Lok Sabha Question No. 3938 (UNSTARRED), answered on 2018-03-20
Subject: Life Saving Drugs
Ministry: CHEMICALS AND FERTILIZERS
Asked by: ALOK SANJAR

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

LOK SABHA UNSTARRED QUESTION NO. 3938 TO BE ANSWERED ON 20 th  March, 2018

## Life Saving Drugs

†3938. SHRI ALOK SANJAR:

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

- (a) whether life  saving  drugs  are  being  sold  at  high  prices  due  to  their  scarcity  in  the country;
- (b) if so, the details thereof and the reaction of the Government thereto;
- (c) whether the Government receives updates from time to time regarding the stock of life saving drugs;
- (d) if so, the details thereof and the estimated stock thereof in the country; and
- (e) whether any measures are being taken by the Government for research regarding new life saving drugs?

## ANSWER

## MINISTER  OF  STATE  IN  THE  MINISTRY  OF  ROAD  TRANSPORT  AND  HIGHWAYS; MINISTRY  OF  SHIPPING  AND  MINISTRY  OF  CHEMICALS  AND  FERTILIZERS  (SHRI MANSUKH L. MANDAVIYA)

(a): The  medicines  which  are  covered  under  the  National  List  of  Essential  Medicines (NLEM) announced by Ministry of health & Family Welfare are included in Schedule - I of Drugs (Prices Control) Order, 2013 (DPCO, 2013) and the ceiling price of these medicines are being fixed by the Government. As such no report regarding selling of   drugs at high prices  due  to  scarcity  in  the  country  has  been  received  in  NPPA  recently.  Further,  the production  and  availability  of  scheduled      medicines  is  regularly  monitored  by  the  NPPA mainly through Drugs Control Administration of State Governments. Whenever shortage is reported by the State Drug Controllers or when the matter comes to the notice of NPPA, remedial steps are taken for ensuring availability of drug by impressing upon manufacturers to rush the stocks to the places of shortage.

(b): In view of reply to (a) above, occasion does not arise.

(c) & (d): As provided in the DPCO, 2013, the manufacturer of scheduled formulations are  required  to  submit  quarterly  return  (Form  III)  of  the  production  /  import  of  scheduled formulation  and   the  bulk  drug/active  pharmaceutical  ingredients  used  in  the  formulations specified  in  Schedule  -  I  of  the  DPCO,  2013.  National  Pharmaceutical  Pricing  Authority (NPPA) has developed software, namely Integrated Pharmaceuticals Database Management System (IPDMS) for enabling on-line submission of the data by manufacturer in prescribed Form-III of DPCO, 2013 to NPPA.  Whenever a shortage is reported from any part of the country, the Government ensures that the drug is made available to that part of the  country.  The  data  on  the  estimated  stock  in  the  country  is  not  maintained  by  the Department.

(e): The Government is providing financial support for research and development through Drugs & Pharmaceuticals Research Programme (DPRP) run by the Department of Science & Technology. The companies undertaking Research & Development activities are provided income tax benefits. Further, the Drugs (Prices Control) Order, 2013, Para-32(iii) provides exemptions  from  price  control  to  a  manufacturer  producing  a  new  drug  involving  a  new delivery system developed through indigenous Research and Development for a period of five years from the date of its market approval in India.

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