Lok Sabha Question No. 1586 (UNSTARRED), answered on 2023-07-28
Subject: Revenue Earned from Export of Drugs
Ministry: CHEMICALS AND FERTILIZERS
Asked by: Aparajita Sarangi

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

LOK SABHA UNSTARRED QUESTION No. 1586 TO BE ANSWERED ON 28 th  July, 2023

Revenue Earned from Export of Drugs

## 1586. SHRIMATI APARAJITA SARANGI:

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

- (a) the details of revenue earned by the Government exporting drugs from India in last three years, year-wise;
- (b) whether the Government has taken any measures for promoting export of generic drugs
- from India and reducing the time cost involved in obtaining necessary approvals; (c) if so, the details thereof; and

(d) the step taken/proposed to be taken by the Government to address the issue of counterfeit drugs  in  international  markets  and  ensure  authenticity  of  Indian  pharmaceutical  products throughout the export process?

## ANSWER

## MINISTER OF STATE IN THE MINISTRY OF CHEMICALS & FERTILIZERS (SHRI BHAGWANTH KHUBA)

(a):    The data of India's Pharmaceutical Export for the last three years is as under: -

| India's Pharmaceutical Exports (Rs. in crore)   | India's Pharmaceutical Exports (Rs. in crore)   | India's Pharmaceutical Exports (Rs. in crore)   | India's Pharmaceutical Exports (Rs. in crore)   | India's Pharmaceutical Exports (Rs. in crore)   |
|-------------------------------------------------|-------------------------------------------------|-------------------------------------------------|-------------------------------------------------|-------------------------------------------------|
| S. No                                           | DESCRIPTION                                     | 2020-21                                         | 2021-22                                         | 2022-23                                         |
| 1                                               | Bulk Drugs and Drug Intermediates               | 32,856.71                                       | 33,320.93                                       | 37,852.77                                       |
| 2                                               | Drug Formulations and Biologicals               | 1,41,207.04                                     | 1,41,634.12                                     | 1,56,401.43                                     |
|                                                 | Total                                           | 1,81,260.76                                     | 1,83,339.97                                     | 1,94,254.20                                     |
| Year on Year Growth                             | Year on Year Growth                             |                                                 | 1.1%                                            | 6.0%                                            |

[Source: DGCIS, Ministry of Commerce and Industry]

(b) to (c):      Under the MAI (Market Access Initiative) Scheme of Department of Commerce, financial assistance is provided to develop new markets, to promote new products and new exporters as well as to consolidate the existing Indian exports markets. The activities supported under the MAI scheme include organising/participating in Fairs, Exhibitions and Buyer Seller Meets  abroad.  Pharmaceuticals  Export  Promotion  Council  of  India  (Pharmexcil)  under Department of Commerce organizes export promotion activities including business delegations to different foreign regions such as ASEAN, Africa, CIS, LAC and Oceania countries and also participates in the prominent pharma events worldwide. The participation in the prominent events enables exporters to showcase their products and services to the potential buyers and helps in promotion of export of generic drugs. The business delegations to foreign regions provide an opportunity to interact with the Food and Drug authorities in these countries thus enabling  networking  and  facilitating  discussion  on  fast  tracking  of  registration  of  Indian products. There is already existing arrangement with some of the countries for fast tracking of approvals for Indian pharma products under FTAs such as with Singapore, UAE and Australia. Indian is also negotiating fast track approval for Indian pharma products with EU, UK and Canada under FTA discussions.

- (d):      As per Department of Commerce, the Government has introduced a policy of track and trace system to ensure the authenticity of the exported finished pharmaceutical products. Under the present system, the barcoding is mandatory on secondary and tertiary packages of export consignments.

As per Ministry of  Health  and  Family  Welfare,  they  have  taken  various  regulatory measures to ensure the quality of medicines in the country: -

- (i)            The  Drugs  and  Cosmetics  Act,  1940  was  amended  under  Drugs  &  Cosmetics (Amendment)  Act  2008  to  provide  stringent  penalties  for  manufacture  of  spurious  and adulterated drugs. Certain offences have also been made cognizable and non-bailable.
- (ii)      The Drugs and Cosmetics Rules, 1945 have been amended making it mandatory that before the grant of manufacturing license, the manufacturing establishment is to be inspected jointly by the Drugs Inspectors of Central Government and State Government.
- (iii)      The Drugs and Cosmetics Rules, 1945 have been amended, making it mandatory that the applicants shall submit evidence of stability, safety of excipients etc. to the State Licensing Authority before grant of manufacturing license by the Authority.
- (iv)      CDSCO coordinates activities of State Drug Control Organisations and provides expert advice  through  the  Drugs  Consultative  Committee  (DCC)  meetings  held  with  State  Drugs Controllers for uniformity in administration of the Drugs and Cosmetics Act.

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