Lok Sabha Question No. 1729 (UNSTARRED), answered on 2022-12-16
Subject: Life Saving Drugs
Ministry: CHEMICALS AND FERTILIZERS
Asked by: Mahabali Singh, Khagen Murmu

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

LOK SABHA UNSTARRED QUESTION No. 1729 TO BE ANSWERED ON THE 16 th  DECEMBER, 2022

## Life Saving Drugs

## †1729. SHRI MAHABALI SINGH: SHRI KHAGEN MURMU:

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

- (a) whether life saving drugs have been listed by the Government in the country and if so, the details thereof and if not, the reasons therefor;
- (b)  whether the Government has taken any specific steps to promote the production of life saving drugs in the country;
- (c) whether the Government is dependent on other countries in respect of life saving drugs; and (d) if so, the details thereof?

## ANSWER

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

(a):  The  Ministry  of  Health  &  Family  Welfare  publishes  the  National  List  of  Essential Medicines (NLEM). Life-saving drugs are not specifically mentioned in the NLEM.

The  National  Pharmaceutical  Pricing  Authority  (NPPA)  under  the  Department  of Pharmaceuticals, notifies the above list of essential medicines as the Schedule -I of the Drugs (Price Control) Order  and fixes the ceiling price of these scheduled medicines. NPPA has fixed ceiling  prices  of  890  scheduled  formulations  under  NLEM  2015.  The  formulations  under Schedule-I are mentioned according to their therapeutic category.

Further, Ministry of Health & Family Welfare notified the National List of Essential Medicines (NLEM) 2022 on 13.09.2022. Accordingly, the  Department  of  Pharmaceuticals  (DoP)  has notified Revised Schedule I of DPCO 2013 on the basis of NLEM 2022 vide SO No. 5249 (E) dated 11.11.2022.

(b) to (d):   The Department of Pharmaceuticals implements three Production Linked Incentive (PLI) schemes

-  Under PLI scheme for Bulk Drugs (Active Pharmaceutical Ingredients, Key Starting Materials and Drug Intermediates), domestic production of 41 identified bulk drugs used in the manufacture of critical formulations / medicines under different therapeutic categories is being promoted.
-  PLI Scheme for Pharmaceuticals intends to encourage domestic production of high value drug formulations and bulk drugs.
-  The Department also implements the scheme for promotion of three bulk drug parks in which  crucial  raw  materials  will  be  manufactured  for  subsequent  use  in  drug formulations.
-  Details of all these three schemes are available on the website of the Department of Pharmaceuticals i.e. http://pharmaceuticals.gov.in.

Further, as per information received from Central Drugs Standard Control Organisation (CDSCO) under the Ministry of Health & Family Welfare, CDSCO regulates quality, safety, and efficacy of the drugs, medical devices and cosmetics under the provisions of Drugs & Cosmetic Act, 1940 & Rules, made there under. However, various regulatory measures have been taken to streamline the approval of new drugs including new anticancer drugs as under:

-  New Drug and Clinical Trial Rules, 2019 have been notified vide G.S.R 227 (E) Dated 19/03/2019, which contain various provisions for improving transparency, accountability & predictability of approval process and also to promote research and development of new drugs leading to increased access to new drugs.  The key provisions are as follows:
- o Disposal  of  clinical  trial  and  new  drug  applications  by  way  of  approval  or rejection or seeking further information within a period of 90 working days.
- o In case of application to conduct clinical trial of a new drug or investigational new  drug  as  part  of  drug  discovery,  research  and  manufacture  in  India  the application is to be disposed of within a period of 30 working days, in case of no communication from CDSCO, the application will be deemed to have been approved.
- o In case of application to conduct clinical trial of a new drug which is already approved outside India, the application is to be disposed of within a period of 90 working days.
- o Accelerated/ expedited approval process in certain situation like unmet need, orphan drugs for rare diseases etc.
- o Provisions for pre-submission and post-submission meetings of the applicants with CDSCO for formal discussion and decision about case specific regulatory pathway.
- o Provision for post-trial access of the investigational products for clinical trial participants in case there is no other alternative therapy available.

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