INITIATIVES FOR CURBING THE MENACE OF
SPURIOUS/COUNTERFEIT/SUB-STANDARD/MISBRANDED/ ADULTERATED DRUGS:
a. Special courts
should be designated to try the cases of spurious drugs.
b. Creation of
intelligence cum legal cell to facilitate busting of spurious drug rackets and
their prompt prosecution respectively should receive thrust.
c. Provision of
secret funds and incentives to informers giving information about spurious
drugs should be endeavoured.
d. Effective
networking system between neighbouring states should be developed.
e. Necessary
changes in law should be made to award severe and deterrent punishments as
afforded under law to those dealing with spurious drugs, making the offences
cognizable and non-bailable in the light of similar provisions in Narcotic
Drugs and Psychotropic Substances Act.
f. Proliferation of
drug distribution outlets should not be encouraged. A distance of at least 500
meters should be maintained between two successive shops.
g. Drug sale
licences should be issued only to persons holding diploma or degree in pharmacy
from a recognized/duly approved university/institution. Necessary amendments
should be made in the relevant Acts to enforce this provision.
h. Preparation of
dossiers of suspected dealers and manufactures should be a perpetual exercise.
Such dealers should be black-listed and their licences cancelled.
i.
Manufacturers should be
encouraged to have their own anti-counterfeit
drug strategies like RFID, QRC etc, better surveillance and efficient
complaint handling system.
j.
A statewide survey should
be conducted to measure the magnitude
of spurious drug trade in the state, lifting samples from every nook and
corner of the state in a statistically designed scientific manner.
k. Effective
interaction between the stakeholders i.e. industry and regulators, industry and
consumers, trade and regulators and medical professional and regulators, should
be developed
INITIATIVES
IN RESPECT OF DRUGS BELONGING TO AYUSH SYSTEMS OF MEDICINE:
a.
A committee comprising
of traditional health practitioners and healers, and experts in pharmacognosy,
toxicology and related fields should be constituted to study and guide the various activities with respect to AYUSH drugs.
b.
The health
conditions that can be treated with these traditional systems of
medicine should be identified.
c.
An appropriate methodology and technology for the identification, development and production of
medicinal items used by the traditional systems of medicine should be
developed.
d.
Scientific studies to evaluate the quality, safety and efficacy of traditional
and herbal medicines should be fostered and promoted.
e.
All practitioners of traditional medicine systems as well
as the public should be encouraged to remain alert to adverse reactions to traditional and herbal medicines and
to notify them to the Drug Information Centres and the nodal centre for drug
information in the State.
f.
Cultivation and research of
medicinal plants, should also be encouraged and promoted.
INITIATIVES
FOR RATIONAL DRUG PROMOTIONAL PRACTICES:
a.
All drug promotional practices of pharmaceutical
companies and prescribing practices of doctors should be in accordance with
Dec.,2010 amendments of the MCI code of Medical Ethics (professional conduct,
etiquette and ethics Regulations), 2002 and the prescribers should be made to
adhere to these guidelines in letter and spirit.
b.
Authorities of government hospitals,
particularly teaching hospitals, should ensure that medical and pharmaceutical sales representatives’
activities and conduct are in conformity with standard ethical norms and
do not, in any way, hamper routine patient care. All sales representatives
should be allotted a specified time and venue inside the hospital for detailing
their products.
c.
Drug Policy should ensure rational prescribing practices by doctors,
rational dispensing practices by pharmacists and rational use of medicines by
the consumers in an integrated and seamless manner.
d.
Promotion-making claims of pharmaceutical
suppliers should be reliable, accurate,
truthful, informative, balanced, up-to-date, capable of substantiation and in
good taste.
e.
Product information of all kinds, should be
scientifically valid and evidence-based.
f.
Offering,
soliciting or accepting inducements of any kind, monetary or material (except
free samples of product in modest quantity) for promotional purpose should not be indulged in.
g.
Prescribing doctors or dispensing
pharmacists should not accept support or
assistance of any kind conditional upon obligation to promote a
medicinal product.
h. Professional
societies, educational organizations may accept partial sponsorship from the
pharmaceutical companies for holding scientific meetings and
symposia, but this should be clearly stated at the meetings and in proceedings.
Care should be taken to ensure that the sponsorship in no way affects the
quality of scientific deliberations in the meeting.
INITIATIVES
TO COUNTER THE MENACE OF DRUG ADDICTION AND SUBSTANCE ABUSE:
a.
Sale, storage and use of drugs specified under Schedule X of the Drugs and Cosmetics
Act, 1940 should be regulated with a greater
vigil by the inspectorate working under Drug and Food Control
Organization, J&K. Proliferation of
drug stores should be discouraged and easy availability of substances of abuse should be reversed.
b. Record-keeping
of such drugs should be made indispensable and the same should be checked
regularly by the inspectorate. Special checking squads should be framed and
authorized to undertake periodic necessary inspections in this regard along the
length and breadth of the state.
c. License
to sell, stock and distribute drugs pertaining to Schedule X should be restricted to dealers with absolutely
spotless track record and should not be issued to those indulging in any
sort of unlawful activities.
d. Workforce
of the Narcotics Control Bureau should be augmented and its nodal centre
established at Srinagar.
e. A multi-disciplinary Coordination Committee under the Chairmanship of Chief Secretary or
a senior Secretary should be established for regular interaction with various
Central and State agencies; to receive support and grant-in-aid assistance
from Narcotics Control Bureau of India.
f.
