Lok Sabha Question No. 901 (UNSTARRED), answered on 2018-12-14
Subject: Import of Drugs
Ministry: HEALTH AND FAMILY WELFARE
Asked by: KUNWAR PUSHPENDRA SINGH CHANDEL

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

LOK SABHA UNSTARRED QUESTION NO. 901 TO BE ANSWERED ON 14 TH DECEMBER, 2018

## IMPORT OF DRUGS

## 901. SHRI KUNWAR PUSHPENDRA SINGH CHANDEL:

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

- (a) the details of medical services and drugs imported during the last three years;
- (b) whether the Government is planning to take special policy measures to reduce dependence on importof drugs and if so, the details thereof;
- (c) whether the Government is planning to make special provision for drugs under 'Make in India' Program; and
- (d) if so, the details thereof?

## ANSWER

## THE MINISTER OF HEALTH AND FAMILY WELFARE (SHRI JAGAT PRAKASH NADDA)

- (a): The  details  of  drugs  imported  during  the  last  three  financial  years  and  the financial year (upto October 2018), principal commodity wise, are annexed .
- (b) to (d): The Government formulates the policies from time to time to reduce country's dependence  on  imports.  In  this  direction,  the  Government  had  on  29.01.2016  notified withdrawal of exemption in custom duties which were earlier given to certain categories o and bulk drugs to provide a boost to the domestic manufacture rs.

Further,  the  Ministry  of  Health  and  Family  Welfare  has  taken  various  measures streamline the regulatory process to achieve the mission of 'Make in India' with assurance of safety  ,  efficacy  and  quality  of  drugs  manufactured/marketed  in  the  c ountry.  These  include perpetual validity of manufacturing and sale licenses subject to certain cond implementation  of  e - governance  in  Central  Drugs  Standard  Control  Organisation  (CDSCO) through SUGAM portal, measures to promote scientific and ethica l clinical trials in the country, guidelines  for  similar  biologics,  framing  and  implementation  of  Medical  Device  Rules  2 increase  in  the  validity  period  of  Certificate  of  Pharmaceutical  Product  (CoPP)  under GMP (Good Manufacturing Practices) certif ication scheme, waiver of the requirement of NOC from  CDSCO  port  offices  for  export  purposes,  and  delegation  of  powers  to  State/UT  Dr Controllers for issuance of NOC with respect to unapproved drugs for export purposes only.

Annexure

| Principal Commodity            | 2015-16         | 2015-16              | 2016-17         | 2016-17              | 2017-18         | 2017-18              | 2018-19(up to October, 2018)   | 2018-19(up to October, 2018)   |
|--------------------------------|-----------------|----------------------|-----------------|----------------------|-----------------|----------------------|--------------------------------|--------------------------------|
| Principal Commodity            | Quantity in TON | Value in Million USD | Quantity in TON | Value in Million USD | Quantity in TON | Value in Million USD | Quantity in TON                | Value in Million USD           |
| AYUSH AND HERBAL PRODUCTS      | 11668           | 54                   | 11359           | 53                   | 13639           | 61                   | 11681                          | 43                             |
| BULK DRUGS, DRUG INTERMEDIATES | 269169          | 3248                 | 278822          | 2738                 | 310002          | 2993                 | 201158                         | 2182                           |
| DRUG FORMULATIONS, BIOLOGICALS | 3288            | 1583                 | 4325            | 1662                 | 9141            | 1841                 | 9781                           | 1152                           |
| Total Import of Drugs          | 284125          | 4885                 | 294507          | 4454                 | 332782          | 4895                 | 222621                         | 3377                           |