Lok Sabha Question No. 3635 (UNSTARRED), answered on 2021-03-17
Subject: Ease of Doing Business
Ministry: COMMERCE AND INDUSTRY
Asked by: Nama Nageswara Rao

## GOVERNMENT OF INDIA MINISTRY OF COMMERCE & INDUSTRY

## DEPARTMENT FOR PROMOTION OF INDUSTRY AND INTERNAL TRADE

## LOK SABHA

## UNSTARRED QUESTION NO. 3635. TO BE ANSWERED ON WEDNESDAY, THE 17 TH  MARCH, 2021.

## EASE OF DOING BUSINESS

## 3635.  SHRI NAMA NAGESWARA RAO:

Will the Minister of COMMERCE AND INDUSTRY be pleased to state: वाणिज्य  एवं उद्योग मंत्री

- (a) whether  the  Government  has  taken  any  steps  to  improve  ease  of  doing business in pharma sector;
- (b) if so, the details thereof; and
- (c) if not, the reasons therefor?

## ANSWER

## वाणिज्य  एवं उद्योग मंत्रालय में राज्य मंत्री (श्री सोम प्रकाश) THE MINISTER OF STATE IN THE MINISTRY OF COMMERCE & INDUSTRY (SHRI SOM PARKASH)

(a) & (b):

Yes,  Sir.  Department  for  Promotion  of  Industry  and  Internal  Trade (DPIIT),  in  coordination  with  Central  Ministries/Departments,  States and  Union  Territories  (UTs),  has  spearheaded  various  reforms  to improve business regulatory environment in the country across all the sectors  including  the  pharmaceuticals  sector.  As  a  result  of  the initiatives  undertaken,  India  ranks  63 rd in  the  World  Bank's  annual Doing Business Report (DBR), 2020 as against 77 th rank in DBR, 2019, registering a jump of 14 ranks.

As a part of State Reforms Action Plan (SRAP), DPIIT has recommended  States/UTs  to  design  and  implement  an  online  single window system for submission, processing and issuance of applications for grant of Retail Drug License, Wholesale Drug License, Drug Manufacturing License. The SRAP also recommends States/UTs to eliminate the requirement of renewal and allow for auto-renewal in case of drug licenses.

During the last five years,  Ministry of Health and Family Welfare and Central  Drugs  Standard  Control  Organization  (CDSCO)  have  taken various measures for streamlining regulatory system and ease of doing business in the country such as notification of Medical Devices Rules, 2017,  New  Drugs  and  Clinical  Trials  Rules,  2019,  online  submission and  processing  of  various  applications  under  SUGAM  portal,  for evaluation of applications of Clinical Trials, New Drugs and Investigational New Drugs (IND) including r-DNA derived products and vaccines,  new  medical  devices,  etc.,  notification  of  Cosmetics  Rules, 2020,  increasing  the  validity  of  World  Health  Organizations'  (WHO) Certificate  of  Pharmaceutical  Product  (COPP)  under  the WHO  Good Manufacturing Practice (GMP) Certification Scheme from 2 years to 3 years, waiver of No Objection Certificate (NOC) for export purpose for the  export  consignments  to  any  country,  delegation  of  power  to  all States'/UTs'  Drug  Controllers  for  issuance  of  NOC  with  respect  to unapproved /banned drugs for export purpose only, etc.

M/o Environment, Forest and Climate  Change (MoEFCC), vide Notification S.O. 1223(E) dated 27 th March, 2020 and vide Notification S.O.  3636(E). dated 15 th October,  2020 has  decided that all proposals for projects or activities in respect of Active Pharmaceutical  Ingredients  (API)  received  up  to 30 th March,  2021, shall  be  appraised,  as  Category  'B2'  projects.  MoEFCC,  vide  Office Memorandum  dated  28 th January,  2021,  has  categorized  'API  and Intermediates'  as  single  category  instead  of  individual  products,  in order to provide flexibility to the Industry to change the raw materials mix and/or product mix within the sanctioned pollution load. MoEFCC, vide  Notification  S.O.980(E)  dated  2 nd March,  2021,  has  decided  that any  increase  in production  capacity  in respect  of  processing  or production or manufacturing sectors (listed against item numbers 2,3, 4 and 5 in the Schedule to this notification) with or without any change in (i) raw material-mix or (ii) product-mix or (iii) quantities within products or (iv) number of products including new products falling  in the same category  or  (v)  configuration  of  the  plant  or  process  or  operations  in existing area or in areas contiguous to the existing area (for which prior environmental clearance has been granted) shall be exempt from the requirement of Prior Environmental Clearance provided that there is no increase in pollution load. Expert Appraisal Committee (EAC) meetings are  conducted  by  MoEFCC  fortnightly  for  expeditious  appraisal  of environmental clearance proposals.

Department  of  Pharmaceuticals  has  constituted  a  Committee  on  6 th January, 2021 for suggesting ways for reducing the compliance burden faced by the Industry.

(c): Does not arise.

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