The state should set up an Anti Narcotics Task Force under an IG level officer with
duties and responsibilities duly demarcated.
INITIATIVES
FOR RATIONAL BLOOD BANKING AND TRANSFUSION POLICY
a.
Procedures of blood banks e.g. blood collection, processing, compatibility testing, storage, component
separation, transfusion of blood and blood products and all other related
activities should be practised as per the rules and regulations under the
Drugs and Cosmetics Act 1940 and the Drugs and Cosmetics Rules 1945 and in
accordance with relevant statutory guidelines.
b.
In keeping with the constant needs and constraints,
special provisions should be made to facilitate availability of blood and blood
products through a substitute storage
system, in peripheral areas where good blood banking system is still in
the process of development.
c.
An expert Committee
shall devise Standard Operating Procedures and oversee the functioning
of all blood banks and peripheral storage facilities to ensure and facilitate
the above goals.
INITIATIVES FOR PHARMACY EDUCATION REGULATION POLICY
a.
For this purpose central Pharmacy Act of 1948
should be enforced in the state to replace J&K Pharmacy Act 2011 (samvat)
and the J&K Pharmacy Council should endeavour to constitute its executive
committee and frame Pharmacy Education Regulations and implement them as soon
as possible so that minimum standards can be prescribed for colleges and
institutes offering diploma or degree courses in Pharmacy.
b.
This will make sure that nobody enters the
profession of pharmacy without earning a legal qualification. Further the
constitution and scope of J&K Pharmacy Council should be broadened, making
it all-inclusive by enrolling professionals from academia, hospitals, industry
and trade as its members.
INITIATIVES FOR DRUG SAFETY MONITORING POLICY
a.
Although medicines are useful to alleviate human illness,
all medicines are not completely safe. Therefore, pharmacovigilance is
necessary to safeguard the public from the possible adverse drug reactions and
prevent the cause of false public alarm and misinterpretation.
Pharmacovigilance activities should be funded through the State drug budget.
b.
Pharmacovigilance centres should be established to monitor
and document adverse drug reactions and events.
These centres should collect data on adverse reactions and events and
other drug related problems like substandard drugs, counterfeit drugs, inappropriate
use, medication errors etc. from various health professionals/workers.
c.
Pharmacovigilance centres should also be established under
the national Pharmacovigilance Programme of India in all hospitals of the
state.
d.
Measures should be taken to enhance spontaneous reporting
of adverse drug reactions in all hospitals of the state.
e.
All adverse drug reaction reports and other drug related
problems should be properly documented and follow up action including preventive
measures shall be taken.
f.
Besides Pharmacovigilance, other clinical pharmacy services
including Pharmaceutical Care Services, Drug Utilization Studies, Therapeutic
Drug Monitoring, Patient Counseling, Evaluation of Prescribing Practices, Pharmaco-economics
& Cost analysis and Pharmacy Practice divisions should be established in all
hospitals.
INITIATIVES FOR DRUG
LICENSING POLICY
In
order to control mushrooming of retail shops in urban areas at least 500 meters
distance to be kept between two shops. Stringent norms should be followed with
regard to service of Pharmacists, storage & issuing of cash memos.
INITIATIVES
FOR DRUG INFORMATION POLICY
a.
All potential and actual
users of medicines must have ready and meaningful access to scientific,
truthful, unbiased, evidence based and independent drug information.
b.
Drug Information Dissemination Centres (DIDC) must be established in all major hospitals of the state.
c.
The Nodal Centre should
collate all current information on drug use and disseminate them appropriately
to all potential users in general and the prescribers in particular, towards
the promotion of RUD.
d.
The feasibility and
prospect of collaborating with NGOs in the State, working in this area should be
explored.
e.
A Committee with the
representatives from Drugs Control Authority, Health Administration, Drug
Seller's Association, Consumers and Academia, must oversee and monitor the
functioning of the DIDC and suggest changes, if and as necessary.
INITIATIVES FOR LOCAL (STATE LEVEL) DRUG
INDUSTRIAL POLICY
a.
Development of
Pharmaceutical manufacturing Industry/Pharma Zone within the state by providing
capacity building, soft loans, subsidies and special exemptions
b.
To attract pharmaceutical
formulation and bulk drug manufacturers to set up plants at an area which is
easily accessible will be provided for developing an upgraded Pharma zone /
city.
c.
The govt. of J&K must
consider providing the following facilities:
Ø Sufficient and uninterrupted supply of electricity
Ø Common effluent treatment plant
Ø Single window system
Ø A liaison officer to co-ordinate between industry and govt.
Ø Provision for low cost land and relaxation of tax and duties
Ø Special packages for encouraging NRK investors
Ø Soft loan to encourage R & D
Ø Subsidy for modernisation of existing facilities.
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