| |
Clearance for making of new Drugs
Shri Somjibhai Damor raised a question about the
delay in permitting marketing of new drugs and the
criteria adopted for clearing applications.
In reply, Shri Dalit Ezhilmalai, Minister of State,
Ministry of Health and Family Welfare stated that the
average time taken for registration and approval of a new
drug in India is two years whereas the same is 8 years in
developed countries including USA, UK, Germany, France
etc. 23 new drug applications have been received by the
Drug Controller General (India) during January to June
1998. All these applications are at different stages of
examination including clinical trial.
The criteria adopted for clearing the application is
based on the guidelinesgiven in Schedule Y of the Drugs
and Cosmetics Rules. This includes information on
Chemistry and Pharmaceutics of the new drug molecule,
method of manufacturer and testing of the drug,
laboratory and multiple species-animal-experimental data
of safety and efficacy of the drug, clinical trial report
of safety and efficacy of the drug carried out abroad,
clinical data of safety and efficacy on local population,
the marketing status of the drug in other countries, the
expert’s comments on the generation of the data and
the quality test certificates of Central Drug Laboratory,
Calcutta which is the statutory laboratory under the
Drugs and Cosmetics Act.
Lok Sabha, Unstarred Question No 3920 dated 14
July 1998.
Population in the
country
Questions were raised about the current total
population in India and the measures taken by the
government towards population stabilization.
The Health Minister said that the total population of the
country as on 1st March 1998 is estimated to be around
966 million (96.6 crores). As per the latest estimate
available from the Sample Registration System, the birth
rate in 1996 was at 2.75 per thousand population.
As for the population stabilization, government is
against use of coercion. The Reproductive and Child
Health Programme (RCH) which is an integrated approach to
the family welfare programme is being implemented in the
9th Five Year Plan. The system of centrally determined
method-specific targets for family planning has been
dispensed with since April 1996 in all the States/UTs,
because working on the basis of such targets/quotas led
to many distortions at the cost of quality of services to
the citizens.
LS, USQ No 4098 dated 14 July 1998
In reply to another
question (LS USQ No 959 of 2 June 1998), the Minister
stated that the long-term demographic goal for the
country as laid down in the National Health Policy of
1983 was to achieve annual natural growth rate of 1.2 per
cent by 2000 AD. A growth rate below this goal has
already been achieved by Tamil Nadu, Kerala, Goa,
Pondicherry and Tripura by 1996.
Study on AIDS, TB
and Cancer
In reply to a question by Shri Nripen Goswami,
the Health Minister stated that there are 6059 AIDS cases
reported so far. It is estimated that about 1.4 per cent
of the population are suffering from TB. During 1997-98,
about 33,600 TB cases were detected in the North-Eastern
States and were put on anti-TB treatment. The estimated
number of Cancer cases in the country is about 2 - 2.5
million.
There are 62 Surveillance Centres with HIV testing
facilities in various states, besides 9 HIV reference
centres. There are also 36 sentinel surveillance centres
for HIV infection in the North-Eastern states.
LS USQ 3900 dated 14 July 1998
In response to a related
question on the money spent on AIDS victims, the Minister
stated that a Strategic Plan which offers "care and
support of the Patients Living With AIDS’ has been
initiated with the following measures:
- Instructions have
been issued to all the Superintendents of the
Central and State Medical College Hospitals to
treat all AIDS cases without discrimination,
without stigmatization and patient to be treated
in the general wards of the hospitals. No case of
AIDS is to be refused admission.
- For treatment of the
victims of the AIDS cases, NACO has already
allocated funds for Treatment of opportunistic
infections from which AIDS patients usually
suffer. These include anti-tuberculosis medicine,
anti-protozoal medicines and anti-fungal
medicines. The AIDS patients are to be given free
treatment.
- Pilot study is being
undertaken in Manipur, Maharashtra and Tamil Nadu
for the care of the AIDS patients right from the
home level up to the tertiary level. Separate
funds have been sanctioned for the AIDS care
continuum project.
RS
USQ 333 dated 29 May 1998
Shortage of
Doctors/Medicines
Dr M.P. Jaiswal inquired about the inadequacy of
health care facilities in rural areas and the result of
the study conducted by the government in this respect.
The Health Minister mentioned about the 1993 survey at
Primary Health Centre level of 90 demographically weak
districts covering 32 districts in UP, 23 each in M.P.
and Rajasthan, 5 in Bihar 2 each in Bengal and Gujarat
and 1 each in Haryana, Kerala and Orissa.
Of the 3405 Primary Health Centres covered under the
survey only 15 per cent had labour rooms and 13 per cent
had operation theatres. Only 18 per cent of the PHCs have
conducted deliveries and 19 per cent of them had no
medical officers. The main reason being lack of funding
for PHCs leading to lack of infrastructure, reluctance on
the part of the medical and para-medical staff to work in
rural areas and shortage of medicines and equipments.
Health being a state subject, the states are advised to
strengthen the system.
Eradication of
Malaria
Shri Ramachandra Mallik and Kumari Mamta
Banerjee asked the government about the increase in
Malaria cases and the action plan adopted to combat the
problem.
The statement issued in reply by the Health Minister
showed that Malaria cases in the country have declined in
1997 as compared to 1996.
The number of measures taken to control malaria,
particularly in tribal areas of the country which are
more vulnerable, include:
- 100% central
assistance provided to the seven North-Eastern
States since December 1994.
- an Enhanced Malaria
Control project with World Bank support to cover
essentially 100 districts in seven states of
Andhra Pradesh, Bihar, Gujarat, Maharashtra,
Madhya Pradesh, Orissa and Rajasthan as well as
19 towns/cities having endemicity of malaria
since September, 1997.
- observance of
anti-Malaria month in June every year beginning
from 1997 to create public awareness about
prevention and containment of malaria and other
vector-borne diseases and to propagate the theme
‘Malaria control everyone’s
concern’ to make it a people’s movement
in the country.
Apart from supporting
certain ongoing strategies in the identified areas, newer
interventions such as the use of synthetic pyrethroids,
medicated mosquito nets, bio-larvicides, larvivorus
fishes are also being resorted to.
From the 25 states and 7 Union Territories 276184 Malaria
cases were reported in the 1st quarter of 1998. The
highest number was from Orissa with 69988 cases followed
by M.P. with 57208 cases and Maharashtra with 30450
cases.
LS SQ. No. 394 dated 14 July 1998
Infant Mortality
There was a question raised by Shri Pankaj
Choudhry and Shri Mahesh Kanodia regarding the increasing
rate of infant mortality in the country and the steps
taken to arrest the trend.
The Health Minister informed that as a result of the
immunization programme infant mortality rate has been
declining at the national level over the years. The
infant mortality rate which was 96 per 1000 live births
in 1986 has declined to 72 in 1996. According to UNICEF,
47 countries have higher infant mortality rate than
India. Infant mortality rate is prominently influenced by
incidence of vaccine preventable diseases, acute
respiratory diseases, diarrhoeal diseases and quality of
new born care. Assistance to states in strengthening of
child health care facilities is being continued under the
RCH programme. These measures are expected to
substantially bring down infant mortality rate in the
country in coming years.
[top] [index]
|
