Lok Sabha Question No. 4365 (UNSTARRED), answered on 2024-12-20
Subject: Domestic Production of Generic Medicines
Ministry: CHEMICALS AND FERTILIZERS
Asked by: Shri Selvam G

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

LOK SABHA UNSTARRED QUESTION No. 4365 TO BE ANSWERED ON THE 20 th  DECEMBER, 2024

## Domestic Production of Generic Medicines

## 4365. Shri Selvam G:

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

- (a) the details on the current production levels of generic medicines in the country;
- (b) the percentage of the total pharmaceutical market in the country is comprised of generic medicines, and manner in which the Government plan to increase this percentage to improve affordability;
- (c)  the  incentives  or  schemes  that  are  in  place  to  support  the  establishment  and  growth  of manufacturing units dedicated to producing generic medicines;
- (d) the data on the estimated savings to patients as a result of increased generic medicine usage, particularly for chronic diseases; and
- (e) the percentage of domestically produced generic medicines is exported, and the manner in which the Government balances domestic demand with export opportunities?

## ANSWER

## THE MINISTER OF STATE IN THE MINISTRY OF CHEMICALS & FERTILIZERS (SMT. ANUPRIYA PATEL)

(a) to (e): India's pharmaceutical market for FY 2023-24 is valued at USD 50 billion with domestic consumption valued at USD 23.5 billion and export valued at USD 26.5 billion. India's pharma industry is considered to be the world's third largest by volume and 14th in terms of value of production. With an extremely diversified product base covering generic drugs,  bulk  drugs,  over-the-counter  drugs,  vaccines,  biosimilars,  and  biologics,  the  Indian pharmaceutical  industry  has  a  strong  presence  at  the  global  level.  According  to  National Accounts Statistics 2024, published by the Ministry of Statistics and Programme Implementation,  total  output  for  industry  i.e.  Pharmaceuticals,  medicinal  and  botanical products is Rs. 4,56,246 crores for FY 2022-23 at constant prices, of which value added is Rs. 1,75,583 crores. The production level of generic medicines is not available separately.

The Government launched Pradhan Mantri Bhartiya Janaushadhi Pariyojana (PMBJP) with an objective of making quality generic medicines available at affordable prices to all. Under  this  scheme,  dedicated  outlets  known  as  Jan  Aushadhi  Kendras  (JAKs)  are  opened across the country to provide medicines at 50%-80% cheaper rates than branded medicines. A total of 14,320 JAKs have been opened across the country till 30.11.2024. Under PMBJP, 2047 medicines  and  300  surgicals/devices  are  part  of  the  product  basket,  covering  all  major therapeutic groups such as cardiovascular drugs, anti-cancers, anti-diabetics, anti-infectives, anti-allergic, gastro-intestinal medicines, nutraceuticals, etc. It is estimated that on a daily basis 10-12 lakhs consumers buy medicines from more than 14300 Jan Aushadhi Kendras spread across the country. In last 10 years, sales of medicines worth Rs. 6,462 crore have been made through JAKs. This has led to estimated savings of Rs. 30,000 crore for citizens, compared with spending on branded medicines.

Also,  Government  of  India  has  taken  several  measures  to  encourage  domestic manufacturing  in  Pharmaceutical  Sector  to  reduce  import  dependence,  boost  domestic manufacturing and attract large investments. The Production Linked Incentive (PLI) scheme for Pharmaceuticals has been launched in FY 2020-21, with a financial outlay of Rs. 15,000 crores and the production tenure from FY 2022- 2023 to FY 2027-28, provides for financial incentive  to  55  selected  applicants  for  manufacturing  of  identified  products  under  three categories  for  a  period  of  six  years.  Under  this  scheme,  apart  from  patented  drugs, biopharmaceuticals, bulk drugs,  In  Vitro Diagnostic (IVD) devices and  excipients (used in production of medicines), generic medicines of various categories such as -  complex generics, auto immune drugs, anti-cancer drugs, anti-diabetic drugs, anti-infective drugs, cardiovascular drugs, psychotropic drugs and anti-retroviral drugs are produced and incentivised under the scheme.

National  Pharmaceutical  Pricing  Authority  (NPPA)  is  an  attached  office  of  the Department of Pharmaceuticals and is entrusted to implement and enforce the provisions of the Drugs Price Control Order (DPCO), 2013, in accordance with the powers delegated to it. NPPA is entrusted with the function of monitoring the availability of drugs in the country, identify shortages, if any, and to take remedial steps, in accordance with the provisions of the Drugs (Prices Control) Order, 2013.

*******