Lok Sabha Question No. 364 (STARRED), answered on 2024-12-20
Subject: Generic Medicines
Ministry: CHEMICALS AND FERTILIZERS
Asked by: Shri Shyamkumar Daulat Barve

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

LOK SABHA STARRED QUESTION No 364 TO BE ANSWERED ON THE 20 th  DECEMBER, 2024

## Generic Medicines

## †*364. Shri Shyamkumar Daulat Barve:

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

- (a) whether generic medicines manufactured by pharmaceutical companies are being sold by chemists with the claim to be ethical, if so, the details thereof;
- (b) whether the Government has developed any mechanism/systems to make the patients aware about the generic and ethical medicines, if so, the details thereof;
- (c)  whether  the  Government  has  permitted  the  pharmaceutical  companies  to  re-patent  any generic composition, if so, the details thereof; and

(d) whether the Government is aware that pharmaceutical companies get in touch with doctors and  Registered  Medical  Practitioners  (RMPs)  of  Government  hospitals  through  medical representatives in order to promote their brand aggressively and to get it prescribed by the doctor, if so, the details thereof?

## ANSWER

THE MINISTER IN THE MINISTRY OF CHEMICALS & FERTILIZERS (SHRI JAGAT PRAKASH NADDA)

(a) to (d):        A statement is laid on the Table of the House.

## STATEMENT  REFERRED  TO  IN  REPLY  TO  THE  LOK  SABHA  STARRED QUESTION NO. *364 (4 TH  POSITION) FOR ANSWER ON 20.12.2024 RAISED BY SHRI SHYAMKUMAR DAULAT BARVE REGARDING 'GENERIC MEDICINES'

- (a): Yes. 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 AushadhiKendras (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 types of medicines and 300 surgicals/devices have been brought under the product basket covering all  major  therapeutic  groups  such  as  Cardiovascular,  Anti-cancers,  Anti-diabetics,  Antiinfectives, 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 AushadhiKendras spread across the country. In last 10 years, sales of medicines worth Rs. 6462.00 crore have been made through JAKs, which has led to estimated savings of Rs. 30,000 crore to the citizens as compared to the branded.
- (b):  Government  is  spreading  awareness  about  the  features  of  PMBJP  and  benefits  of  Jan Aushadhi  generic  medicines  through  various  types  of  advertisements  such  as  Print  Media, Radio advertisements, TV advertisements, Cinema Advertisements and Outdoor publicity like Hoardings, Bus Queue Shelter branding, Bus branding, Auto wrapping, etc. In addition to this, Government is also educating the public about the benefits of Jan Aushadhi generic medicines through social media platforms like Facebook, Twitter, Instagram, YouTube, etc. regularly.
- (c): As per the information provided by Department for Promotion of Industry & Internal Trade (DPIIT), Ministry of Commerce& Industry, under the provisions in the Patents Act,1970 (as amended), Patent is granted for an invention in all fields of technologies and the term of the patent is 20 years from date of filing of the application on the said technology. There is no statutory provision to re-patent a generic composition.
- (d): To regulate the interaction betweenDoctors/Registered Medical Practitioners (RMPs) of Government hospitals and Medical Representatives, Department of Pharmaceuticals notified Uniform Code of Pharmaceuticals Marketing Practices (UCPMP), 2024 on 12.03.2024. The code allows promotion of all informational and persuasive activities by  manufacturers and distributors, the effect of which is to induce the prescription, supply, purchase and/or use of medical drugs as per the 'Ethical Criteria for Medicinal Drug Promotion' endorsed by the World Health  Assembly  in  1988.  Further,  the  code  delineates  permissible  and  non-permissible business  expenditure  for  ethically  promoting  drugs  and  addressing  complaints  regarding unethical marketing practices by pharmaceutical companies. It governs the interaction between the Pharmaceutical Industry and healthcare practitioners, wherein expenditure is permissible to be incurred on legitimate business activities such as honorarium payments to speakers, and provision of free samples to healthcare practitioners as prescribed in the UCPMP 2024. Further, The Indian Medical Council (Professional Conduct, Etiquette and Ethics) Regulations, 2002 formed  under  Indian  Medical  Council  Act,  1956  (102  of  1956), provides  for  conduct  for doctors and professional association of doctors in their relationship with pharmaceutical and allied health industry.

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