DCGI Asks State DCs To Collect Data On
Impact Of Revised Sch M Norms On SSIs
Tuesday, April 20, 2010 08:00 IST
Joseph Alexander, New Delhi
The Drugs Controller General (India) has asked all State drug
controllers to collect the information on the closure of small scale pharma
units following the amendment of the Drugs and Cosmetics Act enforcing the
revised Schedule M guidelines in the country from July, 2005.
The DCGI has called for the information including the names
of units along with their addresses closed since July 2005 due to non-compliance
of Schedule M requirements after the Ministry of Micro, Small and Medium
Enterprises (MSME) made a request in this regard in view of the proposed
detailed survey to ascertain the extent of the impact of Schedule M.
MSME, the agency entrusted to conduct the survey as
recommended by the Rajya Sabha committee on subordinate legislation, had
informed the DCGI office that it did not have sufficient infrastructure and
manpower to conduct the survey and had requested the assistance. Hence the DCGI,
after taking up the matter with the DTAB, has instructed the State drug
controllers to collect the data as they are the licensing authorities to enforce
the Schedule M, sources said.
Apart from the information on the closed units, the DCGI has
also asked the State authorities to gather data on the cases in which licences
have been surrendered by the manufacturers. “It is also requested to provide
information on the cases in which licenses have been suspended or cancelled by
the authorities due to the non-compliance to revised Schedule M. Please indicate
separately the cases in which licences remained suspended or cancelled and those
where licences have been reinstated after due compliance,” the DCGI letter said.
“Names of drugs and pharmaceutical units which are partly
compliant to Schedule M in respect of specific sections while licence for other
categories has been suspended, cancelled or surrendered specifically due to
non-compliance of Schedule M also be forwarded,’’ the letter said.
The DCGI has asked the State licensing authorities to collect
the data on top priority basis so that information could be forwarded to the
Committee on Subordinate Legislation, sources said.
DoP Suggests Public Private Model For
Development, Maintenance Of New NIPERs
Friday, April 23, 2010 08:00 IST
Gireesh Babu, Mumbai
The Department of Pharmaceuticals (DoP) which took the
initiative of the project of establishing six new National Institutes of
Pharmaceutical Education and Research (NIPERs) has suggested in its detailed
project report that development and maintenance of infrastructural facilities
should be under the Public Private Partnership (PPP) model.
The new NIPERs, set up at Hajipur in Bihar, Rae Bareli in
Uttar Pradesh, Ahmedabad in Gujarat, Hyderabad in Andhra Pradesh, Kolkata in
West Bengal and Guwahati in Assam, are currently run with the help of mentor
institutes already existing in these places. Now, the government intends to set
up these institutes independently on a full scale basis with increased
participation from the private sector, according to DoP officials.
A partnership model has been designed, wherein there would be
four types of collaboration opportunities available for the private partner
under the header, Package A to D. The Package A entitles the partner firm to
have the onus to design, build, finance, maintain and transfer the NIPER complex
including land co-development for the activities related to pharmaceutical
sciences or life sciences or academic activities.
The Package B consists of responsibilities to design, build,
finance, operate and transfer of certain facilities in NIPER campus by co-usage
of facilities and creation of surplus capacity for commercial exploitation, even
as the Package C offers the private partner to conduct operation and management
of the academic and related functions of NIPER.
Package D would be for the partners who are looking for deals
in any other manner in which they would like to be associated with NIPERs under
PPP. According to the detailed project report submitted by the consultant firm,
Deloitte Touche Tohmatsu Pvt Ltd, the estimated cost on each NIPER is expected
at approximately Rs 330 crore including PPP element.
According to the DoP plans, the NIPER Hyderabad will have a
total area of 150 acres while the indicative area available for land
co-development for purposes other than NIPER construction is 100 acres. NIPER
Ahmedabad will be set up in a total area of 60 acres with indicative area of 10
acres, NIPER Guwahati with total area of 100 acres and indicative area of 50
acres and NIPER Kolkata with total area of 35 acres and NIPER Hajipur with total
area of 12.43 acres and the last two facilities, respectively, without
indicative area specified. All the projects are planned to be completed through
three phases of setting up facilities.
The department has already collected Expression of Interest (EoI)
from eligible bidders and will soon proceed to the next level of operations. The
EoI was not intended as pre-qualification bid and the government will call for
Request for Quotation or Request for Proposal at subsequent stage, based on the
EoIs and the interested and serious bidders shall work with the ministry in a
consultative manner at the time.
The four new NIPERs at Ahmedabad, Hyderabad, Kolkata and
Hajipur started working with the help of mentor institutes at these places and
classes were started from the academic session 2007-08. NIPER, Guwahati and
NIPER Rae Bareli have been started through mentor institutes in 2008-09. The
students are being selected through common admission test conducted by NIPER
S.A.S. Nagar in association with these new NIPERs.
The new NIPER projects are envisaged by the government to
provide adequate supply of quality man-power, cutting edge facilities for
research and development and to foster the spirit of PPP for the overall
development of the pharmaceutical industry in a sustainable manner.