Lok Sabha Question No. 786 (UNSTARRED), answered on 2025-02-07
Subject: Production of Indigenous Antibiotic
Ministry: CHEMICALS AND FERTILIZERS
Asked by: Shri P P Chaudhary

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

LOK SABHA UNSTARRED QUESTION No. 786 TO BE ANSWERED ON THE 07 TH  FEBRUARY 2025

## Production of Indigenous Antibiotic

## 786. Shri P P Chaudhary:

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

- (a) the specific research and development efforts that led to the successful development of Nafithromycin, along with details of institutions and investments involved therein;
- (b) whether any clinical trials have been conducted to establish Nafithromycin's effectiveness against  resistant  bacterial  infections,  if  so,  the  findings  thereof  compared  to  existing antibiotics;
- (c)  whether  any  plan  has  been  formulated  for  domestic  production  and  pricing  of
- Nafithromycin to ensure its affordability and accessibility, if so, the details thereof; and (d) whether any assessment has been made regarding potential reduction in antibiotic imports through indigenous production of Nafithromycin, if so, the details thereof?

## ANSWER

## THE  MINISTER  OF  STATE  IN  THE  MINISTRY  OF  CHEMICALS  AND FERTILIZERS

(SMT. ANUPRIYA PATEL)

(a) and (b): Nafithromycin has been developed by Wockhardt Group. The Phase III trial for this  antibiotic  was  partly  supported  by  the  Biotechnology  Industry  Research  Assistance Council (BIRAC), a public sector enterprise under the Department of Biotechnology. BIRAC committed financial support to the tune of Rs. 9.18 crore.

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.

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.

(c): As per the provisions of the Drugs and Cosmetics Act, 1940, manufacture of a drug is permissible only under and in accordance with conditions of a licence issued under the Act by  the  licensing  authority.  To  promote  the  manufacture  of  pharmaceuticals  in  India,  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 made under the scheme.

The prices of drugs are regulated by the Drugs (Prices Control) Order, 2013, issued by the Government  under  the  Essential Commodities  Act,  1955,  pursuant to the National Pharmaceuticals  Pricing  Policy,  2012.  Under  the  said  Order,  the  manufacturer  of  a  nonscheduled formulation is at liberty to fix the maximum retail price of the formulation launched by it, subject to the stipulation that the manufacturer shall not increase the maximum retail price of the formulation by more than 10% during preceding 12 months. As a non-scheduled drug, the pricing of Nafithromycin is governed by the aforesaid provisions.

(d): No, sir.

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