrophe, mishap, calamity or grave occurrence in any
area, arising from natural or man made causes, or by accident or negligence
which results in substantial loss of life or human suffering or damage to, and
destruction of, property, or damage to, or degradation of, environment, and is
of such a nature or magnitude as to be beyond the coping capacity of the
community of the affected area.
“Disaster Management" means a continuous and integrated process of
planning, organising, coordinating and implementing measures which are
necessary or expedient for:
- Prevention of danger or threat of any disaster
- Mitigation or reduction of risk of any disaster or its severity or consequences
- Capacity-building;
- Preparedness to deal with any disaster
- Prompt response to any threatening disaster situation or disaster
- Assessing the severity or magnitude of effects of any disaster
- Evacuation, rescue and relief
-Rehabilitation and reconstruction
Picture Source: National Disaster Management Authority
Impact of a Chemical Disaster
» Hazards pose risks to the people in the neighbourhood, to the living
organisms and to the environment and to the environmental resources.
» Risks of hazards depend on the severity and likelihood of the event.
Picture Source: National Disaster Management Authority
Institutional Framework
for Disaster Management
Ministry of Chemicals & Fertilizers is part of the institutional
framework for disaster management
Source: National Disaster Management Authority
Some Relevant Acts, Rules (1)
» Manufacture, Storage and Import of Hazardous Chemicals Rules,
1989 (The Environment Protection Act, 1986)
 Identify whether the chemicals handled, used and stored or
imported are covered in the Schedule 1 and/or 3 of the Rules,
Schedule 2 for isolated storages.
 Occupier (industry) to submit a safety audit update report once a
year and forwarding a copy within 30 days.
 Occupier to prepare up-to-date on-site emergency plan before
commencing a new industrial activity involving specified chemicals.
 Occupier shall conduct a mock drill of emergency plan every six
months and submit a report.
» The Public Liability Insurance Act, 1991
 Owner to provide relief in case of death or injury or damage to
property from an accident on the principle of no fault.
 Owner to draw insurance policies more than the paid-up capital but
less than Rs. 50 Crores.
Some Relevant Acts, Rules (2)
The Chemical Accidents (Emergency Planning, Preparedness, And
Response) Rules, 1996 [The Environment Protection Act, 1986]
» Central Crisis Group shall be tile apex body to deal with major chemical
accidents and to provide expert guidance for handling major chemical
accidents. Meet once in six months.
» State Crisis Group shall be the apex body in the State to deal with major
chemical accidents and to provide expert guidance for handling major
chemical accidents. Meet once in 3 months.
» District Crisis Group shall be the apex body in the district to deal with
major chemical accidents and to provide expert guidance for handling
chemical accidents. Meet once in 45 days.
» Local Crisis Group shall be the body in the industrial pocket to deal with
chemical accidents and coordinate efforts in planning, preparedness and
mitigation of a chemical accident. Meet every month.
Some Relevant Acts, Rules (3)
Functions of Local Crisis Group
» Prepare local emergency plan for the
industrial pocket,
» Ensure dovetailing of the local
emergency plan with the district off-site
emergency plan.
» Train personnel involved in chemical
accident management.
» Educate the population likely to be
affected in a chemical accident about the
remedies and existing preparedness in
the area.
» Conduct at least one full scale mock-drill
of a chemical accident at a site every six
months forward a report to the District
Crisis Group.
» Respond to all public inquiries on the
subject.
» Sub-divisional magistrate
» Inspector of Factories
» Industries in the industrial
area
» Transporters of hazardous
chemicals
» Fire officer
» SHO (police)
» BDO
» Rep of Civil Defence
» Primary Health Officer
» Editor of local News Paper
» Community
leader/Sarpanch/Village
Pradhan
» Rep. of NGO
» Two eminent doctors
» Two social workers
Some Relevant Acts, Rules (4)
Disaster Management Act, 2005
» National Disaster Management Authority - lays down the policies, plans
and guidelines for disaster management for ensuring timely and effective
response to disaster.
» State Disaster Management Authority - lays down policies and plans for
disaster management in the State.
» District Disaster Management Authority - acts as the district planning,
coordinating and implementing body for disaster management in the
district in accordance with the guidelines laid down by the National
Authority and the State Authority.
» “Local Authority" includes panchayati raj institutions, municipalities, a
district board, cantonment board, town planning authority or Zila Parishad
etc. for rendering essential services or, with the control and management
of civic services, within a specified local area.
Ministries or Departments of GoI
to prepare Disaster Management Plans
(as per Disaster Management Act)
» Specify measures to be taken for prevention and mitigation of
disasters in accordance with the National Plan.
» Specifications regarding integration of mitigation measures in its
development plans in accordance with the guidelines of the National
Authority and the National Executive Committee.
» Specify its roles and responsibilities in relation to preparedness
and capacity-building to deal with any threatening disaster situation or
disaster.
» Specify roles and responsibilities in regard to promptly and
effectively responding to any threatening disaster situation or
disaster.
Ministries or Departments of GoI
to prepare Disaster Management Plans
(as per Disaster Management Act)
» Specify present status of its preparedness to perform the roles and
responsibilities on above.
» Specify the measures required to be taken in order to enable it to
perform its responsibilities specified above.
» Update annually the plan referred above and forward a copy of the
plan to the Central Government, which Government shall forward a
copy thereof to the National Disaster Management Authority for its
approval.
First Ideas for
Pharmaceuticals Sector
» On-site plans for hazard/disaster preparedness/management
systems needed at the industry level, at the industry park level
» Off-site plans required around the industry/industrial park covering
the neighbourhood.
» SMEs may beneficially integrate their own disaster/hazard
management systems with the Industry Park level hazard/disaster
management systems for sharing of equipment, facilities, personnel
etc.
» Very less hazardous Industrial/Chemical Parks may possibly rely
partially/ completely on the emergency services of a nearby
chemical park.
NDMA
CCG
SDMA,
DDMA
SCG,
DCG
LCG
National
Response
Team
Disaster
Management
Team/Cell
(at Industry Park
Disaster
Management
Team/Cell
(at industry
level)
shared
emergency
services)
level –
Industry level – onsite disaster management plans, Neighborhood – Offsite disaster
management plans; District level – District disaster management plans, State level - State
Disaster Management Plans, National level – National Disaster Management Plans
Advantages of Industrial/Chemical Park
Level Disaster Management
» Improved emergency response due to far shorter response times
and emergency services which know the disaster premises
perfectly.
» A resulting fall in the cost of fire protection equipment and
insurance premiums.
» The fact that the public emergency services only has to be called
out for major incidents – thereby drawing less public attention to
smaller incidents,
Next Steps (1)
» Managing hazards due to effluents, emission and hazardous
wastes: Could be handled by DoPharma through the environmental
management initiatives proposed to be taken up.
» Understanding DoPharma roles in hazard/disaster risk
management – Consultations with NDMA and the Central Crisis
Group(MoEF) to develop an overall strategy including the objectives,
results, processes, cooperation networks, steering structures and
learning & knowledge management.
» Preparation of Disaster Management Plans - Undertake preparation
of national/state/regional level Disaster Management Plan for
Pharmaceuticals Sector in India (through GTZ TC with national and
international experts).
Next Steps (2)
» Demonstrate pilot efforts - in a State/region and selected
Industrial Parks/Areas including setting up of disaster
management teams.
» Development of guidelines for Chemical Disaster Management
(CDM) in Pharmaceuticals Sector (Chemical Park level, industry
level).
» Capacity building (training/capacity development needs
assessment, plan preparation with strategy for implementation)
Thank You