Lok Sabha Question No. 2430 (UNSTARRED), answered on 2019-12-03
Subject: Nano  Pharmaceuticals
Ministry: CHEMICALS AND FERTILIZERS
Asked by: Raksha Nikhil Khadse

## GOVERNMENT OF INDIA MINISTRY OF CHEMICALS AND FERTILIZERS DEPARTMENT OF PHARMACEUTICALS

LOK SABHA UNSTARRED QUESTION No. 2430 TO BE ANSWERED ON THE 3 rd  December, 2019

## Nano Pharmaceuticals

## 2430. SHRIMATI RAKSHA NIKHIL KHADSE:

Will the Minister of CHEMICALS AND FERTILIZERS be pleased to state:

- (a) whether the Government is formulating a new policy & guidelines for evaluation of nano pharmaceuticals which have higher efficacy and lower toxicity than the conventional drugs; and
- (b) if so, the details thereof?

## ANSWER

## MINISTER IN THE MINISTRY OF CHEMICALS AND FERTILIZERS (SHRI D. V. SADANANDA GOWDA)

- (a):  Yes,  Sir.  Department  of  Biotechnology  (DBT),  Ministry  of  Science  and  Technology, Indian Council of  Medical  Research  (ICMR)  and  Central  Drugs  Standard  Control Organization  (CDSCO),  Ministry  of  Health  and  Family  Welfare  have  jointly  developed 'Guidelines  for  Evaluation  of  Nanopharmaceuticals  in  India'.    These  guidelines  are  an outcome  of  concerted  Inter-Ministerial  efforts  coordinated  by  DBT.  Dr.Harsh  Vardhan, Honorable  Minister,  Science  &  Technology  released  these  Guidelines  on  24 th October 2019
- (b):  Nanocarrier  based  targeted  drug  delivery  is  an  emerging  field  with  a  lot  of  market potential.  There  are  no  uniform  internationally  accepted  guidelines  for  evalation  of nanopharmaceuticals. These 'Guidelines for Evaluation of Nanopharmaceuticals in India' is one of the most important steps for delineating quality, safety and efficacy assessment of  novel  nanoformulations  which  can  be  commercialized.  These  guidelines  are  also intended  to  provide  transparent,  consistent  and  predictable  regulatory  pathways  for nanopharmaceuticals in India.

The guidelines apply to the nanopharmaceuticals in the form of finished formulation as well as  Active  Pharmaceutical  Ingredient  (API)  of  a  new  molecule  or  an  already  approved molecule with altered nanoscale dimensions, properties or phenomenon associated with the  application  of  nanotechnology  intended  to  be  used  for  treatment, in  vivo diagnosis, mitigation, cure or prevention of diseases and disorders in humans.

In  these  guidelines,  the  nanopharmaceuticals  (nanomedicines)  have  been  classified according  to  their  degradability,  organicity,  function  and  status  of  approval.  Hence,  the safety  and  efficacy  data  requirements  have  been  described  for  different  categories  of nanopharmaceuticals.

Specific  scientific  evidence  required  for  approval  of  any  nanopharmaceutical  and  the strategies  for  pharmacovigilance  of  such  products  have  been  incorporated  in  these guidelines.  Each  application  should  be  considered  on  its  own  merit  based  on  data submitted, using scientific judgment and logical argument.

These  guidelines  would  facilitate  Indian  researchers  and  industries  to  optimise  their research on developing the product based on the regulatory requirements which will make our country a global leader in this area.

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