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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.

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