Lok Sabha Question No. 3143 (UNSTARRED), answered on 2016-03-16
Subject: R&D in Drug and Pharmaceutical Sector
Ministry: SCIENCE AND TECHNOLOGY
Asked by: DUSHYANT SINGH

## GOVERNMENT OF INDIA MINISTRY OF SCIENCE AND TECHNOLOGY DEPARTMENT OF SCIENCE AND TECHNOLOGY

LOK SABHA

UNSTARRED QUESTION NO.3143

TO BE ANSWERED ON 16/03/2016

## R&D IN DRUG AND PHARMACEUTICAL SECTOR

## 3143. SHRI DUSHYANT SINGH:

Will the Minister of SCIENCE AND TECHNOLOGY òãðìððÐð ¡ðøÜ ÑßðøÌðð÷ò±ð¨îó Ùðüëðó be pleased to state:

- (a) the details of the collaborative projects between industries and academic institutions, sanctioned by the Department of Science and Technology (DST) for Research and Development (R&D) in drug and pharmaceutical sector in the last three years;
- (b) whether there has been a delay in the completion of many such sanctioned projects;
- (c) if so, the details thereof and the steps taken by the Government to ensure their timely completion;
- (d) the  details  of  the  outcomes  of  these  projects  which  have  partially  or  fully  been  funded  by  the Government;
- (e) whether  there  has  been  inadequate  project  monitoring  by  DST  which  led  to  bad  financial management of the Government funds and inefficient research; and
- (f) if so, the details thereof along with the remedial measures taken by the Government?

## ANSWER

## MINISTER OF STATE IN THE MINISTRY OF SCIENCE AND TECHNOLOGY AND MINISTER OF STATE IN THE MINISTRY OF EARTH SCIENCES (SHRI.Y. S. CHOWDARY)

òãðìððÐð ¡ðøÜ ÑßðøÌðð÷ò±ð¨îó ÙðüëððâðÚð Ùð÷ü Üð¸Úð Ùðüëðó +ÉÉè® ÑðöÆãðó òãðìððÐð ÙðüëððâðÚð Ùð÷ü Üð¸Úð Ùðüëðó (gÉÉÒ ´ÉÉ<Ç. AºÉ. SÉÉèvÉ®ÉÒ)

(a) The  details  of  the  collaborative  projects  in  drug  and  pharmaceutical  sector  for  Research  and Development (R&D) sanctioned by the Department of Science and Technology (DST) between industries and academic institutions in the last three years is enclosed as Annexure 1.

(b) & (c):  The collaborative projects funded by DST are maximum of 3 years' duration. The R&D projects in drug and pharmaceutical sector have to undergo various phases such as drug discovery, pre-clinical and clinical trial which are resource intensive as well as time consuming. Every study has to be undertaken after taking necessary approvals like ethical clearance, compliance of ICMR guidelines, DCGI approval for  clinical  trials,  etc.  The  government  takes  various  steps  to  ensure  timely  completion  by  getting  the progress report on time, constituting the monitoring committee of experts to monitor the progress. Based on the recommendations of the committee, DST and industry release their committed funds to academic institutions.

(d) The outcomes of these projects are mainly generating data for regulatory requirement such as safety, efficacy, stability, etc. However, some of the outcomes of the projects which have partially or fully been funded by the DST in drug and pharmaceutical sector are enclosed as Annexure 2.

(e) & (f):  The projects are being monitored adequately by the experts in that area after receiving the technical  and  financial  progress  from  the  collaborative  partners.  The  suggestions  of  the  monitoring committee are communicated to project executives for compliance and implementing.

## Annexure - 1

## Collaborative Projects funded by DST in Drugs and Pharmaceutical Sector in the last three years

(Rs. in lakhs)

| S.No       | Project Title                                                                                                                                                                                                                          | Duration   | Name of the collaborating institutes/ industry                                                                                                                   |   Total approved cost |   DST share |   Amount released |
|------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------|-------------|-------------------|
| 2012-13 1. | Product Development of Phyllanthus niruri and Glycine max (L.) Merr ., formulation for the management of Diabetes and associated complications, its Validation, Standardisation, Preclinical Toxicology and Pharmacological evaluation | 3 yrs      | Sri Ramachandra University, Chennai. Visva Bharati University, School of Life Science, Shantiniketan East India Pharmaceutical Works Ltd., Kolkata               |               251.91  |     158.052 |           146.718 |
| 2.         | Scientific Validation of Safety, Protective and curative Efficacy of a Patented Folklore Medicine 'Savliv' Developed for the Management of Hepatic Disorders- A preclinical Study                                                      | 2 yrs      | Sri Ramachandra University, Chennai M/s. Harshul Ayur Pharma, Ramnagar                                                                                           |                33.654 |      21.246 |            20.308 |
| 3.         | Genome wide association study to identify genetic variants conferring risk to cardiovascular disease - Indian population                                                                                                               | 3 yrs      | Alluri Sitaramaraju Academy of Medical Sciences, Eluru M. S. University, Vadodara Sri Ramachandra University, Chennai Laila Pharmaceuticals Pvt Ltd., Vijayawada |               214.852 |     179.374 |           156.328 |
| 2013-14 1. | Development of Novel Mycotoxin binders for the management for mycotoxicosis in animal and human                                                                                                                                        | 1 yr       | Tamil Nadu Veterinary and Animal Sciences University, Chennai M/s. Neospark Drugs and Chemicals Pvt. Ltd., Hyderabad                                             |                65     |      42.6   |            42.6   |
| 2.         | Development of targeted stealth nanocarrier for dual delivery in the treatment of oral cancer                                                                                                                                          | 3 yrs      | Sastra University, Thanjavur Orchid Research laboratories Ltd, Chennai                                                                                           |                58.73  |      20.265 |             6.104 |

## Annexure - 2 Some of the products developed under the DST funded projects in Drug and Pharmaceutical

## Sector

BONISTA - Teriparatide Injection (recombinant human parathyroid hormone) for the treatment of Osteoporosis was developed by Virchow Biotech Pvt. Ltd., Hyderabad ALQUIT - Ectoparasiticidal natural product developed for pet animals by Central Institute for Research on Goats, Mathura and M/s Natural Remedies Pvt. Ltd., Bangalore. RHOCLONE  -    Anti-Rho-D  Immunoglobulin  Injection  (Monoclonal)  300mcg  developed  for Hemolytic disease of the new born (HDN) by M/s Bharat Serums & Vaccines Limited, Mumbai. ARTHAN - A novel topical aerosol spray developed for anti-arthritic using herbs by KMCH College of Pharmacy, Coimbatore and M/s Doctor Thangs Products, Coimbatore. SYNRIAM - A new anti-malarial drug was developed by M/s Ranbaxy Laboratories Ltd. AMPHOMUL - A drug for Visceral Leishmaniasis (Kala Azar) was developed by M/s Bharat Serums & Vaccines Ltd., Mumbai. MYCIDAC  -  M/s  Cadila  Pharmaceuticals  Ltd.,  Ahmedabad  developed  in  combination  with

Pacletaxel Cisplatin for advanced Non Small Cell Lung Cancer (NSCLC).

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