Lok Sabha Question No. 205 (UNSTARRED), answered on 2018-02-02
Subject: Import of Active Pharmaceutical Ingredients
Ministry: HEALTH AND FAMILY WELFARE
Asked by: GAJANAN CHANDRAKANT KIRTIKAR, T. RADHAKRISHNAN, VIJAY KUMAR S.R., KUNWAR HARIBANSH SINGH, SUNIL BALIRAM GAIKWAD, ASHOK SHANKARRAO CHAVAN, SUDHEER GUPTA, BIDYUT BARAN MAHATO, NARANBHAI KACHHADIA

## GOVERNMENT OF INDIA MINISTRY OF HEALTH AND FAMILY WELFARE

## DEPARTMENT OF HEALTH AND FAMILY WELFARE

LOK SABHA UNSTARRED QUESTION NO. 205 TO BE ANSWERED ON 2 ND FEBRUARY, 2018

## IMPORT OF ACTIVE PHA RMACEUTICAL INGREDIENTS

205. SHRI GAJANAN KIRTIKAR:

SHRI T. RADHAKRISHNAN:

SHRI S.R. VIJAYAKUMAR:

KUNWAR HARIBANSH SINGH:

DR. SUNIL BALIRAM GAIKWAD:

SHRI ASHOK SHANKARRAO CHAVAN:

SHRI SUDHEER GUPTA:

SHRI BIDYUT BARAN MAHATO:

SHRI NARANBHAI KACHHADIYA:

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

- (a) the total amount of import of Active Pharmaceutical Ingredients (APIs) during each of the last three years and the current yea , country -wise;
- (b) whether the Drug Controller General of India (DCGI) has banned the import of APIs of drugs from some Chinese Pharmaceutical firms recently due to serious health risks and if so, the details thereof;
- (c) whether the said move have serious ramifications for the Indian pharma industry;
- (d) if so, the details thereof and the corrective measures taken/b eing taken by the Government in this regard; and
- (e) the steps taken/being taken by the Government for indigenous manufacture of APIs in the country to avoid imports?

## ANSWER THE MINISTER OF STATE IN THE MINISTRY OF HEALTH AND FAMILY WELFARE

(SHRI ASHWINI KUMAR CHOUBEY)

- (a):  The  details  of  India's  imports  of  Active  Pharmaceutical  Ingredients  (APIs)  from  top  five countries during the last three years are as under:

e (Rs. cr)

| Year     |   Total import (Rs. |   cr) Import from China (Rs. cr) |   Import from Germany (Rs. cr) |   Import from USA (Rs. cr) |   Import from Italy (Rs. cr) |   Import from Singapor e (Rs. |
|----------|---------------------|----------------------------------|--------------------------------|----------------------------|------------------------------|-------------------------------|
| 2014- 15 |             19833.2 |                            12758 |                        1172.05 |                     791.16 |                       644.37 |                        241.25 |
| 2015- 16 |             21226   |                            13853 |                        1054.71 |                     980.38 |                       663.44 |                        593.57 |
| 2016- 17 |             18372.5 |                            12255 |                         485.11 |                     820.18 |                       701.85 |                        422.01 |

(b): Central Drugs Standard Control Organisation (CDSCO) has inspected seven manufacturing sites of bulk drug in China during 30 th Oct., 2017 to 11 th Dec., 2017. On the basis of  observations  of  inspecting  team,  show  cause  notice  was  issued  to  all  the  site subsequently stop import order was issued to six out of seven sites and authorized age importers were asked to stop import till a satisfactory response to the show cause notic is submitted.

With respect to the seventh site, the po rt offices have been directed to monitor the import of products and draw the samples from every batch of the imported consignment to ensure qua of the product.

(c) & (d): No such report has been received to the effect that the above said move is l ely to have serious ramification for the Indian pharma Industry.

(e): The policies formulated by Government from time to time are made so that the country's dependence  on  imports  is  minimized.  In  this  direction,  the  Government  had  on  29.01.2 notified  t he  withdrawal  of  exemption  in  custom  duties  which  were  earlier  given  to  cert categories of drugs and bulk drugs to provide a boost to the domestic manufacturers.