Lok Sabha Question No. 192 (STARRED), answered on 2016-11-29
Subject: Pharma Sector
Ministry: CHEMICALS AND FERTILIZERS
Asked by: HARI OM PANDEY, (SMT.) RATNA DE(NAG)

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

## LOK SABHA

## STARRED QUESTION No. 192

## TO BE ANSWERED ON THE 29 th  November, 2016

## Pharma Sector

- *192.   SHRI HARI OM PANDAY:

DR. RATNA DE (NAG):

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

- (a)  whether  the  Government  is  satisfied  with  the  performance  of  pharma industry in the country and if so, the details thereof;
- (b) the major initiatives taken in the pharma sector in recent times;
- (c) whether the Government proposes to amend the existing licensing policy for pharma sector in the country and if so, the details thereof; and
- (d) whether this proposal is likely to help in revamping the pharma sector as well as ensuring the growth and development of the said sector and if so, the details thereof?

## ANSWER

MINISTER IN THE MINISTRY OF CHEMICALS AND FERTILIZERS AND PARLIAMENTARY AFFAIRS

(SHRI ANANTHKUMAR)

- (a) to (d): A statement is laid on the Table of the House.

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## Statement  referred  to  in  reply  to  LOK  SABHA  STARRED  QUESTION No. 192 to be answered on 29 th  November, 2016 regarding Pharma Sector

(a): Yes,  Madam.  The  Indian  Pharmaceutical  Industry  is  witnessing  a robust growth. In the beginning of 11 th Plan in 2007 it stood at approximately Rs. 71000 crores which has now risen to approximately Rs. 2,00,000  crores  as  per  data  of  Pharmatrac  and  Pharmaceutical  Export Promotion Council (Pharmexcil) upto 2015-16. (b): The Government has taken various initiatives to help the Pharma Sector  grow  and  this  is  an  ongoing  process.  Some  of  the  major initiatives taken by the Government are as under: (i) Withdrawal of exemption of Customs Duty on certain categories of drugs/medicines to promote domestic manufacturing of these medicines; (ii)  Implementing  'Cluster  Development  Programme  for  Pharma Sector  (CDP-PS)'  in  Public  Private  Partnership  made  through Special Purpose Vehicle (SPV) through one time grant -in- aid to be released for creation of identified infrastructure and common facilities in the form of Common Facility Centers (CFC).; (iii) Financial support for research and development under Drugs & Pharmaceuticals Research Programme (DPRP) of the Department of Science & Technology; (iv) Section 35 of Income Tax Act grants weighted deduction for expenditure on scientific research. (v)The Drugs (Price Control) Order, 2013, Para-32 (iii) provides exemptions  from  price  control  to  a  manufacturer  producing  a new  drug  involving  a  new  delivery  system  developed  through indigenous Research and Development for a period of five years from the date of its market approval in India; (vi)  Foreign  Direct  Investment  (FDI)  Policy has  been  liberalised whereby  Pharmaceutical  Companies  for  Greenfield  Pharma  Projects can  invest  100%  FDI  through  automatic  route  and  for  Brownfield Pharma  Projects  foreign  investment  upto  74%  is  allowed  under automatic route and beyond that the companies have to come through government route.

(c) & (d): Under the Drugs and Cosmetics Act, 1940 and Rules 1945 made thereunder, the manufacturers/Importers are required to obtain license from Drug Controller / State Drug Controllers. The Drugs and Cosmetics Rules 1945 are amended from time to time to streamline the  regulatory  process  with  respect  to  manufacturing,  import,  sales and distribution of Drugs & Cosmetics.

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