Lok Sabha Question No. 427 (UNSTARRED), answered on 2020-09-15
Subject: Impact of COVID-19 on Pharma Industry
Ministry: CHEMICALS AND FERTILIZERS
Asked by: Manoj Kishorbhai Kotak

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

LOK SABHA UNSTARRED QUESTION No. 427 TO BE ANSWERED ON THE 15 th  September, 2020

## Impact of COVID-19 on Pharma Industry

## 427. SHRI MANOJ KOTAK:

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

(a) whether the Government has made any assessment of the impact of COVID-19 pandemic  on  the  country's  pharma  industry  in  view  of  the  fact  that  the  country imports 70 per cent of raw materials from China for manufacture of medicines;

(b) if so, the Government's plan thereof;

(c)  whether the Government has any plan to support pharma sector to source raw materials for drugs from other countries; and

(d) if so, the details thereof?

## ANSWER

## MINISTER IN THE MINISTRY OF CHEMICALS & FERTILIZERS (SHRI D. V. SADANANDA GOWDA)

(a)  &  (b):          Many  raw  materials  are  imported  from  China,  for  manufacturing  of medicine. As per available data from the various Port Offices of the Central Drugs Standard  Control  Organization  (CDSCO),  the  details  of  the  percentage  of  raw materials imported from China are as under.

| Year    | Percentage (in terms of value)   |
|---------|----------------------------------|
| 2017-18 | 68.62%                           |
| 2018-19 | 66.53%                           |
| 2019-20 | 72.40%                           |

The  reported  restrictions  on  movement  of  people,  lockdown  enforced  in  various places,  logistic  issues,  etc.  due  to  outbreak  of  Coronavirus  in  China  could  have impacted the supply of raw materials from China.

(c) & (d): Under the provisions of the Drugs and Cosmetics Rules, 1945 various sites of  different  countries  are  registered  by  the  CDSCO  for  import  of  various  Active Pharmaceutical  Ingredients  (API)  which  are  used  in  the  manufacture  of  drug formulations in the country. CDSCO is reviewing all such applications for import of APIs in  an  expeditious  manner  for  which  India  is  highly  dependent  on  China. The Government assessed the impact of COVID-19 pandemic on the availability of Active Pharmaceutical  Ingredients  (API),  intermediates  and  Key  Starting  Materials  (KSM) for  which  India  is  critically  dependent  on  China.  Accordingly,  an  inter-ministerial Committee was constituted on 06.02.2020 to address the issue of drug security in the  country.  The  committee  submitted  its  report  on  27.02.2020.  The  Committee observed that there are 58 APIs for which the country is heavily dependent on China. Further,  a Technical  Committee  was  also  constituted  on  02.03.2020  to  make recommendations  for  the  revival  of  fermentation  industry,  new  technologies  for manufacturing of APIs including its backward integration, costing of the projects and identification  of  strategic  business  models.  The  Committee  also  examined  the  58 APIs identified by the Drug Security Committee and recommended a scheme for 53 APIs.

On the basis of the recommendations of the committee, the Department has prepared two schemes for promoting domestic manufacturing of Bulk Drugs which were  approved  by  Cabinet  on  20.03.2020  viz. Production  Linked  Incentive  (PLI) scheme  and  scheme  for  Promotion  of  Bulk  Drug  Parks. Under  the  PLI  Scheme, financial incentives shall be given based on sales made by selected manufacturers for 41 products which cover all the identified 53 APIs.

The new Schemes are expected to attract substantial investments, increase domestic  production  of  KSMs,  DIs  and  APIs  and  reduce  the  country's  import dependence to a large extent.

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