Lok Sabha Question No. 260 (UNSTARRED), answered on 2021-02-03
Subject: Export by Pharmaceutical Manufactures
Ministry: COMMERCE AND INDUSTRY
Asked by: Amol Ramsing Kolhe, Subhash Ramrao Bhamre, Sunil Dattatray Tatkare, DNV Senthilkumar. S., Kuldeep Rai Sharma

## GOVERNMENT OF INDIA MINISTRY OF COMMERCE & INDUSTRY (DEPARTMENT OF COMMERCE)

## LOK SABHA UNSTARRED QUESTION NO.  260 TO BE ANSWERED ON 03 rd FEBRUARY, 2021

## EXPORT BY PHARMACEUTICAL MANUFACTURERS

260. DR. AMOL RAMSING KOLHE:

DR. SUBHASH RAMRAO BHAMRE:

SHRI SUNIL DATTATRAY TATKARE:

DR. DNV SENTHILKUMAR S.:

SHRI KULDEEP RAI SHARMA:

वा�ण�य  एवं  उ�योग  मं�ी Will the Minister of COMMERCE & INDUSTRY ( वा�ण�य  एवं  उ�योग  मं�ी ) be pleased to state:

- (a) whether majority of small and medium pharmaceutical manufacturers in the country are working for bigger pharmaceutical units which export pharmaceutical products under their brand names;
- (b) if so, whether there is any proposal to boost the exports of pharmaceutical products by small  and  medium  Pharmaceutical  manufacturers  under  their  own  brands  under Atmanirbhar Bharat initiative;
- (c) whether the export of pharmaceutical items from India have declined drastically and if so, the details thereof and the reasons therefor and the steps taken to overcome it;
- (d) the  present  policy  of  the  Government  on  Foreign  Direct  Investment(FDI)  in  the Pharmaceutical sector; and
- (e) whether the Government has any regulations for the export of pharmaceutical products and if so, the details thereof and the extent to which these regulations have impacted the volume of exports from the country?

## ANSWER

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THE MINISTER OF STATE IN THE MINISTRY OF COMMERCE AND INDUSTRY (SHRI HARDEEP SINGH PURI)

(a)  & (b): Manufacturers are required to obtain a license for manufacturing drugs for export from the concerned State Licensing Authority (SLA) under the provision of Drugs and Cosmetic Act,

1940 and Rules made thereunder. Further, the manufacturer is required to meet the requirements of the importing country. In the global pharma supply chain, there are small, medium and large manufacturers from India, who are engaged at different levels of the value chain.  The measures taken by Government of India to promote exports, including those of small and medium pharmaceutical manufacturers, include  various  schemes  under  the  Foreign  Trade  Policy  (FTP),  assistance  under  the  Market Access Initiative (MAI) scheme, setting up district export hubs, Transport and Market Assistance Scheme etc. Trade delegations/buyer-seller meets with various countries are regularly organized for the benefit of exporters. Airfare support is also provided to the exporters with a turnover of Rs.30 crore and below to encourage participation in business delegations/trade fairs. (c) India's  exports  of  Pharmaceutical  products  have  not  declined  and  they  are  growing consistently. During the year 2019-20, India's exports of Pharmaceuticals were USD 20.58 billion with a growth rate of 7.57% over the previous year. Total pharma exports during Apr -Dec 202021  were  USD  17.57  billion,  registering  a  growth  rate  of  12.43%  over  the  same  period  of  the previous year. (d) As per the extant FDI Policy, 100% foreign investment is allowed under the automatic route in Medical Devices. Foreign investments in pharmaceuticals in greenfield projects are allowed upto  100%  under  the  automatic  route  and  for  brownfield  pharmaceutical  projects,  foreign investment beyond 74% to up to 100% Government approval is required. (e) The manufacturers are required to obtain license for manufacturing of drugs for export under the provision of Drugs and Cosmetic Act, 1940 and Rules made thereunder.  The current policy pertaining to the pharmaceuticals products is outlined in chapter 30 of the ITC(HS) Export Policy 2018. Currently, restrictions are placed on export of RT-PCR Kits, VTM Kits, RNA Extraction kits and 12 other laboratory reagents in the context of COVID-19 in accordance with Notification th

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no. 09/2015-2020 dated 10 June 2020.