Lok Sabha Question No. 4215 (UNSTARRED), answered on 2019-12-13
Subject: Medicines under Make in India
Ministry: HEALTH AND FAMILY WELFARE
Asked by: Pushpendra Singh Chandel

## GOVERNMENT OF INDIA MINISTRY OF HEALTH AND FAMILY WELFARE DEPARTMENT OF HEALTH AND FAMILY WELFARE

LOK SABHA UNSTARRED QUESTI ON NO. 4215 TO BE ANSWERED ON 13 TH DECEMBER, 2019

## MEDICINES UNDER MAKE IN INDIA

## 4215. SHRI KUNWAR PUSHPENDRA SINGH CHANDEL:

Will the Minister of HEALTH AND FAMILY WELFARE be pleased to state:

- (a) the details of the medical services and medicines imported during the last three years
- (b) whether the Government proposes any specific policy measures to reduce the dependency import for medicines;
- (c)  whether  the  Government  proposes  special  provision  for  formulation/  manufacturing medicines under 'Make in India' program; and
- (d) if so, the details thereof?

## ANSWER THE MINISTER OF STATE IN THE MINISTRY OF HEALTH AND FAMILY WELFARE (SHRI ASHWINI KUMAR CHOUBEY)

- (a): The data regarding category wise imports of medicines during the last three financia is annexed .
- (b) to (d): T he  Government formulates the policies  from  time  to  time  to  promote  'Make  in India' and reduce country's dependence on imports.

The Department of Pharmaceuticals has prepared an umbrella Scheme for Development of Pharmaceutical Industry with the objective to ensure drug security in the country by inc the  efficiency  and  competit iveness  of  domestic  pharmaceutical  industry.  Under  this  umbrella scheme, the Department is implementing schemes viz. 'Assistance to Pharmaceutical Industr Common  Facilities',  'Assistance  to  Bulk  Drug  Industry  for  Common  Facility  Centre'  and 'Assistance  to  Medical  Device  Industry  for  Common  Facility  Centre'  for  financing  common facilities in Pharma Clusters, Bulk Drug Parks and Medical Device Parks respectively i country.

In addition to these three schemes, umbrella scheme also consists of two other schemes, Pharmaceutical  Promotion  Development  Scheme  (PPDS)  and  Pharmaceuticals  Technology Upgradation  Assistance  Scheme  (PTUAS).  Under  Pharmaceutical  Promotion  Development Scheme (PPDS), financial support is provided for conducting seminars, co nferences, exhibitions, mounting  delegations  to  and  from  India  for  promotion  of  exports  as  well  as  investm conducting  studies/  consultancies  for  facilitating  growth  and  exports.  Under  'Pharmace Technology  Upgradation  Assistance  Scheme'  (PTUAS), assistance  in  the  form  of  interest subvention against sanctioned loan by any scheduled commercial bank/financial institution in  Public  and  Private  sector,  is  provided  to  facilitate  Small  and  Medium  Pharma  Enter (SMEs)  to  upgrade  their  plant  an d  machinery  to  World  Health  Organization  (WHO)  Good Manufacturing Practices (GMP) standards so as to enable them to participate and compet global markets.

Further,  the  Ministry  of  Health  and  Family  Welfare  has  taken  various  measures stre amline the regulatory process to achieve the mission of 'Make in India' with assurance of safety,  efficacy  and  quality  of  drugs  manufactured/marketed  in  the  country.  These  in perpetual validity of manufacturing and sale licenses subject to certain con ditions, implementation  of  e - governance  in  Central  Drugs  Standard  Control  Organisation  (CDSCO) through SUGAM portal, measures to promote scientific and ethical clinical trials in the guidelines  for  similar  biologics,  framing  and  implementation  of Medical  Device  Rules  2017, increase  in  the  validity  period  of  Certificate  of  Pharmaceutical  Product  (CoPP)  under GMP (Good Manufacturing Practices) certification scheme, waiver of the requirement of NO from  CDSCO  port  offices  for  export  purposes,  and delegation  of  powers  to  State/UT  Drug Controllers for issuance of NOC with respect to unapproved drugs for export purposes only.

The Ministry of Health & Family Welfare has amended the Drugs & Cosmetics Rules, 1945 vide notification No.GSR 1193 ( E) dated 12.12.2018 wherein application fees have been increased for grant of various import Registration Certificate as well as overseas inspect

## Annexure

| USD Million                     | USD Million   | USD Million   | USD Million   |
|---------------------------------|---------------|---------------|---------------|
| Category                        | 2016-17       | 2017-18       | 2018-19       |
| Bulk Drugs & Drug Intermediates | 2725.52       | 2992.21       | 3558.07       |
| Drug formulations & Biologicals | 1080.38       | 1489.43       | 1595.58       |
| Vaccines                        | 294.35        | 274.22        | 332.10        |
| Surgicals                       | 70.14         | 78.18         | 93.18         |
| Herbal Products                 | 28.08         | 31.05         | 42.93         |
| Ayush                           | 25.42         | 29.88         | 29.96         |
| Total                           | 4223.89       | 4894.96       | 5651.81       |