Lok Sabha Question No. 715 (UNSTARRED), answered on 2025-02-07
Subject: Production of Nafithromycin
Ministry: CHEMICALS AND FERTILIZERS
Asked by: Shri Vishweshwar Hegde Kageri, Shri Chavda Vinod Lakhamshi, Shri Pratap Chandra Sarangi, Shri Khagen Murmu, Dr. Rajesh Mishra, Shri Balabhadra Majhi, Shri Anurag Sharma, Shri Praveen Patel

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

LOK SABHA UNSTARRED QUESTION No. 715 TO BE ANSWERED ON THE 07 TH  FEBRUARY 2025

## Production of Nafithromycin

715. Shri Khagen Murmu:

Shri Chavda Vinod Lakhamshi:

Dr. Rajesh Mishra:

Shri Vishweshwar Hegde Kageri:

Shri Praveen Patel:

Shri Pratap Chandra Sarangi:

Shri Anurag Sharma:

Shri Balabhadra Majhi:

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

- (a) the manner in which launch of Nafithromycin is aligned with India's long-term strategy to become self-reliant in the production of essential medicines and reduce dependence on imports;
- (b) whether the Government is making any efforts to promote the production and distribution of Nafithromycin within the Country;
- (c) if so, the details thereof; and
- (d)  the  comparison  between  Nafithromycin  and  other  antibiotics  in  terms  of  effectiveness, safety and side effects especially in the treatment of resistant bacterial infections?

## ANSWER

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

- (a): Based on non-clinical and clinical data including results of comparative clinical trial with Moxiflioxacin and the recommendations of the Subject Expert Committee (Investigational New Drugs),  on  1 st January  2025,  Nafithromycin  tablet  400  mg  has  been  approved  under  the provisions of the New Drugs and Clinical Trials Rules, 2019 for manufacturing in the country for  treatment of  adults (above 18  years old) with community acquired bacterial pneumonia (CABP), for supply only to medical colleges,  tertiary care hospitals or district hospitals. This is in line with India's vision of becoming Atmanirbhar.
- (b) and (c): With the objective of enhancing India's manufacturing capabilities by increasing investment and production in the pharmaceutical sector, the Department of Pharmaceuticals is implementing the Production Linked Incentive (PLI) Scheme for Pharmaceuticals with total financial outlay of ₹15,000 crore with scheme tenure till the financial year 2027-28. Under the scheme, 55 selected applicants are eligible for production linked financial incentive for the manufacturing  of  identified  products  under  various  product  categories,  including  patented drugs, for a period of six years. As a patented drug, Nafithromycin is eligible for incentives at the rate of 10% on sales.

(d): Nafithromycin is a novel macrolide specifically designed for the treatment of CABP. It offers  several  key  advantages  in  terms  of  effectiveness,  safety  and  side-effect  profile, particularly in addressing resistant bacterial infections, details of which are as under:

- (i) Effectiveness: Nafithromycin has a broad spectrum of activity, making it effective against all major CABP pathogens. Its bactericidal activity, high lung penetration and prolonged post-antibiotic effect ensure effective pathogen clearance and enable an  ultra-short,  three-day,  once-daily  dosing  regimen,  which  improves  patient compliance and outcomes.
- (ii) Safety and side effects: Nafithromycin stands out as a safer option compared to other antibiotics. Unlike fluoroquinolones, which carry risks of severe side effects such as tendonitis, neuropathy and cardiac issues, Nafithromycin is well-tolerated across age groups, including elderly patients, the key population vulnerable to CABP. It does not  need  a  combination  drug  treatment,  providing  a  safer  alternative  therapy  for CABP.  Further,  as  an  alternative  to  fluoroquinolones,  Nafithromycin  avoids concerns  regarding  selection  of  resistant Mycobacterium  tuberculosis bacterial infections.

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