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Centralised Licensing With
Inadequate Staff May Lead To Delay In Granting Product Licences
Pharmaceutical companies in the country may have to cope with serious delays in
getting their applications for drug licenses cleared once Central Drugs
Authority (CDA) of India is formed. Such delays in the initial phase of its
existence are inevitable as the staff strength of Central Drugs Control
Organisation is highly inadequate to handle the vast number of applications that
may pour in from various states, according to All India Drug Control Officers
Association (AIDCOC).
The Central Drugs Standard Control Organisation (CDSCO), which is to be
entrusted as the licensing authority for drug formulations under the CDA, has
staff strength of less than 40 now, whereas the current strength of drug control
officials in states is around 1,200. Although there are recommendations to
induct more staff into CDA, the chances are less for the time being as such
large-scale recruitment of staff will take time, officials said.
"The staff strength of CDSCO is over 75 per cent less than the existing staff
strength of state drug control officials all over India. This limited number of
staff has to issue licenses for several thousands of products in the entire
country. We doubt whether with the existing infrastructure, the authority can
meet the challenge of issuing licenses for these products without delay, "Ravi
Uday Bhaskar, secretary general, AIDCOC told Pharmabiz.
As the authority has not come up with any specific details on increasing the
staff strength, adding more infrastructures is not practical. There has been no
major recruitment of staff in CDSCO for the last 7 to 8 years despite assurances
in this regard by the central government, he added. On the other hand, the state
drug control authorities are increasing their staff strength and yet many of
them are not able to operate efficiently, maintained Uday Bhaskar.
The new responsibility of issuing product licenses may lead to the collapse the
entire operations of the CDSCO, as the existing limited number of officials have
to carry out the multiple tasks including inspection and licensing of blood
banks and evaluation, screening and granting of NOCs for export of unapproved or
banned drugs, Bhaskar pointed out. He revealed that the present number of zonal
offices under CDSCO is inadequate to carry even the current procedures under
their purview.
One of the main attractions for CDA is said to be the introduction of a common
database of approved combinations all over the country. Currently there is no
comprehensive database, which leads to improper approvals by various state drug
authorities. If a database is provided to each state drug authorities, the
current system itself can give more accurate results, he opined.
(Ref : Chronicle Pharmabiz dated February 1, 2007)
Central Drug Authority Will Be Formed In
Six Months : Dr Ramadoss
The much awaited Central Drugs Authority of India (CDA (I), stated to be formed
in line with the US FDA would be ready within six months from now. The meeting
was held to discuss relevant issues about the same and it was cleared by the
cabinet. The issue to set up the CDA (I) had been pending for the last many
years and the final decision to set it up had been taken on Thursday.
Speaking to press persons after presiding over the Silver Jubilee Celebrations
of Madras Medical Mission, Union Minister For Health and Family Welfare, Dr.
Anbumani Ramadoss said that there would be ten divisions to handle the segments
including new drugs, biotechnology, pharmacovigilance, imports of pharmaceutical
products, Quality Analysis, Indian Systems of Medicines, traditional medicines,
international co-operation and patent of pharmaceutical production. The Drug
Controller would be on the top most position in the body. He said that the
building and other infrastructure facilities for the same were ready and the
proposal had to go through the parliament.
Speaking to Pharmabiz about the proposed Vaccine Park, the Minister said that
200 acres of land was identified in Kancheepuram and it would become functional
in near future. About the medicinal plant processing zones, the Minister said
that it would be set up in Uttranchal, Kerala, Chattisgarh and one in Tamil Nadu.
While the process in Uttranchal had already started, discussions for setting one
in Tamil Nadu was under discussion.
Anbumani earlier while speaking in the function said that there were plans to
introduce an authoritative body to regulate the hospital sector. He said that
the hospital would have to get mandatory accreditation within a few years of
setting up the centre and had to follow the Indian Public health standards. The
Minister stated that rural posting for one year would be given to doctors after
they finish their internship. This was as the part of the move to improve health
care facilities in rural areas.
He said that the Government was trying to promote medicinal parks that would be
the main centre for locally manufacturing medical equipments and diagnostic
tools. This was mainly aimed at reducing the cost of patient care. He said that
90 percent of the products manufactured from here would be for domestic use and
not for export. One park is planned in Chengalpattu.
The Health Minister stated that he was taking action to reduce the health care
costs in India. "With the medical tourism booming in India, the cost of
treatment is also increasing. So we have been constantly telling the hospital
authorities and those from the pharma sector to reduce the prices for the
citizens of India," he said. Anbumani urged the need for public - private
partnership in improving health care in the country.
Anbumani Ramadoss also presented the MMM Award for Excellence in Healthcare to
Christian Medical College, Vellore. He then urged such Not For Profit hospitals
to come together to fight against non-communicable diseases.
First President of Zambia, Kenneth Kaunda, said that there was a need for his
country to have links with hospitals such as MMM to provide better healthcare in
Zambia. He also spoke on how AIDS had spread its harmful tentacles in his
country and how they were trying to erase the stigma related to the disease.
Tamilnadu Health and Family Welfare Minister K K S S R Ramachandran released a
souvenir on the occasion. Also present on the occasion were vice president of
MMM, Verghese Eapen, President of MMM, His Grace Yakob Mar Irenios and honorary
secretary of MMM, K V George.
(Ref : Chronicle Pharmabiz dated January 18, 2007)
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